human drugs list - nda

150
NATIONAL_DRUG_REGISTER_OF_UGAND LICENCE HOLDER DRUG NAME REG NO GENERIC NAME MANUFACTURER STRENGTH DOSAGE FORM PACK SIZES CTRY OF MAN LTR DATE INSPECTED RECIEPT NO s_GUID INDOCO REMEDIES LTD ERYTHROMYCIN STEARATE /06/06 ERYTHROMYCIN STEARATE INDOCO REMEDIES LTD,AT:L-14,VERNA INDUSTRIAL AREA, 250MG TABLET 1*10*10 & 1*1000 INDIA TATA (U) LTD 10/05/2010 RT29332 & JV11/148 DATED 16/09/11 {1ED54771-313D-438EB9B8- F8DC9A9CE3F0} Ranbaxy Laboratories Ltd. Coviro-LS 30 4570/06/04 Lamivudine + Stavudine RANBAXY LABORATORIES LTD, PAONTA SAHIB DIST. SIRMOUR H.P 173 025 MFG. LIC: MNB/95/2 150mg + 30mg Tablets 1* 60 HDPE India SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED 12/09/2011 {91A149EC-24ED- 4A68-AB75- 3606B53C0EE8} AEGIS LTD FLUCOZAL 0011/06/97 FLUCONAZOLE AEGIS LTD 17 ATHINON STREET ERGATES IND AREA 200MG CAPSULE 10 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED 02/08/11 {D3F3DE12-3236- 4FD9-9DD9- 3DFD9AA0BA70} AEGIS LTD FLUCOZAL 0012/06/97 FLUCONAZOLE AEGIS LTD 17 ATHINON STREET ERGATES IND AREA 100MG CAPSULE 10 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED 02/08/11 {C20E1A37-B6A2- 42BB-80E6- 42ED7AFEC2E7} AEGIS LTD VIRUCID 0013/06/97 ACYCLOVIR AEGIS LTD 17 ATHINON STREET ERGATES IND AREA 200MG TABLET 1 * 25 IN BOTTLE, 1 * 3 * 10 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED 02/08/11 {4360E013-7CF8-4636- BCD1- 09B0229FCE9C} ALCON PHARMACEUTICALS LTD TOBREX 0014/21/97 TOBRAMYCIN ALCON COUVREUR NV B-2870 PUURS BELGIUM 0.3%W/V EYE DROP 5ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {8C82BE51-AC64- 44EB-A5C1- B0598717BB99} ALCON PHARMACEUTICALS LTD PROVISC 0015/21/97 SODIUM HYALURONATE ALCON COUVREUR NV B-2870 PUURS BELGIUM 1%W/V EYE DROP 0.45ML IN 10ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {99FB1304-2B44-4525- 9838-E9D53C3CC5F2} ALCON PHARMACEUTICALS LTD MAXITROL 0016/21/97 DEXAMETHASONE NEOMYCIN SULPHATE POLYMYXIN B SULPHATE ALCON COUVREUR NV B-2870 PUURS BELGIUM 0.1% 3,500I.U/ML 6,000I.U/ML EYE DROP 5ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {0E8A7EAE-B06D- 4EF2-8032- 357D9FF0E2AD} ALCON PHARMACEUTICALS LTD ISOPTO CARPINE 4% 0018/21/97 PILOCARPINE ALCON COUVREUR NV B-2870 PUURS BELGIUM 4%W/V EYE DROP 15ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {21FE401A-2826-4BD096E0-079F6646C6A5} ALCON PHARMACEUTICALS LTD MAXIDEX 0019/21/97 DEXAMETHASONE ALCON COUVREUR NV B-2870 PUURS BELGIUM 0.1%W/V EYE DROP 5ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {FB2E232C-7EB2- 4E67-9A55- C3C2E2405AE2} ALCON PHARMACEUTICALS LTD BETOPTIC 0022/21/97 BETAXOLOL ALCON COUVREUR NV B-2870 PUURS BELGIUM 0.5%W/V EYE DROP 5ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {FC0BEF35-6195-435AA610-E5F7D9965393} ALCON PHARMACEUTICALS LTD ISOPTO CARPINE 2% 0023/21/97 PILOCARPINE ALCON COUVREUR NV B-2870 PUURS BELGIUM 2%W/V EYE DROP 15ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {105D4075-3A7C- 48DE-9160- C25F44CFEF14} ALCON PHARMACEUTICALS LTD TOBRADEX 0024/21/97 TOBRAMYCIN DEXAMETHASONE ALCON COUVREUR NV B-2870 PUURS BELGIUM 0.3% 0.1% EYE DROP 5ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {092257DE-51FF-4AF09854-1A8DD9818678} ALCON PHARMACEUTICALS LTD MAXITROL 0027/21/97 DEXAMETHASONE NEOMYCIN SULPHATE POLYMYXIN B SULPHATE ALCON COUVREUR NV B-2870 PUURS BELGIUM 0.1%W/W, 0.1%W/W 6000I.U EYE OINTMENT 3.5GM BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {4B51A6A4-E9E0- 42CF-96A5- 854D576FA52F} ALCON PHARMACEUTICALS LTD TEARS NATURALE II 0028/21/97 NATURAL TEARS ALCON COUVREUR NV B-2870 PUURS BELGIUM EYE DROP 15ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {EB2743F4-A182-40D4B357-F9B87D94FDBC} ALCON PHARMACEUTICALS LTD ISOPTO ATROPINE 1% 0030/21/97 ATROPINE SULPHATE ALCON COUVREUR NV B-2870 PUURS BELGIUM 1%W/V EYE DROP 5ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {8AEEF648-B041-44FA 9066-ACAD2C67243C} ALCON PHARMACEUTICALS LTD CILOXAN 0033/21/97 CIPROFLOXACIN ALCON COUVREUR NV B-2870 PUURS BELGIUM 0.3%W/V EYE DROP 5ML BELGIUM KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {ED6DA300-0886-489F9F3C-C85F74F54DBC} ALCON PHARMACEUTICALS LTD ECONOPRED PLUS 0037/21/97 PREDNISOLONE ACETATE ALCON (PUETRO RICO) LABORATORIES INC USA 1% /W EYE SUSPENSION 5ML USA KARURI PHARMA. LTD RT27350 DATED 27/06/2011 RT28865 DATED 29/08/2011 {137B7344-A1DB-403D B191-83AEEEBFE955} Page 1

Upload: waswahans495

Post on 10-Oct-2014

1.979 views

Category:

Documents


16 download

TRANSCRIPT

Page 1: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

LICENCE HOLDER DRUG NAME REG NO GENERIC NAME MANUFACTURER STRENGTH DOSAGE FORM PACK SIZES CTRY OF MAN LTR DATE INSPECTED RECIEPT NO s_GUID

INDOCO REMEDIES LTD

ERYTHROMYCIN STEARATE /06/06 ERYTHROMYCIN

STEARATE

INDOCO REMEDIES LTD,AT:L-14,VERNA INDUSTRIAL AREA,

250MG TABLET 1*10*10 & 1*1000 INDIA TATA (U) LTD 10/05/2010 RT29332 & JV11/148 DATED 16/09/11

{1ED54771-313D-438E-B9B8-

F8DC9A9CE3F0}

Ranbaxy Laboratories Ltd. Coviro-LS 30 4570/06/04 Lamivudine +

Stavudine

RANBAXY LABORATORIES LTD, PAONTA SAHIB DIST.

SIRMOUR H.P 173 025 MFG. LIC:

MNB/95/2

150mg + 30mg Tablets 1* 60 HDPE India SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011

{91A149EC-24ED-4A68-AB75-

3606B53C0EE8}

AEGIS LTD FLUCOZAL 0011/06/97 FLUCONAZOLEAEGIS LTD 17

ATHINON STREET ERGATES IND AREA

200MG CAPSULE 10 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED

02/08/11

{D3F3DE12-3236-4FD9-9DD9-

3DFD9AA0BA70}

AEGIS LTD FLUCOZAL 0012/06/97 FLUCONAZOLEAEGIS LTD 17

ATHINON STREET ERGATES IND AREA

100MG CAPSULE 10 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED

02/08/11

{C20E1A37-B6A2-42BB-80E6-

42ED7AFEC2E7}

AEGIS LTD VIRUCID 0013/06/97 ACYCLOVIRAEGIS LTD 17

ATHINON STREET ERGATES IND AREA

200MG TABLET 1 * 25 IN BOTTLE, 1 * 3 * 10 BLISTER CYPRUS SURGIPHARM (U)

LTD 01/07/11 RT28278 DATED 02/08/11

{4360E013-7CF8-4636-BCD1-

09B0229FCE9C}

ALCON PHARMACEUTICALS

LTDTOBREX 0014/21/97 TOBRAMYCIN

ALCON COUVREUR NV B-2870 PUURS

BELGIUM0.3%W/V EYE DROP 5ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011

{8C82BE51-AC64-44EB-A5C1-

B0598717BB99}ALCON

PHARMACEUTICALS LTD

PROVISC 0015/21/97 SODIUM HYALURONATE

ALCON COUVREUR NV B-2870 PUURS

BELGIUM1%W/V EYE DROP 0.45ML IN 10ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011{99FB1304-2B44-4525-9838-E9D53C3CC5F2}

ALCON PHARMACEUTICALS

LTDMAXITROL 0016/21/97

DEXAMETHASONE NEOMYCIN SULPHATE

POLYMYXIN B SULPHATE

ALCON COUVREUR NV B-2870 PUURS

BELGIUM

0.1% 3,500I.U/ML 6,000I.U/ML EYE DROP 5ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011

{0E8A7EAE-B06D-4EF2-8032-

357D9FF0E2AD}

ALCON PHARMACEUTICALS

LTDISOPTO CARPINE 4% 0018/21/97 PILOCARPINE

ALCON COUVREUR NV B-2870 PUURS

BELGIUM4%W/V EYE DROP 15ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011{21FE401A-2826-4BD0-96E0-079F6646C6A5}

ALCON PHARMACEUTICALS

LTDMAXIDEX 0019/21/97 DEXAMETHASONE

ALCON COUVREUR NV B-2870 PUURS

BELGIUM0.1%W/V EYE DROP 5ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011

{FB2E232C-7EB2-4E67-9A55-

C3C2E2405AE2}ALCON

PHARMACEUTICALS LTD

BETOPTIC 0022/21/97 BETAXOLOLALCON COUVREUR NV B-2870 PUURS

BELGIUM 0.5%W/V EYE DROP 5ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011{FC0BEF35-6195-435A-A610-E5F7D9965393}

ALCON PHARMACEUTICALS

LTDISOPTO CARPINE 2% 0023/21/97 PILOCARPINE

ALCON COUVREUR NV B-2870 PUURS

BELGIUM 2%W/V EYE DROP 15ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011

{105D4075-3A7C-48DE-9160-

C25F44CFEF14}ALCON

PHARMACEUTICALS LTD

TOBRADEX 0024/21/97 TOBRAMYCIN DEXAMETHASONE

ALCON COUVREUR NV B-2870 PUURS

BELGIUM0.3% 0.1% EYE DROP 5ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011{092257DE-51FF-4AF0-9854-1A8DD9818678}

ALCON PHARMACEUTICALS

LTDMAXITROL 0027/21/97

DEXAMETHASONE NEOMYCIN SULPHATE

POLYMYXIN B SULPHATE

ALCON COUVREUR NV B-2870 PUURS

BELGIUM

0.1%W/W, 0.1%W/W 6000I.U EYE OINTMENT 3.5GM BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011

{4B51A6A4-E9E0-42CF-96A5-

854D576FA52F}

ALCON PHARMACEUTICALS

LTDTEARS NATURALE II 0028/21/97 NATURAL TEARS

ALCON COUVREUR NV B-2870 PUURS

BELGIUMEYE DROP 15ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011{EB2743F4-A182-40D4-B357-F9B87D94FDBC}

ALCON PHARMACEUTICALS

LTD

ISOPTO ATROPINE 1% 0030/21/97 ATROPINE

SULPHATE

ALCON COUVREUR NV B-2870 PUURS

BELGIUM1%W/V EYE DROP 5ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011{8AEEF648-B041-44FA9066-ACAD2C67243C}

ALCON PHARMACEUTICALS

LTDCILOXAN 0033/21/97 CIPROFLOXACIN

ALCON COUVREUR NV B-2870 PUURS

BELGIUM0.3%W/V EYE DROP 5ML BELGIUM KARURI PHARMA.

LTDRT27350 DATED

27/06/2011RT28865 DATED

29/08/2011{ED6DA300-0886-489F-9F3C-C85F74F54DBC}

ALCON PHARMACEUTICALS

LTDECONOPRED PLUS 0037/21/97 PREDNISOLONE

ACETATE

ALCON (PUETRO RICO)

LABORATORIES INC USA

1% /W EYE SUSPENSION 5ML USA KARURI PHARMA. LTD

RT27350 DATED 27/06/2011

RT28865 DATED 29/08/2011

{137B7344-A1DB-403DB191-83AEEEBFE955}

Page 1

Page 2: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

GLAXO WELLCOME (KENYA) LTD MYOLGIN CAPSULES 0045/02/97 CHLORZOXANE,

PARACETAMOL

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

250MG, 300MG CAPSULE 2 * 10 BLISTER EGYPT ERIS LTD 08/09/11 RT28825 DATED 27/08/11

{5CB21167-07CE-4EC7-B8AD-

AD9D0AFEB811}

GLAXO WELLCOME (KENYA) LTD VITAMAX 0048/27/97 z

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

CAPSULE 1 * 15BLISTER EGYPT ERIS LTD 08/09/11 RT28825 DATED 27/08/11

{F6B83BED-6869-45E1B89D-3067B727AC91}

GLAXO WELLCOME (KENYA) LTD OXYBRAL SR 0049/12/97 VINCAMINE

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

30MG CAPSULE S/R 2 * 10 BLISTER EGYPT ERIS LTD 08/09/11 RT28825 DATED 27/08/11

{ED025789-5B3E-459B-89AD-5A01407BC7B8}

AMOUN PHARMACEUTICAL

INDUSTRIES COANTINAL 0051/06/97 NIFUROXAZIDE

AMOUN PHARMACEUTICAL SAE, ELBOUR CITY

CAIRO EGYPT

200MG CAPSULE 1 * 12 BLISTER EGYPTBOOTS

PHARMACEUTICALS LTD

26/10/10 RT28284 DATED 02/08/11

{E90EDBCC-362A-48EC-8D43-

275984568B31}

GLAXO WELLCOME (KENYA) LTD GYNORYL 150MG 0054/13/97 ECONAZOLE

NITRATE

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

150MG OVULE 3 & 5 BLISTER EGYPT ERIS LTD 08/09/11 RT28825 DATED 27/08/11

{DD374161-2C6F-4477-9AA6-1BD14F201D19}

AMOUN PHARMACEUTICAL

INDUSTRIES CO LACTODEL 0061/18/97 BROMOCRIPTINE

AMOUN PHARMACEUTICAL SAE, ELBOUR CITY

CAIRO EGYPT

2.5MG TABLET 2 * 10 BLISTER EGYPTWIDE SPECTRUM ENTERPRISES (U)

LTD26/10/10 RT28284 DATED

02/08/11

{77C664ED-1A9D-4811-B52D-

DC547E193F8C}

AMOUN PHARMACEUTICAL

INDUSTRIES CONASOTAL SPRAY 0068/25/97 SODIUM

CROMOGLYCATE

AMOUN PHARMACEUTICAL SAE, ELBOUR CITY

CAIRO EGYPT

20MG/ML SPRAYS FOR NASAL USE I UNIT EGYPT

BOOTS PHARMACEUTICALS

LTD26/10/10 RT28284 DATED

02/08/11

{E50DC60D-A661-44A8-8B58-

A527B68EC35D}

BAYER AG BILTRICIDE TABLETS 0080/06/97 PRAZIQUANTEL9 BAYER AG D-5136 LEVERKUSEN 600MG TABLET 1 * 4, 1 * 10 TABS

GLASS BTL GERMANY SURGIPHARM (U) LTD

{9F76F690-AC13-47A0-8E70-32246791C7A1}

BAYER AG MYCOSPOR CREAM 0085/13/97 BIFONAZOLE BAYER AG D-5136 LEVERKUSEN 1% CREAM 15GM, 50GM GERMANY SURGIPHARM (U)

LTD

{57902F39-2234-43D7-82BD-

64DBDA7CFFF8}

BAYER AG CIPROBAY 0086/06/97 CIPROFLOXACIN BAYER AG D-5136 LEVERKUSEN 250MG TABLET 10 & 20 BLISTER GERMANY SURGIPHARM (U)

LTD

{E2FC69D8-862E-42ED-8789-

77C76DD224E8}

BAYER AG CIPROBAY 0089/06/97 CIPROFLOXACIN BAYER AG D-5136 LEVERKUSEN 500MG TABLET 10 BLISTER GERMANY SURGIPHARM (U)

LTD{AAF27A06-A309-4984-9D28-1DD3B1449C9F}

BAYER AG CIPROBAY I.V 0091/06/97 CIPROFLOXACIN BAYER AG D-5136 LEVERKUSEN 200MG/100ML INFUSIONS,LARGE

VOL. 100ML GERMANY SURGIPHARM (U) LTD

{AFDFC085-D6CF-4B3B-AF9C-

F1D28C7ECD62}

BAYER AG MYCOSPOR SOLUTION 0092/13/97 BIFONAZOLE BAYER AG D-5136

LEVERKUSENSOLUTION FOR

EXTERNAL 15ML, 50ML GERMANY SURGIPHARM (U) LTD

{4C1A8AF3-3B02-4237-B456-5C1189C41418}

BAYER AG ADALAT RETARD 0098/12/97 NIFEDIPINE BAYER AG D-5136 LEVERKUSEN 20MG TABLET S/R 6 * 10 BLISTER GERMANY SURGIPHARM (U)

LTD

{9F477F7C-D0D1-4CAD-9526-

3F64C55ECC57}

BAYER AG GLUCOBAY 50 0101/18/97 ACARBOSE BAYER AG D-5136 LEVERKUSEN 50MG TABLET 15* 6 BLISTER GERMANY SURGIPHARM (U)

LTD

{FA6E3783-CB3D-4F5E-928D-

09A52FB4CC27}

BAYER AG GLUCOBAY 100 0103/18/97 ACARBOSE BAYER AG D-5136 LEVERKUSEN 100MG TABLET 15 * 6 BLISTER GERMANY SURGIPHARM (U)

LTD

{A5D22DDA-1654-4937-B00E-

627FA4D11E04}

BETA HEALTHCARE INTERNATIONAL LTD ACTION TABLETS 0139/02/97

ASPIRIN CAFFEIN

PARACETAMOL

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BOX

600MG 50MG 400MG TABLET 12 ,100, 110 & 200 KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11

{0AD40EEF-3F8C-4B9A-9B0A-

8E7BC205F2D6}

BETA HEALTHCARE INTERNATIONAL LTD ASPIRIN TABLETS 0142/02/97 ACETYLSALICYCLIC

ACID

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BOX

300MG TABLET 200,500,1000 KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11{69426278-184A-4ED0-A320-9C5E87669F27}

BETA HEALCARE INTERNATIONAL LTD ASPRO TABLETS 0143/02/97 ACETYLSALICYCLIC

ACID

BETA HEALCARE INTERNATIONAL LTD PLOT NO. 209/796 B

324MG TABLET 2*15, 2*100, 200 KENYA BETA HEALTHCARE (U) LTD. 04/02/09 RT27853 DATED

15/07/11

{7379D96B-26D8-4113-BB91-

FADE8ECC6CF6}

Page 2

Page 3: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

BETA HEALTHCARE INTERNATIONAL LTD OPELE LOTION 0145/13/97 BENZYL BENZOATE

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BO

25%W/V LOTION 50ML KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11{E061730B-BE00-48EE81B0-FB90BEC032F7}

BETA HEALCARE INTERNATIONAL LTD

GOODMORNING LUNG TONIC 0146/25/97 MULTINGREDIENT

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BO

MULTINGREDIENT SYRUP 50ML KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11{CC014F74-0BB1-4014-9E25-D6F8B1893B38}

CADILA PHARMACEUTICALS

LTD

ENVAS 10MG TABLETS 0163/12/97 ENALAPRIL MALEATE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

10MG TABLET 10*10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{2BC44A75-0C65-4DC5-BA48-

E3A32EF65D3E}

CADILA PHARMACEUTICALS

LTDENVAS 5MG TABLETS 0164/12/97 ENALAPRIL MALEATE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

5MG TABLET 10 *10STRIP INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{5EC0B6B7-BFFE-45AD-94F8-

6E52D1BF09A1}

CADILA PHARMACEUTICALS

LTDNORFEN-400 0166/06/97 NORFLOXACIN

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

400MG TABLET 10 STRIP INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{A87A7705-FE99-42C1-B313-C1CE92366D62}

CADILA PHARMACEUTICALS

LTD

CADIPHEN EXPECTORANT 0171/25/97 z

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

SYRUP 60ML &100ML INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{83AF0D10-6BFF-41FD-B6E5-

8E2166BEDDC3}

CADILA PHARMACEUTICALS

LTDAMTIBA 500 TABLET 0172/06/97 TINIDAZOLE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

500MG TABLET F/C 4 BLI INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{542995AC-A321-4C81-AAE6-FB60747429C6}

CADILA PHARMACEUTICALS

LTD

ORITAXIM 1000MG INJECTION 0174/06/97 CEFOTAXIME

SODIUM

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

1GM POWDER FOR INJECTION VIAL INDIA

KARURI PHARMACEUTICALS

LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{1F44C27B-3785-4101-AC3B-0261A9AB3E73}

CADILA PHARMACEUTICALS

LTDFLUDAC CAPSULES 0175/25/97 FLUOXETINE

HYDROCHLORIDE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

20MG CAPSULE 20 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{7437ACB6-D238-4FFE-B455-

86F0FB8326D3}

CADILA PHARMACEUTICALS

LTDCEFAMOR-250 0176/06/97 CEPHALEXIN

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

250MG CAPSULE 5*20 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{487C29A1-E074-43B2-AFA3-45ABAC5F6664}

CADILA HEALTHCARE LTD DEPIN-E RETARD 0180/12/97 NIFEDIPINE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

20MG TABLET S/R 10*10 STRIP INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{01E76495-3D56-410F-80B0-6D0644F986F8}

CADILA HEALTHCARE LTD

CATENOL-50 TABLETS 0181/12/97 ATENOLOL

CADILA HEALTHCARE

LIMITED KUNDAIM INDUSTRIAL ESTATE

50MG TABLET 10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{77E13022-28D0-4639-9D39-E8A3E5D1884C}

Page 3

Page 4: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CADILA HEALTHCARE LTD CYCLOVIR 0182/06/97 ACICLOVIR

CADILA HEALTHCARE

LIMITED KUNDAIM INDUSTRIAL ESTAT

200MG TABLET 1 * 10, 1 * 10 * 10 BLISTER INDIA ABACUS PHARMA (A)

LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{5E96661A-1CEF-4E309187-8980D0DE519C}

CADILA HEALTHCARE LTD

PIRICAM-20 CAPSULES 0183/02/97 PIROXICAM

CADILA HEALTHCARE

LIMITED KUNDAIM INDUSTRIAL

ESTATE, PONDA,GOA 403401

20MG CAPSULE 20 & 10*10 BLISTER INDIA ABACUS PHARMA (A) LTD 19/03/2009 RT28660 DATED

19/08/2011{87449892-6FB0-4893-976D-2D82F7DA892D}

CADILA HEALTHCARE LTD CIPROBID-500 0185/06/97 CIPROFLOXACIN

CADILA HEALTHCARE LTD,

KUNDAIM IND. ESTATE, PONDA,

500MG TABLET F/C 10*10 INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{13457C8B-68AB-48A4-8476-7D0354925649}

CADILA HEALTHCARE LTD CARBADAC-200 0186/05/97 CARBAMAZEPINE

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

200MG TABLET 10*10BLISTER, 1*1000 INDIA ABACUS PHARMA (A)

LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{16DAD5CE-24E6-4306-A117-

9ECE552340DD}

CADILA HEALTHCARE PVT

LTDORIPHEX CAPSULES 0187/06/97 CEPHALEXIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/24

250MG CAPSULE 10 * 10 BLISTER INDIA ABACUS PHARMA AFRICA LTD 28/10/2010 RT28660 DATED

19/08/2011

{BDFF97BE-CCE0-4A4B-B30A-

31FAF9CDF29D}

CADILA HEALTHCARE LTD LOCK-2 TABLETS 0189/17/97 CIMETIDINE

CADILA HEALTHCARE LTD,

KUNDAIM INDUSTRIAL ESTATE

P

200MG TABLET 10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{80796EF3-E242-497D-83BB-54FB33BBCCF3}

CADILA HEALTHCARE PVT

LTDORIPHEX SYRUP 0190/06/97 CEPHALEXIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/24

125MG/5ML POWDER FOR ORAL SUSPN 100ML HDPE INDIA ABACUS PHARMA

AFRICA LTD 28/10/2010 RT28660 DATED 19/08/2011

{D940506B-EE83-46F6-8425-9AA376E8C6A3}

CADILA HEALTHCARE LTD

CATENOL-100 TABLETS 0191/12/97 ATENOLOL

CADILA HEALTHCARE

LIMITED KUNDAIM INDUSTRIAL ESTATE

100MG TABLET 10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{9D43DAC4-BFF5-43E7-B21C-

37A70F0D3D4A}

CADILA HEALTHCARE PVT

LTD

CAMICIL 250MG CAPSULES 0193/06/97 AMPICILLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/24

250MG CAPSULE 10 * 10, 1000 INDIA ABACUS PHARMA AFRICA LTD 28/10/2010 RT28660 DATED

19/08/2011

{EBC8ED4C-6FC9-4EEB-8118-

FF38119E2CE2}

CADILA HEALTHCARE LTD ORIPRIM TABLET 0198/06/97 CO-TRIMOXAZOLE

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

480MG TABLET 10*10 BLISTER, 1000 HDPE INDIA ABACUS PHARMA (A)

LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{80046255-9BD1-456D-B73C-05FD0D432E87}

CADILA HEALTHCARE LTD TINIBA-500 TABLETS 0199/06/97 TINIDAZOLE

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

500MG TABLET 25*4 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{127E76BB-1A21-4207-9D19-69CC4A619FC8}

Page 4

Page 5: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CADILA HEALTHCARE LTD

CADISTIN EXPECTORANT 0201/25/97 MULTI-INGREDIENT

SAKAR HEALTHCARE PLOT NO 10/13 SARKHEJ

BAVLA RD, C

SYRUP 60ML & 100ML INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{0E0D4844-39BF-459B-9ED0-592EFC344675}

CADILA HEALTHCARE LTD

DEXONA EYE/EAR DROP 0203/21/97

DEXAMATHASONE SODIUM

PHOSPHATE/ NEOMYCIN SULPHATE

AHLCON PARENTERALS LTD,

SP-918, PHASE III, INDUSTR

0.35/ 0.1 W/V EYE DROP 2.5ML & 5ML INDIA ABACUS PHARMA (A) LTD 21/02/2011 RT28660 DATED

19/08/2011

{CBF702FF-DF3E-47A1-813C-

8E138B97AC8C}

CADILA HEALTHCARE LTD DEXONA INJECTION 0204/18/97

DEXAMETHASONE DISODIUM

PHOSPHATE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

4MG/ML INJECTION 2ML VIAL INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{AAC1CECB-43A2-4182-82B7-

1741476BCEA5}

CADILA HEALTHCARE LTD DEXONA TABLETS 0206/18/97 DEXAMETHASONE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

0.5MG TABLET 10*10, 1000 INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{4382C4BC-1ABC-4241-8B69-

5EAB6D00AF80}

CADILA HEALTHCARE PVT

LTDHIPEN CAPSULES 0207/06/97 AMOXYCILLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/24

250MG CAPSULE 10 * 10, 1000 INDIA ABACUS PHARMA AFRICA LTD 28/10/2010 RT28660 DATED

19/08/2011{6947992A-2EC1-4BFB8EBE-57BE2163EF4D}

CADILA HEALTHCARE PVT

LTDHIPHEN SYRUP 0210/06/97 AMOXYCYLLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/24

125MG/5ML POWDER FOR ORAL SUS 100ML HDPE INDIA ABACUS PHARMA

AFRICA LTD 28/10/2010 RT28660 DATED 19/08/2011

{09A09028-A6AC-4F44-93A3-EAC05575307B}

CENTAUR PHARMACEUTICALS

LTDORAXIN SYRUP 0295/25/97 MULTI-INGRDIENT

CENTAUR PHARMACEUTICALS LTD, KARASWADA

MAPUSA GOA

MULTI-INGRDIENT SYRUP 100ML & 200ML AMBER PET BOTTLE INDIA

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{3CDDB65B-F833-4FA3-937D-

F7BD25D35F2B}

CENTAUR PHARMACEUTICALS

LTDCENTIPAR ELIXIR 0296/06/97 PIPERAZINE CITRATE

CENTAUR PHARMACEUTICALS LTD, KARASWADA

MAPUSA GOA

750ML/5ML ELIXIR 30ML INDIAGITTOES

PHARMACEUTICALS LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{4423DEB4-96E2-4751-BD8D-

4A470DDC9DCA}

CENTAUR PHARMACEUTICALS

LTDPROTOBEX SYRUP 0299/27/97 MULTI-INGREDIENT

CENTAUR PHARMACEUTICALS LTD, KARASWADA

MAPUSA GOA

MULTI-INGREDIENT SYRUP 100ML & 200ML AMBER PET BOTTLES INDIA

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{F3B1D997-0BDE-4D96-9E73-

2C8DAF10E0B2}

NOVARTIS CONSUMER

HEALTHCARE INTERNATIONAL

VOLTAREN EMULGEL 1% 0306/13/97 DICLOFENAC

DIETHYLAMONNIUMNOVARTIS

CONSUMER HEALTH 1%/W/W TOPICAL GEL 20GM SWITZERLAND BETA HEALTH CARE (U) LTD

{3EC74097-376B-4850-B95A-1AC8411B3426}

NOVARTIS PHARMA AG APRESOLINE 0310/12/97 HYDRALAZINE

NOVARTIS PHARMACEUTICALS LTD HORSHAM, UK

20MG/ML INJECTION 1ML AMP SWITZERLAND SURGIPHARM (U) LTD

{5DCD59D6-E3D1-4524-A87D-

F0AC645362C3}

NOVARTIS PHARMA AG

VOLTAREN INJECTION 0311/02/97 DICLOFENAC

NOVARTIS PHARMA STEIN AG,

SWITZERLAND 25MG/ML INJECTION 3ML AMPOULE SWITZERLAND SURGIPHARM (U)

LTD

{2EEE6BE0-0F72-4C1A-91A5-

E4AA2359D660}

NOVARTIS PHARMA AG

CATAFLAM 25MG TABLETS 0312/02/97 DICLOFENAC

POTASSIUM

NOVARTIS PHARMA SPA, TORRE

ANNUNZIATA ITALY 25MG TABLET S/C 20 & 100 ITALY SURGIPHARM (U)

LTD

{052DC319-C4C4-4E8C-878F-

25D7909F8419}

NOVARTIS PHARMA AG TEGRETOL 200MG 0313/05/97 CARBAMAZEPINE

NOVARTIS PHARMA SPA, TORRE

ANNUNZIATA ITALY200MG TABLET 50 ITALY SURGIPHARM (U)

LTD

{FA5D63C9-7BC9-4457-982C-

0AF2AB3CC550}

NOVARTIS PHARMA AG VOLTAREN RETARD 0314/02/97 DICLOFENAC

SODIUM

NOVARTIS PHARMA STEIN AG,

SWITZERLAND100MG TABLET S/R 30 SWITZERLAND SURGIPHARM (U)

LTD{A059A9CE-3966-46D682F0-368CA8040744}

NOVARTIS PHARMA AG ANAFRANIL 0320/24/97 CLOMIPRAMINE

NOVARTIS PHARMA SPA, TORRE

ANNUNZIATA ITALY 25MG TABLET 30 ITALY SURGIPHARM (U)

LTD{2838A15D-5D4D-4639-9449-860C9B23A931}

Page 5

Page 6: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

NOVARTIS PHARMA AG

CATAFLAM 50MG TABLETS 0321/02/97 DICLOFENAC

POTASSIUM

NOVARTIS PHARMA SPA, TORRE

ANNUNZIATA ITALY 50MG TABLET S/C 1 * 20, 10*10 BLISTER ITALY SURGIPHARM (U)

LTD{173FE70E-C739-432F-9EED-4843B6625960}

NOVARTIS PHARMA AG TEGRETOL 100MG 0322/05/97 CARBAMAZEPINE

NOVARTIS PHARMA SPA, TORRE

ANNUNZIATA ITALY 100MG TABLET 50 ITALY SURGIPHARM (U)

LTD{284461EC-E5A5-4A36-B553-38A6CF5F003C}

NOVARTIS PHARMA AG

CATAFLAM ORAL DROPS 0323/02/97 DICLOFENAC

POTASSIUM

NOVARTIS PHARMA S.A RUE DE LA

CHAPELLE, HUNIGUE,

15MG/ML ORAL DROP 15ML FRANCE. SURGIPHARM (U) LTD

{C679E578-2C5D-4752-A023-5A4CD529F3F2}

NOVARTIS PHARMA AG VOLTAREN SR 75MG 0324/02/97 DICLOFENAC

SODIUM

NOVARTIS PHARMA SPA, TORRE

ANNUNZIATA ITALY75MG TABLET S/R 30 ITALY SURGIPHARM (U)

LTD{7192DF1B-5741-4759-B94F-2213F4AEF5A2}

CLARIS LIFE SCIENCES METRIS INFUSION 0333/06/97 METRONIDAZOLE

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

5MG/ML INFUSIONS,LARGE VOL 100ML INDIA REDDY`S PHARMA

LTD 01/03/2010 RT31356 DATED 24/11/2011

{37462784-FC8C-46A8-937F-033DB5CD9AFC}

DAWA PHARMACEUTICALS

LTDCURAMOL PLUS 0361/02/97 PARACETAMOL,

CAFFEINE

DAWA LIMITED, BABDONG ROAD RUARAKA, MOBIL

PLAZA, P

500MG,60MG TABLET 50*2 STRIPS KENYA SUPER MEDIC LTD RT24080 DATED 27/01/2011

RT28507 DATED 12/08/2011

{EC90C4BE-E9CB-4D68-AE19-

9D373A7A0DDE}

DAWA LTD DAWASPRIN 0366/02/97 ACETYLSALICYCLIC ACID

DAWA LIMITED BABA DOGO ROAD

RUARAKA300MG TABLET 10 *10 BLISTER KENYA SUPER MEDIC RT24080 DATED

27/01/2011RT28507 DATED

12/08/2011

{C36C0DDF-68C1-41A9-AD90-

36ABF1750411}

ELYS CHEMICAL INDUSTRIES LTD ELYMOL 0423/02/97 PARACETAMOL ELYS CHEMICAL

INDUSTRIES LTD 120MG/5ML ORAL SUSPENSION 60ML & 100ML KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/09 RT31596 DATED

06/12/11{459F2689-B211-4480-9B43-0B0DB0B831AA}

ELYS CHEMICAL INDUSTRIES LTD ELYCORT 0425/13/97 HYDROCORTISONE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

1%W/W OINTMENT 15GM KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{54EBD35D-C7C5-470E-9B73-

3EBCACFAB8EB}

ELYS CHEMICAL INDUSTRIES LTD ALPRIM 0426/06/97 CO-TRIMOXAZOLE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRIZE ROAD, PLOT 209/8727 IND.

AEA NAIROBI

240MG/5ML ORAL SUSPENSION 60ML, 100ML & 5LTS KENYA ELYS CHEMICAL INDSTRIES (U) LTD

02/02/2009 VALID 02/02/2012

RT27567 DATED 04/07/11

{A2EEEE80-CC7D-4B75-9664-

F07914A8461C}

ELYS CHEMICAL INDUSTRIES LTD ELYVATE 0427/13/97 BETAMETHASONE

VALERATE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

1%W/W OINTMENT 15GM KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{A9A9ACCD-D1FA-4931-AED6-

CDC45F701AA3}

ELYS CHEMICAL INDUSTRIES LTD AMPILIN 0429/06/97 AMPICILLIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

125MG/5ML POWDER FOR ORAL SUSPN 100ML KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{F274BB0F-F06D-4078-B7EE-

90B8AB3B62CC}

ELYS CHEMICAL INDUSTRIES LTD ELYCORT 0430/13/97 HYDROCORTISONE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

1%W/W CREAM 15GM KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{9076E03F-299D-443F-84ED-C319A10B5DB8}

ELYS CHEMICAL INDUSTRIES LTD ALPRIM 0431/06/97 CO-TRIMOXAZOLE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

480MG TABLET 1000 & 10*10 KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{0D2687AF-7278-405D-885F-CD952CF0452C}

ELYS CHEMICAL INDUSTRIES LTD MULTIVITAMIN 0432/27/97 MULTIVITAMINS

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

TABLET S/C 1000 HDPE KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{2F5E6293-6590-400C-9096-9102A22E3DFE}

ELYS CHEMICAL INDUSTRIES LTD IBUFEN TABLETS 0433/02/97 IBUPROFEN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

200MG TABLET S/C 10*10 & 1000 HDPE KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{E85A2C2A-7EEE-4803-8BDD-

E95BBD6DA1A6}

ELYS CHEMICAL INDUSTRIES LTD ELYMOX 0435/06/97 AMOXYCILLIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

125MG/5ML POWDER FOR ORAL SUSPN 100ML KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{B565B7D2-BCF1-4DF8-981E-

134C6568E48D}

Page 6

Page 7: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ELYS CHEMICAL INDUSTRIES LTD ALUGEL 0436/17/97 ALUMINIUM

HYDROXIDE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

ORAL SUSPENSION 100ML & 5LTS KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{FD00377D-9FED-446A-BA55-

924AC9F6C794}

ELYS CHEMICAL INDUSTRIES LTD ELYCETIN 0437/06/97 CHLORAMPHENICOL

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

250MG CAPSULE 1000 HDPE, 10*10 BLISTER KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{EE0E6A53-4F86-4B8EBC0B-

2E7AF5FFD1D7}

ELYS CHEMICAL INDUSTRIES LTD WORMOL 0438/06/97 MEBENDAZOLE ELYS CHEMICAL

INDUSTRIES LTD 100MG TABLET, CHEWABLE 1000 KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/09 {8A125F15-1F2B-41A2-

B045-F89C88D0C547}

ELYS CHEMICAL INDUSTRIES LTD QUININE TABLETS 0439/06/97 QUININE SULPHATE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

300MG TABLET S/C 10*10, 1000 HDPE KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{4A4935F1-7D1B-4819-BACD-05E5B460FB89}

ELYS CHEMICAL INDUSTRIES LTD

PREDNISOLONE TABLETS 0440/18/97 PREDNISOLONE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

5MG TABLET 1000 HDPE KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{25AED746-7E41-4B2E8485-B099E5C08705}

ELYS CHEMICAL INDUSTRIES LTD

CLOXACILLIN CAPSULES 0441/06/97 CLOXACILLIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

250MG CAPSULE 10*10 BLISTER, 1X1000 HDPE KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{E8701AA6-C3B4-4094-9FDA-4755A03FF142}

ELYS CHEMICAL INDUSTRIES LTD MIFUPEN TABLETS 0442/02/97 ASPIRIN/CAFFEINE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

TABLET 100 STRIP KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{2F38A115-FFC2-4E1D-89D7-

78FBF0E47AD6}

ELYS CHEMICAL INDUSTRIES LTD

PARACETAMOL TABLETS 0443/02/97 PARACETAMOL

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

500MG TABLET 10*10 BLISTER &1000HDPE KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{5D66FD8F-7504-41F6-9F45-64BB89311128}

ELYS CHEMICAL INDUSTRIES LTD LYFE 0445/23/97 ORAL REHYDRATION

SALT

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

ORAL SOLUTION POWDER

14GM & 28 GMSACHET KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{7BBA1B7B-BD39-46DE-B0F5-

9326FB731C45}

ELYS CHEMICAL INDUSTRIES LTD

ELYMOX CAPSULES 250MG 0447/06/97 AMOXYCILLIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

250MG CAPSULE 10*10 & 1000HDPE KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{5FBA8D49-8574-46D4-B9CB-93FF21E00AC6}

ELYS CHEMICAL INDUSTRIES LTD ELYDAC 0449/27/97 MULTIVITAMIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

SYRUP 100ML & 5LTS KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{DFF13807-356F-4E22-A3E7-6ED6C9A6669A}

ELYS CHEMICAL INDUSTRIES LTD CANDISTAT 0452/13/97 CLOTRIMAZOLE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

100MG PESSARY 2*3 & 6 STRIP KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{E473C97F-D05E-478A-B8F0-

B7722FC33772}

ELYS CHEMICAL INDUSTRIES LTD AMPILIN 0454/06/97 AMPICILLIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

250MG CAPSULE 10*10 & 1000 KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{441498E1-ED54-4090-AE0F-

3FCC3DB0FA7D}

ELYS CHEMICAL INDUSTRIES LTD ELOGYL 0455/06/97 METRONIDAZOLE

BENZOATEELYS CHEMICAL INDUSTRIES LTD 200MG/5ML ORAL SUSPENSION 100ML KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/09 RT31596 DATED 06/12/11

{3E38428F-D258-4CE6-B1AA-

D1CE699D905C}

ELYS CHEMICAL INDUSTRIES LTD ELYVATE CREAM 0457/13/97 BETAMETHASONE

VALERATE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

0.1%W/W CREAM 15GM KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{2A63B7C3-E88A-49E49F01-991412F36A5D}

ELYS CHEMICAL INDUSTRIES LTD ELOGYL 0459/06/97 METRONIDAZOLE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

200MG TABLET 1000HDPE, 10*10 BLISTER KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{F6BC80DB-5305-4960-8CBD-4917F729D765}

ELYS CHEMICAL INDUSTRIES LTD ELYCLOX CAPSULES 0460/06/97 AMPICILLIN/CLOXACI

LLIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

500MG CAPSULE 10*10 & 500 HDPE KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{37BA273D-BE24-4697-992A-2619FAE17BAA}

ELYS CHEMICAL INDUSTRIES LTD ELYPEN 0461/06/97 PHENOXYMETHYLPE

NICILLIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

250MG TABLET 1000HDPE, 10 * 10 BLISTER KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{3776B7EF-7353-489B-98D6-CB760ECF0FA1}

Page 7

Page 8: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

FREDUN PHARMACEUTICALS

LTDFRUSINA TABLETS 0479/16/97 FUROSEMIDE

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

40MG TABLET 10 & 500, 1000 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011{485EFFA1-D1FB-4331-B41B-249E336DEF56}

FREDUN PHARMACEUTICALS

LTDLAXAFRED TABLETS 0484/17/97 BISACODYL

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

5MG TABLET 10*10 BLI. & 1000 HDPE INDIA ABACUS PHARMA (A)

LTD 23/11/2009 RT293353 DATED 16/09/2011

{01E8F8F4-FC97-41E0-906F-F05DE5586559}

FREDUN PHARMACEUTICALS

LTDCOTRIFRED TABLETS 0485/06/97 CO-TRIMOXAZOLE

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

480MG TABLET 10*10, 1000 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011

{24345ADB-29C0-4AAE-8142-

3747947316EA}

FREDUN PHARMACEUTICALS

LTD

GRISEOFRED TABLETS 0486/06/97 GRISEOFULVIN

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

500MG TABLET 10*10 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011{4A07625B-6521-4F6B-A91B-8C4127273E6B}

FREDUN PHARMACEUTICALS

LTDFOLIFRED TABLETS 0487/10/97 FOLIC ACID

FREDUN PHARMACEUTICALS

LTDFREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

5MG TABLET 10 BLISTER & 1000 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011

{B264AEC0-787E-4AE0-A8E7-

4D26975D7CBD}

FREDUN PHARMACEUTICALS

LTDFRADOX CAPSULES 0488/06/97 DOXYCYCLINE

HYDROCHLORIDE

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

100MG CAPSULE 10*10BLISTER INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011{32B9DF08-3F4A-4686-B227-31B3C24A1A76}

GEOFMAN PHARMACEUTICALS BETACIN-N-CREAM 0490/13/97 z

GEOFMAN PHARMACEUTICALS 20/23 KORANGI IND

AREA 755

CREAM 5GM & 15GM PAKISTAN HEALTH CARE LTD 27/02/09 RT31697 DATED 09/12/11

{62C90FD3-22B8-4DCA-8D3A-

88C0E74DADA2}

GEOFMAN PHARMACEUTICALS

OXYTOCIN INJECTION 0491/22/97 OXYTOCIN

GEOFMAN PHARMACEUTICALS 20/23 KORANGI IND

AREA 755

10I.U/ML INJECTION 1ML AMPPOULE PAKISTAN HEALTH CARE LTD 27/02/09 RT31697 DATED 09/12/11

{21650418-46E0-461D-A1AA-BA44F216A681}

GEOFMAN PHARMACEUTICALS

BISACODYL TABLETS 5MG 0494/17/97 BISACODYL

GEOFMAN PHARMACEUTICALS 20/23 KORANGI IND

AREA 755

5MG TABLET F/C 10*10 STRIP & 1000 PAKISTAN HEALTH CARE LTD 27/02/09 RT31697 DATED 09/12/11

{BF5BD88E-B7F4-44BE-8EEB-

1FA926F2A7F3}

GLAXO WELLCOME (KENYA) LTD DERMOVATE 0501/13/97 CLOBETASOL

PROPIONATE

GLAXOSMITHKLINE HARMIRE ROAD

BARNARD CASTLE DURHAM

0.05%W/W OINTMENT 25GM & 30GM UK ERIS LTD 18/08/09 RT28825 DATED 27/08/11

{6318673F-1B83-4F6F-986F-C894772A39F9}

GLAXO WELLCOME (KENYA) LTD DERMOVATE 0508/13/97 CLOBETASOL

PROPIONATE

GLAXOSMITHKLINE HARMIRE ROAD

BARNARD CASTLE DURHAM

0.05%W/W CREAM 25GM & 30GM UK ERIS LTD 18/08/09 RT28825 DATED 27/08/11

{66068FDE-08C7-4983-9B8E-09B1DFD70DF3}

Page 8

Page 9: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

GLAXO WELLCOME (KENYA) LTD ZINNAT 0509/06/97 CEFUROXIME AXETIL

GLAXO OPERATIONS UK LTD, BARNARD

CASTLE250MG TABLET F/C 10 & 50 UK ERIS LTD 18/08/09 RT28825 DATED

27/08/11

{C2AC4A26-E344-426F-89A3-

A80EF1E27DF1}

GLAXO WELLCOME (KENYA) LTD ZINNAT 0510/06/97 CEFUROXIME AXETIL

GLAXO OPERATIONS UK LTD, BARNARD

CASTLE500MG TABLET F/C 10 & 50 UK ERIS LTD 18/08/09 RT28825 DATED

27/08/11

{AC00C4E4-A15F-4937-BB95-

EDE4F69736CE}

GLAXO WELLCOME (KENYA) LTD ZANTAC 0515/17/97 RANITIDINE

GLAXOSMITHKLINE LIKONI ROAD IND.

AREA, NAIROBI 150MG TABLET F/C 10,20, 30 KENYA ERIS LTD 23/06/08 + RE-AUDIT

FEES (JV11/190)RT28825 DATED

27/08/11

{F358FFAD-3CCB-454E-A1E5-

C35423342AEF}

GLAXO WELLCOME (KENYA) LTD VENTOLIN 0516/25/97 SALBUTAMOL

GLAXOWELLCOME PRODUCTION ,

EVREUX- FRANCE 100MCG EVOHALER CANNISTER FRANCE ERIS LTD 08/10/07 + RE-AUDIT

FEES ( RT21579)RT28825 DATED

27/08/11{BBA99932-8372-41AB-8A68-92FAE0500E4A}

GLAXO WELLCOME (KENYA) LTD VENTOLIN 0517/25/97 SALBUTAMOL

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

2MG/ML SYRUP 100ML &150ML EGYPT ERIS LTD 08/09/11 RT28825 DATED 27/08/11

{F92AC620-90F5-4BFB-8C65-9DEB7E2AF520}

GLAXO WELLCOME (KENYA) LTD SEPTRIN 0525/06/97

TRIMETHOPRIM, SULPHAMETHOXAZO

LE

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

40MG/5ML, 200MG/5ML ORAL SUSPENSION 50ML, 100ML EGYPT ERIS LTD 08/09/11 RT28825 DATED

27/08/11

{D43D189A-4AD5-4C1C-A870-

CEFC20D9C78D}

GLAXO WELLCOME (KENYA) LTD SEPTRIN INJECTION 0527/06/97 CO-TRIMOXAZOLE

DRAXIS PHARMA INC, QUEBEC,

CANADA 480MG/5ML INJECTION 10 * 5ML AMPOULE CANADA ERIS LTD

RT22505 DATED 17/11/10(DOC

REVIEW)

RT28825 DATED 27/08/11

{30591A89-FF8F-4453-8E72-DFCE4F427576}

GLAXO WELLCOME (KENYA) LTD ACTIFED SYRUP 0533/25/97 TRIPLORIDINE HCL,

PSEUDOEPHEDRINE

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

1.25MG, 30MG SYRUP 60ML & 100ML & 2LTS EGYPT ERIS LTD 08/09/11 RT28825 DATED 27/08/11

{92A51C42-AAB9-4518-9827-1FB458DC90A7}

GLAXO WELLCOME (KENYA) LTD

ACTIFED WET COUGH & COLD 0536/25/97

TRIPLORIDINE HCL, PSEUDOEPHEDRINE,

GUAIPHENESIN

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

1.25MG, 30MG, 100MG SYRUP 100ML & 2LTS EGYPT ERIS LTD 08/09/11 RT28825 DATED

27/08/11{01894DFE-4E71-4E18-B68D-33BC0666DF2E}

GLAXO WELLCOME (KENYA) LTD CALPOL 0537/02/97 PARACETAMOL

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

120MG/5ML SYRUP 60ML & 100ML EGYPT ERIS LTD 08/09/11 RT28825 DATED 27/08/11

{05A913AF-8C49-4FA5-A809-E56FB091B449}

GLAXO WELLCOME (KENYA) LTD EPIVIR TABLETS 0543/06/97 LAMIVUDINE

PHARMACARE, 7 FAIRCLOUGH ROAD,

KORSTEN PORT ELIZABETH

150MG TABLET FC 60 SOUTH AFRICA ERIS LTD 04/09/08+ RT29672 DATED 29/11/11

RT28825 DATED 27/08/11

{FA7608FF-AA87-4EC6-90BD-

0F15C3E4D348}

GLAXO WELLCOME (KENYA) LTD EPIVIR SYRUP 0544/06/97 LAMIVUDINE GLAXOSMITHKLINE

INC., MISSISSAUGA 50MG/5ML ORAL SOLUTION 240ML CANADA ERIS LTD DOC REVIEW (RT22505

RT28825 DATED 27/08/11

{A55269A6-F845-43E6-BEF1-014E75B9269E}

INTAS PHARMACEUTICALS

LTDCARDITAS RETARD 0659/12/97 NIFEDIPINE

INTAS PHARMACEUTICALS

LTD, 7/3 GIDC ESTATE VATVA

AHMEDABAD 382 445 INDIA

20MG TABLET S/R 10*10 BLIETR INDIANORVIK

ENTERPRISES (U) LTD

04/10/11 RT29052 DATED 06/09/11

{1472FD0E-9D0A-42C1-B2C2-

6B5AC11C4A2A}

INTAS PHARMACEUTICALS

LTDZEN-200 0662/05/97 CARBAMAZEPINE

INTAS PHARMACEUTICALS LTD MATODA 382 210 DIST AHMEDABAD,

INDIA

200MG TABLET 10*5 & 1000 HDPE, 1*10*10 BLISTER INDIA

NORVIK ENTERPRISES (U)

LTD06/09/09 RT29052 DATED

06/09/11

{0C57634B-4C5A-4D06-B791-

C93A28CCE362}

INTAS PHARMACEUTICALS

LTDSPASMINTAS-10 0664/17/97 HYOSCINE N-

BUTYLBROMIDE

INTAS PHARMACEUTICALS

LTD, 7/3 GIDC ESTATE VATVA

AHMEDABAD 382 445 INDIA

10MG TABLET F/C 1000 HDPE, 10*10 BLISTER INDIA

NORVIK ENTERPRISES (U)

LTD04/10/11 RT29052 DATED

06/09/11

{A53D4258-93CE-4C4C-A129-

5A1B7EE0683C}

INTAS PHARMACEUTICALS

LTDKEZOLE 0665/06/97 KETOCONAZOLE

INTAS PHARMACEUTICALS

LTD, 7/3 GIDC ESTATE VATVA

AHMEDABAD 382 445 INDIA

200MG TABLET 3*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

04/10/11 RT29052 DATED 06/09/11

{2601C53E-DE6E-42BA-B94F-

AC4F7D4F65B7}

Page 9

Page 10: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

INTAS PHARMACEUTICALS

LTDC-FLOX 500 0666/06/97 CIPROFLOXACIN

INTAS PHARMACEUTICALS LTD MATODA 382 210 DIST AHMEDABAD,

INDIA

500MG TABLET F/C 1*10 & 10*10 BLITER INDIANORVIK

ENTERPRISES (U) LTD

06/09/09 RT29052 DATED 06/09/11

{E4EE618A-CFE2-4AE8-B7B1-

D4592F66EF8C}

INTAS PHARMACEUTICALS

LTDDICLOFLAME-50 0670/02/97 DICLOFENAC

INTAS PHARMACEUTICALS

LTD, 7/3 GIDC ESTATE VATVA

AHMEDABAD 382 445 INDIA

50MG TABLET F/C 10 *10, & 1000 INDIANORVIK

ENTERPRISES (U) LTD

04/10/11 RT29052 DATED 06/09/11

{2875724E-ADFC-4040-A172-E20E5088E2D7}

JASSEN-CILAG (PTY) LTD MOTILIUM 0707/17/97 DOMPERIDONE

SPECPHARMV HOLDINGS . 15TH ROAD HALFWAY

HOUSE

10MG TABLET F/C 20, 30 SOUTH AFRICA LABOREX (U) LTD11/09/2008 AND RT29194 DATED

12/09/2011 RE-INSP

RT29142 DATED 08/09/2011 & JV11/134

DATED 08/09/2011

{C8C74AE3-9A82-48FC-AE9D-

E4AB2F0145FF}

JASSEN-CILAG (PTY) LTD GYNO-DAKTARIN 0710/13/97 MICONAZOLE

NITRATE

SPECPHARM HOLDINGS. 15TH ROAD HALFWAY

HOUSE

20MG/G VAGINAL CREAM 40GM SOUTH AFRICA LABOREX (U) LTD11/09/2008 AND RT29194 DATED

12/09/2011 RE-INSP

RT29142 DATED 08/09/2011 & JV11/134

DATED 08/09/2011

{08D9B211-BCB2-4791A7BE-32538E249777}

JASSEN-CILAG (PTY) LTD HALDOL DECANOAS 0711/24/97 HALOPERIDOL

DECANOATE

JANSSEN PHARMACEUTICA

N.V TURNHOUTSEWEG 30 B-2340 BEERSE

50MG/ML INJECTION 5 *1ML AMPOULE BELGIUM LABOREX (U) LTD 24/11/08RT29142 DATED

08/09/2011 & JV11/134 DATED 08/09/2011

{54A28D84-E341-41E9-A245-40987DF30038}

JASSEN-CILAG (PTY) LTD VERMOX 0712/06/97 MEBENDAZOLE

JANSSEN PHARMACEUTICA

PTY LTD. 15TH ROAD HALFWAY

100MG TABLET 6 BLISTER SOUTH AFRICA LABOREX (U) LTDRT304481 DATED

18/10/2011 & JV11/205 DATED 19/10/2011

{91EEEC0B-7929-43E9B56D-FD8F21C03410}

JASSEN-CILAG (PTY) LTD NIZORAL 0715/06/97 KETOCONAZOLE

SPECPHARM HOLDINGS 15TH ROAD HALFWAY

HOUSE

20MG/G CREAM 15GM SOUTH AFRICA LABOREX (U) LTD11/09/2008 AND RT29194 DATED

12/09/2011 RE-INSP

RT29142 DATED 08/09/2011 & JV11/134

DATED 08/09/2011

{F4132647-A538-4981-B8D2-7B4AF74A1DF3}

JASSEN-CILAG (PTY) LTD NIZORAL 0716/06/97 KETOCONAZOLE

SPECPHARM HOLDINGS 15TH ROAD HALFWAY

HOUSE

200MG TABLET 10 BLISTER SOUTH AFRICA LABOREX (U) LTD11/09/2008 AND RT29194 DATED

12/09/2011 RE-INSP

RT29142 DATED 08/09/2011 & JV11/134

DATED 08/09/2011

{FA514BF9-772E-41A3-8E01-E889B26A0184}

JASSEN-CILAG (PTY) LTD NIZORAL 0720/13/97 KETOCONAZOLE

JANSSEN PHARMACEUTICA

PTY LTD. 15TH ROAD HALFWAY

20MG/G SHAMPOO 80ML SOUTH AFRICA LABOREX (U) LTDRT304481 DATED

18/10/2011 & JV11/205 DATED 19/10/2011

{97EC009A-5F07-49EF-A714-6A186096DDC9}

JASSEN-CILAG (PTY) LTD DAKTACORT 0721/13/97 z

SPECPHARM HOLDINGS 15TH ROAD HALFWAY

HOUSE

CREAM 15GM SOUTH AFRICA LABOREX (U) LTD11/09/2008 AND RT29194 DATED

12/09/2011 RE-INSP

RT29142 DATED 08/09/2011 & JV11/134

DATED 08/09/2011

{AE82E139-BA57-494EA27B-F278C870D85F}

JASSEN-CILAG (PTY) LTD DAKTARIN 0722/13/97 MICONAZOLE

NITRATE

SPECPHARM HOLDINGS 15TH ROAD HALFWAY

HOUSE

20MG/G CREAM 20GM SOUTH AFRICA LABOREX (U) LTD11/09/2008 AND RT29194 DATED

12/09/2011 RE-INSP

RT29142 DATED 08/09/2011 & JV11/134

DATED 08/09/2011

{1AEFCC3F-1A73-4DA4-9142-

3C60B7AF41F9}

JASSEN-CILAG (PTY) LTD DAKTARIN ORAL GEL 0723/06/97 MICONAZOLE

NITRATE

SPECPHARM HOLDINGS 15TH ROAD HALFWAY

HOUSE

20MG/G GEL FOR ORAL USE 40GM SOUTH AFRICA LABOREX (U) LTD11/09/2008 AND RT29194 DATED

12/09/2011 RE-INSP

RT29142 DATED 08/09/2011 & JV11/134

DATED 08/09/2011

{FBA51303-08B3-46C4-9894-B3C9844761F9}

JASSEN-CILAG (PTY) LTD IMODIUM 0725/17/97 LOPERAMIDE

HYDROCHLORIDE

SPECPHARM HOLDINGS. 15TH ROAD HALFWAY

HOUSE

2MG CAPSULE 6BLISTER SOUTH AFRICA LABOREX (U) LTD11/09/2008 AND RT29194 DATED

12/09/2011 RE-INSP

RT29142 DATED 08/09/2011 & JV11/134

DATED 08/09/2011

{2A34243B-55CA-46C491A0-D355C102D4C8}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM PHEN 0727/06/97 PHENOXYMETHYLPE

NICILLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

250MG TABLET 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{F0E85F17-A02E-45C3-8EB6-BBA48303AC4D}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM COTRI 0728/06/97 CO-TRIMOXAZOLE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

480MG TABLET 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{2F6828CE-7B9E-42C8-B503-

3FBE05CEEB3E}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAMSPRO 0729/02/97 ACETYLSALICYCLIC

ACID

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

300MG TABLET 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{2CA0D531-8DC8-4EFE-95DC-

E3947F3800D5}

Page 10

Page 11: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM-AMOXY 0730/06/97 AMOXYCILLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

250MG CAPSULE 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{A2AF48F6-BC1F-41B7-B3F7-

153DBA8C8BB3}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM BENDAZOLE 0731/06/97 MEBENDAZOLE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

100MG TABLET 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{FD8F5B76-BEC7-4644-9FC1-

75B837EFA4C7}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM-VENT 0732/25/97 SALBUTAMOL

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

4MG TABLET 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{F0BCBC6E-2204-4E81-8781-

2E3F1F642700}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAMOMINT 0735/17/97

COMPOUND MAGNESIUM TRISILICATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

TABLET, CHEWABLE 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{355809F2-EE24-4FEF-9857-1B6A295B338B}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAMADOL 0736/02/97 PARACETAMOL

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

500MG TABLET 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{5799D2C0-6C22-47E2-A5DE-D158CE8F6937}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM METRO 0738/06/97 METRONIDAZOLE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

200MG TABLET 10*10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{97B7436B-D69A-47ED-B1DC-

6278278EDEBF}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM-AMPI 0739/06/97 AMPICILLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

250MG CAPSULE 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{3CCD35E6-CCDA-4363-9690-

284075D3966D}

KAMPALA PHARMACEUTICALS

INDUSTRIESAZUDOX 0743/06/97 DOXYCYCLINE

HYDROCHLORIDE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

100MG CAPSULE 10, 100, 250 500 & 1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{0B23E4D3-A611-4018-A64F-456EC1302630}

KAMPALA PHARMACEUTICALS

INDUSTRIES

KAMODIUM

0744/17/97 LOPERAMIDE HYDROCHLORIDE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

2MG CAPSULE 10, 100 UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{D854A7E5-7469-47DAA2E5-6725CC0212FB}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAMSIDAR 0745/06/97 SULFADOXINE/PYRIM

ETHAMINE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

525MG TABLET 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{34A045A8-0219-4E1D-90BF-3621E4C032A9}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM CHLOR 0746/06/97 CHLORAMPHENICOL

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

250MG CAPSULE 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{308B123B-4CB6-474F-A752-183177183151}

KAMPALA PHARMACEUTICALS

INDUSTRIESAZUCLOX 0747/06/97 AMPICILLIN/CLOXACI

LLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

500MG CAPSULE 10 & 100, 250 & 500, 1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{1B78967E-4821-42BC-A201-898813B8862E}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAMCLOXA 0748/06/97 CLOXACILLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

250MG CAPSULE 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{C41A2858-B497-4948-9D21-231937A53EFC}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM COTRI 0751/06/97 CO-TRIMOXAZOLE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

240MG/5ML SUSPENSION FOR ORAL 60ML & 100ML UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{81EFB3F4-C55F-44DB-BAC0-

48440F693327}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAMCLOXA 0752/06/97 CLOXACILLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

125MG/5ML POWDER FOR ORAL SUSPN 100ML UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{F3F4D3B8-6F99-48F1-9777-F07D0634A2C1}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM AMPI 0758/06/97 AMPICILLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

125MG/5ML POWDER FOR ORAL SUSPN 100ML UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{2D62F9DF-0EDF-46C0-9989-

251DB670A469}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM AMOXY 0759/06/97 AMOXYCILLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

125MG/5ML POWDER FOR ORAL SUS 100ML UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{C2BBC3EF-9417-4CC0-B800-

7982CA70E499}

Page 11

Page 12: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

KAMPALA PHARMACEUTICALS

INDUSTRIESERYMYCIN 0762/06/97 ERYTHROMYCIN

ESTOLATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

250MG TABLET 10 BLISTER & 1000 UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{38B54A67-C5B7-4FCD-9923-

CD3DA3972E15}

KAMPALA PHARMACEUTICALS

INDUSTRIESFLUCAP 0763/25/97 Z

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

Z SYRUP 100ML UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{AA6E04A0-4C99-4CC1-9DC5-

F9F6FF5E6663}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM PREDSOL 0768/18/97 PREDNISOLONE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

5MG TABLET 10, 100, 250, 500 &1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{66A5659A-4603-4341-AF45-766AF948DED4}

KAMPALA PHARMACEUTICALS

INDUSTRIESB-TONE 0771/05/97 PHENOBARBITONE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

30MG TABLET 10 BLISTER & 1000 UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{84E88DD6-CF72-449C-B7A0-

F86AE4923475}

KAMPALA PHARMACEUTICALS

INDUSTRIESBETASOL OINTMENT 0773/13/97 BETAMETHASONE

VALERATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

0.1%W/W OINTMENT 15GM & 30GM UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{166A0754-1B2D-4A90-BB4C-3E117BE4971B}

KAMPALA PHARMACEUTICALS

INDUSTRIESFLUFED 0775/25/97 z

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

TABLET 10 BLISTER, 100, 250 , 500 & 1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{0FCA08C8-17C0-42A2-80C2-

22A67308CFDD}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM ERYMYCIN 0776/06/97 ERYTHROMYCIN

ESTOLATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

125MG/5ML POWDER FOR ORAL SUSPN 100ML UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{ED83AD9D-8728-462A-ACDE-

5EB412D93105}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM FLUFED ELIXIR 0777/25/97 Z

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

Z ELIXIR 60ML UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{D61C2159-90CF-4469-8487-193D256CD8C5}

KAMPALA PHARMACEUTICALS

INDUSTRIESAZUCLOX 0779/06/97 AMPICILLIN/CLOXACI

LLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

250MG/5ML POWDER FOR ORAL SUSPN 100ML UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011{FB114922-8C0D-4325-8811-EF5E6AB103A8}

KAMPALA PHARMACEUTICALS

INDUSTRIESQUINE 0780/06/97 QUININE SULPHATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

300MG TABLET 10, 100, 250, 500, 1000 UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{D6DE6888-3201-4248-A85C-4E7EB63DE9E0}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM METRO 0781/06/97 METRONIDAZOLE

BENZOATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

200MG/5ML ORAL SUSPENSION 100ML UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{A9526260-E5BB-4AEF830B-5FD17F22336E}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAMADOL SYRUP 0782/02/97 PARACETAMOL

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

120MG/5ML SYRUP 60ML & 100ML UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{5158DC3A-12DE-4906-91BF-

CE82F26CAC60}

KAMPALA PHARMACEUTICALS

INDUSTRIESHYCORT CREAM 0784/13/97 HYDROCORTISONE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

1%W/W CREAM 15GM & 30GM UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{696E4E67-153F-44D8-B8B2-2C2720E365BA}

KAMPALA PHARMACEUTICALS

INDUSTRIESIBUFEN 0785/02/97 IBUPROFEN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

200MG TABLET 10 BLISTER & 100 ,250, 500,1000 UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{D9ED7114-8D0A-4833-A2DF-

16FF5699F6FA}

KAMPALA PHARMACEUTICALS

INDUSTRIESBETASOL CREAM 0786/13/97 BETAMETHASONE

VALERATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

0.1%W/W CREAM 15GM & 30GM UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{0AA3B0A2-1977-4B41-9C19-F0938C944EF9}

KAMPALA PHARMACEUTICALS

INDUSTRIESHYCORT OINTMENT 0787/13/97 HYDROCORTISONE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

1%W/W OINTMENT 15GM & 30GM UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{FAA63CFD-BDBA-459A-ACE6-

E9C1D9F0E36B}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM PHEN 0789/06/97 PHENOXYMETHYLPE

NICILLIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

125MG/5ML POWDER FOR ORAL SUS 60ML & 100ML UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{C767AACB-45F2-4C39-AF95-

600E5AB636E6}

Page 12

Page 13: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

KAMPALA PHARMACEUTICALS

INDUSTRIESFLUCAP 0790/25/97 Z

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

Z CAPSULE 10*10 UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{F231F158-8C99-4A7E-8C0B-5EF942BA61EA}

KAMPALA PHARMACEUTICALS

INDUSTRIESPYRI 0791/27/97 PYRIDOXINE

HYDROCHLORIDE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

25MG TABLET 10, 100, 250, 500, 1000 UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{636FF0A7-C336-4F47-98C8-58CE60E11FC4}

KOPRAN LIMITED DIFISAL-SR 0795/02/97 DICLOFENAC

KOPRAN LIMITED VILLAGE SAVROLI

TALUKA KHALAPUR RAIGAD DISTRICT

PIN 410202

100MG TABLET S/R 10*10 BLISTER INDIASUPER

PHARMACEUTICALS LTD.

29/01/09 RT28108 DATED 26/07/11

{7127927A-710A-47E6-8C7F-9C4F003DE63D}

KOPRAN LIMITED CLOXIN-250 0798/06/97 CLOXACILLIN

KOPRAN LIMITED VILLAGE SAVROLI

TALUKA KHALAPUR RAIGAD DISTRICT

PIN 410202

250MG CAPSULE 10*10 BLISTER 100, 1000 INDIA

SUPER PHARMACEUTICALS

LTD.29/01/09 RT28108 DATED

26/07/11{C23555C5-A164-4561-B890-02A72BC519B5}

KOPRAN LIMITED AMPIK-250 0799/06/97 AMPICILLIN

KOPRAN LIMITED VILLAGE SAVROLI

TALUKA KHALAPUR RAIGAD DISTRICT

PIN 410202

250MG CAPSULE 10*10 BLISTER, 1 * 1000HDPE INDIA

SUPER PHARMACEUTICALS

LTD.29/01/09 RT28108 DATED

26/07/11

{84A68A2F-2499-4A98-AECE-

538618B2D0CD}

KOPRAN LIMITED AMPICLOXA 0800/06/97 AMPICILLIN/CLOXACILLIN

KOPRAN LIMITED VILLAGE SAVROLI

TALUKA KHALAPUR RAIGAD DISTRICT

PIN 410202

500MG CAPSULE 10*10 BLISTER INDIASUPER

PHARMACEUTICALS LTD.

29/01/09 RT28108 DATED 26/07/11

{1A8E5D57-1666-4A30-97D0-

1B2CA1CBB65B}

KOPRAN LIMITED DIFISAL 0801/02/97 DICLOFENAC

KOPRAN LIMITED VILLAGE SAVROLI

TALUKA KHALAPUR RAIGAD DISTRICT

PIN 410202

50MG TABLET 10*10 BLISTER INDIASUPER

PHARMACEUTICALS LTD.

29/01/09 RT28108 DATED 26/07/11

{05DB32FA-AC16-4166-8644-

8DE72C2DA35A}

KOPRAN LIMITED TRIM-480 0806/06/97 CO-TRIMOXAZOLE

KOPRAN LIMITED VILLAGE SAVROLI

TALUKA KHALAPUR RAIGAD DISTRICT

PIN 410202

480MG TABLET 10*10 INDIASUPER

PHARMACEUTICALS LTD.

29/01/09 RT28108 DATED 26/07/11

{27F472F4-E944-4786-95D8-619B779128EA}

KOPRAN LIMITED AMYN-250 0808/06/97 AMOXYCILLIN

KOPRAN LIMITED VILLAGE SAVROLI

TALUKA KHALAPUR RAIGAD DISTRICT

PIN 410202

250MG CAPSULE 10 * 10 BLISTER, 1 * 1000HDPE INDIA

SUPER PHARMACEUTICALS

LTD.29/01/09 RT28108 DATED

26/07/11{69F1E932-0E56-4910-91F5-D30C37A98E12}

LABORATORY & ALLIED FERROUS SULPHATE 0813/10/97 FERROUS SULPHATE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

200MG TABLET 0813/10/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{46E3444E-9422-4DD3-97FB-04A63C448D89}

LABORATORY & ALLIED O.R.S 0814/10/97 ORAL REHYDRATION

SALT

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

POWDER FOR ORAL SOLUTION 0814/10/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED

18/07/2011

{3A5CD00D-3B67-4B55-B9A6-

58FA3007CA54}

LABORATORY & ALLIED CHALEATE 0816/03/97 CHLORPHENIRAMINE

MALEATE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

4MG TABLET 0816/03/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{11069514-9261-4F26-80A9-8895A5EBDB26}

LABORATORY & ALLIED WHITFIELD'S 0818/13/97 z

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

OINTMENT 0818/13/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED 18/07/2011

{5EE6598D-AC79-47E9-9943-

474A6E030574}

LABORATORY & ALLIED HYCORUM 0819/13/97 HYDROCORTISONE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

1%W/W CREAM 0819/13/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{F99AE408-6BDF-4D3A-98DC-

1D23EF048819}

Page 13

Page 14: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

LABORATORY & ALLIED LABESTEN 0820/13/97 CLOTRIMAZOLE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

1%W/W CREAM 0820/13/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{A317D8D3-9C84-45F8-8BFA-14B7DF8F4AB9}

LABORATORY & ALLIED KLOXY 0821/06/97 CLOXACILLIN

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

125MG/5ML POWDER FOR ORAL SUSPN 0821/06/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED

18/07/2011

{1565DC34-E841-4F8A-AEEA-

1448EDEFD962}

LABORATORY & ALLIED

ASPIRIN TABLETS B.P 0822/02/97 ACETYLSALICYCLIC

ACID

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

300MG TABLET 0822/02/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{BD6A996F-DC1B-4DC4-B79C-

0A41E0FB188A}

LABORATORY & ALLIED HYODOPA 0823/12/97 METHYLDOPA

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

250MG TABLET 0823/12/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{314AD251-76E9-4183-A417-0DFA7ED17706}

LABORATORY & ALLIED LAE-PEN V 0825/06/97 PHENOXYMETHYLPE

NICILLIN

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

250MG TABLET 0825/06/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED 18/07/2011

{DAE6FA45-EAA4-4535-B098-

C45E319D87EE}

LABORATORY & ALLIED LAEOVATE 0828/13/97 BETAMETHASONE

VALERATE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

0.1%W/W OINTMENT 0828/13/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED 18/07/2011

{D4DA7085-27FD-405E-9947-

34D12E8D7D15}

LABORATORY & ALLIED LACILLIN 0833/06/97 AMPICILLIN

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

125MG/5ML POWDER FOR ORAL SUSPN 0833/06/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED

18/07/2011

{6D6DC92A-C721-49AC-BD78-

8D6122D625F2}

LABORATORY & ALLIED VIPRIN 0835/02/97 ACETYLSALICYCLIC

ACID

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

300MG TABLET 0835/02/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED 18/07/2011

{2C3BB0AA-779E-4319B29E-113E98DE5AA0}

LABORATORY & ALLIED FOLIC ACID 0836/10/97 FOLIC ACID

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

5MG TABLET 0836/10/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{49DE09FE-6EEC-4583-A257-

276E99D507B6}

LABORATORY & ALLIED LACILLIN 0837/06/97 AMPICILLIN

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

250MG CAPSULE 0837/06/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED 18/07/2011

{FC8A6614-2AFE-4BFD-9C46-

6BB1CF5F0C8C}

LABORATORY & ALLIED LECOTRIM 0839/06/97 CO-TRIMOXAZOLE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

480MG TABLET 0839/06/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED 18/07/2011

{51A5A4EE-12B7-42B4A6D7-392AD105555D}

LABORATORY & ALLIED LTD. AMOXYCILLIN 0840/06/97 AMOXYCILLIN

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

250MG CAPSULE 0840/06/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{DB7681E8-A7B1-4773-BA6C-A6A9DE608F95}

LABORATORY & ALLIED NATOA 0842/06/97 MEBENDAZOLE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

100MG TABLET 0842/06/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED 18/07/2011

{2A14176B-2F53-4BA7-93D9-B845C346A9CA}

LABORATORY & ALLIED HYCORUM 0844/13/97 HYDROCORTISONE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

1%W/V OINTMENT 0844/13/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{6DE287A2-C4DD-4F24-8ED0-

76030333A91A}

Page 14

Page 15: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

LABORATORY & ALLIED LAEOVATE 0846/13/97 BETAMETHASONE

VALERATE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

0.1%W/W CREAM 0846/13/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED 18/07/2011

{14C9D5C3-49EC-45C8-BFF2-

FA131F29B3EE}

LABORATORY & ALLIED TRYACTIN 0847/17/97

COMPOUND MAGNESIUM TRISILICATE

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

370MG TABLET, CHEWABLE 0847/17/97 KENYA METRO P'CALS LTD 02/08/2010 RT27901 DATED 18/07/2011

{9E424DB3-588D-4001-A1B9-1637C549C107}

LABORATORY & ALLIED KLOXY 0850/06/97 CLOXACILLIN

LABORATORY & ALLIED LTD. PLOT

209/10349 OFF MOMBASA RD

NAIROBI

250MG CAPSULE 0850/06/97 KENYA METRO P'CALS LTD 02/08/10 RT27901 DATED 18/07/2011

{0E109162-5C57-42D4-9742-46F9BB4F0059}

MAC'S PHARMACEUTICALS

LTDMAXADOL TABLETS 0911/02/97 PARACETAMOL

MAC'S PHARMACEUTICALS LTD OFF SHIMO LA TEWA RD NAIROBI

500MG TABLET 10 * 10, 2 * 10, 2 * 50 KENYA MATRIX (U) LTD

RE-INSP PAYMENT RT14843 DATED

13/11/2009. INSP 2010 PASSED

RT31681 DATED 08/12/2011

{B4AFD23F-1AF2-4D60-8C76-

4FDDEC364E31}

MEPHA LTD OLFEN-50 0934/02/97 DICLOFENAC SODIUM

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

50MG TABLET F/C 20 SWITZERLAND GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011{65E49E85-58D2-4968-A4C1-66633509B0BB}

MEPHA LTD SIMEPAR CAPSULES 0938/27/97 MULTINGREDIENT

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

MULTINGREDIENT CAPSULE 40 SWITZERLAND GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011{FE730A04-83A9-4595-9576-CFB8A3A8CEB1}

MEPHA LTD OLFEN-75 0939/02/97 DICLOFENAC SODIUM

MERCKLE GMBH, LUDWIG MERCKLE STRASSE3 D-89143

BLAUBEUREN

75MG/2ML INJECTION 2ML AMPOULE GERMANY GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011{989478B8-9713-4616-85A4-97A41E2000D9}

MEPHA LTD OLFEN-100 SR DEPOCAPS 0940/02/97 DICLOFENAC

SODIUM

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

100MG CAPSULE S/R 10 BLISTER SWITZERLAND GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011

{905BC95B-3BB2-48F0B8BA-

3A000DAAADFC}

MEPHA LTD NEURORUBINE 0942/27/97 MULTIVITAMIN

MERCKLE GMBH, LUDWIG MERCKLE STRASSE3 D-89143

BLAUBEUREN

MULTINGREDIENT INJECTION 1ML, 3ML AMPOULE GERMANYGOODMAN

PHARMACEUTICALS LTD

19/08/2009 RT28480 DATED 11/08/2011

{04FC8E57-A8A1-4671-A282-D01CD5285032}

MEPHA LTD NEURORUBINE 0943/27/97 MULTIVITAMIN

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

MULTINGREDIENT TABLET F/C 1 * 2*10 , 1 * 100 * 10 BLISTER SWITZERLAND GOODMAN

INTERNATIONAL LTD 19/08/2009 RT28480 DATED 11/08/2011

{9142F24E-61DE-4633-9FB8-B3F188FDDC3B}

MEPHA LTD MEPHAQUIN LACTAB 0945/06/97 MEFLOQUINE

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

250MG TABLET F/C 4 BLISTER SWITZERLAND GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011{C3521F64-2CA9-4152-882A-D9E9395670DB}

MEPHA LTD OLFEN GEL 0946/13/97 DICLOFENAC SODIUM

MERCKLE GMBH, LUDWIG MERCKLE STRASSE3 D-89143

BLAUBEUREN

1% GEL FOR TOPICAL USE 20GM & 50GM GERMANY GOODMAN

INTERNATIONAL LTD 19/08/2009 RT28480 DATED 11/08/2011

{07F9C426-D3D4-4A28-9EAB-C0B56AB30874}

NEM LABORATORIES (PVT) LTD RHEUMATIC CREAM 1028/13/97 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT CREAM 15GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011{A64F6F26-83EA-429C-B684-394518D01AA9}

NEM LABORATORIES (PVT) LTD TIGBODERM 1029/13/97 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT CREAM 3GM &15GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{C15BE818-5CCA-4A78-BDCF-

61B352BE1314}

NEM LABORATORIES (PVT) LTD BURNCURE 1030/13/97 SILVER

SULPHADIAZINE

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

1%W/W CREAM 15GM & 200GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{0D8326B5-36E9-4ADA-A08E-

A9160089B3EF}

Page 15

Page 16: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

NEM LABORATORIES (PVT) LTD BETAVEL N 1031/13/97 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT CREAM 3GM &15GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{1C6DFF78-DE19-4E6C-ACC1-

C7ECA5F24760}

NEM LABORATORIES (PVT) LTD BETAVEL 1032/13/97 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT CREAM 15GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011{A8909711-DBA6-47EA9468-6D41615B3D6C}

NEM LABORATORIES (PVT) LTD BETAVEL C 1038/13/97 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT CREAM 15GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{22FD577B-BA44-4C2B-B9D9-

48AD18911205}

NEM LABORATORIES (PVT) LTD TINODERM 1040/13/97 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT OINTMENT 18GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{82AEE0A9-89DD-449B-8D56-

F5DBE574FE71}

NEM LABORATORIES (PVT) LTD NEM SCAB 1042/13/97 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT OINTMENT 15GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{CAFA2CE7-D193-45C1-ABD1-

0079AE758130}

NEM LABORATORIES (PVT) LTD CLONEM 1043/13/97 CLOTRIMAZOLE

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

1%W/W CREAM 20GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{AD564230-5315-4AFC-9548-

972DDAAAADE6}

NEM LABORATORIES (PVT) LTD BURNNEM 1044/13/97 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT CREAM 20GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011{60EA79FE-D377-4139-B53A-28E6FFA3B036}

NEM LABORATORIES (PVT) LTD H-CORT 1046/13/97 HYDROCORTISONE

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

0.1%W/W CREAM 15GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{E7F908ED-0836-4B6C-AA31-

193320E7CD1E}

NEM LABORATORIES (PVT) LTD NEODINE OINMNET 1047/13/97 POVIDONE IODINE

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

5%W/W OINTMENT 15GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011{4622A812-10E0-47BB-A27A-D7C9165072AC}

NEM LABORATORIES (PVT) LTD

WHITTFIELDS OINMNET BP 1048/13/97 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT OINTMENT 20GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011{1B44F10B-EC55-4074-A88F-E3EFF9EB6AF9}

NEM LABORATORIES (PVT) LTD SULPHUR OINMENT 1049/13/97 SULPHUR

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

10%W/W OINTMENT 25GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011{B34289AE-2442-4BF7-9E17-62DCFBBD9F26}

Page 16

Page 17: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

PFIZER LABORATORIES

(PTY) LTDDIFLUCAN 1079/06/97 FLUCONAZOLE

PFIZER PGM AMBROISE ZONE INDUSTRIELLE 29

ROUTE DES INDUSTRIES 37530 POCE SUR CISSE

50ML/5ML ORAL POWDER 35ML FRANCE LABOREX (U) LTD RT28810 DATED 26/08/2011

{9DB797C9-31B6-4757-B45E-A09ACFD13004}

PFIZER LABORATORIES

(PTY) LTDFASIGYN 1080/06/97 TINIDAZOLE

PFIZER PGM AMBROISE ZONE INDUSTRIELLE 29

ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE

FRANCE

500MG TABLET 4 & 8 BLISTER FRANCE LABOREX (U) LTD RT28810 DATED 26/08/2011

{07D37FD6-8F1C-4D23-A330-

760920C6B04A}

PFIZER LABORATORIES

(PTY) LTDNORVASC 1086/12/97 AMLODIPINE

PFIZER LABORATORIES

(PTY) LTD5MG TABLET 30 BLISTER SOUTH AFRICA LABOREX (U) LTD RT28810 DATED

26/08/2011

{BABD68F4-2796-4C18-BE29-

D8F075A6100F}

PFIZER LABORATORIES

(PTY) LTDTERRA-CORTRIL 1087/12/97 MULTI-INGREDIENT

PFIZER PGM ORLEANS FRANCE,

AVENUE DE CONCYR, F-450

MULTI-INGREDIENT EYE SUSPENSION 4ML, 5ML & 10ML FRANCE LABOREX (U) LTD RT28810 DATED 26/08/2011

{DEA6B102-6393-4E9D-825A-

2243B95E035E}

PFIZER LABORATORIES

(PTY) LTDDIFLUCAN 1088/06/97 FLUCONAZOLE

PFIZER PGM AMBROISE ZONE INDUSTRIELLE 29

ROUTE DES INDUSTRIES 37530 POCE SUR CISSE

150MG CAPSULE 1 BLISTER FRANCE LABOREX (U) LTD RT28810 DATED 26/08/2011

{3A693889-832F-4D7F-BB9B-ED892505CE7A}

PFIZER LABORATORIES

(PTY) LTDDIFLUCAN 1089/06/97 FLUCONAZOLE

PFIZER PGM AMBROISE ZONE INDUSTRIELLE 29

ROUTE DES INDUSTRIES 37530 POCE SUR CISSE

2MG/ML INJECTION 5ML 25ML &100ML FRANCE LABOREX (U) LTD RT28810 DATED 26/08/2011

{E6A96812-5044-4DEB-9234-ACD5169FA391}

JOHNSON&JOHNSON PTY LTD COMBANTRIN 1094/06/97 PYRANTEL PAMOATE

JOHNSON&JOHNSON PTY LTD -241 MAIN RD/HOOFWEG 241,

125MG TABLET 6 BLISTER & 100 SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED 18/10/2011

{A378586E-16AB-48FCB708-C022AC2E260C}

PFIZER LABORATORIES

(PTY) LTDZITHROMAX 1096/06/97 AZITHROMYCIN

DIHYRATE

PFIZER LABORATORIES

(PTY) LTD200MG/5ML SUSPENSION PODER 15ML & 30ML SOUTH-AFRICA LABOREX (U) LTD RT28810 DATED

26/08/2011

{1FDDCF1A-63AC-49EE-80CC-

31A506902911}

JOHNSON&JOHNSON PTY LTD VISINE 1097/21/97 TETRAHYDROZOLINE

PFIZER INC. 365 MADAWASKA BOULEVARD, ARNPRIOR, ONTARIO

0.5MG/ML EYE DROP 15ML CANADA ERIS LIMITED 03/08/2009 RT30480 DATED 18/10/2011

{9D13CA67-02A5-449EBC43-1B6C97E1A721}

PFIZER LABORATORIES

(PTY) LTDDIFLUCAN 1098/06/97 FLUCONAZOLE

PFIZER PGM AMBROISE ZONE INDUSTRIELLE 29

ROUTE DES INDUSTRIES 37530 POCE SUR CISSE

200MG CAPSULE 7 BLISTER FRANCE LABOREX (U) LTD RT28810 DATED 26/08/2011

{5F3D965F-1C1D-4260-9328-1C2D1576D07D}

RENE PHARMACY LTD

PRIMAQUINE TABLETS 1256/06/97 PRIMAQUINE

PHOSPHATE

CYANO PHARMA(P) 115-C IND ESTATE

POLOGROUND, INDORE 452015

15MG TABLET 1000 INDIA RENE PHARMACY LTD 21/04/09 RT29482 DATED

22/09/11

{EC5C39A0-C5B3-49F3-85E7-

A4A4A578A607}

RENE PHARMACY LTD LEVATEX TABLETS 1261/06/97 LEVAMISOLE

HYDROCHLORIDE

CYANO PHARMA(P) 115-C IND ESTATE

POLOGROUND, INDORE 452015

40MG TABLET 10*3 & 500 HDPE INDIA RENE PHARMACY LTD 21/04/09 RT29482 DATED

22/09/11{670A6BD7-5C33-4501-A513-349287EE7252}

RENE PHARMACY LTD

PHENOBARBITONE TABLETS 1262/05/97 PHENOBARBITONE

CYANO PHARMA(P) 115-C IND ESTATE

POLOGROUND, INDORE 452015

30MG TABLET 1000 INDIA RENE PHARMACY LTD 21/04/09 RT29482 DATED

22/09/11

{E44F5633-E448-4710-AE0C-

F73DFA26FBE1}

RENE PHARMACY LTD DIAZPAM TABLETS 1265/24/97 DIAZEPAM

CYANO PHARMA(P) 115-C IND ESTATE

POLOGROUND, INDORE 452015

5MG TABLET 1000 INDIA RENE PHARMACY LTD 21/04/09 RT29482 DATED

22/09/11

{250FCBC9-3C80-4465-BDA3-

9F86EB9D6EB9}

RENE PHARMACY LTD ADSOCARB TABLETS 1266/17/97 ACTIVATED

CHARCOAL

CYANO PHARMA(P) 115-C IND ESTATE

POLOGROUND, INDORE 452015

250MG TABLET 100'S INDIA RENE PHARMACY LTD 21/04/09 RT29482 DATED

22/09/11

{A965FA01-76CE-49EB-9B83-

E42D10F4E521}

Page 17

Page 18: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

RENE PHARMACY LTD

CODIENE PHOSPHATE

TABLETS1269/02/97 CODEINE

PHOSPHATE

CYANO PHARMA(P) 115-C IND ESTATE

POLOGROUND, INDORE 452015

30MG TABLET 100 HDPE INDIA RENE PHARMACY LTD 21/04/09 RT29482 DATED

22/09/11{853FD012-8043-4D50-BA4B-F4D8B9F0C5B9}

ROYAL GROUP BETADERM N OINTMENT 1373/13/97

BETAMETHASONE VALERATE + NEOMYCIN

ATCO LABORATORIES PVT

LTD B - 18, S.I.T.E KARACHI 75700

OINTMENT 5GM & 15GM PAKISTAN ABACUS PHARMA (A) LTD 02/03/09 RT28249 DATED

01/08/11

{688017B4-0C58-4BDC-9FC7-

B574B0206B6E}

ROYAL GROUP BETADERM N CREAM 1374/13/97BETAMETHASONE

VALERATE + NEOMYCIN

ATCO LABORATORIES PVT

LTD B - 18, S.I.T.E KARACHI 75700

CREAM 5GM & 15GM PAKISTAN ABACUS PHARMA (A) LTD 02/03/09 RT28249 DATED

01/08/11{D472DB53-8E51-4413-89D4-1E83FBED0556}

ROYAL GROUP HAEMOFORTE SYRUP 1375/10/97 MULTI-INGREDIENT

NABIQASIM INDUSTRIES (PVT)

LTD 17/24 KORANGI I IND'L AREA KARACHI

MULTI-INGREDIENT SYRUP 90ML & 250ML PAKISTAN ABACUS PHARMA (A) LTD 25/02/09 RT28249 DATED

01/08/11{FB1C161A-C37F-4314-985C-07813026DDEB}

ROYAL GROUP BETADERM CREAM 1376/13/97 BETAMETHASONE VALERATE

ATCO LABORATORIES PVT

LTD B - 18, S.I.T.E KARACHI 75700

0.1%W/W CREAM 5GM & 15GM PAKISTAN ABACUS PHARMA (A) LTD 02/03/09 RT28249 DATED

01/08/11

{6CE0B710-DA67-494A-9A08-

7FA9041CE441}

ROYAL GROUP PROBETA EYE DROPS 1377/21/97 BETAMETHASONE

SODIUM PHOSPHATE

ATCO LABORATORIES LTD

B - 18, S.I.T.E KARACHI 75700

0.1%W/V EYE DROP 7.5ML PAKISTAN ABACUS PHARMA (A) LTD 02/03/09 RT28249 DATED

01/08/11

{BDCCEBD9-E683-44EC-B3E2-

ABFEAC339FBE}

ROYAL GROUP PROBETA N EYE DROP 1378/21/97 BETAMETHASONE +

NEOMYCIN

ATCO LABORATORIES PVT

LTD B - 18, S.I.T.E KARACHI 75700

EYE DROP 7.5ML PAKISTAN ABACUS PHARMA (A) LTD 02/03/09 RT28249 DATED

01/08/11{50D438A4-07C9-40B9-9678-B2AF0C8BB879}

ROYAL GROUP BETADERM OINTMENT 1379/13/97 BETAMETHASONE

VALERATE

ATCO LABORATORIES PVT

LTD B - 18, S.I.T.E KARACHI 75700

0.1%W/W OINTMENT 5GM & 15GM PAKISTAN ABACUS PHARMA (A) LTD 02/03/09 RT28249 DATED

01/08/11{49F4D8F7-86D0-4624-A0BA-8DD77016F953}

NOVARTIS PHARMA AG LAMISIL 1383/06/97 TERBINAFINE

NOVARTIS PHARMACEUTICALS LTD, HORSHAM, UK

125MG TABLET 14 UK SURGIPHARM (U) LTD

{494F6703-8995-4A7C-8F11-FB1DB1215836}

NOVARTIS PHARMA AG LAMISIL 1385/06/97 TERBINAFINE

NOVARTIS PHARMACEUTICALS LTD, HORSHAM, UK

250MG TABLET 14 UK SURGIPHARM (U) LTD

{222F524D-D616-41A8-B7AD-94DCB9A23298}

NOVARTIS CONSUMER

HEALTHCARE INTERNATIONAL

LAMISIL CREAM 1386/13/97 TERBINAFINE NOVARTIS CONSUMER HEALTH 1%W/W CREAM 15GM SWITZERLAND BETA HEALTH CARE

(U) LTD{057134C4-41A2-4EE5-AE33-C84B2712DDA0}

SCHERING N.V, SA NORIGYNON 1389/22/97 z SCHERING AG 50MG/5MG INJECTION 1ML AMPOULE GERMANYSTAR

PHARMACEUTICALS LTD

{F29590B8-6E54-4F09-A4BB-E711D6B90E9F}

SCHERING N.V, SA UROGRAFIN 1390/14/97 DIATRIZOIC ACID SCHERING N.V, SA 76% INJECTION 20ML SPAIN SURGIPHARM (U) LTD

{FEE5431A-36E3-41FBAE37-45733C3B157D}

SCHERING N.V, SA GYNO TRAVOGEN OVULE 1393/13/97 ISOCONAZOLE

NITRATE SCHERING AG 600MG PESSARY 1 STRIP GERMANY SURGIPHARM (U) LTD

{D3185FDD-8B59-4E21-A988-

21830F4A5105}

SCHERING N.V, SA TRAVOCORT 1394/13/97

DIFLUCORTONE VALERATE +

ISOCONAZOLE NITRATE

INTENDIS MANUFACTURING

S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN)

ITALY

0.1% +0.1% CREAM 15GM ITALY SURGIPHARM (U) LTD

{E971DFFB-49E1-484D-8C19-

C516D315C1B6}

SCHERING N.V, SA SCHERIPROCT SUPPOSITORIES 1396/13/97

PREDNISOLONE CAPROATE/

CICHOCAINE HCLSCHERING N.V, SA SUPPOSITORY 12 STRIP GERMANY SURGIPHARM (U)

LTD

{3728AFEF-501A-44AB8DEB-

2F394BACD8D5}

Page 18

Page 19: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SCHERING N.V, SA PRIMOLUT N 1400/22/97 NORETHISTERONE SCHERING N.V, SA 5MG TABLET 30'S BOTTLE GLASS GERMANY SURGIPHARM (U) LTD

{49CDB2FE-0A2A-4373-84FA-

17E7F16D83D9}

SCHERING N.V, SA PROVIRON 1401/18/97 MESTEROLONE SCHERING N.V, SA 25MG TABLET 20 STRIP GERMANY SURGIPHARM (U) LTD

{BA5A5C83-8DAC-4B1B-A2C0-

ED6C4E11893A}

SCHERING N.V, SA NORISTERAT 1402/22/97 NORETHISTERONE ENANTATE SCHERING AG 200MG SUSPENSION FOR

INJECTION 1ML SYRINGE GERMANY SURGIPHARM (U) LTD

{2D563164-24C2-46DB-9470-AF135190EDB4}

SCHERING N.V, SA PRIMOLUT DEPOT 1403/22/97 HYDROXYPROTERONE HEXANOATE SCHERING N.V, SA 250MG INJECTION

SUSPENSION 1ML AMPPOULE GERMANY SURGIPHARM (U) LTD

{9E86BFA5-E05F-4C48-8D98-

A4323C7F8F6F}

SCHERING N.V, SA SCHERIPROCT OINTMENT 1405/13/97

PREDNISOLONE CAPROATE/

CICHOCAINE HCL

INTENDIS MANUFACTURING

S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN)

ITALY

1.9MG/G & 5MG/G OINTMENT 10GM ITALY SURGIPHARM (U) LTD

{2A684485-DDFE-45BA-9ADF-

C5239E30918C}

SMITHKLINE BEECHAM

INTERNATIONALFLOXAPEN SYRUP 1419/06/97 FLUCLOXACILLIN

SMITHKLINE BEECHAM

PHARMACEUTICALS, CLARENDON ROAD

125MG/5ML ORAL SUSPENSION 100ML UK ERIS LTD 19/08/09 RT28825 DATED 27/08/11

{653A674B-8E96-4280-B7F3-E02233A4483E}

SMITHKLINE BEECHAM

INTERNATIONALAMOXIL 1432/06/97 AMOXYCILLIN

SMITHKLINE BEECHAM

CLARENDON RD WORTHING WEST

SUSSEX

125MG/5ML SUSPENSION POWDER 100ML UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11

{093FDC3B-7941-4239-AEED-

CC90C53C81E3}

SMITHKLINE BEECHAM

INTERNATIONALAMOXIL 1433/06/97 AMOXYCILLIN

SMITHKLINE BEECHAM

CLARENDON RD WORTHING WEST

SUSSEX

250MG/5ML SUSPENSION POWDER 100ML UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11{2112773B-8662-4B23-90DB-E275844FBC43}

SMITHKLINE BEECHAM

INTERNATIONALFLOXAPEN 1435/06/97 FLUCLOXACILLIN

SMITHKLINE BEECHAM

CLARENDON RD WORTHING WEST

SUSSEX

250MG CAPSULE 100 BLISTER UK ERIS LTD 19/08/09 RT28825 DATED 27/08/11

{E612B730-C759-4BBEBB42-99612E3ADE5D}

SMITHKLINE BEECHAM

INTERNATIONALAUGMENTIN 1438/06/97 AMOXYCILLIN/CLAVU

LANIC ACID

SMITHKLINE BEECHAM

WORTHING ,UK (MEMBER OF THE

GLAXOSMITHKLINE GROUP OF

COMPANIES)

1.2 GM POWDER FOR INJECTION (1 * 10) VIAL UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11{89589874-001E-4C7C-ADD6-F41140856639}

SMITHKLINE BEECHAM

INTERNATIONALAUGMENTIN 1439/06/97 AMOXYCILLIN/CLAVU

LANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICALS, CLARENDON ROAD

600MG POWDER FOR INJECTION (1 * 10) VIAL UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11{8D085084-2176-4481-BF67-AB0F8DB434FC}

SMITHKLINE BEECHAM

INTERNATIONALAUGMENTIN 1440/06/97 AMOXYCILLIN/CLAVU

LANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICALS, CLARENDON ROAD

375MG TABLET 2*10 BLISTER UK ERIS LTD 19/08/09 RT28825 DATED 27/08/11

{5799E3E1-64C6-4A41-9CE1-2C4134830FAF}

SMITHKLINE BEECHAM

INTERNATIONALAMOXIL 1446/06/97 AMOXYCILLIN

SMITHKLINE BEECHAM

CLARENDON RD WORTHING WEST

SUSSEX

250MG CAPSULE 10*10 BLISTER UK ERIS LTD 19/08/09 RT28825 DATED 27/08/11

{3E2142DE-ECBA-4502-A85E-

8E331DDBACAA}

SMITHKLINE BEECHAM

INTERNATIONALENGERIX-B VACCINE 1449/19/97 HEPATITIS B

VACCINE

GLAXOSMITHKLINE BIOLOGICALS B-1330, RIXENSART

BELGIUM

20MCG INJECTION SUSPENSION VIAL BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11

{9DE9FF8B-52C7-481A-9929-

4C237D778353}

SMITHKLINE BEECHAM

INTERNATIONALZENTEL 1451/06/97 ALBENDAZOLE

FARMACLAIR 440 AVENUE DU

GENERAL DE GAULLE 14200

HEROUVILLE SAINT CLAIR FRANCE

100MG/5ML ORAL SUSPENSION 20ML FRANCE ERIS LTD 10/10/07 + RE-AUDIT FEES (RT22506)

RT28825 DATED 27/08/11

{96632173-5597-4A13-B106-3DE9F03E7B8A}

Page 19

Page 20: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SMITHKLINE BEECHAM

INTERNATIONALBACTROBAN 1452/13/97 MUPIROCIN

GLAXO OPERATIONS UK LTD HARMIRE ROAD, BARNARD CASTLE COUNTY

DURHAM

2%W/W OINTMENT 3GM & 15GM UK ERIS LTD 18/08/09 RT28825 DATED 27/08/11

{32E18A3D-960A-4D0288C1-539298BC7131}

SMITHKLINE BEECHAM

INTERNATIONALHAVRIX 1440 1453/19/97 HEPATITIS A

VACCINE

SMITHKLIME BEECHAM

BIOLOGICALS1440 ELISA INJECTION

SUSPENSION VIAL BELGIUM ERIS LTD 04/10/07 + RE-AUDIT FEES (RT22504)

RT28825 DATED 27/08/11

{C34DC03F-475C-4904-8AD2-

9A293E2F26B7}

SMITHKLINE BEECHAM

INTERNATIONALCOTREICH 1454/06/97 CO-TRIMOXAZOLE

MEDRIECH STERILAB LTD, ANALGHALLI,

BANGLORE - 5600

960MG TABLET 10*10, 1000 INDIA ERIS LTD 03/12/07 RT28825 DATED 27/08/11

{992DA8A0-5835-4948-820E-7AD0AE65EBB0}

SMITHKLINE BEECHAM

INTERNATIONALINFANTRIX 1456/19/97 DIPHTHERIA

TETANUS PERTUSSIS

SMITHKLINE BEECHAM

BIOLOGICALS , BELGIUM

INJECTION SUSPENSION 0.5ML BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11{B61C5B77-F63E-47A3A64D-FFDE3E310051}

SMITHKLINE BEECHAM

INTERNATIONALMENCEVAX AC 1472/19/97 MENINGOCOCCAL

A+C

GLAXOSMITHKLINE BIOLOGICALS B-1330, RIXENSART

BELG

50MCG INJECTION SUSPENSION 0.5ML BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11

{4CA22C62-EB0C-4C2D-9C09-

241F4FE84F17}

SMITHKLINE BEECHAM

INTERNATIONALDYCLOMAX 1489/02/97 DICLOFENAC

SODIUM

MEDRIECH STERILAB LTD, ANALGHALLI,

BANGLORE - 5600

50MG TABLET F/C 10*10 & 1000 INDIA ERIS LTD 03/12/07 RT28825 DATED 27/08/11

{04A8DA55-8C11-4FEB-B8CB-

86077DA7BF46}

SMITHKLINE BEECHAM

INTERNATIONALAUGMENTIN BD 1504/06/97 AMOXYCILLIN/CLAVU

LANIC ACID

SMITHKLINE BEECHAM

CLARENDON RD WORTHING WEST

SUS

625MG TABLET 1 * 14 BLISTER UK ERIS LTD 19/08/09 RT28825 DATED 27/08/11

{95A562CB-A620-4ED2-A16D-

7EEB5C805FF0}

SMITHKLINE BEECHAM

INTERNATIONALTRITANIX HB 1509/19/97 DPT-HEPATITIS B

VACCINE

SMITHKLINE BEECHAM

BIOLOGICALS , BELGIUM

INJECTION SUSPENSION 3ML & 10ML BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11

{CA2EF17B-FA70-4A07-AC46-

98286A4E2D06}

SMITHKLINE BEECHAM

COMSUMER HEALTHCARE LTD

SCOTT'S EMULSION ORANGE FLAVOUR 1515/27/97 z SMITHKLINE

BEECHAM (NAIROBI) ORAL EMULSIONS 100ML, 200ML KENYA ERIS LTD23/06/08 + RE-AUDIT

FEES-JV11/190 DATED 12/10/11

RT28825 DATED 27/08/11

{B574A984-A550-4D5E-A557-EED2D13EB586}

SMITHKLINE BEECHAM

COMSUMER HEALTHCARE LTD

HEDEX CAPLETS 1523/02/97 z SMITHKLINE BEECHAM (NAIROBI) CAPLET 20,110 & 100 BLISTER KENYA ERIS LTD

23/06/08 + RE-AUDIT FEES-JV11/190 DATED 12/10/11

RT28825 DATED 27/08/11

{EDFFC2F9-1406-472A-BBC1-

48A4541A3762}

SMITHKLINE BEECHAM

COMSUMER HEALTHCARE LTD

ANDREWS LIVER SALT REGULAR 1524/17/97 z SMITHKLINE

BEECHAM (NAIROBI)SUSPENSION

POWDER 5GM*8, 5GM*48 KENYA ERIS LTD23/06/08 + RE-AUDIT

FEES-JV11/190 DATED 12/10/11

RT28825 DATED 27/08/11

{3C58A9F0-BC91-4C8E-A215-

482911693088}

SMITHKLINE BEECHAM

COMSUMER HEALTHCARE LTD

LEMON ENO FRUIT SALT 1529/17/97 z SMITHKLINE

BEECHAM (NAIROBI)ORAL SOLUTION

POWDER 4.5GM*8, 4.5GM*48 KENYA ERIS LTD23/06/08 + RE-AUDIT

FEES-JV11/190 DATED 12/10/11

RT28825 DATED 27/08/11

{C7AA487A-9E7E-4B2A-9916-

04CA0DDA814C}

TORRENT PHARMACEUTICALS

LTDANTIDEP 1567/24/97 IMIPRAMINE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

25MG TABLET 10*10 & 1000 INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {36960582-0AFC-478C-

BD65-577E045F51B3}

TORRENT PHARMACEUTICALS

LTDANGIOPRIL-25 1581/12/97 CAPTOPRIL

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

25MG TABLET 10*10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {C28A3C09-3106-4412-

9337-6158B6DC9EF1}

TORRENT PHAMACEUTICALS

LTDTRIDEP-25 1582/24/97 AMITRIPYLINE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

25MG TABLET 1 * 10 * 10 BLISTER, 1 * 1000 HDPE INDIA

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {415FAE01-2F22-4E19-

BEE9-9A275321CA5D}

TORRENT PHARMACEUTICALS

LTDCALCIGARD-10 1585/12/97 NIFEDIPINE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

10MG CAPSULE 10*10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{31B9ACAB-2495-4D82-B228-

9ACFA53297C3}

Page 20

Page 21: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

UNIQUE PHARMACEUTICAL

LABORATORIES

METROGYL SUSPENSION 1605/06/97 METRONIDAZOLE

BENZOATE

J.B. CHEMICALS & PHARMACEUTICALS

LTD, 128/1, GIDC, ANKLESHWAR 393

002

200MG/ML ORAL SUSPENSION 100ML INDIA TATA (U) LTD 06/05/10 RT28496 DATED 12/08/11

{EA4A6687-1658-4B33-84A5-

7BC5F1C1AD6D}

UNIMED INDIA CHLORAMPHENICOL ORAL SUSPENSION 1611/06/97 CHLORAMPHENICOL

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

125MG/5ML ORAL SUSPENSION 100ML INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{785484C1-17AE-4427-9918-853C54AD439B}

UNIMED INDIA COLDAFEX TABLETS 1613/02/97 MULTI-INGREDIENT

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

MULTI-INGREDIENT TABLET 50*4 STRIP, 1*10*10 BLISTER INDIA META PRODUCTS (U)

LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{4F99DA71-BDDF-41AB-925F-

5BB8FAB52473}

UNIMED INDIA METRONIDAZOLE ORAL SUSPENSION 1615/06/97 METRONIDAZOLE

BENZOATE

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

125MG/5ML ORAL SUSPENSION 100ML INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{AAC8B3AE-3F37-4F6A-8867-

8CA6A5ECF4D7}

UNIMED INDIACOMPOUND MAGNESIUM TRISILICATE

1618/17/97 MAGNESIUM TRISILICATE

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

370MG TABLET, CHEWABLE 1000 HDPE INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{1FD535FB-D004-4627-9DCB-D24D34867666}

UNIMED INDIA FERROUS SULPHATE TABLETS BP 1619/10/97 FERROUS SULPHATE

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

200MG TABLET S/C 1000HDPE INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{945B1AC8-79BA-46DC-9A6B-

913A78A23BE4}

UNIMED INDIA CO-TRIMOXAZOLE TABLET BP 1620/06/97 CO-TRIMOXAZOLE

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

480MG TABLET 10BLISTER & 1000 HDPE INDIA META PRODUCTS (U)

LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{98D7AB58-FB9F-482E-836C-

4E4270ADD941}

UNIMED INDIA SPECTRIM SUSPENSION 1622/06/97 CO-TRIMOXAZOLE

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

240MG/5ML ORAL SUSPENSION 60ML & 100ML INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{3B9C3CBB-16CB-4038-937C-

C2698835F183}

PFIZER LABORATORIES

(PTY) LTDPROSTIN E2 1625/22/97 DINOPROSTONE

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUURS

3MG TABLET VAGINAL 4 BELGIUM LABOREX (U) LTD RT28810 DATED 26/08/2011

{92640A9E-81E5-46C1-ADD6-A0540385DB06}

PFIZER LABORATORIES

(PTY) LTDDEPO-PROVERA 1627/22/97 MEDROXYPROGEST

ERONE ACETATE

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUURS

150MG/ML INJECTION 1ML & 3.5ML BELGIUM ERIS LTD RT28810 DATED 26/08/2011

{8D57324E-0786-4A74-846A-1095D5A00DD7}

PFIZER LABORATORIES

(PTY) LTDDALACIN C 1628/06/97 CLINDAMYCIN

PALMITATE

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUUR

75MG/5ML GRANULE FOR ORAL USE 80ML BELGIUM LABOREX (U) LTD RT28810 DATED

26/08/2011{55355E7A-348F-4840-8684-FD75C6ADF4A6}

PFIZER LABORATORIES

(PTY) LTDDALACIN C 1629/06/97 CLINDAMYCIN

HYDROCHLORIDE

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUURS

300MG CAPSULE 16 & 100 BELGIUM LABOREX (U) LTD RT28810 DATED 26/08/2011

{A90ED69D-8431-442C-AD48-

DCB24A26ECCB}

PFIZER LABORATORIES

(PTY) LTDXANAX 1630/24/97 ALPRAZOLAM

SANICO N.V INDUSTRIEZONE 4, VEEDIJK 59 B-2300

TURNHOUT BTW BE 404 190 288

0.25MG TABLET 30 & 100 BELGIUM ERIS LTD RT28810 DATED 26/08/2011

{6BC15D61-2C6E-42AA-8BD3-

05F1B89ECC49}

Page 21

Page 22: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

PFIZER LABORATORIES

(PTY) LTDSOLU-MEDROL 1634/18/97

METHYLPREDNISOLONE

HEMISUCCINATE

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUUR

125MG/2ML INJECTION POWDER 2ML & 8ML BELGIUM LABOREX (U) LTD RT28810 DATED 26/08/2011

{2D85480F-F2F7-4D78-9E80-F4491ADC9EEE}

PFIZER LABORATORIES

(PTY) LTDDALACIN C 1637/06/97 CLINDAMYCIN

PHOSPHATE

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUUR

150MG/ML INJECTION 2ML & 4ML BELGIUM LABOREX (U) LTD RT28810 DATED 26/08/2011

{22C23916-7072-4BAF-97F1-0468C7CE3AF8}

PFIZER LABORATORIES

(PTY) LTDDALACIN C 1638/06/97 CLINDAMYCIN

HYDROCHLORIDE

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUURS

150MG CAPSULE 16 & 100 BELGIUM LABOREX (U) LTD RT28810 DATED 26/08/2011

{E52E555E-C851-4CF8-A363-

71250933CA60}

PFIZER LABORATORIES

(PTY) LTDDEPO-MEDROL 1642/18/97 METHYLPREDNISOL

ONE ACETATE

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUUR

40MG/ML INJECTION SUSPENSION 1ML. 2ML, & 5ML BELGIUM LABOREX (U) LTD RT28810 DATED

26/08/2011{D088423C-1776-46B2-94F2-FACF93A5966D}

PFIZER LABORATORIES

(PTY) LTDDALACIN T 1643/06/97 CLINDAMYCIN

PHOSPHATE

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUUR

1%W/V EXTERNAL SOLUTION 30ML BELGIUM LABOREX (U) LTD RT28810 DATED

26/08/2011{4A7B0416-79C8-4E55-B9FE-9455A44DEC27}

PFIZER LABORATORIES

(PTY) LTDNEO MEDROL 1647/13/97 MULTI-INGREDIENT PATHEON YM INC.

TORONTO, CANADA MULTI-INGREDIENT LOTION 25ML CANADA LABOREX (U) LTD RT28810 DATED 26/08/2011

{30061AB1-5F3C-4613-AB71-861FF3CE7C6D}

JOHNSON&JOHNSON PTY LTD

BENYLIN WITH CODIENE 1649/25/97

DIPHENHYDRAMINE HCL, AMMONIUM

CHLORIDE, CODEIN PHO

JOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD

/HOOFWEG 241,RETREAT

7945,SOUTH AFRICA

12.5MG, 125MG, 10MG / 5ML SYRUP 100ML & 200ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED

18/10/2011

{CABCB936-CE4A-4703-BFCE-

3F7764A9BDE5}

JOHNSON&JOHNSON PTY LTD BENYLIN ORIGINAL 1650/25/97

DIPHENHYDRAMINE HCL,

AMMONIUM CHLORIDE

JOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD

/HOOFWEG 241,RETREAT

7945,SOUTH AFRICA

12.5MG, 125MG /5ML SYRUP 100ML & 200ML,

2.5LTS SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED 18/10/2011

{3BFF80EF-9108-47AD-93BB-AD6FB993084C}

JOHNSON&JOHNSON PTY LTD

BENYLIN DRY COUGH DM 1651/25/97 DEXTROMETHORPAN

HYDROBROMIDE

JOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD

/HOOFWEG 241,RETREAT

7945,SOUTH AFRICA

15MG/5ML SYRUP 100ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED 18/10/2011

{244F5011-ADE0-4C11-A0F7-8CF7EAF7C192}

WOCKHARDT LIMITED ZEDEX 1655/25/97 z

WOCKHARDT LIMITED, PLOT NO 57

VILLAGE KUNJHAL POST

SYRUP 100ML INDIASTAR

PHARMACEUTICALS LTD

21/09/09 RT28254 DATED 01/08/11

{765FBAB0-7E6C-468B-9D1F-

59F8F01AC00A}

WOCKHARDT LIMITED BRO-ZEDEX 1656/25/97 z

WOCKHARDT LIMITED, PLOT NO 57

VILLAGE KUNJHAL POST

SYRUP 100ML INDIASTAR

PHARMACEUTICALS LTD

21/09/09 RT28254 DATED 01/08/11

{35D7B4F3-5631-4654-85DA-

4DA3EBC6DE48}

WOCKHARDT LIMITED PELOX-400 1665/06/97 PEFLOXACIN

WOCKHARDT LIMITED, PLOT NO 57

VILLAGE KUNJHAL POST

400MG TABLET 10 STRIP INDIASTAR

PHARMACEUTICALS LTD

21/09/09 RT28254 DATED 01/08/11

{8B579921-6EF3-4E92-91B1-FE29F8D519D6}

XEPA SOUL PATTISON (M) SDN

BHDLOPERAX CAPSULES 1668/17/97 LOPERAMIDE

HYDROCHLORIDE

XEPA SOUL PATTINSON

(MALAYSIA) SDN BLD 1-5 CHENG IND. ESTATE 75250

MELAKA

2MG CAPSULE 1*10 * 10 MALAYSIA MATRIX (U) LTD 05/02/2009 RT28476 DATED 11/08/11

{1441BF43-ED04-4CE8-B30A-

3874C4A22F96}

Page 22

Page 23: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

XEPA SOUL PATTISON (M) SDN

BHDFEBRICOL TABLETS 1677/02/97

PARACETAMOL / PSEUDOEPHEDRINE/ CHLORPHENIRAMINE

XEPA SOUL PATTINSON

(MALAYSIA) SDN BLD 1-5 CHENG IND. ESTATE 75250

MELAKA

500/ 30/ 2MG TABLET 1*10*10, 1*2*10 BLISTER MALAYSIA DELMAW

ENTERPRISES LTD 02/05/2009 RT29151 DATED 08/09/2011

{F50787FE-5658-4812-8E2A-8B38964213C8}

ASTRAZENECA TENORETIC 1691/12/97 ATENOLOL/CHLORTHALIDONE

ASTRAZENECA MACCLESFIELD

CHESHIRE100/25MG TABLET FC 1*14 BLISTER, 1*2*14

BLISTER UK MACNAUGHTON (U) LTD 19/08/09 RT29484 DTED

22/09/11

{FF6EC2BA-582B-4C9D-AEDC-

9C58B6E4915D}

ASTRAZENECA TENORET 1692/12/97 ATENOLOL/CHLORTHALIDONE

ASTRAZENECA MACCLESFIELD

CHESHIRE50/12.5MG TABLET FC 1 * 2 * 14 BLISTER UK MACNAUGHTON (U)

LTD 19/08/09 RT29484 DTED 22/09/11

{352948C2-0C12-4FA3-AF7E-828E98D1879E}

ASTRAZENECA TENORMIN 1702/12/97 ATENOLOLASTRAZENECA MACCLESFIELD

CHESHIRE50MG TABLET FC 1*14BLISTER, 1*2*14

BLISTER, 500 UK MACNAUGHTON (U) LTD 19/08/09 RT29484 DTED

22/09/11

{AF13D7CB-6A57-4FFC-B22F-

0ECB691DFC20}

ASTRAZENECA TENORMIN 1703/12/97 ATENOLOLASTRAZENECA MACCLESFIELD

CHESHIRE100MG TABLET FC 1 * 2 * 14 BLISTER,

500 UK MACNAUGHTON (U) LTD 19/08/09 RT29484 DTED

22/09/11{FF360B86-C9D3-4F20-9208-6EF542D76D0C}

ASTRAZENECA ZESTRIL 1704/12/97 LISINOPRILASTRAZENECA MACCLESFIELD

CHESHIRE20MG TABLET 1 * 2 * 14 BLISTER UK MACNAUGHTON (U)

LTD 19/08/09 RT29484 DTED 22/09/11

{6A388DCE-3A0F-456B-9458-

B1A3BE922DC4}

ASTRAZENECA ZOLADEX 1705/08/97 GOSERELINASTRA ZENECA MACCLESFIELD

CHESHIRE3.6MG INJECTION 1*1*1.2MM*1CM

INJECTION UK MACNAUGHTON (U) LTD 19/08/09 RT29484 DTED

22/09/11{1B69CA5B-7712-4734-8FFC-EB1AB8976385}

ASTRAZENECA ZESTORETIC 1706/12/97LISINOPRIL

/HYDROCHLORTHIAZIDE

ASTRAZENECA MACCLESFIELD

CHESHIRE20/12.5MG TABLET 1 * 2 * 14 BLISTER UK MACNAUGHTON (U)

LTD 19/08/09 RT29484 DTED 22/09/11

{18ED2B05-6C94-41EE-A647-

36344B2926A7}

ASTRAZENECA ZESTRIL 1707/12/97 LISINOPRILASTRAZENECA MACCLESFIELD

CHESHIRE10MG TABLET 1*14 BLISTER, 1*2*14

BLISTER UK MACNAUGHTON (U) LTD 19/08/09 RT29484 DTED

22/09/11

{A8EAD6D0-5E25-4AEC-B83E-

A7EF461F4134}

ASTRAZENECA NOLVADEX 1718/18/97 TAMOXIFENASTRAZENECA MACCLESFIELD

CHESHIRE10MG TABLET FC 1 * 3*10, 1 * 5*10

BLISTER UK MACNAUGHTON (U) LTD 19/08/09 RT29484 DTED

22/09/11{9139EB34-A2C2-47B6-8B1B-08DA63363F14}

ASTRAZENECA NOLVADEX 1719/18/97 TAMOXIFENASTRAZENECA MACCLESFIELD

CHESHIRE20MG TABLET FC 1 * 3*10 BLISTER UK MACNAUGHTON (U)

LTD 19/08/09 RT29484 DTED 22/09/11

{2A386B3A-C639-4562-8956-

EACDF1CA7B2B}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM QUIN MIXTURES 1726/06/97 QUININE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

100MG/5ML MIXTURES 60ML & 100ML UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{3398C073-F3D0-46E9-A31D-7398432B53BA}

ALEMBIC LTDBENZATHINE PENICILLIN INJECTION

1729/06/97 BENZATHINE BENZYLPENICILLIN

INJECTCARE PARENTERALS LTD.

PLOT NO. 130 SILVASSA

2.4 MEGAUNIT INJECTION POWDER VAIL INDIAGITTOES

PHARMACEUTICALS LTD.

28/06/2010 RT28449 DATED 10/08/2011

{44EBF3BC-CE31-4911-A6DB-

62AB8B534659}

ALEMBIC LTD ROXID TABLETS 150MG 1731/06/97 ROXITHROMYCIN

ALEMBIC LTD PLOT NO. 21-22 EPIP,

PHASE 1 JHARMAJRI 150MG TABLET F/C 10*10 BLISTER INDIA

GITTOES PHARMACEUTICALS

LTD.28/06/2010 RT28449 DATED

10/08/2011{9548F73A-FFAA-49B5-85D1-D11525230289}

ALEMBIC LTD CIPROWIN TABLETS 500MG 1734/06/97 CIPROFLOXACIN

ALEMBIC LTD PLOT NO. 21-22 EPIP,

PHASE 1 JHARMAJRI500MG TABLET F/C 10*10 BLISTER INDIA

GITTOES PHARMACEUTICALS

LTD.28/06/2010 RT28449 DATED

10/08/2011{138C2591-B4C1-44A8-900E-00AB8E3ABC35}

ALEMBIC LTD BENZYLPENICILLIN INJECTION 1735/06/97 BENZYLPENICILLIN

SODIUM

INJECTCARE PARENTERALS LTD.

PLOT NO. 130 SILVASSA

1.000.000 I.U INJECTION POWDER VIAL INDIAGITTOES

PHARMACEUTICALS LTD.

28/06/2010 RT28449 DATED 10/08/2011

{763B8016-7EFD-4E87-B126-18E655E67C8F}

ARENCO PHARMACEUTICA NV ARTENAM 1737/06/97 ARTEMETHER

EBEWE PHARMA MONDSEESTRASSE

11 A-4866 UNTERACH

100MG/ML INJECTION 1ML BELGIUM MCNAUGHTON(U) LTD 12/03/10 RT28522 DATED

15/08/11{D845F7EA-F90B-4216-9164-0C8052080A1A}

CADILA HEALTHCARE LTD BETANASE TABLETS 1741/18/97 GLIBENCLAMIDE

CADILA HEALTHCARE LTD,

KUNDAIM INDUSTRIAL ESTATE

P

5MG TABLET 1 * 10 * 10, 1 * 5*3*10 &2*50 BLISTER , 1*1000 INDIA ABACUS PHARMA (A)

LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{3B5F87BB-5083-4D84-8379-F68014AF682A}

Page 23

Page 24: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CENTAUR PHARMACEUTICALS

LTDSOLINA TABLETS 1752/24/97 DIAZEPAM

CENTAUR DRUG HOUSE PVT LTD,

PLOT NO. 39 TIVIN IND.

5MG TABLET 1000 HDPE INDIAGITTOES

PHARMACEUTICALS LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{AD734F92-ADEE-4292-B39C-

D5A6063703D4}

CENTAUR PHARMACEUTICALS

LTD

CENTACID SUSPENSION 1754/17/97 z

CENTAUR PHARMACEUTICALS LTD, KARASWADA

MAPUSA GOA

ORAL SUSPENSION100ML &

200ML,170ML AMBER PET BOTTLES

INDIAGITTOES

PHARMACEUTICALS LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{A0AB029C-8557-4334-A87C-4BF65DD127C8}

CENTAUR PHARMACEUTICALS

LTDSINAREST LINCTUS 1757/25/97 z

CENTAUR PHARMACEUTICALS LTD, KARASWADA

MAPUSA GOA

LINCTUS 100ML AMBER PET BOTTLE INDIA

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{1FACED34-E583-4FC0-8223-

3F35B3282EFA}

NOVO NORDISK A/S MIXTARD 30 HM 1870/18/97 INSULIN HUMAN NOVO NORDISK A/S 100I.U/ML INJECTION SUSPENSION 10ML VIAL DENMARK

STAR PHARMACEUTICALS

LTD

21/06/07 + RT20033 DATED 21/07/10

RT28543 DATED 15/08/11

{108F625D-E401-4EE2-A527-F77A3B3A3F1C}

NOVO NORDISK A/S INSULATARD HM PENFILL 1873/18/97 ISOPHANE INSULIN

(HUMAN) NOVO NORDISK A/S 100I.U/ML INJECTION SUSPENSION

1.5ML & 3ML CATRIDGE DENMARK

STAR PHARMACEUTICALS

LTD

21/06/07 + RT20033 DATED 21/07/10

RT28543 DATED 15/08/11

{4DED9BA6-EB03-41BA-A1B6-

C2EB72DF604D}

NOVO NORDISK A/S INSULATARD HM 1874/18/97 ISOPHANE INSULIN (HUMAN) NOVO NORDISK A/S 100 I.U/ML INJECTION

SUSPENSION 10MLVIAL DENMARKSTAR

PHARMACEUTICALS LTD

21/06/07 + RT20033 DATED 21/07/10

RT28543 DATED 15/08/11

{E2CBC551-DE20-424D-90E5-

75928D25247B}

NOVO NORDISK A/S ACTRAPID HM 1876/18/97 HUMAN INSULIN NOVO NORDISK A/S 100I.U/ML INJECTION SUSPENSION 10ML VIAL DENMARK

STAR PHARMACEUTICALS

LTD

21/06/07 + RT20033 DATED 21/07/10

RT28543 DATED 15/08/11

{E509D3DA-0F7B-4BE9-8CBC-

86AB1ACA3BE8}

NOVO NORDISK A/S MIXTARD 30 HM PENFILL 1877/18/97 BIPHASIC ISOPHANE

INSULIN (HUMAN NOVO NORDISK A/S 100I.U/ML INJECTION SUSPENSION

1.5ML, 3ML CATRIDGE DENMARK

STAR PHARMACEUTICALS

LTD

21/06/07 + RT20033 DATED 21/07/10

RT28543 DATED 15/08/11

{CBEFE581-25B6-4370970C-D0EAB64203D3}

NOVO NORDISK A/S ACTRAPID HM PENFILL 1878/18/97 HUMAN INSULIN

(SOLUBLE) NOVO NORDISK A/S 100 I.U/ML INJECTION 1.5ML & 3ML DENMARKSTAR

PHARMACEUTICALS LTD

21/06/07 + RT20033 DATED 21/07/10

RT28543 DATED 15/08/11

{9B06305C-E8AF-4F5A-816A-

B58C770B0121}

PHARMEDIC (PVT) LTD DIABIN TABLETS 1906/18/97 METFORMIN

PHARMEDIC (PVT) LTD 16KM MULTAN

ROAD LAHORE 5380500MG TABLET 10*10 BLISTER PAKISTAN HEALTH CARE LTD

24/04/06 + RE-AUDIT FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{1CAEE8BF-CC58-4DAF-95AC-

1F1DB984E3F0}

PHARMEDIC (PVT) LTD NILPAR TABLETS 1907/06/97 LEVAMISOLE

HYDROCHLORIDE

PHARMEDIC (PVT) LTD 16KM MULTAN

ROAD LAHORE 538050MG TABLET 20*3, 10*10, 500 HDPE PAKISTAN HEALTH CARE LTD

24/04/06 + RE-AUDIT FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{82F04744-A9AF-4B76-B0BE-

6EAFBEEC84F5}

PHARMEDIC (PVT) LTD

NILPAR DRY SUSPENSION 1909/06/97 LEVAMISOLE

HYDROCHLORIDE

PHARMEDIC (PVT) LTD 16KM MULTAN

ROAD LAHORE 538040MG/ML SUSPENSION

POWDER 15ML PAKISTAN HEALTH CARE LTD24/04/06 + RE-AUDIT

FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{DCBED133-AA97-4960-9C0E-

218510D04A91}

PHARMEDIC (PVT) LTD CLOMINOL TABLETS 1910/18/97 CLOMIPHENE

PHARMEDIC (PVT) LTD 16KM MULTAN

ROAD LAHORE 538050MG TABLET 10 BLISTER PAKISTAN HEALTH CARE LTD

24/04/06 + RE-AUDIT FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{5D26A8DE-DB3C-4C4E-BE15-

393B9055079A}

PHARMEDIC (PVT) LTD REGELAN TABLETS 1915/17/97 METOCLOPRAMIDE

PHARMEDIC (PVT) LTD 16KM MULTAN

ROAD LAHORE 538010MG TABLET 10*10, 10*2 & 500 PAKISTAN HEALTH CARE LTD

24/04/06 + RE-AUDIT FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{C4E22159-1856-4DB5-88AC-F6B389EEE2F0}

JOHNSON&JOHNSON PTY LTD ANUSOL OINTMENT 1979/13/97

BISMUTH SUBGALLATE,

BISMUTH OXIDE, ZINC OXIDE

JOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794

22.5MG, 8.75MG, 107.5MG OINTMENT 25G TUBE SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED

18/10/2011

{5DFE5F73-B516-46AE-9DA8-

D69FB0CA2A0E}

JOHNSON&JOHNSON PTY LTD

ANUSOL SUPPOSITORY 1983/13/97

BISMUTH SUBGALLATE,

BISMUTH OXIDE, ZINC OXIDE

JOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794

59MG, 24MG, 296MG SUPPOSITORY 10 BLISTER SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED

18/10/2011

{0EFBE2F2-02E5-4E7E-9300-

F432D564449E}

PFIZER LABORATORIES

(PTY) LTD

EPANUTIN READY MIXED PARENTERAL 1985/05/97 PHENYTOIN SODIUM

PFIZER ITALIA SPL VIA DEL

COMMERCIO 63046 MARINO DEL

TRONTO(AP) ITALY

50MG/ML INJECTION 5ML AMPOULE ITALY LABOREX (U) LTD RT28810 DATED 26/08/2011

{12122021-D228-42D8-BDB4-13C07DB55D59}

PFIZER LABORATORIES

(PTY) LTDEPANUTIN CAPSULE 1990/05/97 PHENYTOIN SODIUM WARNER LAMBERT

S.A (PTY) LTD 50MG CAPSULE 100 HDPE SOUTH AFRICA LABOREX (U) LTD RT28810 DATED 26/08/2011

{58469320-8598-452A-B55F-D401D0505B33}

Page 24

Page 25: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ASTRAZENECA CASODEX 50 MG 1991/08/97 BICALUTAMIDEASTRAZENECA MACCLESFIELD

CHESHIRE 50MG TABLET FC 1 * 2 * 14 BLISTER UK MACNAUGHTON (U)

LTD 19/08/09 RT29484 DTED 22/09/11

{F6FFB11E-041C-4CC4-9503-

E210569F3636}

ASTRAZENECA ZESTRIL 1994/12/97 LISINOPRILASTRAZENECA MACCLESFIELD

CHESHIRE5MG TABLET 1*14 BLISTER, 1*2*14

BLISTER UK MACNAUGHTON (U) LTD 19/08/09 RT29484 DTED

22/09/11

{A8A9B4E3-CC9C-4F1B-A3FC-

252F864D4D49}

BETA HEALTHCARE INTERNATIONAL LTD PRUNOL SYRUP 1998/25/97 IPECACUANHA

TINCTURE

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BO

0.5ML SYRUP 50ML KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11{A486D2E3-789A-4A5A904E-EC9313E98A03}

BETA HEALTHCARE INTERNATIONAL LTD SALIMIA LINIMENT 1999/13/97 METHYL SALICYLATE

TURPENTINE OIL

BETA HEALTHCARE INTERNATIONAL

LTD, BONDO ROAD, NAIROBI

5ML 25ML LINIMENT 50ML KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11{6E55994B-2A49-4B4D-BAC5-F5C54BF59424}

BETA HEALTHCARE INTERNATIONAL LTD

GOODMORNING COUGH TABLETS 2002/25/97 MULTINGREDIENT

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BO

MULTINGREDIENT TABLET 100 KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11

{AA27B351-A8D8-4C20-90ED-

A13549A85086}

ALBERT DAVID LTD MANNITOL INJECTION USP. 2021/16/97 MANNITOL

ALBERT DAVID LTD, B-12-13 MEERUT

ROAD INDUSTRIAL AREA GHAZIABAD

20% W/V INFUSION 100ML LDPE INDIA ANDYCO PHARMACY 03/04/2010 RT29208 DATED 12/09/2011

{DF3C622A-EFCE-4318-BD22-

D15E1D2A1CA5}

ALEMBIC LTDPROCAINE PENICILLIN FORTIFIED

2028/06/97PROCAINE PENICILLIN FORTIFIED

INJECTCARE PARENTERALS LTD.

PLOT NO. 130 SILVASSA

4.000.000 I.U INJECTION POWDER 1*10 VIALS INDIAGITTOES

PHARMACEUTICALS LTD.

28/06/2010 RT28449 DATED 10/08/2011

{C352D4CD-97A5-4094-AB38-

9C40716A3CA0}

CADILA PHARMACEUTICALS

LTD

CIPRODAC 500 TABLETS 2052/06/97 CIPROFLOXACIN

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

500MG TABLET 1*10 & 10*10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{40419C0A-104F-4903-AB4C-

6846EE4C8D3C}

CADILA PHARMACEUTICALS

LTDFLUZON TABLETS 2054/06/97 FLUCONAZOLE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

150MG TABLET 10*2 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{EDA63A9C-EF23-45DF-A3B5-

07020BE4F379}

CADILA PHARMACEUTICALS

LTDVIVORAX 2055/06/97 ACICLOVIR

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

200MG TABLET 10BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{6E35D5A5-69DF-4838-8844-543BE4BCB88B}

ELYS CHEMICAL INDUSTRIES LTD HEDAPAN TABLET 2075/02/97 ASPIRIN/PARACETAM

OL/CAFFEINE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

TABLET 10*10 STRIP KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{486C90F8-C8EA-4DD0-8868-

DA7ADB822C02}

FLAMINGO PHARMACEUTICALS

LTD

DOXYCYCLINE CAPSULES B.P. 2080/06/97 DOXYCYCLINE

HYDROCHLORIDE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

100MG CAPSULE 10*10, 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{D3381F6B-0811-44A5-BE32-9D3DFE2812EB}

FLAMINGO PHARMACEUTICALS

LTDMETROL TABLETS 2081/06/97 METRONIDAZOLE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

200MG TABLET, S/C 10*10, 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{4EF7DECC-18BA-4523-B002-

038F0357DF57}

FLAMINGO PHARMACEUTICALS

LTDFLAMIFEN TABLETS 2082/02/97 IBUPROFEN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

200MG TABLET 10*10, 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{31EC4080-096A-422E-BABD-A2F374098890}

FLAMINGO PHARMACEUTICALS

LTD

MEDICHLOR CAPSULES 2083/06/97 CHLORAMPHENICOL

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

250MG CAPSULE 10*10, 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{2EC3C564-9699-4F4F-817F-69D9994D94F7}

FLAMINGO PHARMACEUTICALS

LTDMZOLE TABLETS 2085/06/97 MEBENDAZOLE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

100MG TABLET 10*10, 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{993ED7D9-0ABD-4242-8D8B-

F6BC5C9C1F5B}

Page 25

Page 26: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

FLAMINGO PHARMACEUTICALS

LTD

NEO KENTAX TABLETS 2086/06/97 LEVAMISOLE

HYDROCHLORIDE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

40MG TABLET 10*10 & 500 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{F4E104F2-EBED-41E7-BA8F-

1EA20CD7B8AA}

FLAMINGO PHARMACEUTICALS

LTDINDO 25 CAPSULES 2087/02/97 INDOMETHACIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

25MG CAPSULE 10*10, 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{19B39833-C553-4115-8242-8C6CB3388150}

FLAMINGO PHARMACEUTICALS

LTDRAPIDOL TABLETS 2088/02/97 PARACETAMOL

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

500MG TABLET 10*10, 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{B7E13CFD-70AC-4256-891F-

5C4C7F28A76B}

FLAMINGO PHARMACEUTICALS

LTDBISEPTON 2091/06/97 CO-TRIMOXAZOLE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

480MG TABLET 10*10, 500, 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{A07FB40A-8225-428A-AD07-2518811ABF1C}

GLAXOSMITHKLINE LTD NIMBEX 2097/01/97 CISATRACURIUM

BESYLATE

GLAXOSMITHKLINE S.P.A STRADA PROVINCIALE

ASOLANA 9

2MG/ML INJECTION 2.5 ML , 1*10ML VIAL ITALY. ERIS 23/06/08 + RE-AUDIT FEES (JV11/190)

RT28825 DATED 27/08/11

{C6907D47-CFA7-494C-A7AB-

EE2F5E9ED3C3}

IDA METHYLERGOMETRINE INJECTION 2119/22/97 METHYLERGOMETRI

NE MALEATE

GLAND PHARMA LTD D.P PALLY DUNDIGAL

HYDERABAD

0.2MG/ML INJECTION SOLUTION 1ML AMPOULE INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11{6B523AA9-F81F-40E4-9061-0F135D5C937C}

IDA CHLORPROMAZINE 50MG INJECTION 2125/24/97 CHLORPROMAZINE

GLAND PHARMA LTD D.P PALLY DUNDIGAL

HYDERABAD

25MG/ML INJECTION SOLUTION 2ML AMPOULE INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11

{0E368049-CBEC-44B8-A77C-

D1D85EE99934}

LABORATORY & ALLIED LTD NOPEN 2168/06/97 ASPRIRIN/CAFFEINE

LABORATORY & ALLIED LTD PLOT NO

209/10349 OFF MOMBASA ROAD

TABLET 10*10 KENYAMETRO

PHARMACEUTICALS LTD

02/08/10 RT27901 DATED 18/07/11

{E4E7F9EF-9692-43E1-AEB4-4AC53C0B2221}

PHARMEDIC (PVT) LTD ATELOR TABLET 2268/12/97 ATENOLOL

PHARMEDIC (PVT) LTD 16KM MULTAN

ROAD LAHORE 5380100MG TABLET 20 BLI & 10*10 PAKISTAN HEALTH CARE LTD

24/04/06 + RE-AUDIT FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{BBDBA3DA-6E78-4DA8-867E-

DAFECA7905C3}

PHARMEDIC (PVT) LTD

ZYNOL-300MG TABLETS 2270/02/97 ALLOPURINOL

PHARMEDIC (PVT) LTD 16KM MULTAN

ROAD LAHORE 5380300MG TABLET 10 *10BLISTER PAKISTAN HEALTH CARE LTD

24/04/06 + RE-AUDIT FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{83E3911E-ECF6-41A0AAF2-40215D19F61A}

ROYAL GROUP GENTAMYCIN INJECTION 2292/06/97 GENTAMYCIN

SULPHATE

ZHENJIANG TIANFENG

PHARMACEUTICAL FACTORY N0 518 DAXIANG ROAD

FENG HUANG DEVT OF HUZHOU, ZHEIJIANG

40MG/ML INJECTION 2ML AMPOULE CHINA ABACUS PHARMA (A) LTD 11/09/08 RT28249 DATED

01/08/11

{AAC24AB7-1842-4FC5-9D06-

225324DA3AF9}

SHAIGAN PHARMACEUTICALS

PVT LTDZEPAR 2305/06/97 ALBENDAZOLE

SHAIGAN PHARMACEUTICALS

PVT LTD,14 KM ADYALA ROAD

200MG TABLET 2 BLISTER PAKISTAN HEALTH CARE LTD 11/02/09 RT31759 DATED 13/12/11

{C4F8C3FC-4D96-4714-8A9F-

336CBB08DAEC}

SHAIGAN PHARMACEUTICALS

PVT LTDMESAN 2306/06/97 NICLOSAMIDE

SHAIGAN PHARMACEUTICALS

PVT LTD,14 KM ADYALA ROAD

500MG TABLET 4 BLISTER PAKISTAN HEALTH CARE LTD 11/02/09 RT31759 DATED 13/12/11

{5E64200A-9D75-474C-B1BE-3928A386A933}

SHAIGAN PHARMACEUTICALS

PVT LTDGYNOMIN 2308/22/97 z

SHAIGAN PHARMACEUTICALS

PVT LTD,14 KM ADYALA ROAD

TABLET 2 BLISTER PAKISTAN HEALTH CARE LTD 11/02/09 RT31759 DATED 13/12/11

{D2B6952B-A303-4C519F1C-E90EB5153F8A}

SHAIGAN PHARMACEUTICALS

PVT LTDERGOMIN 2309/06/97 METHYLERGOMETRI

NE MALEATE

SHAIGAN PHARMACEUTICALS

PVT LTD,14 KM ADYALA ROAD

0.125MG TABLET 150 & 500 PAKISTAN HEALTH CARE LTD 11/02/09 RT31759 DATED 13/12/11

{2A7BFF8D-D4B0-417C-A452-

8F1A606F2C5B}

SMITHKLINE BEECHAM

INTERNATIONALHAVRIX 720 2323/19/97 HEPATITIS A

VACCINE

SMITHKLINE BEECHAM

BIOLOGICALS , BELGIUM

720 ELISA INJECTION SUSPENSION VIAL BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11{616B3DA3-74A0-4500-97A0-E8542DD0DC18}

Page 26

Page 27: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

UNIMED INDIA CHLORPHENIRAMINE TABLETS 2343/03/97 CHLORPHENIRAMINE

MALEATE

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

4MG TABLET 1000 HDPE INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{511FA2C8-9577-4DE4-BE65-3AFF4B5A100E}

GLAXO WELLCOME (KENYA) LTD RETROVIR 2459/06/97 ZIDOVUDINE GLAXO WELLCOME

CRAWELY 100MG CAPSULE 100 HDPE UK ERIS LTD 19/08/09 RT28825 DATED 27/08/11

{1162B7EB-0F4F-449D-A228-0F525C3DFF65}

GLAXO WELLCOME (KENYA) LTD COFTA TABLETS 2460/25/97 z

GLAXOSMITHKLINE LIKONI ROAD IND.

AREA, NAIROBITABLET 50, 100 & 150 KENYA ERIS LTD 23/06/08 + RE-AUDIT

FEES (JV11/190)RT28825 DATED

27/08/11

{2E0B2B2C-8E0C-4DAF-A1CF-

04E96A0BBEF9}

GLAXO WELLCOME (KENYA) LTD

ACTIFED DRY COUGH & COLD 2462/25/97 MULTINGREDIENT

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

SYRUP 60ML , 100ML & 2LTS EGYPT ERIS LTD 08/09/11 RT28825 DATED 27/08/11

{35F378C1-8C9C-4D7F-8CB4-

47B456955D35}

CADILA HEALTHCARE LTD OCID CAPSULES 2552/17/98 OMEPRAZOLE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

20MG CAPSULE 10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{9F49F699-C3A7-427E-B2C0-E83147D8995B}

CADILA HEALTHCARE LTD R-LOCK TABLETS 2553/17/98 RANITIDINE

CADILA HEALTHCARE LTD,

KUNDAIM INDUSTRIAL ESTATE

P

150MG TABLET 10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{892BC8F5-5B66-46F2-8D31-6B60315E289C}

CADILA PHARMACEUTICALS

LTDPEFLOBID TABLET 2555/06/98 PEFLOXACINE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

400MG TABLET 10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{D8E170AA-E76B-46BC-9C2E-

860A41131B48}

DR.REDDY 'S LABORATORIES LTD CETRINE 2592/03/98 CETIRIZINE

DIHYDROCHLORIDE

DR. REDDY'S LABORATORIES LTD. PLOT 42, 45 & 46 BAC

10MG TABLET 5*2*10 BLISTER INDIA STAR PHARMACEUTICALS 23/09/10 RT28825 DATED

27/08/11{083C75DB-4165-4BE693EC-3C7DA24918D0}

DR.REDDY 'S LABORATORIES LTD CIPROLET 500 2594/06/98 CIPROFLOXACIN

DR. REDDYS LABORATORIES LTD, PLOT NO1 137,138 &

14

500MG TABLET 5*2*10 BLISTER INDIA STAR PHARMACEUTICALS 23/09/10 RT28825 DATED

27/08/11{40492A82-3BB4-4AC1-B603-93F7576BB035}

DR.REDDY 'S LABORATORIES LTD ENAM 2596/12/98 ENALAPRIL MALEATE

DR. REDDY'S LABORATORIES LTD SURVEY NO. 42, 45 &

4

5MG TABLET 5*2*10 BLISTER INDIA STAR PHARMACEUTICALS 29/09/10 RT28825 DATED

27/08/11

{A6BE862B-F0FB-470A-BEE0-

A42B2FA3389D}

DR.REDDY 'S LABORATORIES LTD ENAM 2598/12/98 ENALAPRIL MALEATE

DR. REDDY'S LABORATORIES LTD SURVEY NO. 42, 45 &

4

10MG TABLET 5*2*10 BLISTER INDIA STAR PHARMACEUTICALS 29/09/10 RT28825 DATED

27/08/11{BA837AAE-F6E7-4650992D-770D5A396377}

DR.REDDY 'S LABORATORIES LTD OMEZ 2604/02/98 OMEPRAZOLE

DR. REDDY'S LABORATORIES LTD SURVEY NO. 42, 45 &

4

20MG CAPSULE 5*2*10 BLISTER INDIA STAR PHARMACEUTICALS 29/09/10 RT28825 DATED

27/08/11

{3EEF1364-E423-4C6D-B8A3-

3A3C95B0373C}

DR.REDDY 'S LABORATORIES LTD STAMLO 10MG 2606/12/98 AMLODIPINE

BESYLATE

DR. REDDY'S LABORATORIES LTD.

PLOT 42, 45 & 46 BACHUPALLI -

500123, A.P

10MG TABLET 5*2*10 BLISTER INDIA STAR PHARMACEUTICALS 27/09/2010 RT27211 DATED 21

JUNE 2011{08970DA2-1610-4F74-9425-0103E3FA61AD}

DR.REDDY 'S LABORATORIES LTD STAMLO 5MG 2608/12/98 AMLODIPINE

BESYLATE

DR. REDDY'S LABORATORIES LTD.

PLOT 42, 45 & 46 BACHUPALLI -

500123, A.P

5MG TABLET 5*2*10 BLISTER INDIA STAR PHARMACEUTICALS 27/09/2010 RT28825 DATED

27/08/11{52B91276-8E57-4754-A27D-DE4D34FB9784}

Page 27

Page 28: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ERIS LTD CLOTRI-DENK 100 VAGINAL 2612/13/98 CLOTRIMAZOLE

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

100MG PESSARY 6 STRIP, (6 STRIP MEDICAL SAMPLE) GERMANY ERIS LTD 14/01/08 + RT27569

DATED 04/07/11RT28444 DATED

09/08/11

{FFEC785C-E540-48E6-BB05-

62A00E394F41}

ERIS LTD DICLO-DENK 100 RETARD 2613/02/98 DICLOFENAC

SODIUM

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

100MG TABLET S/R 1 * 10, 10 * 10 BLISTER GERMANY ERIS LTD 14/01/08 + RT27569

DATED 04/07/11RT28444 DATED

09/08/11{5A9644A2-633E-4CE0-B96B-C8440B754C65}

ERIS LTD DICLO-DENK 50 2615/02/98 DICLOFENAC SODIUM

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

50MG TABLET F/C 10*10 BLISTER, (1 * 10 SAMPLE) GERMANY ERIS LTD 14/01/08 + RT27569

DATED 04/07/11RT28444 DATED

09/08/11{841138C9-2BE4-4F2B-A0F8-664077B15EAF}

ERIS LTD METFORMIN- DENK 500 2617/18/98 METFORMIN

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

500MG TABLET 1 * 10, 10*10 BLISTER, GERMANY ERIS LTD 14/01/08 + RT27569

DATED 04/07/11RT28444 DATED

09/08/11

{E3F4AF6D-A9A8-45C6-8877-

CB45F881BFF2}

FLAMINGO PHARMACEUTICALS

LTD

MEDICHLOR INJECTION 1GM 2624/06/98 CHLORAMPHENICOL

SODIUM SUCCINATE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

1GM INJECTION POWDER VIAL, 1*50*1GM VIAL WITH G.O.U LABEL INDIA ABACUS PHARMA 17/09/09 RT28444 DATED

09/08/11

{23AAA9BA-AF6F-47E5-B640-

BBF63AE04861}

FLAMINGO PHARMACEUTICALS

LTDCARDILAN 100 2625/08/98 HYDROCORTISONE

SODIUM SUCCINATE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

100MG INJECTION POWDERVIAL, 1*50*100MG VIALS WITH G.O.U

LABELINDIA ABACUS PHARMA 17/09/09 RT28444 DATED

09/08/11

{8DFD0879-093A-4CAD-A559-

D555863856D0}

FLAMINGO PHARMACEUTICALS

LTDMEDIPROC 2626/06/98

FORTIFIED PROCANINE

PENICILLI

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

4.0 MEGA UNIT INJECTION POWDER VIAL INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{DFAFE9F4-894F-4E95-AE7C-

C6CBEB30C346}

FLAMINGO PHARMACEUTICALS

LTD

TETRACYCLINE CAPSULES BP.

250MG2627/06/98 TETRACYCLINE

HYDROCHLORIDE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

250MG CAPSULE 10*10, 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{7B48976F-876E-4960-BD6F-4D5C8D0A9640}

GLAXO WELLCOME (KENYA) LTD BETNOVATE CREAM 2629/13/98 BETAMETHASONE

VALERATE

GLAXO OPERATIONS UK LTD HARMIRE ROAD, BARNARD CASTLE COUNTY

DURHAM

0.1%W/W CREAM 15GM & 30GM UK ERIS LTD 18/08/09 RT28825 DATED 27/08/11

{17B6C226-24E6-4D3BB6B7-1CA26D15CD42}

GLAXO WELLCOME (KENYA) LTD ZINNAT SUSPENSION 2641/06/98 CEFUROXIME AXETIL-

GLAXO OPERATIONS UK LTD, BARNARD

CASTLE125MG/5ML SUSPENSION 1 * 50ML, 1 *

100ML UK ERIS LTD 18/08/09 RT28825 DATED 27/08/11

{C0309437-9866-45E0-8412-9FF7B4DE2AE9}

INTAS PHARMACEUTICALS

LTDKWINIL 2678/06/98 QUININE

DIHYDROCHLORIDE

INTAS PHARMACEUTICALS LTD MATODA 382 210 DIST AHMEDABAD,

INDIA

300MG/ML INJECTION 2ML AMPOULE INDIANORVIK

ENTERPRISES (U) LTD

06/09/09 RT29052 DATED 06/09/11

{1213F91E-BA74-4693-99F6-5A771C77CC66}

MERCK SHARP & DOHME BV CRIXIVAN 2707/06/98 INDINAVIR

SULPHATE

MERCK SHARP & DOHME B.V

WAARDERWEG 39, PC HAARLEM.

HOLLAND

400MG CAPSULE 180 HDPE HOLLAND PHILLIPS P'CALS (U) LTD 29/06/11 RT29554 DATED

26/09/11{195EB934-1F42-4C04-9E46-403C6745C68D}

Page 28

Page 29: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

NEM LABORATORIES (PVT) LTD

VEST MENTAMU BALM 2712/13/98 COMPOUND

METHYLSALICYLATE

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT OINTMENT 15GM INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{E6CF20BC-0F99-4ADE-A728-

2C5C176F62D0}

PFIZER LABORATORIES

(PTY) LTDVIAGRA 50MG 2731/12/98 SILDENAFIL

PFIZER LABORATORIES

(PTY) LTD 50MG TABLET 1, 4,8,12 IN BLISTER SOUTH AFRICA LABOREX (U) LTD RT28810 DATED

26/08/2011{FD65D295-21F7-40B7-A86A-A02DBB3493E9}

PFIZER LABORATORIES

(PTY) LTDGABBRORAL 2751/06/98 AMINOSIDINE

SULPHATEPHARMACIA & UPJOHN S.P.A 250MG TABLET 12 STRIP ITALY LABOREX (U) LTD RT28810 DATED

26/08/2011

{18FB8BCB-88E3-46D2-B861-

B26D76A3EE91}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTDREMIPAR ELIXIR 2802/06/98 PIPERAZINE CITRATE

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

750MG/5ML ELIXIR 30ML BOTTLE PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{D55A06FC-AE2F-4B0C-B844-

99F8BC089F90}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD

SEPRODERM OINTMENT 2803/13/98

SALICYCLIC ACID/SULPHUR

COMPOUND

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

3.6/2.4 MG OINTMENT 20GM PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{004604EB-D638-4DF6-B5CF-8E779A9D25AD}

UNIMED INDIA ANTEST TABLETS 2863/06/98 MEBENDAZOLE

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

100MG TABLET 10*10 BLI,100,1000 INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{46083E93-27DE-4241-8022-04E4B0DF35EE}

UNIMED INDIA PARACETAMOL SYRUP 2867/02/98 PARACETAMOL

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

120MG/5ML SYRUP 60ML INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{5E6EF0E9-715F-4E36-8A96-AF1034E4066D}

UNIQUE PHARMACEUTICAL

LABORATORIES

VERMOREX SUSPENSION 2870/06/98 MEBENDAZOLE

J.B. CHEMICALS & PHARMACEUTICALS

LTD, 128/1, GIDC, ANKLESHWAR 393

002

100MG/5ML ORAL SUSPENSION 30ML BOTTLE INDIA TATA (U) LTD 06/05/10 RT28496 DATED 12/08/11

{AE479110-9329-45E2-B892-7A217D64CC43}

WIN-MEDICARE PVT LTD

DICLOMOL INJECTION 2875/02/98 DICLOFENAC

SODIUM

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

25MG/ML INJECTION 3ML AMPOULE INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{549CC096-4577-4C97-8453-994FB204922C}

WIN-MEDICARE PVT LTD

DICLOMOL SR TABLETS 2876/02/98 DICLOFENAC

SODIUM

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

100MG TABLET S/R 10*10 INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{FF384F9C-59D9-444C-8379-B928B7FFF0F9}

WIN-MEDICARE PVT LTD DICLOMOL TABLETS 2877/02/98 DICLOFENAC

SODIUM

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

50MG TABLET, E/C 10*10 INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{C5C9B798-4978-4A05-B834-94E9ECD22811}

WIN-MEDICARE LTD SOLUDOL TABLETS 2878/02/98 DICLOFENAC SODIUM

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

50MG TABLET, DISPERSIBLE 10*10 INDIA SURGIPHARM (U)

LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{BC5BE198-B975-488C-AC2D-

314DCA0F7A56}

WOCKHARDT LIMITED AZIWOK 2879/06/98 AZITHROMYCIN

DIHYRATE

WOCKHARDT LIMITED, PLOT NO 57

VILLAGE KUNJHAL POST

200MG/5ML SUSPENSION POWDER 15ML BOITTLE INDIA

STAR PHARMACEUTICALS

LTD21/09/09 RT28254 DATED

01/08/11

{E265DE8E-0BF4-4DBE-84B9-

DD889E8181A5}

WOCKHARDT LIMITED AZIWOK 2880/06/98 AZITHROMYCIN

DIHYRATE

WOCKHARDT LIMITED, PLOT NO 57

VILLAGE KUNJHAL POST

250MG CAPSULE 6's INDIASTAR

PHARMACEUTICALS LTD

21/09/09 RT28254 DATED 01/08/11

{AE385CB7-01E0-4134-8515-C646209A0293}

CADILA PHARMACEUTICALS

LTD

DEXASONE EYE/EAR DROP 2900/28/98 DEXAMETHASONE/N

EOMYCIN SULPHATE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

EYE/EAR DROP 5ML INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{7225F281-3E0A-4308-B0D0-E85C29D1D862}

Page 29

Page 30: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

COSMOS LTD PRAZITEL TABLETS 2960/06/98 PRAZIQUANTEL

COSMOS LTD, RANGWE ROAD; OFF

LUNGA LUNGA ROAD. P.O BOX 414

33, NAIORBI

600MG TABLET F/C 2*10 & 10*10 KENYA ASTRA PHARMA (U) LTD 01/11/2010 RT291125 DATED

07/09/2011{94B31795-4AF2-4D82-A62E-18078B03A303}

JASSEN-CILAG (PTY) LTD VERMOX 2991/06/98 MEBENDAZOLE

JANSSEN PHARMACEUTICA

PTY LTD. 15TH ROAD HALFWAY

20MG/5ML ORAL SUSPENSION 30ML SOUTH AFRICA LABOREX (U) LTDRT304481 DATED

18/10/2011 & JV11/205 DATED 19/10/2011

{AD663A7E-8A6B-4601BBD1-

D273CABD2036}

KARNATAKA ANTIBIOTICS &

PHARMA.

CHLORAMPHENICOL INJECTION 1GM. 2995/06/98 CHLORAMPHENICOL

SODIUM SUCCINATE

KARNATAKA ANTIBIOTIC &

PHARMACEUTICALS LTD

1GM INJECTION POWDER VIAL INDIA TATA (U) LTD{42A1432F-ABD4-

45D5-9C2E-D12A19289CBE}

PFIZER LABORATORIES

(PTY) LTDZITHROMAX 3029/02/98 AZITHROMYCIN

DIHYRATE

PFIZER LABORATORIES

(PTY) LTD 500MG TABLET 2 & 3 BLISTER SOUTH AFRICA LABOREX (U) LTD RT28810 DATED

26/08/2011

{7233C5CC-A7A2-4AFA-984B-

7404F087D935}

PFIZER LABORATORIES

(PTY) LTDXALATAN 3035/21/98 LATANOPROST

PHARMACIA & UPJOHN S.P.A-

RIJKSWEG 12, B-2870 PUURS

0.005%W/V EYE DROP 2.5ML BELGIUM LABOREX (U) LTD RT28810 DATED 26/08/2011

{6F8D8C13-FB52-4312-9949-D4D5D7BF2CA4}

SEVEN SEAS LTD MULTIVITAMIN SYRUP 3072/27/98 MULTIVITAMIN

SEVEN SEAS HEALTHCARE LTD

HEDON ROAD HULLMULTI-INGREDIENT SYRUP 150ML UK MEDIPHARM (U) LTD 06/04/2011 RT298866 DATED

06/10/2011{5A8F2233-0FB4-4DC7-ADE9-90161D2D9A12}

SEVEN SEAS LTDCOD LIVER OIL WITH NATURAL VITAMINS

CHERRY3073/27/98

CODLIVER OIL/NATURAL

VITAMINS

SEVEN SEAS HEALTHCARE LTD

HEDON ROAD HULL7000 I.U/10ML SYRUP 150ML UK MEDIPHARM (U) LTD 06/04/2011 RT298866 DATED

06/10/2011{0850C8E8-AA2D-4109AABA-67B16AB09A49}

SEVEN SEAS LTDMINADEX

MULTIVITAMIN SYRUP

3074/27/98 MULTIVITAMINSEVEN SEAS

HEALTHCARE LTD HEDON ROAD HULL

MULTI-INGREDIENT SYRUP 150ML UK MEDIPHARM (U) LTD 06/04/2011 RT298866 DATED 06/10/2011

{B4F6CCE8-0001-4C10-83F6-

8EC4076EAAC5}

SEVEN SEAS LTD COD LIVER OIL 3076/27/98 VITAMIN ASEVEN SEAS

HEALTHCARE LTD HEDON ROAD HULL

7000 I.U/10ML SYRUP 170ML UK MEDIPHARM (U) LTD 06/04/2011 RT298866 DATED 06/10/2011

{E9315395-455B-4B87-B7DF-1CF721BD634B}

SHIJIAZHUANG SECOND

PHARMACEUTICALS

FORTIFIED PROCAINE PENICILIIN

3084/06/98FORTIFIED

PROCANINE PENICILLIN

SHIJIAZHUANG PHARMA. GROUP,

ZHONGUO PHARMACEUTICAL

4.0 MEGA UNIT INJECTION POWDER 1*50 ,1*10 VIAL CHINASINO AFRICA MEDICINES & HEALTH LTD

10/11/08 RT28344 DATED 04/08/11

{1DF1BF44-F20D-44DA-9DBA-

742DD2895E86}

SMITHKLINE BEECHAM

INTERNATIONALCLAVULIN 3085/06/98 AMOXYCILLIN/CLAVU

LANIC ACID

SMITHKLINE BEECHAM

CLARENDON RD WORTHING WEST

SUSSEX

156MG/5ML SUSPENSION POWDER 100ML & 70ML UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11{112849F4-5603-4250-9D41-AF98E54D2386}

SMITHKLINE BEECHAM

INTERNATIONALAUGMENTIN BD 3086/06/98 AMOXYCILLIN/CLAVU

LANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICALS, CLARENDON ROAD

228MG/5ML SUSPENSION POWDER 140ML & 70ML UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11{0C2BCE2B-4064-471097DD-5035DEF66E0A}

JOHNSON&JOHNSON PTY LTD

BENYLIN DMD DECONGESTANT COUGH SYRUP

3098/25/98

DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE

HCL

JOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD

/HOOFWEG 241,RETREAT

7945,SOUTH AFRICA

15MG, 30MG SYRUP 100ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED 18/10/2011

{0DCCB44C-72F1-46FD-92C1-

50B1DAFE4A5B}

AEGIS LTD FLUCOZAL 3122/06/99 FLUCONAZOLEAEGIS LTD 17

ATHINON STREET ERGATES IND AREA

50MG CAPSULE 1 * 14 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED

02/08/11

{FBE21C6A-7E07-4A01-9CEA-

E9797FB2E48E}

FREDUN PHARMACEUTICALS

LTD

ERYFRED ORAL SUSPENSION 3136/06/99 ERYTHROMYCIN

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

125MG SUSPENSION POWDER 100ML INDIA ABACUS PHARMA (A)

LTD 23/11/2009 RT293353 DATED 16/09/2011

{BF1189F3-3043-4B54-B9FC-38620242CC34}

Page 30

Page 31: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

FREDUN PHARMACEUTICALS

LTDFREMOL TABLETS 3138/02/99 PARACETAMOL

TABLETS

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

500MG TABLET 10*10, 1000 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011{F721A777-6461-40C2-92D6-3BF1143B4480}

FREDUN PHARMACEUTICALS

LTD

NEOPHIL -100 TABLETS 3139/25/99 AMINOPHYLLINE

TABLETS

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

100MG TABLET 10*10, 1000 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011

{6EE50CB6-9012-4C7C-863A-

5938C7E6959C}

FREDUN PHARMACEUTICALS

LTDTINIFRED TABLETS 3142/06/99 TINIDAZOLE

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

500MG TABLET 10 & 4 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011

{ECD56CFC-BE48-4F8F-A065-

2271F2ABCD7B}

FREDUN PHARMACEUTICALS

LTDPROFED 40 TABLETS 3143/12/99 PROPRANOLOL

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

40MG TABLET 10, 1000 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT29355 & RT293353

DATED 16/09/2011

{08BE7BF8-EDCE-4A9F-8683-

AD33DCAB480C}

KOPRAN LIMITED CIPROQUIN-500 3164/06/99 CIPROFLOXACIN

KOPRAN LIMITED VILLAGE SAVROLI

TALUKA KHALAPUR RAIGAD DISTRICT

PIN 410202

500MG TABLET F/C 10 * 10 BLISTER INDIASUPER

PHARMACEUTICALS LTD.

29/01/09 RT28108 DATED 26/07/11

{A28B3402-FC65-4EFF-9322-69CEF47DC869}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD

OPTADEX-N EYE DROPS 3181/21/99 DEXAMETHASONE/N

EOMYCIN

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

1MG/3MG EYE DROP 5ML PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{BAFC4AFE-5996-454C-A709-

45ED850BEEFE}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTDS.P.LOTION 3183/13/99 BENZYL BENZOATE

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

25%W/V LOTION 60ML, 120ML PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{C6206F69-E9F9-4726-8C24-6ECA4DBD1705}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD

REMICOL EAR DROPS 3184/28/99 CHLORAMPHENICOL

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

1% EAR DROP 10ML PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{C163A351-8344-4819-AF41-CC79D43B1C7F}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD

METHACHLOR EYE DROPS 3185/21/99 DEXAMETHASONE/C

HLORAMPHENICOL

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

1MG/2MG EYE DROP 5ML PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{B0124FFB-DDD9-4655-B8A1-

E444BB55A265}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD

PREDNICOL EYE DROPS 3187/21/99 PREDNISOLONE/CHL

ORAMPHENICOL

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

5MG/2MG EYE DROP 10ML PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{2D2B4DF2-CAA0-4054-BFC2-

8C75DF46EE4E}

UNICHEM LABORATORIES LTD DOMADOL 3206/02/99 TRAMADOL

HYDROCHLORIDE

UNICHEM LABORATORIES LTD, 17/18 PILERNE IND.

ESTAT

50MG CAPSULE 10*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

12/03/07 + RE-AUDIT FEES (RT20065 DATED 22/07/10)

RT29055 DATED 06/09/11

{82429202-A49A-492B-A187-23DB12BBD025}

UNICHEM LABORATORIES LTD ZYNCET 3207/04/99 CITIRIZINE

DIHYDROCHLORIDE

UNICHEM LABORATORIES LTD, VILLAGE BHATAULI

KALA, B

10MG TABLET 4*5*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

22/11/10 RT29055 DATED 06/09/11

{DC5C780F-C20C-43B2-BC89-

7A6CEB95B011}

UNICHEM LABORATORIES LTD LANPRO 3209/17/99 LANSOPRAZOLE

UNICHEM LABORATORIES LTD, 17/18 PILERNE IND.

ESTAT

30MG CAPSULE 5*2*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

12/03/07 + RE-AUDIT FEES (RT20065 DATED 22/07/10)

RT29055 DATED 06/09/11

{22971368-E7D8-4DE8-BDB2-

5C1BCF5FE85E}

Page 31

Page 32: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

UNICHEM LABORATORIES LTD AMPOXIN 500 3210/06/99 AMPICILLIN/CLOXACI

LLIN

UNICHEM LABORATORIES LTD. VILLAGE BHATAULI

KALA, B

500MG CAPSULE 10*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

22/11/10 RT29055 DATED 06/09/11

{D5892E62-F80D-4500-ADD2-074AD2C9F247}

CADILA PHARMACEUTICALS

LTDTRIGAN-D TABLET 3230/02/99 PARACETAMOL/DYCY

CLOMINE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

TABLET 10 *10 STRIP INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{42A854BA-3FB5-4837-9D10-0ECD6059A0A3}

ERIS LTD TOTAMOL TABLETS 3237/12/99 ATENOLOL

CP PHARMACEUTICALS LTD ASH R'D NORTH

WREXHAN, LL

50MG TABLET 28 BLISTER UK ERIS LTD 18/08/09 RT311322 DATED 23/11/11

{96181ABB-C52C-4E19-99A0-

1CDCE5284D45}

ERIS LTD GLIBENCLAMIDE 3239/18/99 GLIBENCLAMIDE

CP PHARMACEUTICALS LTD ASH R'D NORTH

WREXHAN, LL

5MG TABLET 28 BLISTER & 100 UK ERIS LTD 18/08/09 RT311322 DATED 23/11/11

{81879391-56E2-4620-9B43-BC7321080F17}

ERIS LTD TOTAMOL TABLETS 3240/12/99 ATENOLOL

CP PHARMACEUTICALS LTD ASH R'D NORTH

WREXHAN, LL

100MG TABLET 28 BLISTER UK ERIS LTD 18/08/09 RT311322 DATED 23/11/11

{80784E0A-62D8-4150-80E2-F7401702DCDC}

GLAXO WELLCOME (KENYA) LTD COMBIVIR TABLETS 3261/06/99 LAMIVUDINE/ZIDOVU

DINE

GLAXOSMITHKLINE PRIORY STREET

WARE HERTFORDSHIRE

150MG+300MG TABLET 60 BLISTER UK ERIS LTD 18/08/09 RT28825 DATED 27/08/11

{F061E75F-C622-4CD8-B9E2-

0B3D9A1F6ECE}

GLAXO WELLCOME (KENYA) LTD

RETROVIR ORAL SOLUTION 3280/06/99 ZIDOVUDINE

GLAXOSMITHKLINE INC, MISSISSAUGA,

CANADA10MG/ML ORAL SOLUTION 200ML CANADA ERIS LTD RT22505 (DOC

REVIEW)RT28825 DATED

27/08/11

{CF53CF9A-53AE-4D32-8745-

0447CD79E741}

GLENMARK PHARMACEUTICALS

LTDCANDIDERM CREAM 3284/13/99

BECLOMETASONE CLOTRIMAZOLE

GENTAMICIN SULPHATE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

0.025%W/W 1%W/W 0.1%W/W CREAM 5GM & 15GM INDIA

STAR PHARMACEUTICALS

LTD29/09/2009 RT28761 DATED

24/08/2011

{DFC01C6E-EEB3-43A5-8E79-

C5CFA250D80E}

GLENMARK PHARMACEUTICALS

LTD

CANDID DUSTING POWDER 3285/13/99 CLOTRIMAZOLE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

1%W/W TOPICAL POWDER 30GM, 100GM INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{125913EE-559A-4EE1-B6C8-A007C100DCE9}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD

OPTACHLOR EYE DROPS 3291/21/99 CHLORAMPHENICOL

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

0.5% EYE DROP 10ML PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{03BBA172-17E5-4EE3AEA8-B3400EEBF532}

PFIZER LABORATORIES

(PTY) LTDLIPITOR 3294/12/99 ATORVASTATIN

PFIZER LABORATORIES

GODECKE MOOSWALDALLE

179090 FR

20MG TABLET 28 BLISTER GERMANY LABOREX (U) LTD RT28810 DATED 26/08/2011

{D9607DDD-E1E9-432A-8D20-

DF0AC2FD030B}

PFIZER LABORATORIES

(PTY) LTDLIPITOR 3296/12/99 ATORVASTATIN

PFIZER LABORATORIES

GODECKE MOOSWALDALLE

179090 FR

10MG TABLET 28 BLISTER GERMANY LABOREX (U) LTD RT28810 DATED 26/08/2011

{28EB0A56-A3A1-431C8115-BEC0D6B20047}

SMITHKLINE BEECHAM

INTERNATIONALCLAVULIN TABLETS 3313/06/99 AMOXYCILLIN/CLAVU

LANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICALS, CLARENDON ROAD

375MG TABLET 10 & 20, 10*10 STRIP UK ERIS LTD 19/08/09 RT28825 DATED 27/08/11

{FE2344C4-8AF4-4352-93D3-E3190AFA8EE8}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTDBETADROP-N 3317/21/99 BETAMETHASONE/N

EOMYCIN

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

1MG/5MG EYE DROP 7.5ML PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{9A5BA404-1892-4FFA-807A-728D69A50744}

PFIZER LABORATORIES

(PTY) LTDDOSTINEX TABLETS 3333/18/99 CABERGOLINE PHARMACIA &

UPJOHN S.P.A 0.5MG CAPLET 2 & 8 ITALY LABOREX (U) LTD RT28810 DATED 26/08/2011

{F5D67D2B-E962-4346-83A1-7AA4700BAE7F}

ESAPHARMA SRL MOVATE 3338/13/99 CLOBETASOLESAPHARMA SRL

VIA DE GASPERI 13 20066 MELZO MILA

0.05%W/W CREAM 30GM ITALYBYAMAKA

PHARMACEUTICALS LTD.

RT21544 DATED 30/09/2010.

DOCUMENT REVIEW

RT28235 DATED 01/08/2011

{5B58E1B4-2F81-43C2-AE02-4B8A06F5840B}

Page 32

Page 33: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

GLAXO WELLCOME (KENYA) LTD

BETNOVATE OINTMENT 3345/13/99 BETAMETHASONE

VALERATE

GLAXO OPERATIONS UK LTD HARMIRE ROAD, BARNARD CASTLE COUNTY

DURHAM

0.1%W/W OINTMENT 15GM & 30GM UK ERIS LTD 18/08/09 RT28825 DATED 27/08/11

{D479A318-A131-4BFD-B68F-

14B30F28F581}

FREDUN PHARMACEUTICALS

LTD

COTRIFRED PAEDIATRIC TABLET 3350/06/99 CO-TRIMOXAZOLE

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

120MG TABLET 10*10, 1000 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011

{E91673C7-8ED6-45F6-93E6-

13CECBA33CD9}

FREDUN PHARMACEUTICALS

LTD

CIPROFRED 500 TABLETS 3352/06/99 CIPROFLOXACIN

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

500MG TABLET 10*10 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011{899D93A2-FE76-46C8-BA38-76AF542BE349}

ALCON CUSI S.A. CUSIMOLOL 0.5% 3390/21/00 TIMOLOL MALEATE

ALCON CUSI SA, CAMIL FABRA 58

08320 EL MASNOUR BARCELONA

0.5% EYE DROP 5ML SPAIN KARURI PHARMA. LTD

DATED 27/06/2011 DOC REVIEW

RT28866 DATED 29/08/2011

{43F48B98-F42E-439E-B402-12946BC3102F}

AMOUN PHARMACEUTICAL

INDUSTRIES CO

VITAMOUNT FOR MEN 3394/27/00 Z

AMOUN PHARMACEUTICAL SAE, ELBOUR CITY

CAIRO EGYPT

Z CAPSULE 1 * 10, 1*2*10 BLISTER EGYPT

WIDE SPECTRUM ENTERPRISES (U)

LTD26/10/10 RT28284 DATED

02/08/11{CB4AF10F-13B0-48F0-9554-09ABDCA46231}

AMOUN PHARMACEUTICAL

INDUSTRIES CO

VITAMOUNT FOR WOMEN 3395/27/00 Z

AMOUN PHARMACEUTICAL SAE, ELBOUR CITY

CAIRO EGYPT

Z CAPSULE 1 * 10, 1*2*10 BLISTER EGYPT

WIDE SPECTRUM ENTERPRISES (U)

LTD26/10/10 RT28284 DATED

02/08/11{11201ADF-A950-47FF-B75F-7C9E631DE1C8}

BLUE CROSS LABORATORIES LTD BLUMOX P 3397/06/00 AMOXYCILLIN

BLUE CROSS LABORATORIES LTD, A-12 MIDC AMBAD,

NASHIK 422010

125MG TABLET DISPERSIBLE 10*10*2 IN STRIP INDIASTAR

PHARMACEUTICALS LTD

RE-INP RT24229 DATED 01/02/11

SCHEDULED

RT26935 DATED 08/06/11

{7EFE9EC7-F2E3-4CED-AA5C-

B53C26DD6B6E}

CADILA HEALTHCARE LTD SPARDAC-200 3401/06/00 SPARFLOXACIN

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

200MG TABLET 10*7 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{45B93A2F-5DF5-4399-BDE7-663042DE5249}

ERIS LTD ACYCLOVIR DENK 200 3433/06/00 ACICLOVIR

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

200MG TABLET 1 * 5 * 5 BLISTER, 25 BLISTER GERMANY ERIS LTD 14/01/08 + RT27569

DATED 04/07/11RT28444 DATED

09/08/11

{DC615BD0-24FD-4FD5-9555-

85A5B26175AB}

GLAXO WELLCOME (KENYA) LTD ZIAGEN 3436/06/00 ABACAVIR

GLAXO WELLCOME OPERATIONS

PRIORY STREET WARE HERTF

300MG TABLET6 * 10 BLISTER, [6 * 10

BLISTER ACCESS PACK]

UK ERIS LTD. 18/08/09 RT28825 DATED 27/08/11

{D5D2C14D-A839-4B64-8D28-

E49541632C23}

GLENMARK PHARMACEUTICALS

LTDRELCER GEL 3439/17/00 MULTINGREDIENT

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

MULTINGREDIENT ORAL GEL 180ML PET BOTTLE INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{968BBC28-9000-466A-95D2-CDBB939D149A}

GLENMARK PHARMACEUTICALS

LTD

CANDITRAL CAPSULE 3440/06/00 ITRACONAZOLE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

100MG CAPSULE 4 STRIP INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{D3944C2A-7476-41B6-A380-443C550054CA}

GLENMARK PHARMACEUTICALS

LTD

CANDID -V6 VAGINAL TABLETS 3441/13/00 CLOTRIMAZOLE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

100MG PESARY 6 STRIP INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{EACBF572-D2A8-4BC6-A69A-

EE3E8CADC7CA}

Page 33

Page 34: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

GLENMARK PHARMACEUTICALS

LTDCANDID CREAM 3442/13/00 CLOTRIMAZOLE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

1% CREAM 20GM TUBE INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{905FEB64-5412-48AF-A10A-

39CDBE8D9D0F}

GLENMARK PHARMACEUTICALS

LTD

ASCORIL EXPECTORANT 3443/25/00 MULTINGREDIENT

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

MULTINGREDIENT SYRUP 100ML BOTTLE, 1*200ML INDIA

STAR PHARMACEUTICALS

LTD29/09/2009 RT28761 DATED

24/08/2011{113E6961-5619-4174-A0D6-E310E1185C59}

GLENMARK PHARMACEUTICALS

LTD

CANDID MOUTH PAINT 3444/13/00 CLOTRIMAZOLE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

1% PAINT 15ML BOTTLE INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{D0D76C9E-8965-45BD-B075-

03EA6E85AF40}

IDA GENTAMYCIN INJECTION 3446/06/00 GENTAMYCIN

SULPHATE

GLAND PHARMA LTD D.P PALLY DUNDIGAL

HYDERABAD

40MG/ML INJECTION SOLUTION 2ML AMPOULE INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11{4485283F-83D8-4D77-9D4B-3884D454A01B}

JASSEN-CILAG (PTY) LTD VERMOX 3451/06/00 MEBENDAZOLE

JANSSEN PHARMACEUTICA

PTY LTD. 15TH ROAD HALFWAY

500MG TABLET 1's SOUTH AFRICA LABOREX (U) LTDRT304481 DATED

18/10/2011 & JV11/205 DATED 19/10/2011

{B104C488-1DA5-4E2183C9-FF882488EEBB}

JASSEN-CILAG (PTY) LTD HALDOL 3453/24/00 HALOPERIDOL

JANSSEN PHARMACEUTICA

N.V TURNHOUTSEWEG 30 B-2340 BEERSE

5MG/ML INJECTION 5 * 1ML AMPOULE BELGIUM LABOREX (U) LTD 24/11/08RT29142 DATED

08/09/2011 & JV11/134 DATED 08/09/2011

{F41D971F-6729-4A84-8D3F-

9D4A1FE6FCEB}

TORRENT PHARMACEUTICALS

LTDLISTRIL-10 3505/12/00 LISINOPRIL

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

10MG TABLET 10*10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{AA0BD53D-0C86-4316-AB83-

2D360DF89872}

ALEMBIC LTD ZEET EXPECTORANT 3537/06/00 MULTI-INGREDIENTALEMBIC LTD PLOT

NO. 21-22 EPIP, PHASE 1 JHARMAJRI

MULTI-INGREDIENT SYRUP 100ML INDIAGITTOES

PHARMACEUTICALS LTD.

28/06/2010 RT28449 DATED 10/08/2011

{F32A4EBE-14E7-4C84-9B7E-

3E6FB7140D26}

CADILA HEALTHCARE LTD TRAMAZAC 3541/02/00 TRAMADOL

HYDROCHLORIDE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

50MG CAPSULE 10*10 INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{17A4AE2B-9006-44F9-A4F8-B6A012823373}

CADILA PHARMACEUTICALS

LTDACILOC 150 3542/17/00 RANITIDINE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

150MG TABLET 10*10 INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{11E165B1-3A6A-4960-9403-AAC3526B519C}

CADILA PHARMACEUTICALS

LTD

CEFAMOR DRY SYRUP 3543/06/00 CEPHALEXIN

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

125MG/5ML SUSPENSION POWDER 100ML INDIA

KARURI PHARMACEUTICALS

LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{9EA3DE7C-746C-4FE8-AE5C-

0C483D4E0CD3}

ERIS LTD RANI-DENK 150 3554/17/00 RANITIDINE

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

150MG TABLET 1 * 10, 50 & 20 BLISTER GERMANY ERIS LTD 14/01/08 + RT27569

DATED 04/07/11RT28444 DATED

09/08/11

{CE9B2884-4DB2-4F13-98CC-

151736308A48}

RENE INDUSTRIES LTD RENEQUIN TABLET 3577/06/00 CHLOROQUINE

PHOSPHATE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

250MG TABLET 250 & 1000 UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{A0C55A55-6320-4CF6-B45B-45EA45225971}

RENE INDUSTRIES LTD

RENETRIM SUSPENSION 3578/06/00 CO-TRIMOXAZOLE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

240MG/5ML ORAL SUSPENSION 60ML UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{57C44825-D729-43F0-8FC2-49DA9EDF3E60}

JOHNSON&JOHNSON PTY LTD

ORALDINE MOUTHWASH 3594/13/00 HEXITIDINE

JOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794

15MG/15ML MOUTHWSH 200ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED 18/10/2011

{A7747786-58AF-45CB-A6D7-1298AD083045}

Page 34

Page 35: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CENTAUR DRUG HOUSE PVT LTD

OCUCYCLINE EYE OINTMENT 3603/21/00 TETRACYCLINE

HYDROCHLORIDE

CENTAUR PHARMACEUTICALS

LTD , PLOT NO. 39 TIVIN IN

1%W/W EYE OINTMENT 1*3.5GM , 1*5GM INDIAGITTOES

PHARMACEUTICALS LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{EC021AFB-C85B-4923-B8B8-

C13357BC5C8F}

CENTAUR DRUG HOUSE PVT LTD

OCUMYCIN EYE OINTMENT 3604/21/00 CHLORAMPHENICOL

CENTAUR PHARMACEUTICALS

LTD , PLOT NO. 39 TIVIN IN

1%W/W EYE OINTMENT 3.5GM INDIAGITTOES

PHARMACEUTICALS LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{F1D2EC76-91F6-4073-AF74-09865BD9D4B9}

ERIS LTD NIFEDI-DENK 20 REATRD 3623/12/00 NIFEDIPINE

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

20MG TABLETS S/R 10*10 GERMANY ERIS LTD 14/01/08 + RT27569 DATED 04/07/11

RT28444 DATED 09/08/11

{3763E3BA-7EF7-42FC-8EE3-

B7C9DA458DFE}

ERIS LTD TAMOXIFEN BP 20MG TABLETS 3626/08/00 TAMOXIFEN

CP PHARMACEUTICALS LTD ASH R'D NORTH

WREXHAN, LL

20MG TABLET 3*10 BLISTER UK ERIS LTD 18/08/09 RT311322 DATED 23/11/11

{19E3C0F5-8821-48DB-A848-784D71AAC29E}

FLAMINGO PHARMACEUTICALS

LTD

BENZATHINE PENICILLIN 3627/06/00 BENZATHINE

PENICILLIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

2.400.000 I.U INJECTION POWDER VIAL INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{DCB96D46-41C4-4CED-B529-

719848838FE5}

FLAMINGO PHARMACEUTICALS

LTDCEFTRILE 3628/06/00 CEFTRIAXONE

SODIUM

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

1GM INJECTION POWDER VIAL INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{B2B3E24B-1861-437B-B607-55656CA1C0D9}

FLAMINGO PHARMACEUTICALS

LTDDERMAVIN 500MG 3630/06/00 GRISEOFULVIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

500MG TABLET 10*10,500 &1000 HDPE INDIA ABACUS PHARMA 17/09/09 RT28444 DATED

09/08/11{B0FB8608-A4D5-488BB5F7-084C94B1DB1C}

FLAMINGO PHARMACEUTICALS

LTDFLACI-QUIN 300 3631/06/00 QUININE SULPHATE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

300MG TABLET 1 * 10 * 10 BLISTER, 1 * 100, 1 * 1000 HDPE INDIA ABACUS PHARMA 17/09/09 RT28444 DATED

09/08/11{B2772A03-08D7-42C2-9861-F9E2A4FDC659}

MARCK BIOSCIENCES LTD GLUCOSE 5% I.V 3654/23/00 GLUCOSE

MARCK BIOSCIENCES LTD, PLOT NO 876, N.H.

NO 8, VIL HARIYALA, KHEDA - 387411,

GUJARAT

5%W/V INFUSION, LARGE VOL. 500ML INDIA

KARURI PHARMACEUTICALS

LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{1263F098-D870-4CA6-8CB9-7E3966C97D78}

MARCK BIOSCIENCES LTD RINGER LACTATE 3655/23/00 COMPD SODIUM

LACTATE

MARCK BIOSCIENCES LTD, PLOT NO 876, N.H.

NO 8, VIL HARIYALA, KHEDA - 387411,

GUJARAT

Z INFUSION, LARGE VOL. 500ML INDIA

KARURI PHARMACEUTICALS

LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{1B51ECD1-27B1-4FA1-8098-

3A36DB8531A8}

RENE INDUSTRIES LTD INDOREN CAPSULES 3674/02/00 INDOMETHACIN

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

25MG CAPSULE 10*10 &1000 HDPE UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{27B9E323-7A05-4E79-8FC0-AE07138A93F0}

RENE INDUSTRIES LTD

RENCHLOR CAPSULE 3675/06/00 CHLORAMPHENICOL

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

250MG CAPSULE 10*10 &1000 HDPE UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{A7091B32-8D13-4993-8C93-

EC7EAD29F6AE}

RENE INDUSTRIES LTD RENEDOL 3676/02/00 PARACETAMOL

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

500MG TABLET 10*10 &1000 HDPE UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{A5D7F181-D2ED-458B-8E75-

F6947CDC5307}

RENE INDUSTRIES LTD RENETRIM TABLETS 3677/06/00 CO-TRIMOXAZOLE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

480MG TABLET 1000 HDPE UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{0B61C596-54D8-4F6E-9BD6-E1ABA9B9377C}

RENE INDUSTRIES LTD

TETRAREN CAPSULE 3678/06/00 TETRACYCLINE

HYDROCHLORIDE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

250MG CAPSULE 10*10 &1000 HDPE UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{B5646497-20B6-4D99-8CAD-0AE44670C652}

Page 35

Page 36: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SHAIGAN PHARMACEUTICALS

PVT LTDZEPAR SUSPENSION 3684/06/00 ALBENDAZOLE

SHAIGAN PHARMACEUTICALS

PVT LTD,14 KM ADYALA ROAD

200MG/5ML ORAL SUSPENSION 10ML PAKISTAN HEALTH CARE LTD 11/02/09 RT31759 DATED 13/12/11

{D63C63A6-78ED-4D90-8920-

093BEFD2F6F9}

TORRENT PHARMACEUTICALS

LTDBETAGARD-50 3690/12/00 ATENOLOL

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

50MG TABLET 2*50 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {853850F8-329C-4F9B-

8219-7E53D5FEBB5E}

TORRENT PHARMACEUTICALS

LTDCALCIGARD RETARD 3691/12/00 NIFEDIPINE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

20MG TABLET, S/R 10*10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {4492B04F-462A-4D5C-

B078-1CE327E24C4D}

TORRENT PHARMACEUTICALS

LTDCARBATOL 200 3692/05/00 CARBAMAZEPINE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

200MG TABLET 2*5*10 & 1000HDPE INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{E3335350-D433-4467-ABDC-

C53B77C175FF}

AFFORD INJECTAPLAN 3706/18/01 MEDROXYPROGESTERONE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD, PLOT

150MG INJECTION 1ML AMPOULE UGANDAKAMPALA

PHARMACEUTICALS LTD

{182F8E71-B948-4BF8-A777-00F4D0ECED97}

AFFORD PILPLAN 3707/18/01 NORGESTREL/ETHINYLOESTRADIOL

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD, PLOT

0.3MG/0.03MG TABLET 2*28 BLISTER UGANDAKAMPALA

PHARMACEUTICALS LTD.

{83044A0F-8D17-408E-8B8B-

1DB12C12D6EA}

ALCON CUSI S.A. COLIRCUSI GENTADEXA 3713/21/01 GENTAMICIN

/DEXAMETHASONE

ALCON CUSI SA, CAMIL FABRA 58

08320 EL MASNOUR BARCELONA

0.3%/ 0.1%W/V EYE DROP 10ML SPAIN KARURI PHARMA. LTD

RT27348 DATED 27/06/2011 DOC

REVIEW

RT28866 DATED 29/08/2011

{CB91EE1D-306D-4024-8D50-

57937E77D9BE}

ALCON CUSI S.A. COLIRCUSI GENTAMICIN 3714/21/01 GENTAMICINSULPHA

TE

ALCON CUSI SA, CAMIL FABRA 58

08320 EL MASNOUR BARCELONA

0.3%W/V EYE DRPOS 10ML SPAIN KARURI PHARMA. LTD

DATED 27/06/2011 DOC REVIEW

RT28866 DATED 29/08/2011

{CD7D0AE6-C9AC-4BC8-B6FC-

37D8E190635F}

ALCON CUSI S.A. ERYTHROMYCIN 0.5% 3715/06/01 ERYTHROMYCIN

ALCON CUSI SA, CAMIL FABRA 58

08320 EL MASNOUR BARCELONA

0.5%W/W EYE OINTMENT 3.5G SPAIN KARURI PHARMA. LTD

DATED 27/06/2011 DOC REVIEW

RT28866 DATED 29/08/2011

{9D77795F-DC55-4886-987B-C22E341BE21C}

CADILA HEALTHCARE LTD

TRAMAZAC INJECTION 3723/02/01 TRAMADOL

HYDROCHLORIDE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

50MG/ML INJECTION 2ML AMPOULE INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{2D149FFF-4BE0-47F9-9854-A80FF591612D}

CADILA HEALTHCARE LTD ZEFONE INJECTION 3724/06/01 CEFTRIAXONE

SODIUM

ASTRAL PHARMACEUTICAL INDUSTRIES LTD.

911, GIDC,

1GM INJECTION POWDER VIAL INDIA ABACUS PHARMA (A) LTD 24/05/2010 RT28660 DATED

19/08/2011{C6862C22-E6FA-4465-A703-4AEEBA42F4C8}

EPLA LABORATORIESPVT LTD ASCOBIC ACID 3731/27/01 ASCORBIC ACID

EPLA LABORATORIES PVT

LTD D12 ESTATE AVENUE S.I.T.

100MG TABLET 1 * 1000 HDPE PAKISTAN HEALTHCARE (U) LTD 07/10/10 RT31695 DATED 09/12/11

{E507C22F-EADB-4345-B1A6-

3609F2B66B95}

FLAMINGO PHARMACEUTICALS

LTD

ERYCIN 250MG TABLETS 3734/06/01 ERYTHROMYCIN

STEARATE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

250MG TABLETS 10*10,1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{2555C6E1-FB67-4799-BC19-0471DFF3335D}

FLAMINGO PHARMACEUTICALS

LTDGLIBETICS TABLETS 3735/18/01 GLIBENCLAMIDE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

5MG TABLETS 1 * 100, 1 * 1000 HDPE & 10*10BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED

09/08/11

{34ADFD83-B5D4-4427-81E4-

B431CC7B968F}

FREDUN PHARMACEUTICALS

LTD

NEOPROFANE 200 TABETS 3739/02/01 IBUPROFEN

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

200MG TABLET 10*10,500,1000 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011

{3E2DBB08-A3AE-490E-B6C3-

5E6D44515492}

Page 36

Page 37: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

FREDUN PHARMACEUTICALS

LTDQUINFER 3740/06/01 QUININE SULPHATE

FREDUN PHARMACEUTICALS

LTD MANOJ INDUSTRIAL

PREMISES G.D AMBEKAR MARG WEDALA MUMBAI

400031

300MG TABLET 10*10,500,1000 INDIA ABACUS PHARMA (A) LTD 23/11/2009 RT293353 DATED

16/09/2011{7309E900-6C8C-49EE96D3-9C62620437C7}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM QUIN SYRUP 3746/06/01 CHLOROQUINE

PHOSPHATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

80MG/5ML SYRUP 60ML,100ML UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{3FA0085F-2B68-4B0E-B9C9-03EB72510191}

KAMPALA PHARMACEUTICALS

INDUSTRIESKAM QUIN TABLETS 3747/06/01 CHLOROQUINE

PHOSPHATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

250MG TABLET 10*10 UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{D02DED10-BE96-4E95-B56D-

AE102D7CA5A9}

KAMPALA PHARMACEUTICALS

INDUSTRIESCAMSTON 3748/06/01 CLOTRIMAZOLE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

1%W/W CREAM 1 * 20G UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{74E45F39-2238-4B04-83F7-7680833BA0F6}

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD

OPTA-ATROPINE EYE DROPS 3762/21/01 ATROPINE

SULPHATE

REMINGTON PHARMACEUTICAL

INDUS. PVT LTD, 117 ALLAM

1% EYE DROPS 10ML PAKISTAN HEALTHCARE LTD 01/10/2010 RT30072 DATED 12/10/2011

{7754F6AF-3A17-4EA5-A2B4-864CF7308D48}

RENE INDUSTRIES LTD

METROREN SUSPENSION 3763/06/01 METRONIDAZOLE

BENZOATE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

200MG/5ML ORAL SUSPENSION 100ML UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{F93C2DAF-888F-4E30-AF9E-

C81B413047A1}

RENE INDUSTRIES LTD METROREN TABLETS 3764/06/01 METRONIDAZOLE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

200MG TABLETS 10*10,20,1000 UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{79D1F77B-9493-4D9B-850C-0C9B642F4C10}

TORRENT PHARMACEUTICALS

LTDLISTRIL 3771/12/01 LISINOPRIL

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

5MG TABLET 10*10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{7D9F5C68-91FC-479A-8C14-

A93BDCD92392}

TORRENT PHARMACEUTICALS

LTDTOCOFER 200 3772/27/01 VITAMIN E

TORRENT PHARMACEUTICALS

LTD, INDRAD-382 721, DIST.

200MG SOFT GELATIN CAPSULES 10*10 BLISTER INDIA

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {A7BF947A-8B07-422A-

BD32-F72A373467F5}

TORRENT PHARMACEUTICALS

LTDTOCOFER 3773/27/01 VITAMIN-E SOFT

GELATIN CAPSULE

TORRENT PHARMACEUTICALS

LTD, INDRAD-382 721, DIST.

400MG CAPSULE 10 * 10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{9995E106-C87D-4B28-A0CA-

EE16DE3313DC}

UNICHEM LABORATORIES LTD TRIKA 0.25 TABLETS 3775/05/01 ALPRAZOLAM

UNICHEM LABORATORIES LTD, 17/18 PILERNE IND.

ESTAT

0.25MG TABLET 1*10*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

12/03/07 + RE-AUDIT FEES (RT20065 DATED 22/07/10)

RT29055 DATED 06/09/11

{33836640-9FA3-429C-A478-D210E318E1A9}

WOCKHARDT LIMITED

POWERCEF 1GM INJECTION 3780/06/01 CEFTRIAXONE

SODIUM

WOCKHARDT LIMITED, B-15/2,

MIDC WALUJ AURANGABAD 4

1GM INJECTION POWDER VIAL INDIASTAR

PHARMACEUTICALS LTD

14/12/09 RT28254 DATED 01/08/11

{CC049546-7181-4C4B-B163-E11244D150A6}

CADILA HEALTHCARE LTD

ZYCEL-100 CAPSULES 3790/02/01 CELECOXIB

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

100MG CAPSULE 10*10 INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{933673AD-EA65-435E-8AD4-118FE194EA3F}

FLAMINGO PHARMACEUTICALS

LTDMEDAMPI 1GM 3795/06/01 AMPICILLIN SODIUM

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

1GM INJECTION POWDER VIAL INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{47358642-5965-46E0-9184-253250CCA02E}

FLAMINGO PHARMACEUTICALS

LTDHYOMIDE 3798/17/01 HYOSCINE

BUTYLBROMIDE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

10MG TABLET 10*10 BL &100 HDPE INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{327E40B2-54F3-4C12-A0FC-24E5B3F6C27E}

FLAMINGO PHARMACEUTICALS

LTDCIFIN 500 3799/06/01 CIPROFLOXACIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

500MG TABLET 1*10 & 10*10 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{13A1A2C2-1BF4-4043-BDA8-978027774FAE}

Page 37

Page 38: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ARENCO PHARMACEUTICA NV

ARTENAM PAEDIATRIC INJECTION

3826/06/01 ARTEMETHER

EBEWE PHARMA MONDSEESTRASSE

11 A-4866 UNTERACH

40MG/2ML INJECTION 2ML BELGIUM MCNAUGHTON(U) LTD 12/03/10 RT28522 DATED

15/08/11{AF78076C-09B9-4AE791F4-82690A875319}

FLAMINGO PHARMACEUTICALS

LTDQUINONEG 500 3831/06/01 NALIDIXIC ACID

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

500MG TABLET 100 & 10*10 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{A2E79B9E-1781-4BFEB01C-

D9DFBC28D5BA}

CENTAUR PHARMACEUTICALS

LTD

TRANSLIPO -C CREAM 3832/13/01 CLOTRIMAZOLE

CENTAUR PHARMACEUTICALS

LTD , PLOT NO. 39 TIVIN IN

1% CREAM 15G , 10G & 20GM INDIAGITTOES

PHARMACEUTICALS LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{FF8A16C6-C3D0-45B8-BC1C-

75E842AE864F}

FLAMINGO PHARMACEUTICALS

LTDTRICOGYN 500 3839/06/01 TINIDAZOLE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

500MG TABLET 4 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{BFCEC7AC-1056-47F3-B1E5-

062654905A4F}

CLARIS LIFESCIENCES LTD CELEMIN 10 PLUS 3841/23/01 AMINO ACIDS +

ELECTROLYTES

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

INFUSION 500ML INDIA REDDY`S PHARMA LTD 01/03/2010 RT31356 DATED

24/11/2011{B4E0DA06-978C-481781B1-003A4D3F83D3}

FLAMINGO PHARMACEUTICALS

LTDLOCID 20 CAPSULES 3844/17/01 OMEPRAZOLE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

20MG CAPSULE 1*10, 10*10 BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{01140AA0-E4B5-492D-A448-2E7AA03289F3}

FLAMINGO PHARMACEUTICALS

LTD

PROPRANOLOL TABLETS 3845/12/01 PROPRANOLOL

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

40MG TABLET 10*10 BL & 1000 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{E0C1394D-5C3F-41CD-9103-

DD215DEAEB0F}

CLARIS LIFESCIENCES LTD CELEMIN 5S 3846/23/01 AMINO ACIDS

+SORBITOL

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

5% + 5% INFUSION 500ML INDIA REDDY`S PHARMA LTD 01/03/2010 RT31356 DATED

24/11/2011

{4DC11515-B156-4AFB-B943-

83070F940A39}

TORRENT PHARMACEUTICALS

LTDTOZAAR -50 3850/10/01 LOSARTAN

POTASSIUM

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

50MG TABLET 5*10 INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {C4C8E5B7-166E-4715

BA22-2C8F229B3E9A}

SWISS PHARMACEUTICALS

PVT LTDVITAGLOBIN SYRUP 3860/27/01 MULTI-INGREDIENT

SWISS PHARMACEUTICALS

PVT LTD. A159 SINDH INDUSTRIAL

AREA KARACHI

MULTI-INGREDIENT SYRUP 90ML & 250ML PAKISTAN HEALTH CARE LTD

RE-ISNP PAID 27/07/2009 VIDE

RT12744. REMINDER SENT TO INSP.

RT30076 &RT30073 DATED 12/10/2011

{43E9F743-44DD-4479-9A29-F1B0B6B1D1F1}

JOHNSON&JOHNSON PTY LTD

COOLMINT LISTERINE 3863/13/01 MENTHOL +

ALCOHOL 95%

JOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794

0.02% + 4.58ML ORAL SOLUTION 500ML & 250ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED 18/10/2011

{62B15D84-3A9C-4F77-8DE9-0BBBEEA2333F}

JOHNSON&JOHNSON PTY LTD

LISTERINE ANTISEPTIC 3864/13/01 THYMOL + ALCOHOL

95%

JOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794

12.78MG/20ML + 5.60ML/ML ORAL SOLUTION 500ML & 250ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED

18/10/2011{A8114101-AC81-45C4-9AD6-1DB3990D0C59}

MACNAUGHTON (U) LTD PLENDIL 3866/12/01 FELODIPINE

ASTRAZENECA AB, GARTUNA &

SNACKVIKEN STOCKHOLM

10MG TABLET 30 SWEDEN MACNAUGHTON (U) LTD 30/06/10 RT29485 DATED

22/09/11{E0764B39-9FDB-4233-817A-2A824BE74548}

MACNAUGHTON (U) LTD PLENDIL 3867/12/01 FELODIPINE

ASTRAZENECA AB, GARTUNA &

SNACKVIKEN STOCKHOLM

5MG TABLET 30 SWEDEN MACNAUGHTON (U) LTD 30/06/10 RT29485 DATED

22/09/11

{C325DC15-798E-4B7D-954E-

791FAA1EBECE}

MACNAUGHTON (U) LTD

PULMICORT TURBUHALER 3868/12/01 BUDESONIDE

ASTRAZENECA AB, GARTUNA &

SNACKVIKEN STOCKHOLM

200McG INHALER 100 DOSES SWEDEN MACNAUGHTON (U) LTD 30/06/10 RT29485 DATED

22/09/11

{85CD986D-D453-45FB-A37C-

516311CB1B2A}

RENE INDUSTRIES LTD RENIRON TONIC 3869/27/01 MULTI-INGREDIENT

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

MULTI-INGREDIENT SYRUP 100ML, 200ML UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{1B7084A9-21BD-4D97AA21-73E3AA682FC8}

INTAS PHARMACEUTICALS

LTDHELIGO KIT 3876/17/01

TINIDAZOLE/CLARITHROMYCIN/LANSOPRA

ZOLE

INTAS PHARMACEUTICALS LTD MATODA 382 210 DIST AHMEDABAD,

INDIA

500MG+ 250MG+30MG TABLET +CAPSULE (2+2+2)*7 INDIA

NORVIK ENTERPRISES (U)

LTD06/09/09 RT29052 DATED

06/09/11{3EFC5F28-95C6-411E-B1C5-BA3A87E0D467}

Page 38

Page 39: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

AJANTA PHARMA LTD KAMAGRA 3882/18/01 SILDENAFILAJANTA PHARMA LTD, B-4/5/6 MIDC

AREA PAITHAN 431 150MG TABLET 4 BLISTER INDIA

AARON PHARMACEUTICALS

LTD27/11/08 RT28086 DATED

26/07/11{E13FB509-B9D8-4855-B2DE-2274A3CA0C13}

AMSON VACCINES & PHARMA PVT LTD FEFAN TABLETS 3884/10/01

FERROUS FUMARATE+FOLIC

ACID

AMSON FARMACO BIOLOGICO 154 IND. TRIANGLE ISLAMABA

150MG+0.5MG TABLET 1000 PAKISTAN HEALTH CARE LTD. 09/02/09 RT31758 DATED 13/12/11

{6519D3C6-9EEF-4208-AE70-96371B9614EC}

AMSON VACCINES & PHARMA PVT LTD

MYCONIL ORAL DROPS 3885/06/01 NYSTATIN

AMSON FARMACO BIOLOGICO 154 IND. TRIANGLE ISLAMABA

100.000 IU/5ML ORAL DROPS 30ML PAKISTAN HEALTH CARE LTD. 09/02/09 RT31758 DATED 13/12/11

{B9C64927-2296-4D9A-A57D-33C59D86FAC0}

AMSON VACCINES & PHARMA PVT LTD

MYCONIL VAGINAL TABLETS 3886/06/01 NYSTATIN

AMSON FARMACO BIOLOGICO 154 IND. TRIANGLE ISLAMABA

100.000 IU PESSARIES 2*5 & 15 STRIP PAKISTAN HEALTH CARE LTD. 09/02/09 RT31758 DATED 13/12/11

{87E172F6-55E1-4549-A260-374392E0FC17}

CADILA HEALTHCARE LTD ATORVA TABLETS 3899/10/01 ATORVASTATIN

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

10MG TABLET 1*5*(1*7 ) IN BLISTERS INDIA ABACUS PHARMA (A)

LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{072DCF26-83E4-4EF1-97F2-DDA6B11F1F2C}

CADILA HEALTHCARE LTD

PENEGRA-50 TABLETS 3902/18/01 SILDENAFIL

CADILA HEALTHCARE

LIMITED SWARAJ MAJRA JUDDI KLAN

50MG TABLET 20*4 BLISTER INDIA ABACUS PHARMA (A) LTD 16/11/2012 RT28660 DATED

19/08/2011{FCF5D035-1888-4403-8B08-2844B578C811}

CADILA HEALTHCARE LTD ZYCEL200 3903/02/01 CELECOXIB

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

200MG CAPSULE 10*10 INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{7926710C-217D-4B80-A143-1F4AE0613975}

ELYS CHEMICAL INDUSTRIES LTD CANDISTAT CREAM 3923/13/01 CLOTRIMAZOLE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

1% CREAM 20G KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011{36E796B6-4486-49B1-ACE5-1015D87EE243}

FLAMINGO PHARMACEUTICALS

LTDANALMIN CAPSULES 3927/02/01 MEFENAMIC ACID

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

250MG CAPSULE 10*10 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{CAB2175F-8988-4D1A-9964-

BEF5E2EE3C2F}

FLAMINGO PHARMACEUTICALS

LTDAZIFLAM 250 3929/06/01 AZITHROMYCIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

250MG CAPSULE 2*3 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{51282311-F4FF-4FBA-AA88-

C50AB1B48CED}

FLAMINGO PHARMACEUTICALS

LTDAZIFLAM 500 3930/06/01 AZITHROMYCIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

500MG CAPSULE 1*3 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{F78792BD-BF44-403E-98EB-89BC955B78D6}

FLAMINGO PHARMACEUTICALS

LTDCARBAZINA TABLETS 3932/05/01 CARBAMAZEPINE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

200MG TABLET 10*10 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{853F47E2-8B47-46C8-AF42-8FE346A00E7C}

FLAMINGO PHARMACEUTICALS

LTDCIPRITOL 4 3933/04/01 CYPROHEPTADINE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

4MG TABLET 50 & 10*10 BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{1ADDBA1D-21A2-419B-9C37-

79FC4339AF0E}

FLAMINGO PHARMACEUTICALS

LTDDICLON-50 3934/02/01 DICLOFENAC

SODIUM

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

50MG TABLET 2*10 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{BF18F386-17F7-4023-90C4-5BC1C98AF33F}

FLAMINGO PHARMACEUTICALS

LTDFLAMOCIN 200 3936/02/01 OFLOXACIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

200MG TABLET 10*10 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{A8E86AA8-7AE4-4935A18D-0AB069157ED8}

FLAMINGO PHARMACEUTICALS

LTDKETARIN 3938/06/01 KETOCONAZOLE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

200MG TABLET 10*10 & 3*10 BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{2BA44BEC-59A3-480387C6-DE5747C56DE6}

Page 39

Page 40: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

GLENMARK PHARMACEUTICALS

LTDMILICAL TABLETS 3948/27/01 CALCIUM CITRATE +

VITAMIN D3

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

1000MG +200 I.U TABLET 10*3 INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{230EF60E-6E38-4DD1-AEA4-

76FCF98E88AB}

INDOCO REMEDIES LTD TRIZ TABLETS 3956/04/01 CETIRIZINE

INDOCO REMEDIES LTD, B-20, MIDC,

WALUJ, AURANGABAB 431136 INDIA

10MG TABLET 5*5*10,1*2*5*10 INDIA TATA UGANDA LTD 10/05/2010 RT29332 & JV11/148 DATED 16/09/11

{BCACD395-7DDF-4AE0-8E5E-

501008780A3A}

INTAS PHARMACEUTICALS

LTDSECZOL DS 3957/06/01 SECNIDAZOLE

INTAS PHARMACEUTICALS

LTD, 7/3 GIDC ESTATE VATVA

AHMEDABAD 382 445 INDIA

1G TABLET 1*2 INDIANORVIK

ENTERPRISES (U) LTD

04/10/11 RT29052 DATED 06/09/11

{D56F5B41-46DA-497E-A8B0-

5C475F568250}

MACNAUGHTON (U) LTD NEXIUM 20MG 3963/17/01 ESOMEPRAZOLE

ASTRAZENECA AB, GARTUNA &

SNACKVIKEN STOCKHOLM

20MG TABLET 7, 14 & 28'S SWEDEN MACNAUGHTON (U) LTD 30/06/10 RT29485 DATED

22/09/11{4F98FDA7-9149-43E0-9674-3724A6E72EFE}

MACNAUGHTON (U) LTD NEXIUM 40MG 3964/17/01 ESOMEPRAZOLE

ASTRAZENECA AB, GARTUNA &

SNACKVIKEN STOCKHOLM

40MG TABLET 7, 14 & 28'S SWEDEN MACNAUGHTON (U) LTD 30/06/10 RT29485 DATED

22/09/11

{2F73B3AF-87D4-4A2A-B4B7-

D680F2A33280}

NEM LABORATORIES PVT LTD TRAN-GEL 3965/13/01 DICLOFENAC

DIETHLAMMONIUM

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

1%W/W TOPICOL GEL 20G & 30G INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011{4B4846A2-D3BE-406BAD9E-9D876B31E037}

PFIZER LABORATORIES

(PTY) LTDDIFLUCAN TABLETS 3969/06/01 FLUCONAZOLE

PFIZER LABORATORIES (PTY) LTD 102 RIVONIA RD

SANDTON 2196 SOUTH AFRICA / -

PFIZER PHARMACEUTICALS LTD , LLC ROAD 689 KM 1.9, VEGA BAJA, PUERTO RICO USA

(ADDITIONAL PRIMARY

PACKAGING )

200MG TABLET 28'S SOUTH FRICA LABOREX (U) LTD RT28810 DATED 26/08/2011

{785FC350-6892-45EC-B9A8-C5D2515D3B61}

RENE INDUSTRIES LTD REQUIN SYRUP 3990/06/01 QUININE

HYDROCHLORIDE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

100MG/5ML SYRUP 100ML UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{F1A8CC4C-EE0F-4D36-9351-

6711E86DBE40}

JOHNSON&JOHNSON PTY LTD BENYLIN CHESTY 4009/25/01 ORCIPREALINE+BRO

MHEXINE

JOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD

/HOOFWEG 241,RETREAT

7945,SOUTH AFRICA

5MG+4MG/5ML SYRUP 200ML & 100ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED 18/10/2011

{6C9D6BAA-10E6-4337-91CC-

02A2DF4544A8}

JOHNSON&JOHNSON PTY LTD

BENYLIN FOUR FLU LIQUID 4010/25/01

DIPHENHYDRAMINE+PARACETAMOL+PSE

UDOEPHEDRINE

JOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD

/HOOFWEG 241,RETREAT

7945,SOUTH AFRICA

25MG+1G+45MG/20ML SYRUP 200ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED

18/10/2011

{F56904AC-FD58-4B1F-9E75-

C4181DFF29A6}

Page 40

Page 41: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

WIN-MEDICARE LTD HEPA-MERZ INFUSION 4011/17/01 L-ORNITHINE- L-

ASPARTATE

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

5MG/ML INFUSION 10ML INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{0D36D655-002D-4A23-9C26-2CCBBD010E98}

WIN-MEDICARE LTD HEPA-MERZ TABLET 4012/17/01 L-ORNITHINE- L-ASPARTATE

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

150MG TABLET 10*10 INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{6FE363AF-7FDD-4C0F-8D71-

1D51C0995E57}

WIN-MEDICARE LTD LOGICAN 150 4013/06/01 FLUCONAZOLE

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

150MG CAPSULE 1 *10*1 BLISTER INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{F87DB6EC-47A2-43FB-9DC2-

F8F997561DBC}

WIN-MEDICARE PVT LTD UDIHEP TABLETS 4014/146/01 URSODEOXYCHOLIC

ACID

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

150MG TABLET 3*10 BLISTER INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{8F8B1636-D5B1-4DEF-A13E-

FF88B36E39CF}

WIN-MEDICARE LTD URGENDOL INJECTION 4015/02/01 TRAMADOL

HYDROCHLORIDE

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

50MG/ML INJECTION 1ML & 2ML AMPOULE INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{27C28177-BC7C-440C-B405-

50790E1337B0}

WIN-MEDICARE LTD ZAPACID 30 4016/17/01 LANSOPRAZOLE

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

30MG CAPSULE 3*10 BLISTER INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{F54DF2B6-C73E-4E9C-A673-

EA31562E042B}

BAYER EAST AFRICA LTD AVELON TABLETS 4046/06/01 MOXIFLOXACIN BAYER AG D-5136

LEVERKUSEN 400MG TABLET 2*5 BLISTER, 1 * 5BLISTER GERMANY SURGIPHARM (U)

LTD{2291D524-8A45-4D8F-B996-37EC59C8A514}

BAYER EAST AFRICA LTD ADALAT XL 4047/12/01 NIFEDIPINE BAYER AG D-5136

LEVERKUSEN 30MG TABLET 2 * 14 BLISTER GERMANY SURGIPHARM (U) LTD

{26320F2F-78B5-4A4E-AEDA-

8FDDB90A7942}

BETA HEALTHCARE INTERNATIONAL LTD BETAFEN SYRUP 4048/02/01 IBUPROFEN

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BOX 42569,

NAIROBI, KENYA.

100MG/5ML SYRUP 100ML,60ML KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11

{CC5E4B67-D6D4-46B5-9775-

4E0A003970F8}

CYANO PHARMA METOCLOPRAMIDE 4058/24/01 METOCLOPRAMIDE

CYANO PHARMA(P) 115-C IND ESTATE

POLO GROUND INDORE

10MG TABLET 10*10 BLISTER & 1000 HDPE INDIA RENE PHARMACY 21/04/2009 RT29397 DATED

20/09/2011{36325E80-5A4A-40B1-AD86-D767DBD5A799}

CYANO PHARMA CYANO IRON TABLETS 4059/10/01 FERROUS SULPHATE

CYANO PHARMA(P) 115-C IND ESTATE

POLO GROUND INDORE

200MG TABLET 1000 HDPE INDIA RENE PHARMACY 21/04/2009 RT29397 DATED 20/09/2011

{4D3C42AD-8B4A-40D1-AC11-

340418F39FA0}

CYANO PHARMA PROMETHAZINE TABLETS 4060/03/01 PROMETHAZINE

HYDROCHLORIDE

CYANO PHARMA(P) 115-C IND ESTATE

POLO GROUND INDORE

25MG TABLET 1000 HDPE & 10*10 BLISTER INDIA RENE PHARMACY 21/04/2009 RT29397 DATED

20/09/2011

{C9E8BCBC-CFD5-475D-961B-

F1C0C6EDAE97}

FLAMINGO PHARMACEUTICALS

LTD

SALCRYMOL TABLETS 4065/25/01 SALBUTAMOL

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

4MG TABLET 1000HDPE & 10*10 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{11F495CE-79F4-48D8-A4E2-D96FC9E7C8B2}

INDOCO REMEDIES LTD ABZ SUSPENSION 4067/06/01 ALBENDAZOLE

INDOCO REMEDIES LTD, B-20, MIDC,

WALUJ, AURANGABAB 431136 INDIA

200MG/5ML ORAL SUSPENSION 10ML INDIA TATA UGANDA LTD 10/05/2010 RT29332 & JV11/148 DATED 16/09/11

{277B0E90-775D-41D2-8745-043BCD66B13F}

MACNAUGHTON (U) LTD

SYMBICORT TURBUHALER 4068/25/01 BUDESONIDE+FORM

OTEROL

ASTRAZENECA AB, GARTUNA &

SNACKVIKEN STOCKHOLM

160mCG+4.5McG/DOSE INHALER POWDER 60 DOSES SWEDEN MACNAUGHTON (U)

LTD 30/06/10 RT29485 DATED 22/09/11

{3B9D53F9-40B8-4FE9-8EC0-A322480384EA}

RENE INDUSTRIES LTD RENIRON SYRUP 4078/13/01

FERROUS GLUCONATE+VIT B1

+VIT C + VIT B2+VITB6+VIT

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

200MG+2MG+20MG+2MG+ 2MG+3

MCG+10MG+2MG)/5ML

SYRUP 100ML UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{C8FE260B-2E6E-4EDB-9690-

8E95813C2B71}

Page 41

Page 42: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

RENE INDUSTRIES LTD

RENECHLOR SUSPENSION 4079/06/01 CHLORAMPHENICOL

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

125MG/5ML ORAL SUSPENSION 100ML UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{F38C2A4A-E6B8-4EB2-B0D5-

70FDB3E3257C}

RENE INDUSTRIES LTD ASPIRIN TABLETS 4080/02/01 ACETYLSALICYLIC

ACID

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

300MG TABLET 500 & 1000 UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{DDB71CC3-5674-4DDC-AA2F-

BB839F03E0D4}

RENE INDUSTRIES LTD

RENEGEL SUSPENSION 4081/17/01

ALUMINIUM HYDROXIDE

GEL+MAGNSIUM TRISLILICATE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

120MG+250MG ORAL SUSPENSION 100ML UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{8DCE6FE8-BC0F-4EC4-B658-

88AB4814F0BB}

RENE INDUSTRIES LTD REQUIN TABLETS 4082/06/01 QUININE SULPHATE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

300MG TABLET 10*10 & 1000 UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{369CBCEB-838A-4D4E-BFFF-

AC17559567D5}

SOLVAY PHARMACEUTICALS

BV

DUPHALAC SOLUTION 4084/17/01 LACTULOSE

SOLVAY PHARMACEUTICALS

BV, N.L-WEESP.67G/100ML ORAL SOLUTION 200ML & 10*15ML THE NETHERLANDS

STAR PHARMACEUTICALS

LTD29/09/08 RT17421

DATED16/08/11

{EC35B8E7-22C9-4A7F-A93C-

0F251ADF78B7}SOLVAY

PHARMACEUTICALS BV

BETASEC TABLETS 4085/02/01 BETAHISTINESOLVAY

PHARMACEUTICALS BV, N.L-WEESP.

8MG TABLET 4*25 BLISTER THE NETHERLANDSSTAR

PHARMACEUTICALS LTD

29/09/08 RT17421 DATED16/08/11

{39B1004F-77DD-4552-8F57-

C084DE7DDDB3}SOLVAY

PHARMACEUTICALS BV

DUPHASTON TABLETS 4086/08/01 DYDROGESTERONE

SOLVAY PHARMACEUTICALS

BV, N.L-WEESP.10MG TABLET 20BLISTER THE NETHERLANDS

STAR PHARMACEUTICALS

LTD29/09/08 RT17421

DATED16/08/11

{31DD0F1B-EDC2-48A2-8E95-

3256EA14DC74}

TORRENT PHARMACEUTICALS

LTDSYCAN-100 4087/06/01 FLUCONAZOLE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

100MG CAPSULE 3*2*4 INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {0483B6F0-F5B2-4D38-

A160-CFF94D30913A}

TORRENT PHARMACEUTICALS

LTDTOZAAR -25 4090/12/01 LOSARTAN

POTASSIUM

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

25MG TABLET 5*10 INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{E0DB355C-0143-41A9A028-

A140CD36BDEA}

KAMPALA PHARMACEUTICALS

INDUSTRIESRAPIDEX 4091/02/01 ACETOMINOPHE+AS

PIRIN+CAFFEINE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

200MG+ 400MG+50MG TABLET 10*10 BLISTER UGANDA K.P.I ANNUAL RT29128 DATED

07/09/2011

{5DDD2AE4-A0C7-4174-86C2-

776E995FFBE2}

ABBOTT LABORATORIES S.A

(PTY) LTDNORVIR 4096/06/02 RITONAVIR

AESICA QUEESNBOROUGH

LTD. NORTH RD. QUEENSBOROUGH

KENT

80MG/ML ORAL SOLUTION 90ML HDPE BOTTLE UK MEDICAL ACCESS UGANDA LTD 23/06/2011 RT28979 DATED

12/09/2011{246B9730-9358-4D9C-8588-86D5D1EF4FAC}

ALCON CUSI S.A. CUSICROM 4% EYE DROPS 4098/21/02 SODIUM

CROMOGLYCATE

ALCON CUSI SA, CAMIL FABRA 58

08320 EL MASNOUR BARCELONA

4% EYE DROPS 10ML SPAIN KARURI PHARMA. LTD

DATED 27/06/2011 DOC REVIEW

RT28866 DATED 29/08/2011

{7590B616-056C-4133-B3F2-96A8E1D6DA34}

BETA HEALTHCARE INTERNATIONAL LTD

BETROZOLE TABLETS 4106/06/02 METRONIDAZOLE+DI

LOXANIDE

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BOX 42569,

NAIROBI, KENYA.

200MG+250MG TABLET 30 BLISTER KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11

{6FBF3667-E9FD-4D92-8986-

C2019A8781C0}

CADILA HEALTHCARE LTD GLIZONE 30 4113/18/02 PIOGLITAZONE

CADILA HEALTHCARE LTD,

KUNDAIM INDUSTRIAL ESTATE

P

30MG TABLET 10 * 10 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{E3B04ECF-98BE-4703-9E63-

A5E6316FB03D}

CADILA HEALTHCARE LTD LORIDIN RAPITAB 4114/04/02 LORATIDINE

CADILA HEALTHCARE LTD,

KUNDAIM INDUSTRIAL ESTATE

P

10MG TABLET, DISPERSIBLE 10*10 BLISTER INDIA ABACUS PHARMA (A)

LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{EC5CDD83-FD21-434B-BDED-

B2240A79AE9A}

CADILA HEALTHCARE LTD

PENEGRA-100 TABLETS 4115/18/02 SILDENAFIL

CADILA HEALTHCARE

LIMITED SWARAJ MAJRA JUDDI KLAN

100MG TABLET 20*4 BLISTER INDIA ABACUS PHARMA (A) LTD 16/11/2012 RT28660 DATED

19/08/2011{81F67F20-A4A9-4D1B-85C0-27D1E871C6B9}

Page 42

Page 43: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CLARIS LIFE SCIENCES PROVIVE 1% 4118/01/02 PROPOFOL

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

10MG/ML INFUSION 20ML, 50ML VIAL INDIA REDDY`S PHARMA LTD 01/03/2010 RT31356 DATED

24/11/2011{472EE731-F470-4DF6-8382-153591CB416E}

ELYS CHEMICAL INDUSTRIES LTD

FUNGISTIN PESSARIES 4122/13/02 NYSTATIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

100.000 I.U PESSARY 14 , 5*3 STRIP & 100HDPE KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{2BA822AD-64EF-446598A3-02659EA99A86}

ELYS CHEMICAL INDUSTRIES LTD

FUNGISTIN ORAL SUSPENSION 4123/06/02 NYSTATIN

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

100.000 I.U/ML ORAL SUSPENSION 30ML KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{8D3390CA-9DB2-425B-BB93-

9E5CFA1F16AA}

FLAMINGO PHARMACEUTICALS

LTD

STREPTOMYCIN INJECTION 4128/06/02 STREPTOMYCIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

1G INJECTION POWDER VIAL INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{FF3D2EEF-BDE8-4398-8793-

DE0A4F84DBFA}

FLAMINGO PHARMACEUTICALS

LTD

AMPICILLIN INJECTION 4130/06/02 AMPICILLIN SODIUM

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

500MG INJECTION POWDER VIAL INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{456DF8DE-52C8-4289-B146-F9D0688252C6}

FLAMINGO PHARMACEUTICALS

LTD

URIFLOX 400MG TABLETS 4133/06/02 NORFLOXACIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

400MG TABLET 10*10 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{9034A80A-9967-4317-98B5-F9E143F12B71}

HETERO DRUGS LTD ZIDO-H 300 TABLETS 4135/06/02 ZIDOVUDINE

HETERO DRUGS LTD, UNIT-111, 22-

110 I.D.A, JEEDIMET, HYDERABAD

300MG TABLET 60 BOTTLE INDIA ASTRA PHARMA (U) LTD 17/12/09 RT28304 DATED

03/08/11

{3135FDFD-558C-416E-A6BC-

C31C1BE66167}

HETERO DRUGS LTD STAG-30 CAPSULES 4136/06/02 STAVUDINE HETERO DRUGS LTD 30MG CAPSULE 60 BOTTLE INDIA ASTRA PHARMA (U) LTD 17/12/09 RT28304 DATED

03/08/11{01365BB8-0F00-4C58-A930-99A3F370F620}

HETERO DRUGS LTD NEVIVIR 200 TABLETS 4137/06/02 NEVIRAPINE

HETERO DRUGS LTD, 22-110, 1.D.A,

JEEDIMETLA HYDERABAD

200MG TABLET 60 BOTTLE INDIA ASTRA PHARMA UGANDA LTD 17/12/09 RT28304 DATED

03/08/11

{85E9AEE2-FE1D-4AE6-9C1D-

CE30D31BF99B}

HETERO DRUGS LTD HEPTAVIR-150MG TABLETS 4138/06/02 LAMIVUDINE

HETERO DRUGS LTD, 22-110, 1.D.A,

JEEDIMETLA HYDERABAD

150MG TABLET 60 BOTTLE INDIA ASTRA PHARMA UGANDA LTD 17/12/09 RT28304 DATED

03/08/11{3793FC2F-DF35-40E5-AC45-5C03F840B5B9}

HETERO DRUGS LTD. ZIDOLAM 4139/06/02 LAMIVUDINE + ZIDOVUDINE

HETERO DRUGS LTD. 22-110 IDA

JEEDIMELTA HYDERBAD-0

150MG + 300MG TABLET 1 * 60 HDPE INDIA ASTRA PHARMA UGANDA LTD 17/12/09 RT28304 DATED

03/08/11

{ED992AA0-BAF5-44C3-931E-

DFBF8C1987E2}

KAMPALA PHARMACEUTICALS

INDUSTRIESSUGAQUIN TABLETS 4145/06/02 CHLOROQUINE

PHOSPHATE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

250MG TABLET, S/C 1000 ,10*10 UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{E9004F86-5891-4744-9813-506517EA665C}

MARCK BIOSCIENCES LTD

CIPROFLOXACIN INJECTION 4146/06/02 CIPROFLOXACIN

MARCK BIOSCIENCES LTD, PLOT NO 876, N.H.

NO 8, VIL HARIYALA, KHEDA - 387411,

GUJARAT

0.2%W/V INFUSION, LARGE VOL. 100ML INDIA

KARURI PHARMACEUTICALS

LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{8C064EDC-5699-4FBC-89AA-

C58CD7620034}

MARCK BIOSCIENCES LTD

METRONIDAZOLE INFUSION 4147/06/02 METRONIDAZOLE

MARCK BIOSCIENCES LTD, PLOT NO 876, N.H.

NO 8, VIL HARIYALA, KHEDA - 387411,

GUJARAT

5MG/ML INFUSION, LARGE VOL. 100ML INDIA

KARURI PHARMACEUTICALS

LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{82A07911-1959-4831-B17D-17347B614A6D}

MARCK BIOSCIENCES LTD

SODIUM CHLORIDE INFUSION 4148/23/02 SODIUM CHLORIDE

MARCK BIOSCIENCES LTD, PLOT NO 876, N.H.

NO 8, VIL HARIYALA, KHEDA - 387411,

GUJARAT

0.9% INFUSION, LARGE VOL. 500ML INDIA

KARURI PHARMACEUTICALS

LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{F6D5B5EB-B7C4-43BE-9964-

72FC1D88E481}

MEPHA LTD MESPORIN 1000MG I.V 4152/06/02 CEFTRIAXONE

SODIUM

LABESFAL S.A CAMPO DE

BESTERIROS & AMANDORA

1000MG INJECTION POWDER VIAL+10ML WFI PORTUGAL GOODMAN INTERNATIONAL LTD 29/04/2010 RT28480 DATED

11/08/2011

{D7629C10-ABCC-4E02-8A2B-

4B785878723E}

Page 43

Page 44: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

RENE INDUSTRIES LTD ALZOL TABLETS 4166/06/02 ALBENDAZOLE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

200MG TABLET 30*2 BLISTER UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{DCB75585-766E-4AE3-B43E-

52949CF942C6}

UNICHEM LABORATORIES LTD M-CAM TABELTS 4180/02/02 MELOXICAM

UNICHEM LABORATORIES UNIT II, VILLAGE

BHATAULI KALAN, BADDI, DIST. SOLAN

(H.P) 173205

15MG TABLET 4*5*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

22/11/10 RT29055 DATED 06/09/11

{41703CF7-E621-46CA-A931-7167ED0F6A41}

CADILA HEALTHCARE LTD NOKLOT TABLETS 4195/10/03 CLOPIDOGREL

CADILA HEALTHCARE LTD,

KUNDAIM INDUSTRIAL ESTATE

P

75MG TABLET 3*10 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{CC1AE142-0DAD-48EC-8060-

30552545A50F}

CADILA PHARMACEUTICALS

LTDAXONE 1000 4196/06/03 CEFTRIAXONE

SODIUM

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

1000MG INJECTION POWDER VIAL INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{59386B6B-5B60-4E86-AC2A-

D55E3BADD605}

CHINA ASSOCIATES BENZYLPENICILLIN INJECTION 4200/06/03 BENZYLPENICILLIN

SODIUM

JIANGXI DONGFENG PHARMACEUTICAL LTD. 15 DONGFENG ROAD LEPING CITY

1.000.000 IU INJECTION POWDER VIAL CHINA RENE PHARMACY LTD. 31/03/2011 RT29400 DATED

20/09/2011{36033372-5350-406F-A8A5-B64109FFE847}

CHINA ASSOCIATESFORTIFIED PROCIANE PENICILLIN

4201/06/03PROCAINE PENICILLIN FORTIFIED

JIANGXI DONGFENG PHARMACEUTICAL LTD. 15 DONGFENG ROAD LEPING CITY

4.000.000 IU INJECTION POWDER VIAL CHINA RENE PHARMACY LTD. 31/03/2011 RT29400 DATED

20/09/2011{4FEED5F1-F6B8-4980-A980-212E5B926088}

CYANO PHARMA DEXAMETHASONE TABLETS 4205/18/03 DEXAMETHASONE

CYANO PHARMA(P) 115-C IND ESTATE

POLO GROUND INDORE

0.5MG TABLET 1000 HDPE INDIA RENE PHARMACY 21/04/2009 RT29397 DATED 20/09/2011

{D2F123F8-067B-4916-A64C-C70F9FD15BF9}

ELYS CHEMICAL INDUSTRIES LTD VUMTREX SYRUP 4210/06/03 LEVAMISOLE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

40MG/5ML SYRUP 30ML KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{1BFEEE94-FF6B-470D-BA69-

4FAEB5E5E10C}

FLAMINGO PHARMACEUTICALS

LTDCETIRIZINE TABLETS 4215/06/03 CETIRIZINE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

10MG TABLET 10*10 INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{57DA055E-2A03-4577-A473-02D5DCF39D7F}

FLAMINGO PHARMACEUTICALS

LTD

PRAZIQUANTEL TABLETS 4216/06/03 PRAZIQUANTEL

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

600MG TABLET 8'S INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{29528A6C-E123-4D51-81D7-371FE7B24B89}

GLAXOSMITHKLINE LTD

COMBIVIR TABLETS, (ACCESS PACK) 4219/06/03 LAMIVUDINE/ZIDOVU

DINE

ASPEN PHARMACARE, 7

FAIRCLOUGH ROAD, KORSTEN PORT ELIZABETH 6020

150MG+300MG TABLET 1 * 60 HDPE SOUTH AFRICA ERIS LTD04/09/08 + REAUDIT

FEES (RT29672 DATED 29/09/11

RT28825 DATED 27/08/11

{39D2411E-4547-4DCF-8BAB-95754CD2FC9E}

GLENMARK PHARMACEUTICALS

LTD

KETO PLUS SHAMPOO 4220/13/03 KETOCONAZOLE+ZIN

C PYRITHIONE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

1+2%W/W SHAMPOO 60ML BOTTLE INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{B09A2431-D203-40FF-B09A-E7BC1355F162}

GLENMARK PHARMACEUTICALS

LTD

SUPIROCIN OINTMENT 4221/13/03 MUPIROCIN

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

2%W/W OINTMENT 15G INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{C9439580-55D6-4581-96FF-1F930A6DA10F}

INTAS PHARMACEUTICALS

LTDAMTAS -5 4241/12/03 AMLODIPINE

INTAS PHARMACEUTICALS

LTD, CAMP ROAD, SELAQUI,

DEHRADUN

5MG TABLET 2*2*7 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

18/02/10 RT29052 DATED 06/09/11

{2D3B7ED5-DC90-4655-9289-

B8D5793DCE06}

Page 44

Page 45: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

INTAS PHARMACEUTICALS

LTDLIPICURE-20 4242/10/03 ATORVASTATIN

INTAS PHARMACEUTICALS

SELAQUI, CAMP ROAD, DEHRADUN-

248 197 UTARANCHAL

20MG TABLET 1*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

18/02/10 RT29052 DATED 06/09/11

{E5A42991-248D-4CD0-8298-

C304B7CE9D99}

INTAS PHARMACEUTICALS

LTD

LOSARTAS 50 TABLETS 4243/12/03 LOSARTAN

POTASSIUM

INTAS PHARMACEUTICALS

LTD CAMP ROAD ,SELAQUI

DEHRADUN , INDIA

50MG TABLET 4 * 7 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

18/02/10 RT29052 DATED 06/09/11

{D577ADE7-BC5F-45E7-AB58-

BCF824AA02E0}

MEDICAL UNION P'CAL CO. LAXOLAC SYRUP 4256/17/03 LACTULOSE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA67G/100ML SYRUP 120ML EGYPT

KARURI PHARMACEUTICALS

LTD12/10/2009 RT27905 DATED

18/07/2011{17A6E74E-2C04-45B1-A014-03FEBAD89A43}

MEDICAL UNION P'CAL CO. MICONAZ CREAM 4257/13/03 MICONAZOLE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA2%W/W CREAM 20G EGYPT

KARURI PHARMACEUTICALS

LTD12/10/2009 RT27905 DATED

18/07/2011{96E8B4C5-E1FF-4790-97F3-0855A2E96ABB}

MEDICAL UNION P'CAL CO. MICONAZ ORAL GEL 4258/13/03 MICONAZOLE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA2%W/W ORAL GEL 20G EGYPT

KARURI PHARMACEUTICALS

LTD12/10/2009 RT27905 DATED

18/07/2011

{ABC7A9F4-1BCA-498C-93C1-

FFA755C50E89}

MEDICAL UNION P'CAL CO.

MUCOSOL PEDIATRIC SYRUP 4259/25/03 CARBOCYSTEINE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA125MG/5ML SYRUP 120ML EGYPT

KARURI PHARMACEUTICALS

LTD12/10/2009 RT27905 DATED

18/07/2011

{8AABC3EE-E9FF-40EF-8C1D-

4A81E5DA09AA}

MEDICAL UNION P'CAL CO. SEDIPROCT CREAM 4260/13/03 HYDROCOTISONE+CI

NCHOCAINE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA

0.5% W/V + 0.5% W/ W CREAM 20G EGYPT

KARURI PHARMACEUTICALS

LTD12/10/2009 RT27905 DATED

18/07/2011{1BE91866-F3EE-4114-8DE6-7AD04771D0E7}

MEDICAL UNION P'CAL CO.

SEDIPROCT SUPOSITORY 4261/13/03

HYDROCOTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETINE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA

5MG + 5MG +10MG +10MG SUPOSITORY 1*6 STRIP EGYPT

KARURI PHARMACEUTICALS

LTD12/10/2009 RT27905 DATED

18/07/2011

{CA13FDCE-ED37-4BFB-85AF-

0B238320292D}

MEPHA LTD TRABILIN- 50 CAPSULES 4266/02/03 TRAMADOL

MERCKLE GMBH, LUDWIG MERCKLE STRASSE3 D-89143

BLAUBEUREN

50MG CAPSULE 10 BLISTER, 2*10BLISTER GERMANY GOODMAN

INTERNATIONAL LTD 19/08/2009 RT28480 DATED 11/08/2011

{2EBEACF7-B729-4A78-AD73-

2AFE5C083B88}

NOVARTIS CONSUMER

HEALTHCARE INTERNATIONAL

OTRIVIN 0.05 % NASAL DROP 4272/21/03 ZYLOMETAZOLE NOVARTIS

CONSUMER HEALTH 0.05%W/V NASAL DROP 10ML SWITZERLAND BETA HEALTH CARE (U) LTD

{703DA529-7029-45E4-9964-46C23C74402F}

NOVARTIS CONSUMER

HEALTHCARE INTERNATIONAL

OTRIVIN 0.1% NASAL DROP 4273/28/03 ZYLOMETAZOLE NOVARTIS

CONSUMER HEALTH 0.1%W/V NASAL DROP 10ML SWITZERLAND BETA HEALTH CARE (U) LTD

{2DFE53DB-961E-466F-BF03-

C3F77071B263}

ESAPHARMA SRL LEMOVATE CREAM 4282/13/03 CLOBETASOL PROPIONATE

ESAPHARMA SRL VIA DE GASPERI 13 20066 MELZO MILA

0.05%W/W CREAM 30GM ITALYBYAMAKA

PHARMACEUTICALS LTD.

RT21544 DATED 30/09/2010.

DOCUMENT REVIEW

RT28235 DATED 01/08/2011

{22199B18-A0FF-4974-9595-9E9A47D07E8E}

RANBAXY LABORATORIES LTD AVIRO-Z TABLETS 4292/06/03 ZIDOVUDINE

RANBAXY LABS LTD, PAONTA SAHIB DIST

SIRMOUR HIMANCHAL

PRADESH 173025

300MG TABLET 1 * 60 HDPE INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011{5F5F22F9-B617-42EC-8BB2-98A263D73F98}

RANBAXY LABORATORIES LTD AVOCOMB TABLETS 4293/06/03 LAMIVUDINE/ZIDOVU

DINE

RANBAXY LABORATORIES LTD, PAONTA SAHIB DIST.

SIRMOUR H.P 173 025 MFG. LIC:

MNB/95/2

150MG+300MG TABLET 1 * 60 HDPE INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011{434687F3-D47F-4780-9F6B-0F833D5C8CAC}

RANBAXY LABORATORIES LTD AVOLAM TABLETS 4294/06/03 LAMIVUDINE

RANBAXY LABS LTD, PAONTA SAHIB DIST

SIRMOUR HIMANCHAL

PRADESH 173025

150MG TABLET 1 * 60 HDPE INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011

{1E83BB24-E0A5-4E30B15B-

AC4ECA72F7C0}

SMITHKLINE BEECHAM

INTERNATIONALCLAVULIN 4305/06/03 AMOXYCILLIN/CLAVU

LANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICALS, CLARENDON ROAD

228MG/5ML SUSPENSION POWDER 70ML, 100ML UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11

{A4D88EFB-B93F-40C4-A010-

84E4AA316E23}

Page 45

Page 46: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SMITHKLINE BEECHAM

INTERNATIONALCLAVULIN TABLETS 4306/06/03 AMOXYCILLIN+CLAV

ULANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICALS, CLARENDON ROAD

500MG+125MG TABLET 14 & 20, 10*10 STRIP UK ERIS LTD 19/08/09 RT28825 DATED 27/08/11

{02B072B8-C0CA-45AE-996A-

C490E492103B}

UNICHEM LABORATORIES LTD CELIB 100MG 4324/02/03 CELECOXIB

UNICHEM LABORATORIES LTD, 17/18 PILERNE IND.

ESTAT

100MG CAPSULE 1 * 10*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

12/03/07 + RE-AUDIT FEES (RT20065 DATED 22/07/10)

RT29055 DATED 06/09/11

{31CE57F3-6919-40F6-B681-6A80C8F172F9}

UNICHEM LABORATORIES LTD CELIB 200MG 4325/02/03 CELECOXIB

UNICHEM LABORATORIES LTD, 17/18 PILERNE IND.

ESTAT

200MG CAPSULE 10*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

12/03/07 + RE-AUDIT FEES (RT20065 DATED 22/07/10)

RT29055 DATED 06/09/11

{827BFD3A-9D29-4B64-91EB-

236B99E9F847}

UNICHEM LABORATORIES LTD TG-TOR 10 4328/12/03 ATORVASTATIN

UNICHEM LABORATORIES LTD, VILLAGE BHATAULI

KALA, B

10MG TABLET 1*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

22/11/10 RT29055 DATED 06/09/11

{86CD9F18-D03F-44B8-902D-

9810956BB967}

UNICHEM LABORATORIES LTD TG-TOR 20 4329/12/03 ATORVASTATIN

UNICHEM LABORATORIES LTD, VILLAGE BHATAULI

KALA, B

20MG TABLET 1*10 BLISTER INDIANORVIK

ENTERPRISES (U) LTD

22/11/10 RT29055 DATED 06/09/11

{3241236B-A345-442B-87B8-F34A48814D90}

ALEMBIC LTD AZITHRAL 4340/0603 AZITHROMYCINALEMBIC LTD PLOT

NO. 21-22 EPIP, PHASE 1 JHARMAJRI

250MG TABLET 10X6 STRIP INDIAGITTOES

PHARMACEUTICALS (U) LTD

28/06/2010 RT28449 DATED 10/08/2011

{79BD80A4-D3E6-42A9-A7BF-

376B6E9C6D18}

ALEMBIC LTD GLYCODIN 4342/25/03 GLYCIRIZA +CODEINE

ALEMBIC LTD PLOT NO. 21-22 EPIP,

PHASE 1 JHARMAJRI10MG+5MG/ML SOLUTION 100ML GLASS

BOTTLE INDIAGITTOES

PHARMACEUTICALS LTD.

28/06/2010 RT28449 DATED 10/08/2011

{4139E49B-07ED-4C9E-9CCE-

EA8B7A2D8152}

CADILA HEALTH CARE LTD AMLODAC 10 4353/12/03 AMLODIPINE

BESYLATE

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

10MG TABLET 10 *10's STRIP INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{F0DEFA78-BF47-43D0-81C5-

F5CBA4798A01}

CADILA HEALTH CARE LTD LOSACAR 50 4356/12/03 LOSARTAN

POTASSIUM

CADILA HEALTHCARE

LIMITED KUNDAIM INDUSTRIAL ESTAT

50MG TABLET 10X7's BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{D4839E05-ABC6-48E0-8EB7-

FB64F4CA3F38}

CADILA HEALTH CARE LTD AMLODAC 5 4357/12/03 AMLODIPINE

BESYLATE

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

5MG TABLET 10X10's STRIP INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{72EAC74E-0D70-412C-88AA-

9546212F3DBC}

CADILA HEALTH CARE LTD LOSACAR 25 4358/12/03 LOSARTAN

POTASSIUM

CADILA HEALTHCARE

LIMITED KUNDAIM INDUSTRIAL ESTAT

25MG TABLET 10X7's BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{49B4E15F-AE67-4C168F1A-8D50D60B4DD0}

ELYS CHEMICAL IND. LTD CIFLO 4365/06/03 CIPROFLOXACIN ELYS CHEMICAL IND. 500MG TABLET 10X10's BLISTER, 1 *

100 HDPE KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/09 RT31596 DATED

06/12/11

{C01317DB-9BEA-43F1-AF0C-

502A81924E1F}

FLAMINGO PHARMACEUTICALS

LTDFOLIC ACID 5MG 4370/10/03 FOLIC ACID 5MG

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

5MG TABLET 1000 JAR INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{B88F3532-8273-4691-8DB0-065D6160AD5F}

FLAMINGO PHARMACEUTICALS

LTDAZICLAR 500 4371/06/03 CLARITHROMYCIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

500MG TABLET 10X10 BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{98D52109-3A26-4BAE-974D-3D0276A78419}

Page 46

Page 47: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

FLAMINGO PHARMACEUTICALS

LTDLIPITIN A-20 4372/12/03 ATORVASTATIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

20MG TABLET 10X10 BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{3DEAA1EE-43D5-4E83-99D6-

64FAFA69CF1F}

FLAMINGO PHARMACEUTICALS

LTDPROFEN PLUS 4375/02/03 IBUPROFEN+PARACE

TAMOL

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

400MG+325MG TABLET 1X10 BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{34C2342C-A628-4734-8E81-7FE17602550A}

FLAMINGO PHARMACEUTICALS

LTDAZICLAR 4376/06/03 CLARITHROMYCIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

250MG TABLET 10X10 BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{F5133DFB-7F36-4C83-A417-ACEA98501B45}

FLAMINGO PHARMACEUTICALS

LTDCLINDACIN-150 4377/06/03 CLINDAMYCIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

150MG CAPSULE 10X10 BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{E1510140-729E-4206-A038-

F6DD1C6FFECB}

FLAMINGO PHARMACEUTICALS

LTDCLINDACIN-300 4378/06/03 CLINDAMYCIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

300MG CAPSULE 1X12 BLISTER INDIA ABACUS PHARMA 17/09/09 RT28444 DATED 09/08/11

{CB53ED1B-9C0D-475F-BC3A-

F13905C76911}

GLENMARK PHARMACEUTICALS

LTDGLEVO-500 4383/06/03 LEVOFLOXACIN-500

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

500MG TABLET 5X5 BLISTER INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{AC26F7B8-2312-48AD-9488-

2B14500ED786}

GLENMARK PHARMACEUTICALS

LTDFINTOP 4384/13/03 BUTENAFINE HCL

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

1%W/W CREAM 15G TUBE INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{2B37EC47-9F75-415F-B903-B856F0CE6643}

GLENMARK PHARMACEUTICALS

LTDESOZ-20 4385/17/03 ESOMEPRAZOLE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

20MG TABLET 10X10 STRIPS INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{9CFF7C09-AA7F-4E45-AB13-

7C34492CA43E}

KAMPALA PHARMACEUTICALS

INDUSTRIESDIFENAC 4387/02/03 DICLOFENAC

SODIUM

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

50MG TABLET 10X10 BLISTER UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{69D92677-FCB7-4DF5-8CEF-

A6413ED33554}

PHARMEDIC LAB (PVT) LTD NAPROX-500 4407/02/03 NAPROXEN SODIUM

PHARMEDIC (PVT) LTD 16KM MULTAN

ROAD LAHORE 5380500MG TABLET 20'S PAKISTAN HEALTH CARE LTD

24/04/06 + RE-AUDIT FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{5FFD24AA-F501-4CD9-9E07-

83BE64CE63A4}

RENE INDUSTRIES LTD

CHLORPHENIRAMINE MALEATE 4416/03/03 CHLORPHENIRAMINE

MALEATE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

4MG TABLET 1000 HDPE JAR UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{7C75FE9C-CDCA-4B16-B0DC-

DF41AFA512EE}

RENE INDUSTRIES LTD PAINEX 4417/02/03

PARACETAMOL AND ASPIRIN AND

CAFFEINE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

500+400 +50 MG TABLET 1*25*4 STRIPS UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{3479C5D6-A284-44E5-BC2D-B506D63BD957}

GSK, KENYA ARTERAX 4423/03/03 HYDROXYZINE DHCL

ASPEN PHARMACARE LTD,

7 FAIRCLOUGH ROAD PO BOX

KORSTEN PORT ELIZABETH

25MG TABLET 10X10 BLISTER S.AFRICA LABOREX (UGANDA) LTDS 04/09/08 RT28825 DATED

27/08/11{B02ED950-0C0B-4843B177-3CFA20F8F1A7}

UCB (S.A) PHARMA LTD ARTERAX 4424/03/03 HYDROXYZINE DHCL

ASPEN PHARMACARE LTD,

7 FAIRCLOUGH ROAD PO BOX

KORSTEN PORT ELIZABETH

2MG/ML SYRUP 100ML GLASS BOTTLE S.AFRICA MEDICAL ACCESS

04/09/08 + RE-AUDIT FEES (RT29672 DATED 29/09/11)

RT28825 DATED 27/08/11

{EF4CF3D9-03CD-495A-B342-

E36493BA31F8}

UCB (S.A) PHARMA LTD ZYRTEC 4425/03/03 CETIRIZINE 2HCL

ASPEN PHARMACARE LTD,

7 FAIRCLOUGH ROAD PO BOX

KORSTEN PORT ELIZABETH

10MG TABLET 10s & 10X3 BLISTER S.AFRICA LABOREX (UGANDA) LTD

04/09/08 + RE-AUDIT FEES (RT29672 DATED 29/09/11)

RT28825 DATED 27/08/11

{91DF5F58-44EC-4EAF-A526-

629131FDDC1F}

Page 47

Page 48: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

UCB (S.A) PHARMA LTD ZYRTEC 4426/03/03 CETIRIZINE 2HCL

ASPEN PHARMACARE LTD,

7 FAIRCLOUGH ROAD PO BOX

KORSTEN PORT ELIZABETH

1MG/ML ORAL SOLUTION 50ML & 150ML GLASS BOTTLE S.AFRICA MEDICAL ACCESS

04/09/08 + RE-AUDIT FEES (RT29672 DATED 29/09/11)

RT28825 DATED 27/08/11

{9B9A8B1A-6189-4B08-B526-273928C22366}

UCB (S.A) PHARMA LTD ZYRTEC 4427/03/03 CETIRIZINE 2HCL

PHARMACARE LTD(A DIV. OF ASPEN

PHARMACARE LTD)10MG/ML ORAL DROPS 15ML GLASS BOTTLE S.AFRICA

04/09/08 + RE-AUDIT FEES (RT29672 DATED 29/09/11)

RT28825 DATED 27/08/11

{AE857D5F-7649-4898-8F21-C0789D3A0716}

GLENMARK PHARMACEUTICALS

LTD

DERIVA AQUEOUS GEL 4429/13/03 ADAPALENE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

0.1 W/W GEL 15MG TUBE INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{F8C824AC-7584-4D1C-88F6-

F1DE1AB6DFC0}

SCHERING OY JADELLA SINE 4432/18/03 LEVONORGESTEREL SCHERING OY 2X75MG INPLANT 3X1 STRIP FINLANDSTAR

PHARMACEUTICALS LTD.

{8F7ECBDB-0274-4614-B0BE-

4012D450F2BC}

SWISS PHARMACEUTICALS(

PVT) LTD.DEXA-N 4436/08/03 DEXAMETHASONE +

NEOMYCIN

SWISS PHARMACEUTICALS

PVT LTD. A159 SINDH INDUSTRIAL

AREA KARACHI

1%/0..5W/W CREAM 15GM TUBE PAKISTAN HEALTH CARE LTD

RE-ISNP PAID 27/07/2009 VIDE

RT12744. REMINDER SENT TO INSP.

RT30076 &RT30073 DATED 12/10/2011

{5AED808D-B2B3-41BB-A84D-

E5ACE20F7230}

CENTUAR PHARMACEUTICALS

LTD.MICONA ORAL GEL 4444/28/03 MICONAZOLE

CENTAUR DRUG HOUSE PVT LTD,

PLOT NO. 39 TIVIN IND. ESTATE

KARASANDARA, MAPUSA, GOA

403526

20MG GEL 40G TUBE , 20G TUBE INDIAGITTOES

PHARMACEUTICALS LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{97826F57-B747-41B6-A27D-5A01595BD693}

WIN-MEDICARE LTD. LABORON 4445/22/03 OXYTOCIN

WIN-MEDICARE PVT LTD, MEERUT

MAZAFFAR NAGAR ROAD

51.U/ML INJECTION 5 * 10 ML AMPS INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{7C8FE959-E5F2-4D98-89A1-C609FAD5516D}

SMITHKLINE BEECHAM

HEALTHCAREPANADOL EXTRA 4446/02/03 PARACETAMOL +

CAFFEINE

GLAXOSMITHKLINE LTD LIKONI ROAD,

NAIROBI500MG/65MG TABLET 10 * 10, 20'S, & 100'S,

BLISTER KENYA ERIS LTD 23/06/08 + RE-AUDIT FEES (JV11/190)

RT28825 DATED 27/08/11

{DF1C8706-DB7B-4A1A-BD8C-

769BC7614384}

ALEMBIC LTD BRO-ZEET 4447/25/04TERBUTALINE SULPHATE +

BROMOHEXINE HCL

ALEMBIC LTD PLOT NO. 21-22 EPIP,

PHASE 1 JHARMAJRI1..5MG + 4MG LIQUID 1 * 100ML INDIA

GITTOES PHARMACEUTICALS

(U) LTD28/06/2010 RT28449 DATED

10/08/2011

{DC9CC1B7-C6F6-4976-A9BC-

2034A4E04858}

CADILA HEALTH CARE LTD OFLIN-200 4457/06/04 OFLOXACIN

CADILA HEALTHCARE

LIMITED KUNDAIM INDUSTRIAL ESTAT

200MG TABLET(1 * 10 * 20), (1 * 2 *

10), 1*10*1*10 BLISTER

INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{B1C5DECF-7B8B-43CE-BE73-

FA241A23D3EA}

CADILA HEALTH CARE LTD LOSACAR-H 4458/12/04

LOSARTAN POTASSIUM +

HYDROCHLOROTHIAZIDE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

50MG + 12.5MG TABLET 10 * 10 INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{7C14A7EF-F2F0-4FD1-8F2D-

34E55E69DF96}

GLAXO-WELCOME LTD

VENTOLIN -COUGH EXPECTORANT,

SUGAR FREE4470/25/04 SALBUTAMOL +

GUAIPHENESIN

GLAXO WELLCOME EGYPT SAE, EL

SALAM CITY 11491, CAIRO

2MG/ 100MG/10ML SYRUP 100ML BOTTLE EGYPT ERIS LTD 08/09/11 RT28825 DATED 27/08/11

{D42FC8C8-5268-4444-A995-7FE7D4F59F21}

GLENMARK PHARMACEUTICALS

LTDCANDID-V GEL 4472/06/04 CLOTRIMAZOLE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

2% VAGINAL GEL 30G TUBE INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{DBAF15B9-2F87-4E18-B1AF-

B9AC30AA50CD}

MERCK SHARP & DOHME STOCRIN 4473/06/04 EFAVIRENZ

MERCK SHARP & DOHME B.V

WAARDERWEG 39, PC HAARLEM.

HOLLAND

600MG TABLET 1 * 30'S HOLLAND PHILLIPS P'CALS (U) LTD 29/06/11 RT29554 DATED

26/09/11{7457F136-9B90-442F-8001-DEEB99DBE75A}

TORRENT PHARMACEUTICALS

LTDTIDOMET FORTE 4488/09/04 CO-CARELDOPA

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

25MG/250MG TABLETS 1X10X10 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {3BA57934-6100-408E-

A118-1E04292D3CD0}

Page 48

Page 49: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

BAYER EAST AFRICA LTD AVELON IV 4501/06/04 MOXIFLOXACIN HCL BAYER AG D-5136

LEVERKUSEN 400MG/ 250ML PARENTERAL 1*250ML IN GLASS BOTTLE GERMANY SURGIPHARM (U)

LTD

{8F648D0F-CC36-4FB5-83F8-

2BAFA74690FC}

CADILA HEALTHCARE LTD ORNI-500 4505/06/04 ORNIDAZOLE

CADILA HEALTHCARE

LIMITED KUNDAIM INDUSTRIAL ESTAT

500MG TABLET 1*10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{BC4A1F71-77FB-4630-8D88-838714367E5F}

CENTAUR PHARMACEUTICALS

LTDHB FORTE 4507/27/04 MUTI-INGRDIENT

CENTAUR PHARMACEUTICALS LTD, KARASWADA

MAPUSA GOA

MULTI-INGRDIENT SYRUP 1*90ML, 1 * 250ML AMBER PET BOTTLE India

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{D0676986-863B-45CA-9C2B-445DF4C91181}

EMCURE PHARMACEUTICALS

LTDOROFER 4515/10/04

FE II HYDROXIDE POLYMALTOSE

COMPLEX

EMCURE PHARMACEUTICALS

LTD LANE NO. 3 PHASE II SIDCO

INDUSTRIAL COMPLEX,BARI-

BRAHMANA JAMMU

50MG/5ML SYRUP 150ML GALSS BOTTLE INDIA PHILIPS P'CALS LTD.

RE-INSP PAYMENT RT27849 DATED

14/03/2011

JV11/098 DATED 22/08/2011

{0D5F9774-B2B9-4AEF-91DC-

4E6EF4008B97}

EMCURE PHARMACEUTICALS

LTDSYCLATE-500 4516/11/04 ETAMSYLATE

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

500MG TABLET 1*3*6 ALU STRIPS INDIAPHILIPS

PHARMACEUTICALS LTD.

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{8A388796-96F5-4115-86AA-7993216D773E}

GLENMARK PHARMACEUTICALS

LTDMumfer 4525/10/04 Iron (111) Polymaltose

cplx + Folic acid

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

100mg + 500mcg Chewable Tablets 1*3*10 Chewable Tablets in Blisters India

STAR PHARMACEUTICALS

LTD29/09/2009 RT28761 DATED

24/08/2011

{1159F1D6-97DF-42CA-94A6-

39D10FADE1F8}

Glenmark Pharmaceuticals CANDID V-1 4526/06/04 CLOTRIMAZOLE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

500MG PESARY1*1 Tablet in

Aluminium Strip + Applicator

IndiaSTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{DAB5E606-5D44-4455B907-795359E31C10}

Glenmark Pharmaceuticals Lizolid-600 4527/06/04 Linezolid

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

600mg Tablets 1*5*4 Tablets in Aluminium Strips India

STAR PHARMACEUTICALS

LTD29/09/2009 RT28761 DATED

24/08/2011{378F72FE-AED1-492F-A904-87EB5B161712}

Glenmark Pharmaceuticals Ltd. CANDID-B LOTION 4528/13/04

CLOTRIMAZOLE + BECLOMETHASONE

DIPROPIONATE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

1% + 0.025% Lotion 15ml Bottle IndiaSTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{41AD9CFE-561F-41DE-A851-

1A6FDDF5DE7E}

Hetero Drugs Ltd Nevilast-40 4531/06/04 Lamivudine + Stavudine + Nevirapine

HETERO DRUGS LTD, 22-110, 1.D.A,

JEEDIMETLA HYDERABAD

150mg +40mg +200mg Tablets 1*60 HDPE India ASTRA PHARMA UGANDA LTD 17/12/09 RT28304 DATED

03/08/11

{70DC2723-D93E-48DA-9090-

A6854AE472BD}

INDOCO REMEDIES LTD ABZ 4533/06/04 ALBENDAZOLE USP

INDOCO REMEDIES LTD. B-20,MIDC,

WALUJ, AURANGABAD 431

136 INDIA

400mg TABLETS 1*1 IN BLISTER, 1*500 HDPE INDIA TATA UGANDA LTD 10/05/2010 RT29332 & JV11/148

DATED 16/09/11{A94FF8FA-0317-489C-A965-D0F84614C39B}

Indoco Remedies Ltd Tuspel Plus 4534/25/04 Multingredient

INDOCO REMEDIES LTD, B-20, MIDC,

WALUJ, AURANGABAB 431136 INDIA

Multingredient Syrup 1*60ml & 1*100ml Glass bottle India TATA UGANDA LTD 10/05/2010 RT29332 & JV11/148

DATED 16/09/11{C379676B-78CE-4B0287CD-39F889B80C93}

Intas Pharmaceuticals Ltd LAN-30 4536/17/04 Lansoprazole

INTAS PHARMACEUTICALS

LTD CAMP ROAD ,SELAQUI

DEHRADUN , INDIA

30mg Capsules 1*1*5*10 Capsules in Aluminium Strips India

NORVIK ENTERPRISES (U)

LTD18/02/10 RT29052 DATED

06/09/11

{16947DCD-2BD9-4040-893B-

51B6A94C19E1}

MEPHA LTD Artequin 600/750 Lactab 4544/06/04 ARTESUNATE +

MEFLOQUINE

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

200mg + 250mg Tablets 1*(3+3) Tablets in Blisters SWITZERLAND GOODMAN

INTERNATIONAL LTD 19/08/2009 RT28480 DATED 11/08/2011

{FCD5F0D9-654E-4329-8457-

50F5875D0BF4}

Mepha Ltd Olfen-75 Retard 4546/02/04 Diclofenac Sodium

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

75mg Tablets (Depotabs) 1*3*10 Tablets in Blisters Switzerland GOODMAN

INTERNATIONAL LTD 19/08/2009 RT28480 DATED 11/08/2011

{6188A4FB-CCB3-4049-AF0B-

2B41E32AF089}

Page 49

Page 50: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

Torrent Pharmaceuticals Ltd. Lefra-20 4556/02/04 Leflunomide

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

20mg Tablets 1 * 5 * 10 Tablets in Blisters India

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{54EDE2D4-5BB9-421D-9C9F-

586CF5BC876B}

Torrent Pharmaceuticals Ltd. Veloz-20 4557/14/04 Rabeprazole Sodium

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

20mg Enteric Coated Tablets 1 * 10 *10 Tablets in Aluminium Strips India

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {C487F3AD-5202-4800-

9CFB-9E5962B3438B}

ABBOTT LABS S. A PTY LTD NORVIR SEC 4571/06/04 RITONAVIR

AESICA QUEESNBOROUGH

LTD. NORTH RD. QUEENSBOROUGH

KENT

100MG CAPSULES 1*84 IN HDPE UK MEDICAL ACCESS UGANDA LTD 23/06/2011 RT28979 DATED

12/09/2011

{7B51D40A-A6B2-4ECB-81A3-

0C2E2B65FD86}

ATCO LABORATORIES LTD

BETADERM NM CREAM 4579/13/04

MICONAZOLE,NEOMYCIN &

BETAMETHASONE VALERATE

ATCO LABORATORIES LTD 2mg, 0.5g & 0.1g CREAM 1*10g PAKISTAN ABACUS PHARMA (A)

LTD 02/03/09 RT28249 DATED 01/08/11

{CDC9256B-D7A6-438E-87CF-

FE3280B66A81}

CADILA HEALTH CARE LTD LEVODAY 500 4590/06/04 LEVOFLOXACIN

HEMIHYDRATE

CADILA HEALTHCARE

LIMITED, SWARAJ JUDDI KLAN POST,

500mg TABLETS 1 * 2 * 5, 1 * 10 * 10, 1*20*5 IN LISTERS INDIA ABACUS PHARMA (A)

LTD 16/11/2012 RT28660 DATED 19/08/2011

{0A34999F-A901-4297-B554-DAA5B6F80378}

CADILA HEALTH CARE LTD EUGLIM 2 4592/18/04 GLIMEPIRIDE

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

2mg TABLETS 1*10*10 IN STRIPS INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{0A74F68A-0C7E-437D-AD0B-

94339078DBB1}

CADILA PHARMACEUTICALS

LTDHAEM F 4593/10/04

FOLICACID VITAMIN B12 FE

AMMONIUM CITRATE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

EACH 15ml CONTAINS 1mg + 5mcg + 200mg

SYRUP 1*200ml IN GLASS BOTTLE INDIA

KARURI PHARMACEUTICALS

LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{2A31E98F-401A-4AE8-B8CB-BA3822A1893D}

CENTAUR PHARMACEUTICALS

LTDSINACAP 4594/25/04 MULTI-INGREDIENT

CENTAUR PHARMACEUTICALS LTD, KARASWADA

MAPUSA GOA

SEE TABLE ATTACHED CAPSULES 1*3*4 STRIPS INDIA

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{CA5F5BAB-1B6F-4BE8-9C3D-

16EDAE43CAE2}

CENTAUR PHARMACEUTICALS

LTDNEURO-FORTE 4595/27/04

VITAMIN B1 + VITAMIN B6 + VITAMIN B12

CENTAUR PHARMACEUTICALS LTD, KARASWADA

MAPUSA GOA

200mg + 50mg + 1mg TABLETS 1*2*10 IN BLISTERS INDIA

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{3ACAFD34-121D-4532-984A-

1222AA8519F9}

EMCURE PHARMACEUTICALS

LTDVIFEX 4607/25/04

SALBUTAMOL + BROMHEXINE + GUAIFENESIN

EMCURE PHARMACEUTICALS

LTD LANE NO. 3 PHASE II SIDCO

INDUSTRIAL COMPLEX,BARI-

BRAHMANA JAMMU

EACH 5ml 1mg + 2mg + 50mg SYRUP 1*100ml IN GLASS

BOTTLE INDIAPHILIPS

PHARMACEUTICALS LTD.

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{071FF58B-5D1E-477F-90FA-0FF9BF94C218}

GLENMARK PHARMACEUTICALS

LTDCANDID-B-CREAM 4620/13/04

CLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE BP

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

1%W/W + 0.025%W/W CREAM 1*15g TUBE INDIA

STAR PHARMACEUTICALS

LTD29/09/2009 RT28761 DATED

24/08/2011

{77F48098-D66B-4405-ACDB-

B0F91CB9104B}

HETERO DRUGS LTD INDIVIR-400 4621/06/04 INDINAVIRHETERO DRUGS

LTD, UNIT 111 22-110,IDA JEEDIMETLA,

400MG CAPSULE 1 * 180 HDPE INDIA ASTRA PHARMA UGANDA LTD 17/12/09 RT28304 DATED

03/08/11{F4931CB8-5820-410A-B069-79A924B10371}

IDA FUROSEMIDE 4625/16/04 FUROSEMIDE

GLAND PHARMA LTD D.P PALLY DUNDIGAL

HYDERABAD

20MG/2ML INJECTION SOLUTION 10 * 10 AMPOULE INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11

{F879CDEB-9E15-4ADA-B202-

22B13CE2850F}

INDOCO REMEDIES LTD CITAL 4629/26/04 DISODIUM

HYDROGEN CITRATE

INDOCO REMEDIES LTD. B-20, MIDC,

WALUJ AURANGABAD 431136 INDIA

1.37g/5ml SYRUP 1 * 100ml PET BOTTLE INDIA TATA UGANDA LTD 10/05/2010 RT29332 & JV11/148 DATED 16/09/11

{682D7E03-91AE-45CB-B1F8-

5508EA65076F}

Page 50

Page 51: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

NEOSIDAR 4632/06/04 SULPHADOXINE,PYRIMETHAMINE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

500mg,25mg TABLET 1*25*3 UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{9700A63F-533E-4418-9075-47C20BDCC7B7}

MEPHA LTD MESPORIN 2000 4641/06/04 CEFTRIAXONE

LABESFAL S.A CAMPO DE

BESTERIROS & AMANDORA

2000mg INJECTION 1*1*50ml VIAL PORTUGAL GOODMAN INTERNATIONAL LTD 29/04/2010 RT28480 DATED

11/08/2011{95F1DA2E-7E08-4870-9E23-F62CD7EF6662}

NOVARTIS CONSUMER

HEALTHCARE INTERNATIONAL

CA-C 1000 4645/27/04 MULT-INGREDIENT NOVARTIS CONSUMER HEALTH 0.327g,1.000g,1.000g TABLET

(DISPERSIBLE) 1*10 SWITZERLAND BETA HEALTH CARE (U) LTD

{F91B7EE8-6A5C-4F41-8E6C-

6A76F6200FCF}

NOVARTIS CONSUMER

HEALTHCARE INTERNATIONAL

EURAX 4646/06/04 CROTAMITON NOVARTIS CONSUMER HEALTH 10% W/W CREAM 1 * 20g SWITZERLAND BETA HEALTH CARE

(U) LTD{81996EC2-9BA9-451DA3A4-65EDA97BAAB7}

RENE INDUSTRIES LTD MALAREN 4672/06/04 SULPHADOXINE +

PYRIMETHAMINE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

500mg/25mg TABLET 1 * 10 * 10, 1 * 50 * 3, 1 * 1000 UGANDA RENE PHARMACY

LTD.ANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011{820368A0-4C89-4AC3-B822-61A97EACA613}

SHAIGAN PHARMACEUTICALS

LTDCLYCIN-V 4682/06/04 CLINDAMYCIN

PHOSPHATE

SHAIGAN PHARMACEUTICALS LTD, 14KM ADYALA

RD RAWALP

2%W/W VAGINAL CREAM1*40g IN

COLLAPSIBLE TUBE + APPLICATOR

PAKISTAN HEALTH CARE LTD 11/02/09 RT31759 DATED 13/12/11

{061D038D-B223-46CC-9910-

0EACF3A92AA5}

SPARSH BIOTEC PVT. LTD SPENIV 4685/06/04 PHENOXYMETHYL

PENICILLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/244,

VILLAGE LAKHABARAD,

JAMNAGAR-361006

125mg/5ml POWDER FOR ORAL SUSPENSION 1*100ml BOTTLE INDIA ABACUS PHARMA

AFRICA LTD 28/10/10 RT28375 DATED 05/08/11

{8D9A870C-FCBB-4BB5-8FC9-

57AA1B78641B}

SPARSH BIO-TECH SPENIV 4686/06/04 PHENOXYMETHYL PENICILLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/244,

VILLAGE LAKHABARAD,

JAMNAGAR-361006

250mg TABLET 1*1000HDPE &1*10*10 INDIA ABACUS PHARMA AFRICA LTD 28/10/10 RT28375 DATED

05/08/11{283E63E3-2B80-424C-B320-B7F102E79283}

SPARSH BIO-TECH LTD SPAMCIL 4687/06/04 AMPICILLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/244,

VILLAGE LAKHABARAD,

JAMNAGAR-361006

250mg CAPSULE 1*10*10 BLISTER, 1 * 1000HPDE INDIA ABACUS PHARMA

AFRICA LTD 28/10/10 RT28375 DATED 05/08/11

{9BF7CE35-7B4C-4447-8CEE-

D21A73F81204}

SPARSH BIO-TECH LTD CLOXISPA 4688/06/04 CLOXACILLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/244,

VILLAGE LAKHABARAD,

JAMNAGAR-361006

250mg CAPSULE 1*10*10 BLISTER, 1 * 1000 HDPE INDIA ABACUS PHARMA

AFRICA LTD 28/10/2010 RT28375 DATED 05/08/11

{C1C1239F-94E8-4958-8726-CFFCCD8B631A}

SPARSH BIO-TECH LTD SPAMCLOX 4689/06/04 AMPICILLIN AND

CLOXACILLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/244,

VILLAGE LAKHABARAD,

JAMNAGAR-361006

250mg, 250mg CAPSULE 1*10*10 BLISTER, 1 * 1000 HDPE INDIA ABACUS PHARMA

AFRICA LTD 28/10/10 RT28375 DATED 05/08/11

{5DB7F28C-A06D-4675-8541-

3334561C6FEE}

SPARSH BIO-TECH LTD SPAMOX 4690/06/04 AMOXYCILLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/244,

VILLAGE LAKHABARAD,

JAMNAGAR-361006

250mg CAPSULE 1*10*10,1*1000 BLISTER ,HPDE INDIA ABACUS PHARMA

AFRICA LTD 28/10/10 RT28375 DATED 05/08/11

{99D5A38F-3EB6-4A849085-993CBAB59D86}

Page 51

Page 52: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SPARSH BIOTECH PVT LTD SPAMCLOX 4691/06/04 AMPICILLIN +

CLOXACILLIN

SPARSH BIO-TECH LTD PLOT NO.1

SURVEY NO.242/234/244,

VILLAGE LAKHABARAD,

JAMNAGAR-361006

125mg/5ml + 125mg/5ml ORAL SUSPENSION 1*100ml INDIA ABACUS PHARMA

AFRICA LTD 28/10/10 RT28375 DATED 05/08/11

{932B31C5-285A-4B84-8974-4DB2C1F24C62}

SWISS PHARMACEUTICALS

PVT LTDTRAMACIN 4693/13/04 NEOMYCIN +

BACITRACIN

SWISS PHARMACEUTICALS

PVT LTD. A159 SINDH INDUSTRIAL

AREA KARACHI

0.052g + 0.0432g TOPICAL POWDER 1* 10g LDPE PAKISTAN HEALTH CARE LTD

RE-ISNP PAID 27/07/2009 VIDE

RT12744. REMINDER SENT TO INSP.

RT30076 &RT30073 DATED 12/10/2011

{EC739A24-445F-48A9-B03E-2200F46739C3}

TORRENT PHARMACEUTICALS

LTDDEPLATT 4694/12/04 CLOPIDOGREL

BISULFATE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

75mg TABLETS 1*3*10 IN BLISTERS INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{9ECE85AB-F069-439B-A010-

16DC1B3E7F6E}

TORRENT PHARMACEUTICALS

LTDSERENATA 50 4695/24/04 SERTRALINE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

50mg TABLETS 1*4*50 IN BLISTERS INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{62C8699E-770C-4210-AFDA-

059BAD88C99F}

TORRENT PHARMACEUTICALS

LTDNEXPRO-40 4697/17/04 ESOMEPRAZOLE

MAGNESIUM

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

40mg TABLETS 1*10*10 IN ALUMINIUM STRIPS INDIA

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{E275EC1F-1293-4E26-876C-

F42C94FEDFDF}

WIN -MEDICARE PVT LTD URGENDOL 4706/02/04 TRAMADOL

HYDROCHLORIDE

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

50MG CAPSULES 1*10*10 IN BLISTER PACK INDIA SURGIPHARM (U)

LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{603C27A1-1FF1-4868-9365-E747B4B782D9}

WIN MEDICARE PVT LTD VARIACE 5 4707/12/04 RAMIPRIL

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

5MG CAPSULES 1*4*7, 1*3*10 IN BLISTERS INDIA SURGIPHARM (U)

LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{FE1CDF6D-CA04-4AA4-8A38-

196F19C3A4E2}

WIN MEDICARE PVT LTD VARIACE 2.5 4708/12/04 RAMIPRIL

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

2.5MG CAPSULES 1*4*7 , 1*3*10 IN BLISTERS INDIA SURGIPHARM (U)

LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{80B7027E-C468-480E-9536-86C5F5ABDA02}

WIN-MEDICARE PVT LTD LOGICAN-200 4710/06/04 FLUCONAZOLE

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

200MG CAPSULES 1*10*4, 1*4*7 IN BLISTERS INDIA SURGIPHARM (U)

LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{AE5D8A9B-6D91-4532-BDC8-

5FA58D9EE32C}

WIN-MEDICARE PVT LTD HEPAMERZ 4711/27/04 L-ORNITHINE-L-

ASPARTATE

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

3G/5G GRANULES 1*10*5g SACHETS INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{A370C883-8878-4B6B-B831-01525354E879}

WOCKHARDT LIMITED KEFSTAR 4712/06/04 CEFUROXIME

WOCKHARDT LIMITED, B-15/2,

MIDC WALUJ AURANGABAD 4

125mg/5ml SUSPENSION 1 * 50ML INDIASTAR

PHARMACEUTICALS LTD

14/12/09 RT28254 DATED 01/08/11

{8FA898E7-CB8F-47E0-B2CF-

E6AA4FC9D17E}

AJANTA PHARMA LTD KAMAGRA-100 4724/18/05 SILDENAFIL CITRATEAJANTA PHARMA LTD, B-4/5/6 MIDC

AREA PAITHAN 431 1100MG TABLET 1*1*4 BLISTER INDIA

AARON PHARMACEUTICALS

LTD27/11/08 RT28086 DATED

26/07/11

{087A0D45-E4A2-4115-B7DC-

D288E0DB200C}

AJANTA PHARMA LTD APCALIS SX 4725/12/05 TADALAFIL

AJANTA PHARMA LTD (PAITHAN,

431128, AURANGABAD)

20MG TABLET 1*2*2 BLISTERS INDIAAARON

PHARMACEUTICALS LTD

27/11/08 RT28086 DATED 26/07/11

{F5C4BE8C-9E89-4692-ACBE-

9E225BF88F9C}

AMMAN PHARMACEUTICAL

INDUSTRIESNEODEX 4732/13/05

NEOMYCIN SULPHATE +

DEXAMETHASONE SODIUM SULPHATE

AMMAN PHARMACEUTICAL INDUSTRIES KING

ABDULLAH II INSUDTRIAL ESTATE

SAHAB

0.5%, 0.1% EYE/EAR DROPS 1*1*10ML IN VIAL JORDANWIDE SPECTRUM ENTERPRISES (U)

LTD30/07/2009 RT30695 DATED

26/10/2011

{164E807D-77BD-4CE0-B370-

AE963EB799FD}

Page 52

Page 53: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

AMMAN PHARMACEUTICAL

INDUSTRIESOPTIFUCIN 4733/06/05 FUSIDIC ACID

AMMAN PHARMACEUTICAL INDUSTRIES KING

ABDULLAH II INSUDTRIAL ESTATE

SAHAB

1%W/V VISCOUS EYE DROPS 1*1*5GM IN TUBE JORDAN

WIDE SPECTRUM ENTERPRISES (U)

LTD30/07/2009 RT30695 DATED

26/10/2011

{B28FC09F-47BD-44D3-8B94-

E1E3E7BFC978}

AMMAN PHARMACEUTICAL

INDUSTRIESNEOPRED-P 4734/21/05

PREDNISOLONE ACETATE +

NEOMYCIN SO4 + POLYMYXIN-B

AMMAN PHARMACEUTICAL INDUSTRIES KING

ABDULLAH II INSUDTRIAL ESTATE

SAHAB

5MG/ML +5MG/ML + 1M I.U

EYE/EAR SUSPENSION 1*1*10ML IN VIAL JORDAN

WIDE SPECTRUM ENTERPRISES (U)

LTD30/07/2009 RT30695 DATED

26/10/2011{511EF0F5-C6F1-4FE5-8D22-E6FE632D6ED3}

AMMAN PHARMACEUTICAL

INDUSTRIESAPIFLOX 4735/21/05 NORFLOXACIN

AMMAN PHARMACEUTICAL INDUSTRIES KING

ABDULLAH II INSUDTRIAL ESTATE

SAHAB

0.3%W/V EYE DROPS 1*1*10ML IN VIAL JORDANWIDE SPECTRUM ENTERPRISES (U)

LTD30/07/2009 RT30695 DATED

26/10/2011{AAB89802-E360-4108-8382-83CC7BFBD60F}

AMMAN PHARMACEUTICAL

INDUSTRIESAPICORT 4736/21/05 PREDNISOLONE

ACETATE

AMMAN PHARMACEUTICAL INDUSTRIES KING

ABDULLAH II INSUDTRIAL ESTATE

SAHAB

0.12% W/V EYE DROPS 1*1*10ML IN VIAL JORDANWIDE SPECTRUM ENTERPRISES (U)

LTD30/07/2009 RT30695 DATED

26/10/2011{25CE2B86-B825-4D078EBA-5FE78809FB23}

AMMAN PHARMACEUTICAL

INDUSTRIESAPRICROM 4737/21/05 SODIUM

CROMOGLYCATE

AMMAN PHARMACEUTICAL INDUSTRIES KING

ABDULLAH II INSUDTRIAL ESTATE

SAHAB

2% W/V EYE DROPS 1*1*10ML IN VIAL JORDANWIDE SPECTRUM ENTERPRISES (U)

LTD30/07/2009 RT30695 DATED

26/10/2011

{F0CA454E-695A-48F9-BFCA-

D297DE3FB37E}

AMMAN PHARMACEUTICAL

INDUSTRIESAPITROPIN 4738/21/05 ATROPINE

AMMAN PHARMACEUTICAL INDUSTRIES KING

ABDULLAH II INSUDTRIAL ESTATE

SAHAB

1%W/V EYE DROPS 1*1*10ML IN VIAL JORDANWIDE SPECTRUM ENTERPRISES (U)

LTD30/07/2009 RT30695 DATED

26/10/2011

{24DF6E32-6F1E-4BA0-8A68-

B83EDE678BE4}

AMMAN PHARMACEUTICAL

INDUSTRIES - JORDAN

APIMOL 4739/21/05 TIMOLOL MALEATE

AMMAN PHARMACEUTICAL INDUSTRIES KING

ABDULLAH II INSUDTRIAL ESTATE

SAHAB

0.5% W/V EYE DROPS 1*1*5ML IN VIAL JORDANWIDE SPECTRUM ENTERPRISES (U)

LTD30/07/2009 RT30695 DATED

26/10/2011{AA2C68A8-530B-4127-96D2-99480BBCF36B}

AMMAN PHARMACEUTICAL

INDUSTRIES - JORDAN

APIGEN 4740/21/05 GENTAMYCIN AS SULPHATE

AMMAN PHARMACEUTICAL INDUSTRIES KING

ABDULLAH II INSUDTRIAL ESTATE

SAHAB

0.3% W/V EYE/EAR DROPS 1*1*10ML IN VIAL JORDANWIDE SPECTRUM ENTERPRISES (U)

LTD30/07/2009 RT30695 DATED

26/10/2011{69BA2772-AF3B-4B10-A0ED-7E7584DF9965}

BAYER EAST AFRICA LTD LEVITRA 4746/12/05 VARDENAFIL HCL BAYER AG D-5136

LEVERKUSEN 10MG TABLETS 1*1*4 IN BLISTERS GERMANY SURGIPHARM (U) LTD

{44BA3308-2822-4046-AE03-106181E37D75}

BAYER EAST AFRICA LTD LEVITRA 4747/12/05 VARDENAFIL HCL BAYER AG D-5136

LEVERKUSEN 5MG TABLETS 1*1*4 IN BLISTERS GERMANY SURGIPHARM (U) LTD

{A3594E2A-7237-44A9-B74F-6BE1EFA0179F}

BAYER EAST AFRICA LTD LEVITRA 4748/12/05 VARDENAFIL HCL BAYER AG D-5136

LEVERKUSEN 20MG TABLETS 1*1*4 IN BLISTERS GERMANY SURGIPHARM (U) LTD

{6FAB7CB9-DA4B-4BA4-935D-

AFE78DEC2280}

BETA HEALTHCARE INTERNATIONAL LTD MARAMOL 4750/02/05

ASPIRIN + PARACETAMOL +

CAFFEINE

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BO

400MG + 200MG + 50MG TABLETS 1*50*2 , 110, STRIPS KENYA BETA HEALTH CARE

(U) LTD 04/02/09 RT27853 DATED 15/07/11

{EA8540C1-655F-4052-ABFE-7C8E2C2B354F}

CADILA HEALTH CARE LTD ATORVA-20 4757/21/05 ATORVASTATIN

CALCIUM

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

20MG TABLETS 1*5*(1*7 ) IN BLISTERS INDIA ABACUS PHARMA (A)

LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{F9A1B348-8191-4A7C-B8C8-D3613E76DD0A}

IDA PRAZIQUANTEL 4785/06/05 PRAZIQUANTELCIPLA LTD, MIDC

PATALGANGA DIST. RAIGAD

600MG TABLETS 1*500 HDPE INDIA JOINT MEDICAL STORES

JV11/017 DATED 08/07/11

{BF7660B5-E07D-442F-9305-78635B6C1C92}

Page 53

Page 54: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

INTAS PHARMACEUTICALS

LTDRTITAS 4794/06/05 ARTEMETHER

INTAS PHARMACEUTICALS LTD MATODA 382 210 DIST AHMEDABAD,

INDIA

100MG/ML INJECTION 1*1*7 AMPOULES INDIANORVIK

ENTERPRISES (U) LTD

06/09/09 RT29052 DATED 06/09/11

{9A73C323-3CA0-43EF-AF00-

FC84160B6121}

INTAS PHARMACEUTICALS

LTDENAPRIL 10 4795/12/05 ENALAPRIL MALEATE

INTAS PHARMACEUTICALS LTD MATODA 382 210 DIST AHMEDABAD,

INDIA

10MG TABLETS 1*10*10 IN BLISTERS INDIANORVIK

ENTERPRISES (U) LTD

06/09/09 RT29052 DATED 06/09/11

{ED8BA9F2-4A8B-40C2-AEEE-

A29E584A2C9D}

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

NYTIN 4797/06/05 NYSTATIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

500,000IU TABLETS 1*100 IN HDPE UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{605933BE-2B02-432B-8692-098281F1A17D}

MEPHA LTD ARTEQUIN 300/375 4828/06/05 ARTESUNATE + MEFLOQUINE

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

300MG + 375MG TABLETS 1*(3+3) IN BLISTERS SWITZERLAND GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011

{982E1AD7-7637-4D31-BF98-

8AA7ABFDCD6F}

MEPHA LTD MESPORIN -500 4829/06/05 CEFTRIAXONE

LABESFAL S.A CAMPO DE

BESTERIROS & AMANDORA

500MG POWDER FOR INJECTION

1*5ML IN VIAL + 1* 5ML WATER FOR

INJECTIONPORTUGAL GOODMAN

INTERNATIONAL LTD 29/04/2010 RT28480 DATED 11/08/2011

{0A911E99-DAF1-477B8C32-

91A4ECAC9FD5}

MEPHA LTD GASEC-20 4830/17/05 OMEPRAZOLE

SOFARIMEX INDUSTRAIL QUIMICA E

FARMACEUTICA LDA AV

20MG CAPSULES 1*1*14 IN HDPE PORTUGAL GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011

{886CDB36-7C72-42BC-88CC-

C3C022C39389}

SHAIGAN PHARMACEUTICALS

LTDANTIMIN 4858/03/05 LORATIDINE

SHAIGAN PHARMACEUTICALS

PVT LTD,14 KM ADYALA ROAD

5MG/5ML SYRUP 1*1*60ML PAKISTAN HEALTH CARE LTD 11/02/09 RT31759 DATED 13/12/11

{0A717BAE-5CA3-4CE7-9D14-

C7B0045EB811}

SHAIGAN PHARMACEUTICALS

PVT LTDSTAMIN 4859/03/05 CETIRIZINE

DIHYDROCHLORIDE

SHAIGAN PHARMACEUTICALS

PVT LTD,14 KM ADYALA ROAD

1MG/ML ORAL SOLUTION 1*1*60ML BOTTLE PAKISTAN HEALTH CARE LTD 11/02/09 RT31759 DATED 13/12/11

{8FBB0C93-1E21-4747-BD6F-67AA02A04F98}

SHAIGAN PHARMACEUTICALS

PVT LTDCLOZOX 4861/06/05 CLOTRIMAZOLE

SHAIGAN PHARMACEUTICALS

PVT LTD2%W/V VAGINAL CREAM

1*1*35G IN TUBE WITH TWO

APPLICATORSPAKISTAN HEALTH CARE LTD 11/02/09 RT31759 DATED

13/12/11

{3AB030FC-FCBC-4652-A710-

7FCFAA48B937}

STRIDES ARCOLAB LTD NEVIRAPINE 4864/06/05 NEVIRAPINE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

200MG TABLETS 1*60 IN HDPE INDIA VEERAM HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{B3B97241-3195-49C8-9579-3C7DF86A6C6D}

STRIDES ARCOLAB LTD LAMIVUDINE 4866/06/05 LAMIVUDINE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

150MG TABLETS 1*60 IN HDPE INDIA VEERAM HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{B1D68C12-F169-4E04-8C51-2F2631AC2F57}

MEGA PRODUCTS PTY LTD FERROTONE 4867/10/05

FERROUS FUMERATE + FOLIC

ACID + VIT B12

MEGA LIFE SCIENCES LTD. 384 PATTANA 3 ROAD

BANGPOO INDUSTRIAL ESTATE

SAMUTPRAKARN

162MG/0.75MG/7.5MCG CAPSULES 1*10*10, 1 * 3 * 10

BLISTERS THAILAND SURGIPHARM (U) LTD

21/01/2009. NOTIFICATION SENT TO INSP FROM DAR

RT292218 & RT29217 DATED 12/09/2011

{ABBC81B6-9268-47CE-8E3E-

BAA5C3BCF5B5}

TORRENT PHARMACEUTICALS

LTDLISTRIL PLUS 4869/12/05

LISINOPRIL + HYDROCHLOROTHIA

ZIDE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA, GUJARATI

5MG + 12.5MG TABLETS 1*10*10 IN STRIPS INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{CF382E3B-A444-4D3F-A8F6-

99CDB0B229A6}

TORRENT PHARMACEUTICALS

LTDTOZAAR-H 4870/12/05

LOSARTAN POTASSIUM +

HYDROCHLORTHIAZIDE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

50MG + 12.5MG TABLETS 1*10*10 IN STRIPS INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{A088D822-828D-40E1-BBD3-

9A1DD06978FD}

Page 54

Page 55: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

TORRENT PHARMACEUTICALS

LTDMOSID MT-5 4871/17/05 MOSAPRIDE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA, GUJARATI

5MG TABLETS 1 * 3 * 10 , 1 * 10*10 BLISTER INDIA

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {C0270165-55BF-4697-

9167-9DAEFC497816}

UNICHEM LABS LTD MYCLAV 625 4882/06/05AMOXICILLIN + CLAVULANATE

POTASSIUM

UNICHEM LABORATORIES LTD. VILLAGE BHATAULI

KALA, B

500MG + 125MG TABLETS 1*10*6 IN STRIPS , 1*2*7 INDIA

NORVIK ENTERPRISES (U)

LTD22/11/10 RT29055 DATED

06/09/11

{7CD32B1A-D801-4819-BBBB-

170C377F50A5}

UNICHEM LABS LTD LOSAR 50 4883/12/05 LOSARTAN POTASSIUM

UNICHEM LABORATORIES LTD, VILLAGE BHATAULI

KALA, B

50MG TABLETS 1*10*10 IN BLISTERS INDIANORVIK

ENTERPRISES (U) LTD

22/11/10 RT29055 DATED 06/09/11

{D8374C76-3CCF-4DF4-813D-

26A6F35319A7}

UNICHEM LABS LTD MYCLAV 375 4885/06/05AMOXICILLIN + CLAVULANATE

POTASSIUM

UNICHEM LABORATORIES LTD. VILLAGE BHATAULI

KALA, B

250MG + 125MG TABLETS 1*10*6 IN STRIPS INDIANORVIK

ENTERPRISES (U) LTD

22/11/10 RT29055 DATED 06/09/11

{928D50C4-49BC-4D07-AE80-

5ED0EF475DA3}

UNIQUE PHARMACEUTICALS

LABSIFICIPRO 500 4886/06/05 CIPROFLOXACIN

J.B CHEMICALS & PHARMACEUTICALS

LTD, 128/1, GIDC, ANKLESHWAR 393

002, GUJARAT

500MG TABLETS 1*10*10 IN BLISTERS INDIA TATA (U) LTD 06/05/10 RT28496 DATED 12/08/11

{951BA399-ECDD-43BD-98B5-

B194D34B1C89}

UNIQUE PHARMACEUTICAL

LABORATORIESIFICIPRO 250 4887/06/05 CIPROFLOXACIN

J.B CHEMICALS & PHARMACEUTICALS

LTD, 128/1 GIDC,ANKLESHWAR 393 002, GUJARAT

250MG TABLETS 1*10*10 IN BLISTERS INDIA TATA UGANDA LTD 06/05/10 RT28496 DATED 12/08/11

{9098DFDC-C7B5-4094-B1C1-

A34D75039529}

VIFOR INDIA PVT LTD WATER FOR INJECTION 4894/23/05 WATER FOR

INJECTION

VIFOR PHARMA PVT LTD, K.S.E.2

GANDHIDHAM KUTCH

_ INJECTION 1*10*5ML VIALS, 1 * 10 * 10ML VIALS INDIA

SUPER PHARMACEUTICALS

LTD01/12/08 RT28433 DATED

09/08/11{79176491-6A5B-4C9E-84C6-8FD09549EB70}

WIN MEDICARE PVT LTD DICLOMOL PLUS 4895/02/05 PARACETAMOL +

DICLOFENAC

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

500MG + 50MG TABLETS 1*10*10 IN BLISTERS INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{FA00C4F0-C149-4342-B091-E4EDCB684549}

WIN MEDICARE PVT LTD MYOSPAZ 4896/02/05 PARACETAMOL +

CHLORZOXAZONE

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

500MG + 250MG TABLETS 1*10*10 IN BLISTERS INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{23CABD49-4234-4951-8364-28A4A6AAD2AC}

WIN MEDICARE PVT LTD RELISURE 4897/02/05 MEFENAMIC ACID

WIN-MEDICARE PVT LTD,

MODIPURAM;250 110,U.P. ,INDIA

250MG CAPSULES 1*10*10 IN BLISTERS INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{EC2161E6-2C52-4084-B52D-

7C5BD6EBE7D1}

ELYS CHEMICAL INDUSTRIES ELYZOLE 4900/06/05 ALBENDAZOLE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

200MG TABLET 1*20*2 BLISTER KENYA ELYS CHEMICAL INDSTRIES (U) LTD 02/02/2009 RT29236 DATED

13/09/2011

{1A632AC2-7CB1-4ECA-A27C-

8CA912E9F0FD}

IDA AMITRIPTYLINE 4903/24/05 AMITRIPTYLINEMICROLABS LTD 92

SIPCOT HOSUR TAMIL NADU

25MG TABLET 1*1000 HDPE INDIA JOINT MEDICAL STORES

JV11/017 DATED 08/07/11

{72F07807-0D76-4DBC-8688-47A3AA4969F7}

AUROBINDO PHARMA LTD ZUCLOX-500 4914/06/05 AMPICILLIN &

CLOXACILLIN

AUROBINDO PHARMA LTD, UNIT XII, SURVEY NO 314,

BACHUPALLY VILLAGE,

QUTHUBULLAPAR, R.R DISTRICT .A.

PRADESH

250MG + 250MG CAPSULE 1*10*10 IN BLISTERS INDIA GITTOES

PHARMACEUTICALS (U) LTD

17/05/2010 RT28910 + RT28908 DATED 31/08/2011

{B87C971F-3169-4A9C-9881-F5DE9B7305C2}

CADILA HEALTHCARE LTD

DERINIDE 100 INHALER 4928/25/05 BUDESONIDE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

MORAIYA. TAL SANAND DIST

AHMEDABAD 382 210

100MG INHALER 200 METERED DOSES INDIA ABACUS PHARMA (A)

LTDRE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{AE084B22-F0F2-4CED-B3F7-

92BE39A27D5E}

Page 55

Page 56: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CADILA HEALTHCARE LTD

DERINIDE 200 INHALER 4929/25/05 BUDESONIDE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

MORAIYA. TAL SANAND DIST

AHMEDABAD 382 210D

200MG INHALER 200 METERED DOSES INDIA ABACUS PHARMA (A)

LTDRE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{E5805F9F-1530-477A-8E5D-33B64C39EC19}

CADILA PHARMACEUTICALS

LTDTAMBAC 50 4932/06/05 CEFPODOXIME

PROXETIL

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

50MG/5ML ORAL SUSPENSION 1*60ML IN HDPE INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{649860CC-D8C4-4119-A630-80B9D2BD8937}

WOCKHARDT LIMITED KEFSTAR 4935/06/05 CEFUROXIME

WOCKHARDT LIMITED, B-15/2,

MIDC WALUJ AURANGABAD 4

750MG/10ML VIAL POWDER FOR INJECTION 1*10ML VIAL INDIA

STAR PHARMACEUTICALS

LTD14/12/09 RT28254 DATED

01/08/11{F32415FB-D04E-4F16-9997-0F3796590C7E}

WOCKHARDT LIMITED KEFSTAR-250 4936/06/05 CEFUROXIME AXETIL

WOCKHARDT LIMITED, B-15/2,

MIDC WALUJ AURANGABAD 4

250MG TABLET 1*1*4 IN STRIPS. 1*10 BLISTERS INDIA

STAR PHARMACEUTICALS

LTD14/12/09 RT28254 DATED

01/08/11{7E00A770-8F13-40F6-90B6-372F5C4D6A17}

WOCKHARDT LIMITED KEFSTAR-500 4937/06/05 CEFUROXIME AXETIL

WOCKHARDT LIMITED, B-15/2,

MIDC WALUJ AURANGABAD 4

500MG TABLET 1*1*4 IN STRIP, 1*10 BLISTERS INDIA

STAR PHARMACEUTICALS

LTD14/12/09 RT28254 DATED

01/08/11{69581F0E-74EE-4D11-918A-17FB74B63B43}

AUROBINDO PHARM LTD CLOXIL-250 4955/06/05 CLOXACILLIN

AUROBINDO PHARMA LTD, UNIT XII, SURVEY NO 314,

BAC

250MG CAPSULE 1*10*10 IN BLISTERS INDIAGITTOES

PHARMACEUTICALS LTD

17/05/2010 RT28910 + RT28908 DATED 31/08/2011

{7F763B7A-4089-4D12-8983-E8752643D9CE}

ROYAL GROUP DORAN 4960/02/05 DICLOFENAC SODIUM

ZHENJIANG TIANFENG

PHARMACEUTICAL FACTORY N0 518 DAXIANG ROAD

FENG HUANG DEVT OF HUZHOU, ZHEIJIANG

75MG/3ML INJECTION 1*1*5 AMPOULES CHINA ABACUS PHARMA (A) LTD 11/09/08 RT28249 DATED

01/08/11

{EB2DEE58-FB01-4D0B-854F-

DA4DC1F2C8EE}

ELYS CHEMICAL INDUSTRIES LTD DOXYCYCLINE 4970/06/05 DOXYCYCLINE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

100MG CAPSULE 1*10*10 IN BLISTERS, 1 * 1000 HDPE KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{263BE121-1903-48DD-A38C-44863CB858A9}

GLENMARK PHARMACEUTICALS ESOZ 4974/17/05 ESOMEPRAZOLE

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

40MG TABLETS 1*10*10 IN STRIPS INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{AD6ADE11-59BA-428D-A41A-

BFD6A60CB1FB}

MARCK BIOSCIENCES LTD CANDICAN 4979/06/05 FLUCONAZOLE

MARCK BIOSCIENCES LTD, PLOT NO 876, N.H.

NO 8, VIL HARIYALA, KHEDA - 387411,

GUJARAT

0.2%W/V INJECTION 1*100ML HDPE BOTTLE INDIA

KARURI PHARMACEUTICALS

LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{F1293AE6-54DA-49F8-BB4D-1B99A35F6CC7}

CLARIS LIFE SCIENCES HEPAREN 4987/10/05 HEPARIN

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA

AHMEDABAD

5000IU/ML INJECTION 1*5ML VIAL INDIA REDDY`S PHARMA LTD 01/03/2010 RT28354 DATED

04/08/2011{D4FF1930-2C64-48B2-982C-579EAE7A5D0A}

DENK PHARMA IBUPROFEN DENK 400 4994/02/05 IBUPROFEN

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

400MG TABLET 1*10*10, 1 * 10 BLISTERS GERMANY ERIS LTD 14/01/08 + RT27569

DATED 04/07/11RT28444 DATED

09/08/11

{92E80EE6-EDFD-4C31-BE41-

7EB346357230}

CLARIS LIFE SCIENCES LTD CELEPID 20 4997/26/05 INTRAVENOUS FAT

EMULSION

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

20%W/V INJECTION 1*1*250ML & 1*1*500ML INDIA REDDY`S PHARMA

LTD 01/03/2010 RT31356 DATED 24/11/2011

{41831F14-458D-4331-9AD2-36C1AB6265FF}

Page 56

Page 57: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CLARIS LIFE SCIENCES KETAJEX 4999/01/05 KETAMINE

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

50MG/ML INJECTION 1*10ML VIAL INDIA REDDY`S PHARMA LTD 01/03/2010 RT31356 DATED

24/11/2011

{B5A8023B-7A41-43A1-A41D-

F2AB2310CDAD}

EMCURE PHARMACEUTICALS

LTDLAZID 5002/06/05 LAMIVUDINE +

ZIDOVUDINE

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

150MG + 300MG TABLETS 1*60 INHDPE INDIAPHILIPS

PHARMACEUTICALS LTD.

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{B0635E0E-69C0-4621-B098-7138BD84F028}

CLARIS LIFE SCIENCES SENSINIL 5005/01/05 LIDOCAINE

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

2%W/V INJECTION 1 * 20ML, 1 * 30ML VIAL INDIA REDDY`S PHARMA

LTD 01/03/2010 RT31356 DATED 24/11/2011

{22551B12-7B81-4ED5-B0AC-309518BB4C5D}

CLARIS LIFESCIENCES LTD SEDOZ 5017/24/05 MIDAZOLAM

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

1MG/ML INJECTION 1*1*5ML INDIA REDDY`S PHARMA LTD 01/03/2010 RT31356 DATED

24/11/2011{51132A81-5626-41A3-8C4A-E410E4BD4547}

SURGIPHARM (U) LTD ENAT 400 5024/27/05 NATURAL VITAMIN E

MEGA LIFE SCIENCES LTD. 384 PATTANA 3 ROAD

BANGPOO INDUSTRIAL ESTATE

SAMUTPRAKARN

400 IU CAPSULE 1*3*10 BLISTER THAILAND SURGIPHARM (U) LTD

21/01/2009. NOTIFICATION SENT TO INSP FROM DAR

RT292218 & RT29217 DATED 12/09/2011

{B21052BA-8CB9-4125-9638-3C3B55A5F78E}

CADILA HEALTH CARE LTD OLANDUS 10 5029/24/05 OLANZAPINE

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

10MG TABLETS 1*10*10 IN BLISTERS INJDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{196DEAE0-D852-408D-9FAF-

909600C6E3E2}

AJANTA PHARMA LTD APRAZOLE-20 5030/17/05 OMEPRAZOLEAJANTA PHARMA

LTD B-4/5/6 MIDC IND AREA PAITHAN 43

20MG CAPSULE 1*2*7 , 1 * 10 * 10 IN STRIPS INDIA

AARON PHARMACEUTICALS

LTD27/11/08 RT28086 DATED

26/07/11

{0B167A8B-C9C3-4015AB17-

A6FCF2DDFB84}

IDA OXYTOCIN 5034/22/05 OXYTOCIN

GLAND PHARMA LTD D.P PALLY DUNDIGAL

HYDERABAD

10 IU INJECTION SOLUTION 1*10*1ML AMPOULE INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11{57770604-3907-4429-98E7-4B2B7AE18B5C}

SWSS PHARMACEUTICALS

PVT LTDFEVAMOL 5036/02/05 PARACETAMOL

SWISS PHARMACEUTICALS

PVT LTD. A159 SINDH INDUSTRIAL

AREA KARACHI

120MG/5ML SYRUP 1*60ML BOTTLE PAKISTAN HEALTH CARE LTD

RE-ISNP PAID 27/07/2009 VIDE

RT12744. REMINDER SENT TO INSP.

RT30076 &RT30073 DATED 12/10/2011

{78B07C5D-EFFE-4D3D-BD0D-

C32D1C68523A}

CADILA HEALTH CARE LTD XET-20 5040/24/05 PAROXETINE

CADILA HEALTHCARE

LIMITED SARKHEJ-BARLA N.H NO.8A,

20MG TABLETS 1*1*10 IN BLISTER INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{8CF32416-EABB-44A4-B421-

0B711BE2E3C0}

CADILA HEALTHCARE LTD LYSSAVAC N BERNA 5047/19/05

PURIFIED DUCK EMBRYO RABIES

VACCINE

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

2.5IU/DOSE INJECTION 1*2.5IU/DOSE VIAL INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{42306ED2-D382-421E-9FE9-559FD561705D}

IDA CO-TRIMOXAZOLE 5062/06/05 CO-TRIMOXAZOLEMICROLABS LTD 92

SIPCOT HOSUR TAMIL NADU

100MG/200 MG TABLET 1*1000 HDPE INDIA JOINT MEDICAL STORES

JV11/017 DATED 08/07/11

{8687D0C8-FBE0-4EF7-A3F2-

9C2A6715E606}

DENK PHARMA VIT-B-DENK 5068/27/05 THIAMINE HCL + PYRIDOXINE HCL

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

100MG + 200MG TABLET 1 * 10, 1*10*10 IN BLISTERS GERMANY ERIS LTD 14/01/08 + RT27569

DATED 04/07/11RT28444 DATED

09/08/11{F7D2A023-F735-43C4-81D3-07DBA8213DA1}

MEPHA LTD TRABILIN-100 5069/02/05 TRAMADOL

MERCKLE GMBH, LUDWIG MERCKLE STRASSE3 D-89143

BLAUBEUREN

100MG/2ML INJECTION 1*1*5*2ML AMPOULES GERMANY

GOODMAN PHARMACEUTICALS

LTD19/08/2009 RT28480 DATED

11/08/2011{D594C269-D9B2-4417-BC43-B360455EF75A}

Page 57

Page 58: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SWSS PHARMACEUTICALS

PVT LTDSMARTRIM 5070/02/05

TRIMETHOPRIM + SULPHAMETHOXAZO

LE

SWISS PHARMACEUTICALS

PVT LTD. A159 SINDH INDUSTRIAL

AREA KARACHI

40MG/5ML + 200MG/5ML SUSPENSION 1* 60ML BOTTLE PAKISTAN HEALTH CARE LTD

RE-ISNP PAID 27/07/2009 VIDE

RT12744. REMINDER SENT TO INSP.

RT30076 &RT30073 DATED 12/10/2011

{831F349D-CC30-44B8-AB52-2033F0A802FB}

TORRENT PHARMACEUTICALS

LTDVALZAAR-160 5071/12/05 VALSARTAN

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MAHSANA, GUJARATI

160MG CAPSULE 1*3*10 IN STRIPS INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{0DED7B8A-F877-45EB-A8A5-

A8509D56B5B6}

AUROBINDO PHARMA LTD LAMIVUDINE 5074/06/05 LAMIVUDINE

AUROBINDO PHARMA LTD, UNIT III SURVEY NO.313

BACHU

150MG TABLET 1*60 IN HPDE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{240423C7-AB66-4EB2-9A7E-3034D078A530}

AUROBINDO PHARMA LTD STAVUDINE 5075/06/05 STAVUDINE

AUROBINDO PHARMA LTD, UNIT III SURVEY NO.313

BACHU

30MG CAPSULE 1*60 IN HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{A9B132BE-CA5F-4E83-9CE5-

C1F314252C5A}

AUROBINDO PHARMA LTD ZIDOVUDINE 5076/06/05 ZIDOVUDINE

AUROBINDO PHARMA LTD, UNIT III SURVEY NO.313

BACHU

300MG TABLET 1*60 IN HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{51789CD3-9527-4237-BD61-

DAC7C2D8DAE6}

AUROBINDO PHARMA LTD NEVIRAPINE 5079/06/05 NEVIRAPINE

AUROBINDO PHARMA LTD, UNIT III SURVEY NO.313

BACHU

200MG TABLET 1*60 IN HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{E8B7E833-5641-4B80-B15B-8A1DAEE42095}

AUROBINDO PHARMA LTD

LAMIVUDINE & ZIDOVUDINE 5080/06/05 LAMIVUDINE &

ZIDOVUDINE

AUROBINDO PHARMA LTD, UNIT III SURVEY NO.313

BACHU

150 & 300MG TABLET 1*60 IN HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{1C165E9B-F616-41D5-A1FA-F6FD14535A55}

AUROBINDO PHARMA LTD EFAVIRENZ 5081/06/05 EFAVIRENZ

AUROBINDO PHARMA LTD, UNIT III SURVEY NO.313

BACHU

600MG TABLET 1*30 IN HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{9FC7B9F7-C6F7-4A4E-8B5D-

90FC249FEA6C}

BETA HEALTHCARE INTERNATIONAL LTD BETROZOLE 5082/06/05

DILOXANIDE FUROATE &

METRONIDAZOLE

BETA HEALCARE INTERNATIONAL

LTD, BONDO ROAD P.O BOX 42569,

NAIROBI, KENYA.

25MG/ML & 20MG/ML ORAL SUSPENSION 1*100ML IN GLASS BOTTLE KENYA BETA HEALTHCARE

UGANDA LTD 04/02/09 RT27853 DATED 15/07/11

{28E8FF52-B3E1-4061-AFAA-

6A3DCBF4714D}

CADILA HEALTHCARE LTD VOMIZ 5084/17/05 ONDANSENTRON

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

4MG/2ML INJECTION 1*5*4ML & 1*5*2ML AMP INDIA ABACUS PHARMA (A)

LTDRE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{57DCCFAF-3E29-405D-82A0-

F9AD21C34B04}

CADILA HEALTHCARE LTD DERIHALER 5085/25/05 SALBUTAMOL

CADILA HEALTHCARE

LIMITED SARKHEJ-BAVLA N.H NO.8A,

100CMG/DOSE AEROSOL 200 MD INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{E84F311D-ED80-487C-83D5-

35EDAA77095B}

CADILA PHARMACEUTICALS

LTDRABELOC IV 5087/17/05 RABEPRAZOLE

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA AHMEDABABAD

20MG/VIAL INJECTION 1*5ML VIAL INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{A4A6D356-A235-4735-B019-295AF1B0C045}

CENTAUR DRUG HOUSE PVT LTD BENZOX 5 GEL 5088/13/05 BENZOYL PEROXIDE

CENTAUR PHARMACEUTICALS

LTD , PLOT NO. 39 TIVIN IN

5%W/W TOPICAL GEL 1*20GM IN TUBE INDIAGITTOES

PHARMACEUTICALS LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{B6754E77-9A35-4B7F-BDC8-F5E3FA7565A8}

CENTAUR DRUG HOUSE PVT LTD TASOL 5089/13/05 CLOBETASOL

CENTAUR DRUG HOUSE PVT LTD,

PLOT NO. 39 TIVIN IND.

0.05%W/W CREAM 1*15GM TUBE INDIAGITTOES

PHARMACEUTICALS LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{974EB015-9EF1-417B-A51C-081FF5C898E6}

CENTAUR DRUG HOUSE PVT LTD ARGISSEPT 5090/13/05

CHLORHEXIDINE GLUCONATE &

SILVER SULPHADIAZINE

CENTAUR PHARMACEUTICALS

LTD , PLOT NO. 39 TIVIN IN

0.2%W/W & 1%W/W CREAM 1*20 & 1*10 MG IN TUBE INDIA

GITTOES PHARMACEUTICALS

LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{D08B6B9C-71D7-4506-A625-

D7DC9215145E}

CLARIS LIFESCIENCES LTD CIPROX 5114/06/05 CIPROFLOXACIN

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

0.2%W/V INJECTION 1*100ML PLASTIC BOTTLE INDIA REDDY`S PHARMA

LTD 01/03/2010 RT31356 DATED 24/11/2011

{F93E6FCC-C3ED-4985-A019-

45861EE3D014}

Page 58

Page 59: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

EMCURE PHARMACEUTICALS

LTDASOMEX-2.5 5123/12/05 AMLODIPINE

BESILATE

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

2.5MG TABLET 1*5*10 IN BLISTER INDIAPHILIPS

PHARMACEUTICALS LTD.

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{AAA8E773-EAFC-4EF0-9362-

5D5754841E24}

EMCURE PHARMACEUTICALS

LTDASOMEX-5 5124/12/05 AMLODIPINE

BESILATE

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

5MG TABLET 1*5*10 IN BLISTER INDIAPHILIPS

PHARMACEUTICALS LTD.

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{A8803153-26A1-44B1-B2A4-5F1FF5BDF848}

EMCURE PHARMACEUTICALS

LTDNEVIR 5126/06/05 NEVIRAPINE

EMCURE PHARMACEUTICALS LTD PLOT NO. P-Z,

1T-B.T PA

200MG TABLET 1*60 IN HDPE INDIAPHILIPS

PHARMACEUTICALS LTD.

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{86C68175-8EEA-41CF-A7F5-

49DC24F297BA}

GLENMARK PHARMACEUTICALS

LTDMUMFER 5135/10/05

IRON(111) POLYMALTOSE

COMPLEX

GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37,

39 ,D

50MG/5ML SYRUP 1*150ML IN PET BOTTLE INDIA

STAR PHARMACEUTICALS

LTD29/09/2009 RT28761 DATED

24/08/2011

{CF2841B4-9EFC-4C37-8E04-

2B6386FDC476}

INDOCO REMEDIES LTD CIPRIND-500 5149/06/05 CIPROFLOXACIN

INDOCO REMEDIES LTD. B-20,MIDC,

WALUJ, AURANGABAD 431

136 INDIA

500MG TABLET1*1000 HDPE & 1*5*200, 10 * 10

BLISTERINDIA TATA UGANDA LTD 10/05/2010 RT29332 & JV11/148

DATED 16/09/11

{248FBEC1-0EC7-4420-B198-

E7A47B78D1EA}

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

BETASOL N 5162/13/05 BETAMETHASONE AND NEOMYCIN

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

1MG/G & 5MG/G CREAM 1*15GM IN TUBE UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{3BB9489C-1180-4BEC-9AF2-

E7EFEC26AFB8}

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

MCG CREAM 5163/13/05

MICONAZOLE NITRATE +

CLOBETASOL PROPIONATE+GENTA

MI

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

2.0,0.05 & 0.1 %W/W CREAM 1*15,1*25 & 1*30MG UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{A94F7734-8306-4736-AD3A-2EE4A955F3A5}

PACIFIC PHARMACEUTICALS

LTDLOMEXIN 5208/13/05 FENTICONAZOLE

PACIFIC PHARMACEUTICALS LTD 30KM MULTAN

RD LAHORE

2%W/W CREAM 1*40G IN TUBE PAKISTAN HEALTHCARE LTD 16/02/2009 RT 29949 DATED 11/08/2011

{63338B4B-16BE-42D5-A61C-870F989B6E37}

PACIFIC PHARMACEUTICALS

LTD

TYZORIN MOUTH WASH 5210/15/05 TIBOZONIUM IODIDE

PACIFIC PHARMACEUTICALS LTD 30KM MULTAN

RD LAHORE

0.05G/100ML SOLUTION 1*120ML IN GLASS BOTTLE PAKISTAN HEALTHCARE LTD 16/02/2009 RT 29949 DATED

11/08/2011{68FABA45-3202-4A05-B5D0-2A1B718F93CC}

RENE INDUSTRIES CIPROREN 5213/06/05 CIPROFLOXACIN HYDROCHLORIDE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

500MG TABLET 1*10*10 IN BLISTER UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{815349F0-0026-4542-BEF6-1F723566E63A}

RENE INDUSTRIES LTD FOLIC ACID 5214/10/05 FOLIC ACID

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

5MG TABLET 1*1000 IN HDPE UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{81083D78-1149-4DAC-B557-C775A63FE314}

ROYAL GROUP ROGOQUIN 5215/06/05 QUININE DIHYDROCHLORIDE

ZHENJIANG TIANFENG

PHARMACEUTICAL FACTORY N0 518 DAXIANG ROAD

FENG HUANG DEVT OF HUZHOU, ZHEIJIANG

600MG/2ML INJECTION1*10*2ML AMP,

1*100*2ML AMPOULES

CHINA ABACUS PHARMA (A) LTD 11/09/08 RT28249 DATED

01/08/11

{0C8A50C4-098A-463C-881A-

033F69A9A75C}

TORRENT PHARMACEUTICALS

LTDDOMSTAL O 5225/17/05 DOMPERIDONE &

OMEPRAZOLE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

10MG/10MG CAPSULE 1*10*10 IN STRIPS INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {101B39D0-930B-4D50-

92A8-6B3D7149E1B2}

TORRENT PHARMACEUTICALS

LTDESAM 5 5226/12/05 AMLODIPINE

BESYLATE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

5MG TABLET 1*2*50 IN BLISTER INDIA KARURI PHARMACEUTICALS

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{C187981B-6FDE-495A-867D-

661E0562F21E}

TORRENT PHARMACEUTICALS

LTDESAM 2.5 5227/12/05 AMLODIPINE

BESYLATE

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

2.5MG TABLET 1*2*50 IN BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{1A60962F-BC1A-47F1-AB89-

5C1ED8BD25BE}

Page 59

Page 60: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CENTAUR DRUG HOUSE INFLAZONE 5245/13/05 MULTINGREDIENT

CENTAUR PHARMACEUTICALS

LTD , PLOT NO. 39 TIVIN IN

Z OINTMENT 30G INDIAGITTOES

PHARMACEUTICALS LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{01104D45-D397-4392-BD50-9D121C174B68}

ABACUS PHARMA UNICOLD PLUS 5246/03/05

CHLORPHENIRAMINE MALEATE

PARACETAMOL PSEUDOEPHEDRINE

HYDROCHLORIDE

UNIBIOS LABORATORIES LTD, PLOT. C-2 NO. 4712

DEWAN & SONS ESTATES. MANOR

RD. VILLAGE VEOOR MAHARASHTRA

2MG/120 MG/ 10MG TABLET 1*50*4 BLISTER INDIA ABACUS PHARMA (A) LTD

RT29210 DATED 12/09/2011 PAYMENT FOR RE-INSPECTION

RT30000 DATED 11/10/2011

{A88B6184-B572-4B59-8C4C-20A9B84170C8}

CENTAUR PHARMACEUTICALS

LTDOCUREST-AH 5249/21/05 MULTINGREDIENT

CENTAUR PHARMACEUTICALS LTD, KARASWADA

MAPUSA GOA

Z EYE DROP 10ML INDIAGITTOES

PHARMACEUTICALS LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{F781B039-4ADC-4B85-BF00-

0A801C023326}

RENE INDUSTRIES LTD KOF OFF 5250/25/05 MULTINGREDIENT

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

MULTI-INGREDIENT SYRUP 110ML UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{B0B8AB13-65E2-4108-BB49-2B93BA62E43E}

PACIFIC PHARMACEUTICALS RIFIN FORTE 5251/06/05 MULTINGREDIENT

PACIFIC PHARMACEUTICALS LTD 30KM MULTAN

RD LAHORE

MULTINGREDIENT TABLET 1*10*8 PAKISTAN HEALTHCARE LTD 16/02/2009 RT 29949 DATED 11/08/2011

{C8C5E638-5B8E-440E-8443-

D642D3022C5A}

AJANTA PHARMA LTD CLARANTA-500 5260/06/05 CLARITHROMYCINAJANTA PHARMA

LTD B-4/5/6 MIDC IND AREA PAITHAN 43

500MG TABLETS 1*10*2*10 INDIAAARON

PHARMACEUTICALS LTD

27/11/08 RT28086 DATED 26/07/11

{AFFA28C8-D8A2-4A91-9B47-

FC3EDC240DDD}

BEIJING HOLLEY COTEC

PHARMACEUTICALS CO. LTD

DUO-COTECXIN 5271/06/05DIHYDROARTEMISIN/

PIPERAQUINE PHOSPHATE

ZHEJIANG HOLLEY NANHU

PHARMACEUTICAL CO. 25 YUNH

40MG + 320MG TABLET 1*1*9, 1 * 4 , 1*30*9 BLISTER CHINA

SUPER PHARMACEUTICALS

LTD

RT28435 DATED 14/07/2011 PAYMENT FOR RE-INSPECTION

RT28435 DATED 09/08/2011

{EBC4B6AE-1224-4FE1-8E71-

45F4D141FB04}

CADILA HEALTH CARE LTD CARVIL 12.5 5274/12/05 CARVEDILOL

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

12.5MG TABLET 10*10 IN BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{5E6A625E-290C-48F6-B069-620AD42FC37A}

CLARIS LIFE SCIENCES LTD

HESTAR-200 PENTASTARCH 5279/11/05 HYDROXYETHYL

STARCH

CLARIS LIFESCIENCES LTD,

CHACHARWADI VASANA AHMEDA

6%W/V INJECTABLE (LVP) 1*500ML INDIA REDDY`S PHARMA LTD 01/03/2010 RT31356 DATED

24/11/2011{4F6B64BB-2149-48B9-AA2E-B00573D10B6B}

IDALIDOCAINE HCL 5% &

DEXTROSE 7.5% INJECTION

5296/01/05 LIDOCAINE HCL 5% & DEXTROSE 7.5%

GLAND PHARMA LTD D.P PALLY DUNDIGAL

HYDERABAD

50MG +75MG /ML INJECTION SOLUTION 1*1*10 AMPOULE INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11

{ABFDE1ED-AA00-497E-BAB7-

547E78936AE8}

MEPHA LTD BACTIFLOX-500 5307/06/05 CIPROFLOXACIN

SOFARIMEX INDUSTAIL AV DAS

IND ALTO DO CALORIDE

500MG TABLET 1*10 PACK PORTUGAL GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011

{DACBBEFC-EE84-4C00-8C04-

D9C3BB730B62}

RANBAXY LAB LTD TRIVIRO LNS 30 5317/06/05LAMIVUDINE,

NEVIRAPINE & STAVUDINE

RANBAXY LABORATORIES LTD, PAONTA SAHIB DIST.

SIRMOUR H.P 173 025 MFG. LIC:

MNB/95/2

150MG +200MG +30MG TABLET 1 * 60 HDPE INDIA SURGIPHARM (U)

LTD 20/05/2011 RT29222 DATED 12/09/2011

{09E04A33-6968-41BD-BDD5-25524BAEA09A}

RENE INDUSTRIES LTD VITAMIN C 5322/27/05 VITAMIN C

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

100MG TABLET 1*1000 IN HDPE UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{10E41FDF-3477-46F8-973B-C376AE04BB97}

RENE INDUSTRIES LTD EPHEDRINE 5323/12/05 EPHEDRINE

HYDROCHLORIDE

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

30MG TABLETS 1*1000 IN HDPE UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{E59411D8-757F-478A-B044-9D129FEA371A}

Page 60

Page 61: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

TORRENT PHARMACEUTICALS

LTDTOPCEF 200 5325/06/05 CEFIXIME

TORRENT PHARMACEUTICALS LTD, INDRAD 382721

MANSANA

200MG TABLETS 1*5*10 INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {A4152C18-BAA0-48F2

B0E0-D0272D24454D}

RENE INDUSTRIES LTD RENIRON 5334/10/05 MULTI-INGREDIENT

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

MULTI-INGREDIENT CAPSULE 3 * 10 BLISTER UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{6B1C0F23-FE74-4794-9570-

FDEBEDCB9D39}

RENE INDUSTRIES LTD COLD EASE 5335/25/05 MULTI-INGREDIENT

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

MULTI-INGREDIENT CAPSULE 10 * 10 BLISTER UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{0B0DA061-3C8B-4A4C-8E4D-

AB6F3E851225}

RENE INDUSTRIES LTD COLD EASE 5336/25/05 MULTI-INGREDIENT

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

MULTI-INGREDIENT SYRUP 100ML UGANDA RENE PHARMACY LTD.

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{095B4E29-5E5D-4B82-8EA2-

4924ADCCD6C5}

UNIMED INDIA COLDAFEX 5338/25/05 MULTI-INGREDIENT

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

MULTI-INGREDIENT SYRUP 100ML INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{AAA4147D-92CD-4EB4-83A4-

AC1E047F5292}

ABBOTT LABORATORIES

SOUTH AFRICA (PTY) LTD

ENTAMIZOLE 5348/06/06 DILOXANIDE + METRONIDAZOLE

ABBOTT LABORATORIES

(PAKISTAN) LTD,PLOT N0 13,

SECTOR

250/200MG TABLET 1*3*10 PAKISTAN LABOREX (U) LTD 20/09/2011 RT28979 DATED 12/09/2011

{9DF37F02-A95A-4C06-B66F-1E7FF6C6B3D9}

ABBOTT LABORATORIES

SOUTH AFRICA (PTY) LTD

ENTAMIZOLE 5349/06/06

DILOXANIDE FUROATE +

METRONIDAZOLE BENZOATE

ABBOTT LABORATORIES (PAKISTAN) LTD,

PLOT NO 13, SECTOR

250MG/ 10ML + 200MG/10ML SUSPENSION 1*100ML PAKISTAN LABOREX (U) LTD 20/09/2011 RT28979 DATED

12/09/2011{857E3E01-A587-4D4D81C8-752A62D0A5D6}

ABBOTT LABORATORIES

SOUTH AFRICA (PTY) LTD

ENTAMIZOLE DS 5350/06/06DILOXANIDE FUROATE +

METRONIDAZOLE

ABBOTT LABORATORIES (PAKISTAN) LTD,

PLOT NO 13, SECTOR

500MG + 400MG TABLET 1*1*15 BLISTER PAKISTAN LABOREX (U) LTD 20/09/2011 RT28979 DATED 12/09/2011

{C9EC83BC-152C-4C4F-8186-

FA289A7817D3}

AJANTA PHARMA LTD ARTEFAN 20/120 5360/06/06 ARTEMETHER/LUMEFANTRINE

AJANTA PHARMA LTD B-4/5/6 MIDC IND

AREA PAITHAN 4320 & 120 MG TABLET

1*3*8 , 1*30*24,1*30*18,1*30*12, 1*30*6 & UG PACKS 1*30*24,1*30*18,1*30*12, 1*30*6 IN BLISTER, ACTM LOGO PACKS

1*30*6, 1*30*12, 1*30*18, 1*30*24

BLISTER

INDIAAARON

PHARMACEUTICALS LTD

27/11/08 RT28086 DATED 26/07/11

{941BB5E9-667B-4CB8B316-81082A888FBF}

AJANTA PHARMA LTD ZAHA-250 5363/06/06 AZITHROMYCINAJANTA PHARMA

LTD B-4/5/6 MIDC IND AREA PAITHAN 43

250MG TABLET 1*2 *10 IN BLISTERS INDIAAARON

PHARMACEUTICALS LTD

27/11/08 RT28086 DATED 26/07/11

{751D810B-7AFD-4F84-A699-E105CD63CAB3}

AUROBINDO PHARMA LTD LAMIVUDINE 5364/06/06 LAMIVUDINE

AUROBINDO PHARMA LTD. UNIT III,SURVEY NO.313

,BACH

10MG/ML ORAL SOLUTION 1*240ML IN HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{296217D8-CC03-4B87-AD52-7AF1726BCB0A}

BAYER EAST AFRICA LTD

BAYER ASPIRIN CARDIO 5367/02/06 ACETYL SALICYLIC

ACIDBAYER AG, D-51368

LEVERKUSSEN 100MG TABLET 1*3*10 GERMANY SURGIPHARM (U) LTD

{139A5241-6ABF-4FC4-80C7-1075F1FA9509}

BAYER EAST AFRICA LTD CIPROBAY XR 5368/06/06 CIPROFLOXACIN BAYER AG,D-51368 500MG TABLETS 1*1*3 IN BLISTER GERMANY SURGIPHARM (U)

LTD{DEA89ED8-4151-472386E4-84671B274E64}

CADILA HEALTHCARE LTD CARVIL 6.25MG 5374/12/06 CARVEDILOL

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

6.25MG TABLETS 10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{A7681E91-6647-4D00-85A8-E5A7024D20B1}

Page 61

Page 62: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CADILA HEALTHCARE LTD CARVIL 3.125 5375/12/06 CARVEDILOL

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

3.125MG TABLET 10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{6C7BF525-EBA8-44A9-84E6-

24E1FE7F3029}

CADILA HEALTHCARE LTD SOLATRATE SR 60 5376/12/06 ISOSOBIDE-5-

MONONITRATE

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

60MG SR TABLET 1*12*10,1*30*4 BLISTER INDIA ABACUS PHARMA (A)

LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{52FE4FD9-92CD-453D-A558-

6D96BCCA84BF}

CADILA PHARMACEUTICALS

LTDRABELOC 20 5377/17/06 REBEPRAZOLE

SODIUM

CADILA PHARMACEUTICALSLTD, 1389, DHOLKA,

GUJARAT

20MG TABLET 1*1*10 STRIP INDIA KARURI PHARMACEUTICALS

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{48F70A4F-6B30-4CF9-89B9-EB076AC5690C}

CENTAUR DRUG HOUSE

SINAREST-PD NASAL DROPS 5378/28/06 OXYMETAZOLINE

HYDROCHLORIDE

CENTAUR PHARMACEUTICALS PVT LTD, PLOT NO.3,

TIVIM

0.025% NASAL DROPS 1*10ML INDIAGITTOES

PHARMACEUTICALS LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{2048232C-CF23-4B67-9F2B-93F2520693AD}

CLARIS LIFE SCIENCES INDIA BUPICAN 5387/01/06 BUPIVACAINE

CLARIS LIFE SCIENCES

CHACHARWADDI SANAND DIST. AHME

0.5%W/V INJECTION 1*20ML VIAL INDIA REDDY`S PHARMA LTD 01/03/2010 RT31356 DATED

24/11/2011

{C21BB32B-2BCE-4DF2-9AC0-

7B5BD517086F}

DR REDDY'S LABORATORIES LTD ATOCOR 10 5391/12/06 ATORVASTATIN

DR REDDY'S LABORATORIES LTD, PLOT NO. 137, 138 &

1

10MG TABLET 1*10*10 BLISTER INDIASTAR

PHARMACEUTICALS LTD

23/09/10 RT28825 DATED 27/08/11

{5761C81B-3307-4E56-ADE3-9493AD8F1A5D}

DR. REDDY'S LABORATORIES LTD RESILO-50 5394/12/06 LOSARTAN

POTASSIUM

DR. REDDY'S LABORATORIES LTD SURVEY NO. 42, 45 &

4

50MG TABLET 1*5*2*10 STRIP INDIASTAR

PHARMACEUTICALS LTD

29/09/10 RT28825 DATED 27/08/11

{87C67DE0-DE5D-4BB7-9AC8-

471E760A18CA}

EMCURE PHARMACEUTICALS

LTDEFCURE 5399/06/06 EFAVIRENZ

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

600MG TABLET 1 * 30, 1 * 60 IN HDPE INDIAPHILIPS

PHARMACEUTICALS LTD.

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{2C516200-3E77-4F61-8847-77C6A2A937CA}

GLAXO SMITHKLINE LTD KIVEXA 5410/06/06 ABACAVIR +

LAMIVUDINE (FDC)

GLAXO OPERATIONS (UK) LTD, PRIORY STREET, WARE,

HERTFORDSHIRE

600MG + 300MG TABLET 1*1*30'S IN HDPE + 1*3*10'S IN BLISTERS UK ERIS LTD 18/08/09 RT28825 DATED

27/08/11

{CAD680D8-D9A6-4403-9BF0-

550385C6337E}

INDOCO REMEDIES LTD

TAMIGEN EYE/EAR DROPS 5418/02/06

GENTAMICIN SULPHATE E/E

DROPS

INDOCO REMEDIES LTD, L-32,33,34

VERNA INDUSTRIAL AREA GOA

0.3%W/V EYE/EAR DROPS 1*5ML, 1 * 10ML INDIA TATA (U) LTD 05/10/2009 RT29332 & JV11/148 DATED 16/09/11

{8848C782-BFEB-4B549B5F-0B96162788B7}

INDOCO REMEDIES LTD LIDOCAINE INJ.BP 5420/01/06 LIDOCAINE

INJECTION BP

INDOCO REMEDIES LTD, L-32,33,34

VERNA INDUSTRIAL A

2%W/V INJECTION 1*20ML VIAL INDIA TATA (U) LTD 05/10/2009 RT29332 & JV11/148 DATED 16/09/11

{D4BCE18E-3B7D-45DC-BBDC-

DDA358445F3D}

INTAS PHARMACEUTICALLS

LTDHIFENAC 5425/02/06 ACECLOFENAC

INTAS PHARMACEUTICALS

LTD, CAMP ROAD SELAQUI

DEHRADUN

100MG TABLET 1*10*10 IN BLISTER INDIA NORVIK ENTERPRISES LTD 18/02/10 RT29052 DATED

06/09/11

{3A39A99D-EDCD-415C-9BC1-

9AFA3C536017}

INTAS PHARMACEUTICALS

LTDAMITONE 5426/24/06 AMITRIPTYLINE-25

INTAS PHARMACEUTICALS

LTD,7/3 GIDC,VATUA,AHMED

ABAD

25MG TABLET 1*10*10 IN BLISTER INDIA NORVIK ENTERPRISES 04/10/11 RT29052 DATED

06/09/11

{CEA000B3-85AF-47F6-979E-

C0B400A23D37}

INTAS PHARMACEUTICALS

LTDENAPRIL-5 5427/12/06 ENALAPRIL MALEATE

INTAS PHARMACEUTICALS

LTD, CAMP ROAD ,SELAQUI ,

DEHRADUN INDAI

5MG TABLET 1*10*10 INDIA NORVIK ENTERPRISES LTD 18/02/10 RT29052 DATED

06/09/11

{D8C5B080-0DC6-4146-8450-

DBA3C0DD55C1}

Page 62

Page 63: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

ACTIZINE 5434/03/06 CETIRIZINE HYDROCHLORIDE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD, PLOT

10MG TABLET 1*15*10 BLISTERS UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{BBF62668-BBF1-4326-90C3-5493FFE54714}

KAMPALA PHARMACEUTICAL INDUSTRIES LTD

FLURID 5435/25/06ACETAMINOPHEN +

PHENIRAMINE MALEATE

KAMPALA PHARMACEUTICAL INDUSTRIES LTD,

PLOT NO M44

500MG + 10.5MG TABLET 1*50*4'S UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{C45CADC6-FC41-4E0E-9EB9-

5122C560A22A}

MEDICAL UNION P'CAL CO. BRONEX 5454/25/06 PSEUDOEPHEDRINE

+ GUAIPHENESIN

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA20G/ML + 20MG/ML SYRUP 1*1*15ML EGYPT

KARURI PHARMACEUTICALS

LTD12/10/2009 RT27905 DATED

18/07/2011{E42E6E6F-0181-440B-B7B2-E2DD8B672638}

MEDICAL UNION P'CAL CO.

ACICONE-S CHEWABLE TABLET 5455/17/06 MAGALDRATE +

SIMETHICONE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA720MG + 25MG CHEWABLE TABLET 1*5*4 BLISTER EGYPT

KARURI PHARMACEUTICALS

LTD12/10/2009 RT27905 DATED

18/07/2011{558B6902-631E-4016-A310-DE6F81B4E5B6}

MEDICAL UNION P'CAL CO.

ACICONE-S ORAL SUSPENSION 5456/17/06 MAGALDRATE +

SIMETHICONE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA

540MG/5ML + 40MG/5ML ORAL SUSPENSION 1*120ML EGYPT

KARURI PHARMACEUTICALS

LTD12/10/2009 RT27905 DATED

18/07/2011

{1A1F651E-A03F-4C69-B6FD-

8CE4AE6F8C49}

MEPHA LTD COAMOX 5469/06/06 AMOXICILLIN + CLAVULANIC ACID

LABESFAL LABORATORIES LTD,

ALMIRO, SA, LAGEDO-SANT

875MG + 125 MG TABLET 1*3*4 SOLVENIA GOODMAN INTERNATIONAL 29/04/2010 RT28480 DATED

11/08/2011{33982CAB-3E22-44FE99AD-10CC401B8DF8}

NABIQASIM INDUSTRIES (PVT)

LTDKLEEN ENEMA 5481/17/06

DISODIUM BIPHOSPHATE/

SODIUM PHOSPHATE

NABIQASIM INDUSTRIES (PVT)

LTD 17/24 KORANGI INDUSTRIAL AREA,

KARACHI

19.2G + 7.2G/120ML ENEMA 135ML IN HDPE PAKISTAN ABACUS PHARMA (A) LTD 25/02/09 RT28349 DATED

01/08/11

{CD79A3F3-7E6A-4BC8-BDEC-

8CDD7B27953E}

NABIQASIM INDUSTRIES (PVT)

LTDDYSEN FORTE 5482/06/06 SECNIDAZOLE

NABIQASIM INDUSTRIES (PVT)

LTD 17/24 KORANGI INDUSTRIAL AREA,

KARACHI

1000MG TABLET 1*2 BLISTER PAKISTAN ABACUS PHARMA (A) LTD 25/02/09 RT28349 DATED

01/08/11

{84CC8EF9-D97A-4DC0-9B39-

0D707BF8449A}

NABIQASIM INDUSTRIES (PVT)

LTDGLANDIN E2 VAGINAL 5483/18/06 DINOPROSTONE

NABIQASIM INDUSTRIES (PVT)

LTD 17/24 KORANGI INDUSTRIAL AREA,

KARACHI

3MG TABLET 1*1 STRIP PAKISTAN ABACUS PHARMA (A) LTD 25/02/09 RT28349 DATED

01/08/11

{EADDCFC5-E87C-49C6-83EB-

E682C5A846AF}

NABIQASIM INDUSTRIES PVT LTD GLANDIN E2 GEL 5484/18/06 DINOPROSTONE

NABIQASIM INDUSTRIES PVT

LTD, 17/24 KORANGI INDUSTRIAL AREA,

KARACHI

0.5MG GEL 1*3G WITH STERILE CATHETER PAKISTAN ABACUS PHARMA (A)

LTD 25/02/09 RT28349 DATED 01/08/11

{A69C8EAB-023C-494B-BC2A-

3B782344B149}

NABIQASIM INDUSTRIES PVT LTD SULPHA KREAM-N 5485/06/06 SULPHANILAMIDE

NABIQASIM INDUSTRIES PVT

LTD, 17/24 KORANGI INDUSTRIAL AREA,

KARACHI

15%W/W CREAM 1*1*80G TUBE PAKISTAN ABACUS PHARMA (A) LTD 25/02/09 RT28349 DATED

01/08/11

{412CF46C-20C6-4FB7-8C51-

BF5DD730FCA3}

NABIQASIM INDUSTRIES PVT LTD VAGIBACT CREAM 5486/06/06 CLINDAMYCIN

PHOSPHATE

NABIQASIM INDUSTRIES PVT

LTD, 17/24 KORANGI INDUSTRIAL AREA,

KARACHI

2%W/W CREAM 1*1*40G TUBE + APPLICATOR PAKISTAN ABACUS PHARMA (A)

LTD 25/02/09 RT28349 DATED 01/08/11

{E515933A-283B-48A1-93CC-78AE8800AF01}

NOVARTIS PHARMA AG TEGRETOL 5490/05/06 CARBAMAZEPINE

NOVARTIS PHARMA S.A, 26 RUE DE LA CHAPELLE, BP 349

20MG/ML SYRUP 1* 100ML, 1 * 250ML FRANCE SURGIPHARM (U) LTD

{49D94963-2327-4CE3-A610-7546EC21A7B9}

NOVARTIS PHARMA AG CO-DIOVAN 80/12.5 5491/12/06

VALSARTAN + HYDROCHLOROTHIA

ZIDE

NOVARTIS PHARMA STEIN AG.

SCHAFFHAVSERSTRASSE CH-4

80+12.5MG TABLET 1*2*14 BLISTER SWITZERLAND SURGIPHARM (U) LTD

{C44EFD4F-DC5C-4455-8C7A-

4AEFBDE68035}

NOVARTIS PHARMA AG DIOVAN 80 5495/02/06 VALSARTAN NOVARTIS PHARMA

AG, CH-4002, BASEL 80MG TABLET 1*1*28 SWITZERLAND SURGIPHARM (U) LTD

{C3A82B77-6CBF-4151-8DDA-

250EF4B36B46}

NOVARTIS PHARMA AG

VOLTAREN SUPPOSITORIES

50MG5496/02/06 DICLOFENAC

SODIUM

NOVARTIS PHARMA SAS, SITE

INDUSTRIAL HUNINGUE, 26

50MG SUPPOSITORIES 1*1*10 FRANCE SURGIPHARM (U) LTD

{F9BE0890-F1CA-49AF-96B6-

0393D5AB9675}

NOVARTIS PHARMA AG TEGRETOL CR 200 5499/05/06 CARBAMAZEPINE

NOVARTIS FARMA S.P.A, TORRE ANNUNZIATA

200MG TABLET 1*5*10 BLISTERS ITALY SURGIPHARM (U) LTD

{78A778AC-D1FE-4DCD-B493-

338534648C3B}

Page 63

Page 64: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

NOVARTIS PHARMA AG

VOLTAREN SUPPOSITORIES

12.5MG5500/02/06 DICLOFENAC

SODIUM

NOVARTIS PHARMA SAS, SITE

INDUSTRIAL HUNINGUE, 26

12.5MG SUPPOSITORIES 1*1*10 FRANCE SURGIPHARM (U) LTD

{69345CA2-649C-4DDB-86DA-

747465B6D80C}

NOVARTIS PHARMA AG

VOLTAREN SUPPOSITORIES

25MG5501/02/06 DICLOFENAC

SODIUM

NOVARTIS PHARMA SAS, SITE

INDUSTRIAL HUNINGUE, 26

25MG SUPPOSITORIES 1*1*10 FRANCE SURGIPHARM (U) LTD

{EAD6D983-D69F-43AA-AF67-

FB37789A5EF4}

PHARMEDIC LAB (PVT) LTD CEFOTRIM-1000 5510/06/06 CEFTRIAXONE

PHARMEDIC LABS(PVT) LTD,16KM

,MULTAN ROAD ,LAHORE

1000MG POWDER FOR INJECTION

1000MG VIAL WITH 5ML AMP OF WATER

FOR INJECTIONPAKISTAN HEALTHCARE LTD

24/04/06 + RE-AUDIT FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{6DDDD036-618A-4859-8000-

004ACC273EB6}

RANBAXY LABORATORIES LTD

AVOCOMB E COMPLIANCE PACK 5514/06/06

LAMIVUDINE + ZIDOVUDINE +

EFAVIRENZ

RANBAXY LABORATORIES LTD,

PAONTA SAHIB, DISTRICT SIRMOUR

HIMACHAL PRADESH - 173 025

150MG + 300MG + 600MG TABLET 1*15(1*(2 + 1)) IN

BLISTER INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011

{FC7EDB3B-5FD9-4DEA-B61E-

DD292EFEE1F3}

RANBAXY LABORATORIES LTD NEVIPAN 5526/06/06 NEVIRAPINE

RANBAXY LABORATORIES

PAONTA SAHIB DIST SIRMOUR HP 173 025

200MG TABLET 1*60 HDPE INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011

{36B3E1D9-6E1D-493785DC-

8C6C7D23A0A2}

RANBAXY LABORATORIES LTD AVIRANZ 5527/06/06 EFAVIRENZ

RANBAXY LABORATIES

LTD,PAONITA SAHIB, DISTRICT.

SIRMOUR,H.P-173025

200MG CAPSULE 1*90 IN HDPE INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011

{D01ACB1E-5F61-4DD7-8A63-

345605275EF9}

RANBAXY LABORATORIES LTD ABAC-LZ 5530/06/06

ABACAVIR SULPHATE +

LAMIVUDINE + ZIDOVUDINE

RANBAXY LABORATORIES LTD,

PAONTA SAHIB DISTRICT SIRMOUR

MP 173025

300MG + 150MG + 300MG TABLET 1*60 IN HDPE INDIA SURGIPHARM (U)

LTD 20/05/2011 RT29222 DATED 12/09/2011

{7A5BDD9F-D094-4909-ADBC-

4D6FA839B18D}

RANBAXY LABORATORIES LTD AVIRANZ 5531/06/06 EFAVIRENZ

RANBAXY LABORATORIES LTD,

PAONTA SAHIB, DIST.SIRMOUR, H.P-

173025

600MG TABLET 1*1*30 IN HDPE INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011

{DE8EEDCE-3D5B-472C-9B68-

0C9E53CE925A}

RANBAXY LABORATORIES LTD AVOSTAV 5532/06/06 STAVUDINE

RANBAXY LABORATORIES LTD,

PAONTA SAHIB DISTRICT SIRMOUR

MP 173025

30MG CAPSULES 1*60 IN HDPE INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011

{4B8EF9E9-BC05-48599041-

C4ADB999ECCD}

RANBAXY LANORATORIES LTD

ABAC TABLETS 300MG 5533/06/06 ABACAVIR

SULPHATE

RANBAXY LABORATORIES LTD,

PAONTA SAHIB, DISTRICT SIRMOUR

HIMACHAL PRADESH - 173 025

300MG TABLET 1*60 INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011

{AF9CD262-471C-4C0B-BEEB-

7CAC4DCE24D3}

ROYAL GROUP ROMETHER INJECTION 5541/06/06 ARTEMETHER

INJECTION

ZHEJIANG TIANFENG PHAMACEUTICAL FACTORY NO.518 DAXIANG ROAD HUZHOU CITY ZHEIJIANG PR.

CHINA

80MG/ML INJECTION 1*6 AMPOULES CHINA ABACUS PHARMA (A) LTD 11/09/08 RT28249 DATED

01/08/11{50BAA587-2853-478A-A137-E0ED8F2D042A}

SINO AFRICA MEDICINES & HEALTH LTD

WATER FOR INJECTION 5542/26/06 WATER FOR

INJECTION

ZHEJIANG TIANFENG PHARMACEUTICAL

FACTORY NO.518 DAN/A INJECTION 1*50*10ML AMP CHINA

SINO AFRICA MEDICINES & HEALTH LTD

11/09/08 RT28343 DATED 04/08/11

{2E43932B-BE8E-4B079D73-CE6B4754FF75}

Page 64

Page 65: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SINO AFRICA MEDICINES & HEALTH LTD

ATROPINE SULPHATE 5543/04/06 ATROPINE

SULPHATE

ZHEJIANG TIANFENG PHARMACEUTICAL

FACTORY NO.518 DA1MG/ML SOLUTION FOR

INJECTION 1*100*1ML AMP CHINASINO AFRICA MEDICINES & HEALTH LTD

11/09/08 RT28343 DATED 04/08/11

{ACFA8161-F6E4-4BE4-A95F-

73C46EF79FBA}

SINO AFRICA MEDICINES & HEALTH LTD

QUJININE DIHYDROCHLORIDE

INJECTION5544/06/06 QUININE

DIHYDROCHLORIDE

ZHEJIANG PHARMACEUTICAL

FACTORY,TIANFENG NO.518 DA

600MG/2ML INJECTION 1*100*2ML CHINASINO AFRICA MEDICINES & HEALTH LTD

11/09/08 RT28343 DATED 04/08/11

{A1577630-559F-440D-A782-F14665E8546F}

SINO AFRICA MEDICINES & HEALTH LTD

AMINOPHYLINE INJECTION 5545/25/06 AMINOPHYLINE

ZHEJIANG PHARMACEUTICAL

FACTORY,TIANFENG NO.518 DA

25MG/ML INJECTION 1*50*10ML CHINASINO AFRICA MEDICINES & HEALTH LTD

11/09/08 RT28343 DATED 04/08/11

{66BA41E9-054E-4483-9B2A-354C8E35A89C}

SINO AFRICA MEDICINES & HEALTH LTD

DEXAMETHASONE INJECTION 5546/03/06 DEXAMETHASONE

ZHEJIANG PHARMACEUTICAL

FACTORY,TIANFENG NO.518 DA

4MG/ML INJECTION1*100*1ML,

1*100*1ML IN A 2ML AMPOULE

CHINASINO AFRICA MEDICINES & HEALTH LTD

11/09/08 RT28343 DATED 04/08/11

{272F5268-0046-4051-B997-FFF52A6901FB}

STRIDES ARCOLAB LTD

STAVUDINE + LAMIVUDINE 5555/06/06 STAVUDINE +

LAMIVUDINE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

30MG + 150MG TABLET 1*1*60 IN HDPE INDIA VEERAM HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{B7F1E424-7999-4F78-9AA3-

D67AC2CBE39D}

STRIDES ARCOLAB LTD

STAVUDINE + LAMIVUDINE + NEVIRAPINE

5556/06/06STAVUDINE + LAMIVUDINE + NEVIRAPINE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

30MG + 150MG + 200MG TABLET 1*1*60 IN HDPE INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{C70A1D70-4220-47C2-8472-DFF4D59E14D9}

STRIDES ARCOLAB LTD

LAMIVUDINE + ZIDOVUDINE 5557/06/06 LAMIVUDINE +

ZIDOVUDINE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

150MG + 300MG TABLET 1*1*60 IN HDPE INDIA VEERAM HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{7D3C18B1-D475-421E-BADF-

3EC5E2D0937F}

TORRENT PHARMACEUTICALS

LTDHERPEX 800 DT 5560/06/06 ACICLOVIR

DISPERSIBLE TABLET

TORRENT PHARMACEUTICALS LTD, INDRAD-382721,

DIST M

800MG TABLET 1*5*5 INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {633785F9-AA41-497F-

B2D4-ABA885875845}

UNIQUE PHARMCEUTICAL

LABSZITHROCIN 500 5569/06/06 AZITHROMYCIN

UNIQUE PHARMACEUTICAL LABS.128/1, GIDC ,ANKLESHWAR

500MG TABLET 1*1*3 IN BLISTER INDIA TATA UGANDA LTD 06/05/10 RT28496 DATED 12/08/11

{379D4302-BDE1-4A0A-8708-

0636BACF9B43}

BETA HEALTHCARE INTERNATIONAL LTD BETACID 5577/17/06

ALUMINIUM HYDROXIDE

MAGNESIUM/ AL SILICATE

MAGNESIUM HYDROXIDE

SIMETHICONE .

BETA HEALTH CARE INTERNATIONAL LTD, INDUSTRIAL

ARE

300MG 50MG 25MG 25MG TABLET 1*2*50 IN STRIPS KENYA BETA HEALTH CARE

(U) LTD 04/02/09 RT27853 DATED 15/07/11

{C6951A59-93EA-457B-8D2B-4D1D6C756639}

MEDICAL UNION P'CAL CO. BEBE VIT 5580/27/06

VITAMIN A VITAMIN D3 VITAMIN E VITAMIN C VITAMIN B1 VITAMIN B2

.

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA

1500 IU 400IU 5MG 40MG 0.5MG 0.6MG

ORAL SOLUTION 1*30ML + DROPPER EGYPTKARURI

PHARMACEUTICALS LTD

12/10/2009 RT27905 DATED 18/07/2011

{6A9CFD38-AB9E-41B1-B556-

D30F2FD5FF28}

JOHNSON&JOHNSON PTY LTD

FRESH BURST LISTERINE 5585/28/06 ALCOHOL 95%

THYMOL

JOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794

4.54ML/20ML 12.78MG/20ML 18.44MG/20ML 13.20MG/20ML 1.5MG/20ML

GARGLE SOLUTION 1*500ML, 1*250ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED 18/10/2011

{CB603B11-7908-43C0-AF4A-

7E4C6D5E2B7B}

Page 65

Page 66: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SMITHKLINE BEECHAM

INTERNATIONAL LIKONI ROAD,

INDUSTRIAL AREA, NAIROBI

HIBERIX VACCINE 5586/19/06HAEMOPHILUS

INFLUENZAE TYPE B VACCINE

GLAXOSMITHKLINE BIOLOGICALS B-1330, RIXENSART

BELG

10 µg/doseLYOPHILIZED POWDER FOR

RECONSTITUTION1*10 µg in Vials BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11

{A4D7DC11-C351-4BCE-9548-

371FDDB49DE4}

GLAXO WELLCOME (KENYA) LTD

EPIVIR TABLETS ACCESS PACK 5588/06/97 LAMIVUDINE

GLAXOOPERATIONS UK LIMITED, WARE,

PRIORY STREET, HERTFORDSHIRE

150MG TABLET 60 UK ERIS LTD 18/08/09 RT28825 DATED 27/08/11

{DA318BC4-69E6-41259744-2D586781733C}

GLAXO WELLCOME (KENYA) LTD

RETROVIR SYRUP ACCESS PACK 5589/06/99 ZIDOVUDINE GLAXOSMITHKLINE

INC, MISSISSAUGA, 10MG/ML SYRUP 200ML CANADA ERIS LTD RT22505 (DOC REVIEW)

RT28825 DATED 27/08/11

{66FE5AAC-34F5-4CB9-A031-

008965C8AEC8}

SMITHKLINE BEECHAM

INTERNATIONALENGERIX-B VACCINE 5590/19/97 HEPATITIS B

VACCINE

GLAXOSMITHKLINE BIOLOGICALS B-1330, RIXENSART

BELG

10MCG INJECTION SUSPENSION VIAL BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11{7BCA02A3-3B01-449AA650-ADB482100849}

AUROBINDO PHARMA LTD

STAVUDINE + LAMIVUDINE 5595/06/07 STAVUDINE +

LAMIVUDINE

AUROBINDO PHARMA LTD, UNIT III SURVEY NO 313,

BACH

30MG + 150MG TABLETS 1*60 HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{5D21C4C4-0723-4475-A479-CA3CC9855FD9}

AUROBINDO PHARMA LTD

ABACAVIR SULPHATE 5596/06/07 ABACAVIR

SULPHATE

AUROBINDO PHARMA LTD, UNIT III SURVEY NO 313,

BACH

300MG TABLETS 1*60 HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{616655B4-1AF7-449B-A97E-

8F3DDFBB299D}

CADILA HEALTH CARE LTD SOLOTRATE 20 5604/12/07 ISOSORBIDE

MONONITRATE

CADILA HEALTH CARE LTD, SARHEJ-BAVLA N.H. NO 8A

MO

20MG TABLET 1*12*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{92540DF3-46B5-4649-B8EA-50E2937732E0}

CENTAUR PHARMACEUTICALS

PVT LTDCOLDAREST 5607/25/07

PARACETAMOL PHENYLEPHRINE

CHLORPHENIRAMINE + CAFFE

CENTAUR PHARMACEUTICALS

LTD, PLOT NO 3, TIVIM INDU

500MG 5MG 2MG 30MG TABLETS 1*10*10 + 1*50*4

STRIPS INDIAGITTOES

PHARMACEUTICALS LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{A712EFBD-813E-4D07-94C8-

FF7AA9C24730}

CLARIS LIFE SCIENCES LTD 5D 5611/26/07 GLUCOSE

CLARIS LIFE SCIENCES LTD,

CHACHARWADI - VASANA,

50G/L LVP 1*500ML, 1 * 250ML INDIA REDDY'S PHARMA LTD 01/03/2010 RT31356 DATED

24/11/2011{2232B869-F0CD-471C-AA8A-B9C380BD9150}

CLARIS LIFE SCIENCES LTD NS 5612/26/07 SODIUM CHLORIDE

CLARIS LIFE SCIENCES LTD,

CHACHARWADI - VASANA,

0.9%W/V LVP 1*500ML & 1*250ML LDPE INDIA REDDY'S PHARMA

LTD 01/03/2010 RT31356 DATED 24/11/2011

{00DC8765-3915-4F6A-B115-

CD0C355DB0CC}

CLARIS LIFE SCIENCES LTD

COMPOUND SODIUM LACTATE

INTRAVENOUS INFUSION BP

5613/26/07 MULTI INGREDIENTS

CLARIS LIFE SCIENCES LTD, CHACHORWADI VASANA, SAMA

MULTI INGREDIENTS INTRAVENOUS INFUSION 1*500ML INDIA REDDY'S PHARMA

LTD 01/03/2010 RT31356 DATED 24/11/2011

{3BE5AF54-1DCD-4A23-B1C5-

760DCF4E9555}

ELYS CHEMICAL INDUSTRIES LTD ELOCIN 5617/06/07 ERYTHROMYCIN

STEARATE

ELYS CHEMICAL INDUSTRIES LTD,

ROAD B, OFF ENTERPRISES

250MG TABLETS 1*1000 HDPE & 1*10*10 BLISTERS KENYA ELYS CHEMICAL

INDSTRIES (U) LTD 02/02/2009 RT29236 DATED 13/09/2011

{EBBCE63B-7A88-43DC-8B4E-

72ACB02EF4A3}

INDOCO REMEDIES LTD METCHEK-500 5622/18/07 METFORMIN

INDOCO REMEDIES LTD, B-20, MIDC,

WALUJ, AURANGABAB 431136 INDIA

500MG TABLETS 1*10*10 BLISTERS INDIA TATA (U) LTD 10/05/2010 RT29332 & JV11/148 DATED 16/09/11

{E4AC3764-115B-46FAA639-39BC4F8C6515}

INTAS PHARMACEUTICALS

LTDRAMITAS 5 5624/12/07 RAMIPRIL

INTAS PHARMACEUTICALS

LTD, CAMP ROAD SELAQUI DEHRADUN

-248 197

5MG HARD GELATIN CAPSULES 1*3*10 STRIPS INDIA NORVIK

ENTERPRISES LTD 18/02/10 RT29052 DATED 06/09/11

{9A56C008-A7CA-4F3F-8978-

A7B27C949433}

UNIQUE PHARMACEUTICAL

LABORATORIESPANUM 40MG 5628/17/07 PANTOPRAZOLE

J.B CHEMICALS & PHARMACEUTICALS

LTD, 128/1, GIDC, ANKLESHWAR 393

002, GUJARAT

40MG TABLETS 1*10*10 BLISTERS INDIA TATA (U) LTD 06/05/10 RT28496 DATED 12/08/11

{0E7F78F5-7045-4BE0-87AF-60591A92FE8E}

MEPHA LTD LOFRAL 10 5629/12/07 AMLODIPINE

ATLANTIC PHARMA SA, ZONA

INDUSTRIAL DA ABRUHEIRA

10MG TABLET 1*3*10 BLISTERS PORTUGAL GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011{63FE3031-3C22-4AC5-A20B-00C0189C5F03}

Page 66

Page 67: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

MEPHA LTD LOFRAL 5 5630/12/07 AMLODIPINE

ATLANTIC PHARMA SA, ZONA

INDUSTRIAL DA ABRUHEIRA

5MG TABLET 1*3*10 BLISTERS PORTUGAL GOODMAN INTERNATIONAL LTD 19/08/2009 RT28480 DATED

11/08/2011

{971E11FB-7EE7-4F1D-929F-

8B9C14D67C5E}

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

FLUFED COUGH FORMULA 5637/25/07 MULTI INGREDIENTS

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD, PLOT NO M444B, STRETCHER

ROAD, NTINDA, KAMPALA

MULTI INGREDIENTS SYRUP 1*100ML UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{671EC921-3CC9-433A-A647-

AF7D78F75146}

MARCK BIOSCIENCES LTD

STERILIZED WATER FOR INJECTION BP 5648/26/07 STERILIZED WATER

FOR INJECTION BP

MARCK BIOSCIENCES LTD, PLOT NO 876, N.H.

NO 8, VIL HARIYALA, KHEDA - 387411,

GUJARAT

INJECTION 1*10*5* 10ML INDIA KARURI PHARMACEUTICALS

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{CC81739A-C612-4C7F-BE3F-

4691CBB1329F}

SURGE LABORATORIES

(PVT) LTDLUMFORT 5665/03/07 LORATADINE

NABIQASIM INDUSTRIES (PVT)

LTD 17/24 KORANGI I IND'L AREA KARACHI

10MG TABLET 1*10*10 BLISTERS PAKISTAN HEALTHCARE LTD 25/02/09 RT31693 DATED 09/12/11

{2B1934DF-C8FB-4DB3-8A76-

F53491C5DD6D}

SURGE LABORATORIES

(PVT) LTDLUMFORT SYRUP 5666/03/07 LORATADINE

NABIQASIM INDUSTRIES (PVT)

LTD 17/24 KORANGI I IND'L AREA KARACHI

5MG/5ML SYRUP 1*60ML PAKISTAN HEALTHCARE LTD 25/02/09 RT31693 DATED 09/12/11

{3937B041-E509-471F-B52F-83120A6667BE}

PFIZER LABORATORIES

(PTY) LTDLYRICA 150MG 5669/05/07 PREGABALIN

PFIZER GMBH, ARZNEIMITTELWERK

, GODECKE, MOOSWALDAA

150MG HARD GELATIN CAPSULES 1*2*14 BLISTERS GERMANY LABOREX (U) LTD RT28810 DATED

26/08/2011{EF0DA431-B055-4725-8821-64E2DB2C1B2A}

PFIZER LABORATORIES

(PTY) LTDLYRICA 75MG 5670/05/07 PREGABALIN

PFIZER GMBH, ARZNEIMITTELWERK

, GODECKE, MOOSWALDAA

75MG HARD GELATIN CAPSULES 1*2*14 BLISTERS GERMANY LABOREX (U) LTD RT28810 DATED

26/08/2011{34315B67-AFF6-4495-8A8C-3A79F12DCC05}

PHARMEDIC LABS PVT LTD TRADOL INJECTION 5675/02/07 TRAMADOL HCL

PHARMEDIC LABS PVT LTD, 16KM MULTAN ROAD,

LAHORE

100MG/2ML INJECTION 1*1*5 AMPOULES PAKISTAN HEALTH CARE LTD24/04/06 + RE-AUDIT

FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{E7EC6497-158E-4C079D7D-50AF75BB39F1}

RANBAXY LABS LTD AVOCOMB-N 5677/06/07LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

RANBAXY LABS LTD, PAONTA SAHIB,

DIST. SIRMOUR, H.P-173 025

150MG + 200MG + 300MG TABLET 1*60 INDIA SURGIPHARM (U)

LTD 20/05/2011 RT29222 DATED 12/09/2011

{5B5EEAF8-1BE2-4BFF-8494-

A60D0F60071B}

RANBAXY LABS LTD COVIRO-E 30 COMPLIANCE PACK 5678/06/07

LAMIVUDINE / STAVUDINE +

EFAVIRENZ (COMBIKIT)

RANBAXY LABS LTD, PAONTA SAHIB,

DIST. SIRMOUR, H.P-173 025

150MG/ 30MG + 600MG TABLET 1*15 (1* (2+1) )

BLISTERS INDIA SURGIPHARM (U) LTD 20/05/2011 RT29222 DATED

12/09/2011{7DA40069-211E-41F1-8C7E-1363DE87377E}

RENE INDUSTRIES LTD DOXYREN 5684/06/07 DOXYCYCLINE

RENE INDUSTRIES LTD, PLOT 680

KAMULI KIREKA, KAMPA

100MG CAPSULE 1*10*10 UGANDA RENE PHARMACY ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{5BE7AA8D-9B82-48AD-9795-

E70E766C7C78}

RENE INDUSTRIES LTD ERYTHROREN 5685/06/07 ERYTHROMYCIN

STEARATE

RENE INDUSTRIES LTD, PLOT 680,

KAMULI - KIREKA, P.250MG TABLETS 1*10*10 BLISTERS &

1*1000 HDPE UGANDA RENE INDUSTRIES LTD

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{56F96D92-6196-4F70-BE42-E26E8264A36A}

RENE INDUSTRIES LTD AMOXIREN 5686/06/07 AMOXICILLIN

TRIHYDRATE

RENE INDUSTRIES LTD, PLOT 680,

KAMULI - KIREKA, P.250MG CAPSULES 1*1000 UGANDA RENE INDUSTRIES

LTDANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011

{E2FCAAF0-65E0-42D6-917F-

6E73B7D8BF99}

RENE INDUSTRIES LTD AMPIREN 5687/06/07 AMPICILLIN

TRIHYDRATE

RENE INDUSTRIES LTD, PLOT 680,

KAMULI KIREKA, KAMP

125MG/5ML DRY POWDER FOR ORAL SUSPENSION 1*100ML UGANDA RENE INDUSTRIES

LTDANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011

{DC404A8B-F52C-4D40-8B6F-

4667A4C42A75}

INDOCO REMEDIES LTD NOCID GEL 5695/17/07

ALUMINIUM HYDROXIDE +

SIMETHICONE + MAGNESIUM

INDOCO REMEDIES LTD, B-20, MIDC,

WALUJ, AURANGABAB 431136 INDIA

400MG/5ML + 25MG/5ML + 100MG/5ML

ORAL SUSPENSION 1* 1*100ML , 1* 1*200ML, 1*170 ML INDIA TATA (U) LTD 10/05/2010 RT29332 & JV11/148

DATED 16/09/11

{F7574705-8516-41EA-AEBE-

1DD2ECD58749}

Page 67

Page 68: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

STRIDES ARCOLAB LTD

STAVUDINE CAPSULES USP

30MG5697/06/07 STAVUDINE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

30MG HARD GELATIN CAPSULES 1*60 IN HDPE INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{5A8EC6AF-579C-4C89-ADA2-

0AE94155DC90}

TORRENT PHARMACEUTICALS

LTDAZULIX-4 5701/18/07 GLIMEPIRIDE

TORRENT PHARMACEUTICALS

LTD, INDRAD - 382721, DIST.

MEHSANA

4MG TABLETS 1*3*10 BLISTERS INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{6AFBF093-E641-4E19-813A-

0EC3FD7A6CAC}

UNIMED INDIA SYMORAL 5705/18/07 TRYPSIN / CHYMOTRYPSIN

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

50,000 IU TABLETS 1*3*10 INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{6D833F0B-0BF9-4471-B8BB-

DAF6335BB9AF}

AUROBINDO PHARMA LTD

LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE

5706/06/07LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE

AUROBINDO PHARMA LTD,

SURVEY NO.313 (P) BACHUPALL

150MG + 300MG + 200MG TABLETS 1*60 INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011

{4B5EEFAF-18BD-4C2A-9054-

FF0EFB27C27F}

VOGEN LABORATORIES LTD DURAMOX 500 5707/06/07 AMOXICILLIN

VOGEN LABS LTD, 70, M.HERACLEOUS

STR. AYIOS ATHANASIOS

INDUSTRIAL AREA, LIMASSOL

500MG CAPSULES 1 * 2 * 10, 1*10*10 BLISTER CYPRUS

GILEAD PHARMACEUTICALS

LTD19/03/2010 RT29840 DATED

06/10/2011

{4895DC48-ABE3-45F1-A3C2-

976C87603FF4}

VOGEN LABORATORIES LTD DURAMOX 250 5708/06/07 AMOXICILLIN

VOGEN LABS LTD, 70, M.HERACLEOUS

STR. AYIOS ATHANASIOS

INDUSTRIAL AREA, LIMASSOL

250MG CAPSULES 1*10*10, 1*100*10 BLISTERS CYPRUS

GILEAD PHARMACEUTICALS

LTD19/03/2010 RT29840 DATED

06/10/2011

{A03B105C-21EF-4DFD-8D24-

74605942215D}

VOGEN LABORATORIES LTD DURAMOX 125 5709/06/07 AMOXICILLIN

VOGEN LABS LTD, 70, M.HERACLEOUS

STR. AYIOS ATHANASIOS

INDUSTRIAL AREA, LIMASSOL

125MG/5ML POWDER FOR ORAL SUSPENSION 1*100ML CYPRUS

GILEAD PHARMACEUTICALS

LTD19/03/2010 RT29840 DATED

06/10/2011{F22ED7C2-3682-414D-8DAA-0EB4833DF4B7}

SINO AFRICA MEDICINES & HEALTH LTD

DIAZEPAM 5711/05/07 DIAZEPAM

ZHEJIANG TIANGFENG

PHARMACEUTICAL FACTORY, NO.518,

5MG/ML INJECTION 1*100*2ML CHINASINO AFRICA MEDICINES & HEALTH LTD

11/09/08 RT28343 DATED 04/08/11

{FCFE1B9C-B8FF-4242-BDB8-

0C765F3D16EF}

INDOCO REMEDIES FEBREX 5717/02/07 PARACETAMOL TABLETS BP

INDOCO REMEDIES LTD. B-20,MIDC,

WALUJ, AURANGABAD 431

136 INDIA

500MG TABLET (UNCOATED-CAPLET)

1*10*10 BLISTER, 1 * 1000HDPE INDIA TATA (U) LTD 10/05/2010 RT29332 & JV11/148

DATED 16/09/11

{E4F4D74E-E5C1-41F2-B6A8-

798042393026}

IDA ALBENDAZOLE 400MG 5719/17/07 ALBENDAZOLE

MICRO LAB, 92 SIPTCOT HOSUR

TAMIL NADU400MG TABLET (CHEWABLE

) 1*1000 HDPE INDIA LABOREX (U) LTD JV11/017 DATED 08/07/11

{94883646-CC7F-478E-A6F3-BDE6B258B08D}

VOGEN LABORATORIES LTD DURAMOX 5724/06/07 AMOXYCILLIN

TRIHYDRATE

VOGEN LABS LTD, 70, M.HERACLEOUS

STR. AYIOS ATHANASIOS

INDUSTRIAL AREA, LIMASSOL

250MG/5ML POWDER FOR ORAL SUSPENSION

1*1*100 ML IN HDPE -OPAQUE CYPRUS GILEAD

PHARMACEUTICALS 19/03/2010 RT29840 DATED 06/10/2011

{8C53B010-4A25-447F-A931-6CFB4A08A998}

AUROBINDO PHARMA LTD

METFORMIN HCL TABLETS BP 850MG 5747/18/07 METFORMIN HCL

AUROBINDO PHARMA LTD. UNIT III, SURVEY NO.313,

BAC

850MG TABLET (FILM COATED)

1*10*14 IN BLISTER (ALU/PVC) INDIA GITTOES

PHARMACEUTICALS 20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{04B072A0-B3FF-4BFF-9F26-A6ADA5805DD8}

AUROBINDO PHARMA LTD

METFORMIN HCL TABLETS BP 1000MG 5748/18/07 METFORMIN HCL

AUROBINDO PHARMA LTD. UNIT III, SURVEY NO.313,

BAC

1000MG TABLET (FILM COATED)

1*10*10 IN BLISTER (ALU/PVC) INDIA GITTOES

PHARMACEUTICALS 20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{FFBAF557-6647-46D4-A1FC-

4ED058B9A0EA}

AUROBINDO PHARMA LTD

METFORMIN HCL TABLETS BP 500MG 5749/18/07 METFORMIN HCL

AUROBINDO PHARMA LTD. UNIT III, SURVEY NO.313,

BAC

500MG TABLET (FILM COATED)

1*10*14 IN BLISTER (ALU/PVC) INDIA GITTOES

PHARMACEUTICALS 20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{C0BF0679-2AFB-44FF-923E-

7C58D3536CCB}

Page 68

Page 69: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

IDAARTESUNATE 50MG +

AMODIAQUINE HCL 200MG

5759/06/07 ARTESUNATE + AMODIAQUINE HCL

CIPLA LTD MIDC PATALGANGA DIST

RAIGAD50 MG+200 MG TABLET (UNCOATED

+ FILM COATED)

1*(12+12), 1*(6+6), 1*(3+3) IN BLISTER

(ALU/PVC)INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11

{1DF946E7-09F0-4E1F-8B3D-

D6AE0D1FFAF9}

CADILA HEALTHCARE LTD OCID I.V. 5771/17/07 OMEPRAZOLE

CADILA HEALTHCARE LTD. SARKHEJ-BAVLA

N.H. NO.8A TA

40MG/VIAL PARENTERAL1*1 AMBER

COLOURED GLASS VIAL-BLUE CAPPED

INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{6711B7F0-5E9B-4699-87F1-55E87BBF82BD}

AUROBINDO PHARMA LTD

NEVIRAPINE ORAL SUSPENSION 5779/06/07 NEVIRAPINE

AUROBINDO PHARMA LTD,UNIT III, SURVEY NO.313,

BACH

50MG/5ML ORAL SUSPENSION 1*240 ML IN HDPE INDIAGITTOES

PHARMACEUTICALS LTD.

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{197FDA4C-9915-4E66-B044-

D7C9C3CA9F9A}

AUROBINDO PHARMA LTD

ZIDOVUDINE ORAL SOLUTION USP 5780/06/07 ZIDOVUDINE

AUROBINDO PHARMA LTD,UNIT III, SURVEY NO.313,

BACH

50MG/5ML ORAL SOLUTION 1*240 ML IN HDPE INDIA GITTOES PHARMACEUTICALS 20/05/2010 RT28910 + RT28908

DATED 31/08/2011

{7F1D27B3-D9BD-4C00-B75F-

71608A4C4988}

ABBOTT LABORATORIES

SOUTH AFRICA (PTY) LTD

ALUVIA 5781/06/07 LOPINAVIR/ RITONAVIR

ABBOT T GmBh &CO KG- 50

KNOLLSTRASSE, 670671

LUDWIGSHAFEN

200/50 MG TABLET ( F ILM COATED) 1*1*120 IN HDPE GERMANY & UNITED

KINGDOMMEDICAL ACCESS

UGANDA LTD

RT24732 DATED 25/02/2011. DOC.

REVIEW

RT28979 DATED 12/09/2011

{3F37BF9A-83DB-4A94-BB7E-

AD9BA010E391}

AUROBINDO PHARMA LTD

DIDANOSINE CHEWABLE/

DISPERSIBLE TABLETS

5782/06/07 DIDANOSINE

AUROBINDO PHARMA LTD,UNIT III, SURVEY NO.313,

BACH

100MG TABLET (UNCOATED) 1*1*60 IN HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{A55AC35A-BEBE-414C-B8A7-

F3E01373C5E5}

AUROBINDO PHARMA LTD

STAVUDINE CAPSULES USP 5784/06/07 STAVUDINE

AUROBINDO PHARMA LTD,UNIT III, SURVEY NO.313,

BACH

15MG CAPSULE (HARD GELATIN) 1*60 IN HDPE INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011{5186063B-C30E-4F9E-851B-2549FA6EC20C}

AUROBINDO PHARMA LTD

LAMUVIDINE/ ZIDOVUDINE +

EFAVIRENZ (CO-PACK)

5785/06/07LAMUVIDINE/

ZIDOVUDINE + EFAVIRENZ

AUROBINDO PHARMA LTD. UNIT III, SURVEY NO.313,

BAC

150/300+600MG TABLET (FILM COATED)

1*6 (10+5) IN BLISTER (ALU/PVC) INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011

{2D64B4FA-CB67-4C75-9DA8-

37E29A73EA96}

CADILA HEALTHCARE LTD FORMONIDE 400 5787/25/07

BUDENOSIDE + FORMOMETROL

FUMARATE

CADILA HEALTHCARE LTD.CADILA

HEALTHCARE LTD. SARKH

120 METERED DOSES

(400MCG/6MCG)INHALER 1*1 ALUMINUM

CANNISTER INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{DB00C23A-4484-40DE-9746-

2577D9E9DE76}

GLAXOSMITHKLINE LTD

SERETIDE 125 EVOHALER 5788/25/07

SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE

GLAXO WELLCOME PRODUCTION, 23 RUE LAVOISUER

INDUST

120 METERED DOSES (25/125MCG) INHALER 1*1 ALUMINUM

CANNISTER FRANCE ERIS LTD 08/10/07 + RE-AUDIT FEES ( RT21579)

RT28825 DATED 27/08/11

{3D98DD27-D988-42A4-98C6-

B6BEF7022DC4}

CADILA HEALTHCARE LTD FORMONIDE 100 5789/25/07

BUDESONIDE + FORMOTEROL

FUMARATE

CADILA HEALTHCARE LTD.CADILA

HEALTHCARE LTD. SARKH

120 METERED DOSES

(100MCG/6MCG)INHALER 1*1 ALUMINUM

CANNISTER INDIA ABACUS PHARMA(A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{B3A1E805-CF84-4745-9947-E05749431BAC}

UNIQUE PHARMACEUTICAL

LABORATORIESRINZA 5790/25/07

PARACETAMOL/ CAFFEINE /

PHENYLEPHRINE HCL /

CHLORPHENIRAMINE MALEATE

J.B. CHEMICALS & PHARAMACEUTICAL

S LTD,128/1 GIDC, ANKELSHWAR,

GUJARAT 393 002

500/30/10/2MG TABLET (UNCOATED)

1*2*10 BLISTER , 1 * 10 * (2 * 10) BLISTER ,1*10*2*10 BLISTER,

1*50*4 BLISTER

INDIA TATA (U) LTD 06/05/10 RT28496 DATED 12/08/11

{FA7B1E73-21F3-4B73-94C9-FF6223D723D9}

JOHNSON&JOHNSON PTY LTD

BENYLIN PAEDRIATRIC 5795/25/07 DIPHENHYDRAMINE

JOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD

/HOOFWEG 241,RETREAT

7945,SOUTH AFRICA

7MG/5ML ORAL SYRUP 1*1*100ML IN AMBER GLASS BOTTLE SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED

18/10/2011

{B97492FF-DD1B-41FF-B94D-

DAE00528FB3D}

CENTAUR PHARMACEUTICALS

PVT LTDKOFAREST SYRUP 5796/25/07

SALBUTAMOL SO4 + AMBROXOL SO4 +

GUAFENSIN+MENTHOL

CENTAUR PHARMACEUTICALS

PVT LTD, PLOT 3 TIVIM INDU

2+30+100+5MG/10ML SYRUP1*60ML, 1*100ML (AMBER GLASS

BOTTLE)INDIA

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{99069FB5-1498-4B01-BE35-4B40FB69F74D}

CENTAUR PHARMACEUTICALS

PVT. LTDMETOZ 2.5 5798/16/07 METOZALONE

TABLETS USP

CENTAUR PHARMACEUTICALS

PVT. LTD, PLOT 3 TIVIM IND

2.5MG TABLET (UNCOATED) 1*10*10 IN BLISTER (ALU/PVC) INDIA

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{29A9AE8C-F0F1-4C7D-932A-

7197A976BEDA}

Page 69

Page 70: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CENTAUR PHARMACEUTICALS

PVT. LTDMETOZ 5 5799/16/07 METOZALONE

TABLETS USP

CENTAUR PHARMACEUTICALS

PVT. LTD, PLOT 3 TIVIM IND

5.0MG TABLET (UNCOATED) 1*10*10 IN BLISTER (ALU/PVC) INDIA

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{E49B930F-E7BD-45028782-67785F8011D3}

DR. REDDYS LABORATORIES LTD ATOCOR 20 5805/12/07 ATORVASTATIN

CALCIUM

DR. REDDYS LABORATORIES LTD, PLOT NO1 137,138 & 146 IDA BOLLARAM MEDAK DISTRICT,

ANDHRA PRADESH

20MG TABLET (FILM COATED)

10*1*10 IN BLISTER (ALU/PVC) INDIA

STAR PHARMACEUTICALS

LTD23/09/2010 RT27211 DATED 21

JUNE 2011

{9BC4208B-4A44-4599-AF8D-

3B5C4DF07A9C}

UNIMED INDIA EMVIT SYRUP 5808/27/07

FERROUS GLUCONATE + VIT B1

+ VIT B2 + VIT B3 + NIA

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

50.0+1.0+1.0+12.5+0.25MG/ 5ML SYRUP

1*200 ML IN AMBER AMBER GLASS

BOTTLEINDIA META PRODUCTS

LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{B0924A79-534F-47AB-A166-69EBFB782F79}

ARISTO PHARMACEUTICALS

PVT LTD ACECLO 5815/03/07 ACECLOFENAC

ARISTO PHARMACEUTICALS

PVT LTD, NO. 208 NEW INDUST

100MG TABLET (FILM COATED)

1*3*10 IN BLISTER (ALU/PVC) INDIA NORVIK

ENTERPRISES 18/03/2010 RT28634 DATED 19/08/2011

{CE89F2EA-121A-44D3-B07F-

9808A0B53CD2}

CADILA HEALTHCARE LTD MEL-OD 15 5816/03/07 MELOXICAM

CADILA HEALTHCARE LTD.CADILA

HEALTHCARE LTD. SARKH

15MG TABLET (UNCOATED) 1*10 , 1 * 3 * 10 BLISTER INDIA ABACUS PHARMA (A)

LTDRE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{B6A40602-C8DF-44B2-BD1B-

E3C6C8AA0A64}

RENE INDUSTRIES LTD CLOXAREN 5821/06/07 CLOXACILLIN

SODIUM

RENE INDUSTRIES LTD, PLOT 680

KAMULI KIREKA, KAMPA

250MG CAPSULE 1 * 10 * 10 BLISTER UGANDA RENE PHARMACY ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{31AD2173-53D7-4AA9920D-169235DF16BD}

STRIDES ACROLAB LTD

LAMUVIDINE/ ZIDOVUDINE &

EFAVIRENZ COMBIPACK

5826/06/07LAMUVIDINE/

ZIDOVUDONE + EFAVIRENZ

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

150/ 300MG + 600MG TABLET (FILM COATED)

1X[(1X60)+(1X30)] IN HDPE INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{92B60099-6AA9-493F-B1FA-3F6197D6010C}

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

ULSEC 5838/17/07 OMEPRAZOLE

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD, M444

20MG CAPSULE (HARD GELATIN) 1X3X10 IN STRIP UGANDA KPI ANNUAL RT29128 DATED

07/09/2011

{29FDD185-6EF2-49EA-9C43-

B11AAF07E9F7}

ARISTO PHARMACEUTICALS

PVT. LTDPIOSAFE 30 5841/18/07 PIOGLITAZONE HCL

ARISTO PHARMACEUTICALS PVT. LTD, PLOT NO.

208, NEW

30MG TABLET (UNCOATED) 1X3X10 IN BLISTER INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011{5E6DB1B9-8849-4029-940E-9024096E7D6B}

CADILA HEALTHCARE LTD FORMONIDE 200 5845/25/07

BUDENOSIDE/ FORMOTEROL

FUMARATE

CADILA HEALTHCARE LTD. SARKHEJ-BAVLA

N.H. NO 8A, M

200MCG/ 6MCG INHALER (METERED DOSE) 1X1 CANNISTER INDIA ABACUS (A) LTD RE-INSP RT24185

DATED 31/01/2011RT28660 DATED

19/08/2011{F3289761-F362-4B6B-A606-19969FED36B6}

TORRENT PHARMACEUTICALS

LTDAZULIX-2 5850/18/07 GLIMEPIRIDE

TORRENT PHARMACEUTICALS

LTD, INDRAD - 382721 MANSANA,

GUJARAT

2MG TABLET (UNCOATED) 1X10X10XIN BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{AD1C5237-D254-4E62-80EC-

BA9C4D94CEF4}

BETA HEALTHCARE INTERNATIONAL LTD

FEVERIX TOTO SUSPENSION 5853/02/07 PARACETAMOL

BETA HEALTHCARE INTERNATIONAL LTD, INDUSTRIAL

AREA

120MG/5ML ORAL SUSPENSION 1X1X60ML KENYA BETA HEALTH CARE (U) LTD 04/02/09 RT27853 DATED

15/07/11

{DE3AAA50-189C-43C1-BDD6-

DF4949DEA959}

AUROBINDO PHARMA LTD STAVUDINE 5861/06/07 STAVUDINE

AUROBINDO PHARMA LTD, UNIT III, SURVEY NO. 313

(P)

20MG CAPSULE (HARD GELATIN) 1X60 IN HDPE INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011{81C3D169-8468-4CEF-B21F-47183D9377BC}

GLENMARK PHARMACEUTICALS

LTDGLEVO I.V. 5871/06/07 LEVOFLOXACIN

MARCK BIOSCIENCES LTD, PLOT NO. 876 N.H.

NO. 8 VIL

500MG/100ML PARENTERAL 1X100ML LDPE INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{244A9352-C334-41C4-88BC-

4E86E9B5EDAC}

Page 70

Page 71: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

MEPHA LTD ARTEQUIN PAEDIATRIC 5875/06/07 ARTESUNATE/

MEFLOQUINE

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

50/125 MG ORAL PELLETS 1X1X3 IN STICK PACK SACHETS SWITZERLAND GOODMAN

INTERNATIONAL 19/08/2009 RT28480 DATED 11/08/2011

{25F60808-9A31-4ECB-92D2-3C094B7A62AD}

CADILA HEALTHCARE LTD ZYBID 500 5882/06/07 CIPPROFLOXACIN

CADILA HEALTH CARE LTD KUNDAIM

, INDUSTRIAL ESTATE

500MG TABLET (FILM COATED) 1X10X10 IN BLISTER INDIA ABACUS (A) LTD

16/09/2008 BUT DATABASE WAS NOT

UPDATED IN INSPECTORATE. WHILE EXPIRED APPLICANT NOT

INFORMED

RT28660 DATED 19/08/2011

{9BAC2E07-BE93-4B47-AA85-

51DD24A6490E}

GLAXOSMITHKLINE SERETIDE EVOHALER 5884/25/07

SALMETEROL/ FLUTICASONE PROPIONATE

GLAXO WELLCOME PRODUCTION, 23 RUE LAVOISUER

INDUST

25/50 MCG INHALER (METERED DOSE) 1X1 IN CANNISTER 1. FRANCE 2.

AUSTRALIA ERIS LTD 08/10/07 + RE-AUDIT FEES ( RT21579)

RT28825 DATED 27/08/11

{BF92C4DE-A6E3-4843-A320-

7060C188DFA7}

PHARMEDIC LABORATORIES PVT.

LTDTRADOL 5890/02/07 TRAMADOL

PHARMEDIC LABORATORIES PVT. LTD, 16KM MULTAN

ROAD

50MG TABLET (FILM COATED)

1X3X10 IN BLISTER, 1X10X10 IN BLISTER PAKISTAN HEALTHCARE LTD

24/04/06 + RE-AUDIT FEES (RT12745 DATED 27/07/09)

RT31696 DATED 09/12/11

{95E79C84-EE85-4178-845A-

320B0D8CAECC}

RENE INDUSTRIES LTD RENEGEL 5891/17/07

MAGNESIUM HYDROXIDE, ALUMINIUM HYDROXIDE

RENE INDUSTRIES LTD, PLOT 680

KAMULI-KIREKA, KAMPA

250/ 250MG TABLET (CHEWABLE) 1X10X10 IN BLISTER UGANDA RENE INDUSTRIES LTD

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{76443D4A-02F4-4850-9701-42C063F94C81}

UNIQUE PHARMACEUTICAL

LABSUNIKPEF 5893/06/07 PEFLOXACIN

J.B. CHEMICALS , 128/1 G.I.D.C IND

ESTATE ANKLESHWAR

GUJURAT

400MG TABLET (FILM COATED) 1X10X10 IN BLISTER INDIA TATA (U) LTD 06/05/10 RT28496 DATED

12/08/11{FA930E68-B597-4385-A0B6-36BC476A0F7C}

RENEI NDUSTRIES LTD AMPIREN 5896/06/07 AMPICILLIN

TRIHYDRATE

RENE INSUDTRIES LTD, PLOT 680

KAMULI-KIREKA, KAMPA

250MG CAPSULE (HARD GELATIN) 1X1000 HDPE UGANDA RENE INDUSTRIES

LTDANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011{38E1543B-4FC9-4275-81BB-E23F6B7AFD51}

SURGE LABORATORIES PVT

LTDROMYCIN 5898/06/07 AZITHROMYCIN

NABIQASIN INDUSTRIES 17/24 KORANGI I IND'L AREA KARACHI

200MG/5ML POWDER FOR ORAL SUSPENSION

1X1X15 ML IN AMBER GLASS BOTTLE PAKISTAN HEALTHCARE LTD 25/02/09 RT31693 DATED

09/12/11{B44205C2-972D-40C8-8077-E3D1BDB05CC3}

SURGE LABORATORIES PVT

LTDROMYCIN 5899/06/07 AZITHROMYCIN

NABIQASM INDUSTRIES PVT

LTD , 17/24 KORANGI I IND'

250MG CAPSULE (HARD GELATIN) 1X1X6 IN BLISTER PAKISTAN HEALTHCARE LTD 25/02/09 RT31693 DATED

09/12/11

{3E6A0A7B-ECE7-4010-A9AA-

8E49F83CE5A1}

RENE INDUSTRIES LTD MYCOREN 5901/13/07 NYSTATIN

RENE INDUSTRIES LTD, PLOT 680

KAMULI-KIREKA, KAMPA

100,000 IU/ML ORAL SUSPENSION 1X30ML AMBER GLASS BOTTLE UGANDA RENE INDUSTRIES

LTDANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011

{29DFBC5A-BA3B-43A0-B138-

35C634E95B91}

GLAXOSMITHKLINE LTD RELENZA 5907/06/07 ZANAMIVIR

GLAXO WELLCOME PRODUCTION,

EVREUX5MG POWDER FOR ORAL

INHALATION

1X1X5X4 IN BLISTER (ROTADISK )+ 1X1

DISKHALERFRANCE ERIS LTD 08/10/07 + RE-AUDIT

FEES ( RT21579)RT28825 DATED

27/08/11{A9A591E2-18FE-4626-B0B3-9F1840D39BD9}

AUROBINDO PHARMA LTD EFAVIRENZ 5909/06/07 EFAVIRENZ

AUROBINDO PHARMA LTD, UNIT

III, SURVEY NO. 313(P)

200MG CAPSULE 1X30, 1X90 INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{B577B64C-342C-4288-B0C0-

D4C3E2A5BC5B}

STRIDES ACROLAB LTD EFAVIRENZ TABLETS 5919/06/07 EFAVIRENZ

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

600MG TABLET (FILM COATED) 1X1X30 IN HDPE INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{F8B00F78-6D0D-4D2B-A290-

72CF89E322CC}

STRIDES ACROLAB LTD EFAVIRENZ TABLETS 5920/06/07 EFAVIRENZ

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

200MG TABLET (FILM COATED) 1X1X90 IN HDPE INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{3779FFF9-4AC5-4C21-950C-C474CD601324}

MEPHA LTD XYLO-MEPHA 0.05% 5925/28/07 XYLOMETAZOLINE

MERCKLE GMBH, LUDWIG MERCKLE STRASSE3 D-89143

BLAUBEUREN

0.05% NASAL SPRAY 1X1X10ML AMBER GLASS BOTTLE GERMANY GOODMAN

INTERNATIONAL 19/08/2009 RT28480 DATED 11/08/2011

{70C04B67-F6E3-41C3-B40A-6B35444C0F56}

Page 71

Page 72: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

MEPHA LTD XYLO-MEPHA 0.1% 5926/28/07 XYLOMETAZOLINE

MERCKLE GMBH, LUDWIG MERCKLE STRASSE3 D-89143

BLAUBEUREN

0.1% NASAL SPRAY 1X1X10ML AMBER GLASS BOTTLE GERMANY GOODMAN

INTERNATIONAL 19/08/2009 RT28480 DATED 11/08/2011

{E3AD63EA-0C9A-4B4B-B9D9-

09D60E0FBF3D}

CLARIS LIFE SCIENCES LTD BUPICAN HEAVY 5934/01/07

BUPIVACAINE HCL IN DEXTROSE INJECTION

CLARIS LIFE SCIENCES

LTD,CHACHARWADI -VASANA,

0.5% W/V PARENTERAL 1*25*4ML CLEAR GLASS AMPOULE INDIA REDDY'S PHARMA

LTD 01/03/2010 RT31356 DATED 24/11/2011

{6F13A2FB-BDF9-488E-9C7A-

2C5966D222EC}

FLAMINGO PHARMACEUTICALS

LTDTRALOFLAM 50 5935/02/07 TRAMADOL

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

50MG CAPSULE (HARD GELATIN) 1X10X10 BLISTERS INDIA ABACUS (A) LTD 17/09/09 RT28444 DATED

09/08/11{95E6ED6F-6A48-4142-8F69-79B7538A47A6}

RENE INDUSTRIES LTD MINT-O-COOL 5938/17/07

DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE

RENE INDUSTRIES LTD, PLOT 680

KAMULI-KIREKA, P.O.B

120MG + 250MG TABLET (UNCOATED) 1X1000 & 1X 500 IN HDPE UGANDA RENE INDUSTRIES

LTD,ANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011

{B079F747-8692-4EBE-BFE2-

EB73C85E5B0C}

ARISTO PHARMACEUTICALS

LTDTRANLOK 500 5942/10/07 TRANEXAMIC ACID

ARISTO PHARMACEUTICALS PVT LTD, PLOT NO

208, NEW I

500MG TABLET (FILM COATED) 1X10X10 IN BLISTER INDIA NORVIK

ENTERPRISES LTD 18/03/2010 RT28634 DATED 19/08/2011

{455820D3-535B-4577-833B-1AEF9DD71094}

CIRON DRUGS & PHARMACEUTICALS

PVT LTDXYZONE INJECTION 5944/03/07

DEXAMETHASONE SODIUM PHOSPHATE

INJECTION

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

4MG/ML LIQUID INJECTION1X10X10X1ML AMBER

COLOURED GLASS AMPOULE

INDIA RENE PHARMACY LTD

RE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{08DC7409-F59C-430A-BFB8-8155877151CA}

ARISTO PHARMACEUTICALS

LTDDELISPRIN 75MG 5946/10/07 ASPIRIN

ARISTO PHARMACEUTICALS PVT LTD, PLOT NO

208, NEW I

75MG TABLET (ENTERIC COATED)

1X10X14 IN STRIPS, 1*10*10 INDIA NORVIK

ENTERPRISES LTD 18/03/2010 RT28634 DATED 19/08/2011

{7FB9EFC4-4E46-4ECE-88A6-

958496F54419}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

CHLORAMPHENICOL EAR DROPS 5949/06/07 CHLORAMPHENICOL

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

5%W/V EAR DROPS 1X10ML LDPE INDIA RENE PHARMACY LTD

RE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{B859DAE6-0829-465E-B719-78913459F01E}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

CHLORAMPHENICOL SODIUM SUCCINATE 5956/06/07 CHLORAMPHENICOL

SODIUM SUCCINATE

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

1G POWDER FOR INJECTION 1X25X1G INDIA RENE PHARMACY

LTDRE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{FE29738E-E3B6-4E89-B991-507CA8942E7C}

UNIVERSAL CORPORATION LTD SULFRAN 5958/06/07 CO-TRIMOXAZOLE

UNIVERSAL CORPORATION,

KIKUYU, NAIROBI480MG TABLET (UNCOATED) 1X10X10 BLISTER,

1X1000 HDPE KENYA MATRIX (U) LTD 26/10/2009 RT30250 DATED 14/10/2011

{AE4DBC6E-CC7A-4592-82B6-

D43B0C73F62C}

FLAMINGO PHARMACEUTICALSL

TD

CLOXACILLIN SODIUM FOR

INJECTION5960/06/07 CLOXACILLIN

SODIUM

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

500MG POWDER FOR INJECTION

1X10X500MG , 1*50*500MG VIALS INDIA ABACUS PHARMA (A)

LTD 17/09/09 RT28444 DATED 09/08/11

{3E729F06-5604-4B1D-8622-2B4E38EC41C9}

ALEMBIC LTD AZITHRAL-500 5962/06/07 AZITHROMYCINALEMBIC LTD, PLOT 21/22, EPIP PHASE 1,

JHARMAJIR,500MG TABLET 1X5X1X3 IN BLISTER INDIA

GITTOES PHARMACEUTICALS

LTD28/06/2010 RT28449 DATED

10/08/2011{390F58D9-E0F3-43F1-9F61-07D101DF108E}

FLAMINGO PHARMACEUTICALS

LTDAZIFLAM DS 5964/06/07 AZITHROMYCIN

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

200MG/5ML ORAL SUSPENSION 1X15ML HDPE INDIA ABACUS (U) LTD 17/09/09 RT28444 DATED 09/08/11

{8694C68B-F42E-49F8-8E88-DD3B5765C54E}

GSKPROXIMEXA ORAL

SUSPENSION 250MG/5ML

5970/06/07 CEFUROXIME AXETIL

GLAXO OPERATIONS UK LTD, HAMIRE ROAD, BARNARD

CAST

250MG/5ML GRANULES FOR ORAL SUSPENSION

1X1X50ML AMBER GLASS BOTTLES UK ERIS LTD 18/08/09 RT28825 DATED

27/08/11

{8E1B3672-B2DD-41BE-9257-

3CFDD4D9BBC7}

GSK PROXIMEXA 500MG 5973/06/07 CEFUROXIME AXETIL

GLAXO OPERATIONS UK LTD, HAMIRE ROAD, BARNARD

CAST

500MG TABLET (FILM COATED) 1X1X10 BLISTER UK ERIS LTD 18/08/09 RT28825 DATED

27/08/11

{637372BF-C17B-4ED3-BE50-

D255C0D08915}

GSK PROXIMEXA 250MG 5974/06/07 CEFUROXIME AXETIL

GLAXO OPERATIONS UK LTD, HAMIRE ROAD, BARNARD

CAST

250MG TABLET (FILM COATED) 1X1X10 BLISTER UK ERIS LTD 18/08/09 RT28825 DATED

27/08/11

{42DF0011-0DD6-4162-B317-

CEEBB9A5B1DA}

Page 72

Page 73: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

CHLORAMPHENICOL EYE DROPS 5980/06/07 CHLORAMPHENICOL

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

0.5%W/V EYE DROPS 1X10ML LDPE INDIA RENE PHARMACY LTD

RE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{5AC2D63D-22C9-47C9-BD23-

963B7D7B8A37}

RENE INDUSTRIES LTD LOPERAREN 5982/17/07 LOPERAMIDE HCL

RENE INDUSTRIES LTD, PLOT 680,

KAMULI, KIREKA2MG CAPSULE (HARD

GELATIN) 1X10X10 BLISTERS UGANDA RENE INDUSTRIES & PHARMACY LTD

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{2816F037-CEAD-4645-8E3C-BA5A08823E44}

INTAS PHARMACEUTICALS

LTDINTAZIN 5990/03/07 CETRIZINE HCL

INTAS PHARMACEUTICALS

LTD, 7/3 GIDC ESTATE, VATVA

AHMEDABAD, 382445

10MG TABLET (FILM COATED)

1X4X10 , 1*10*10 BLISTERS INDIA NORVIK

ENTERPRISES LTD 04/10/11 RT29052 DATED 06/09/11

{5531EDE1-61C7-48F1-A8D3-87E4F198B739}

AEGIS LTD LORYTEC 10 5992/03/07 LORATIDINE

AEGIS LTD, ERGATES

INDUSTRIAL AREA, NICOSIA

10MG TABLET (UNCOATED) 1X1X10 IN BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED

02/08/11

{D2366BBF-D079-4E4B-9D04-

947D24ABA349}

ARISTO PHARMACEUTICALS

PVT LTDARISTO TELVAS 80 5993/12/07 TELMISARTAN

ARISTO PHARMACEUTICALS LTD, PLOT NO 208,

NEW INDUS

80MG TABLET (UNCOATED) 1X10X10 STRIPS INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011{B874E46E-935B-4FC1955C-4F5AD01A8449}

ARISTO PHARMACEUTICALS

PVT LTDS-AMLOSAFE2.5 5994/12/07 S (-) AMILODIPINE

BESILATE

ARISTO PHARMACEUTICALS LTD, PLOT NO 208,

NEW INDUS

2.5MG TABLET (UNCOATED) 1X10X10 BLISTER INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011{291869B6-C652-49AC-919A-E0465C184BDE}

ARISTO PHARMACEUTICALS

PVT LTDS-AMLOSAFE 5 5995/12/07 S (-) AMILODIPINE

BESILATE

ARISTO PHARMACEUTICALS LTD, PLOT NO 208,

NEW INDUS

5MG TABLET (UNCOATED) 1X10X10 BLISTER INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011{7C8D90A7-3534-48EBA8C0-ABB226D67442}

ARISTO PHARMACEUTICALS

PVT LTDARISTO TELVAS 40 5996/12/07 TELMISARTAN

ARISTO PHARMACEUTICALS LTD, PLOT NO 208,

NEW INDUS

40MG TABLET (UNCOATED) 1X10X10 STRIPS INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011

{8F6BC52B-F241-4BE8-BBEC-

76BCE98432C2}

TORRENT PHARMACEUTICALS

LTDTOPRIL 5 5997/12/07 RAMIPRIL

TORRENT PHARMACEUTICALS LTD, INDRAD, DIST.

MEHSANA

5MG CAPSULE (HARD GELATIN) 1X10X10 IN BLISTER INDIA KARURI

PHARMACEUTICALSRE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {5684C53A-DC60-4659-

871B-513D7F95028B}

TORRENT PHARMACEUTICALS

LTDTOPRIL 2.5 5998/12/07 RAMIPRIL

TORRENT PHARMACEUTICALS LTD, INDRAD, DIST.

MEHSANA

2.5MG CAPSULE (HARD GELATIN) 1X10X10 IN BLISTER INDIA KARURI

PHARMACEUTICALSRE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {D2408942-9B9F-4D60-

9522-187DF7A6B204}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BP

6004/03/07 HYDROCORTISONE

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

100MG POWDER FOR INJECTION

1X50X100MG X 5ML CLEAR GLASS VIAL INDIA RENE PHARMACY

LTDRE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{97973AD6-B5A5-470A-B071-87B35B792C2F}

GSK LTD MALANIL ADULT 6005/06/07 ATOVAQUONE + PROGUANIL HCL

GLAXOSMITHKLINE INC. , 7553

MISSISANGA ROAD, NORTH

250MG + 100MG TABLET (FILM COATED) 1X1X12 IN BLISTER CANADA ERIS LTD DOC REVIEW

(RT22505RT28825 DATED

27/08/11

{B2A2B564-BF96-4586-9AAA-

4289AB0A2DCD}

AJANTA PHARMA LTD ARTEFAN 40/240 6006/06/07 ARTEMETHER + LUMEFANTRINE

AJANTA PHARMA LTD, B-4-5-6, MIDC, INDUSTRIAL AREA,

40MG + 240MG TABLET (UNCOATED) 1X2X6 IN BLISTER INDIAAARON

PHAR,ACEUTICALS LTD

27/11/08 RT28086 DATED 26/07/11

{6DC2C44A-0954-43A7-8749-

B4023F898202}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

STERILE QUININE DIHYDROCHLORIDE CONCENTRATE BP

6008/06/07 QUININE DIHYDROCHLORIDE

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

300MG/ML LIQUID INJECTION1X100X2ML AMBER COLOURED GLASS

AMPOULEINDIA RENE PHARMACY

LTDRE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{95C0DCF5-4D73-43DA-9C36-

FA99CD9BCF1C}

BETA HEALTHCARE INTERNATIONAL LTD FEVEREX 6013/02/07 PARACETAMOL

BETA HEALTHCARE, PLOT NO. LR

209/7961, BONDO ROAD,

500MG TABLET (UNCOATED) 1 * 2 * 10, 1*10*10 IN BLISTER KENYA BETAHEALTH CARE

(U) LTD 04/02/09 RT27853 DATED 15/07/11

{AF8D4372-16CD-4319-B923-A779E8BF511F}

RENE INDUSTRIES LTD

RENEDOL (SUSPENSION) 6014/02/07 PARACETAMOL

RENE INDUSTRIES LTD, PLOT 680

KAMULI, KIREKA, KAMP

120MG/5ML ORAL SUSPENSION

1X1X60ML, 1X1X100ML IN AMBER GLASS

BOTTLE

UGANDA RENE INDUSTRIES LTD

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{C071403E-5752-4399-A4B3-B4F516254C24}

Page 73

Page 74: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SHANGHAI PHARMA INDUSTRIAL CO. LTD PARACETAMOL 6016/02/07 PARACETAMOL

ZHEJIANG HOLLEY NANHU

PHARMACEUTICALS CO. LTD, NO.205

YUNHAI RD ECONOMIC

DEVELOPMENT ZONE, JIAXING

ZHEJIANG

500MG TABLET (UNCOATED) 1X1000 HDPE ,1*10*10BLISTER CHINA ABACUS PHARMA (A)

LTD

RT27821 DATED 14/07/2011 RE-INSP

FEE

RT29181 DATED 09/07/2011

{FAA7CEE3-8711-43F0-80B0-

7FBBD61C60C7}

JOHNSON&JOHNSON PTY LTD

TARTAR CONTROL LISTERINE

ANTISEPTIC6018/15/07

ZINC CHLORIDE + DENATURED

ALCOHOL MENTHOL 95% + T

JOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794

18MG/ 20ML + 0.9ML/20ML + 12.7MG/20ML

ORAL SOLUTION 1X250ML & 1X500ML SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED 18/10/2011

{D9D9F702-F3C8-4E6A-9E01-

A90D0F82AD14}

CADILA HEALTHCARE LTD ZYOM 6019/17/07 OMEPRAZOLE

CADILA HEALTHCARE LTD,

SARKHEJ-BAVAL NH, NO. 8A MO

20MG CAPSULE (HARD GELATIN) 1X10X10 IN BLISTER INDIA ABACUS PHARMA

LTDRE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{6AE06B59-DD11-41A4-A464-

4497D5732967}

CADILA HEALTHCARE LTD HAPPI TABLET 6020/17/07 RABEPRAZOLE

SODIUM

CADILA HEALTHCARE LTD,

P.O.BADDI DIST. SOLAN, HIMA

20MGTABLET (DELAYED

RELEASE UNCOATED)

1*10*10, 1*3*10 BLISTERS INDIA ABACUS PHARMA (A)

LTD 16/11/2012 RT28660 DATED 19/08/2011

{B2618CE8-237B-4556-9C39-8F49651DABE7}

ALCON CUSI S.A. CUSIVAL EYE OINTMENT 6023/06/07 ACYCLOVIR

ALCON CUSI S.A. CAMIL FABRA 58, EL

MASNOU, BARCELONA

30MG EYE OINTMENT 1X1X4.5G ALU COLLAPSIBLE TUBE SPAIN

KARURI PHARMACEUTICALS

LTD

DATED 27/06/2011 DOC REVIEW

RT28866 DATED 29/08/2011

{D641B6B9-5288-4EA6-B3BB-6B02D0737737}

MATRIX LABORATORIES LTD

TENOFOVIR DISOPROXIL FUMARATE

6027/06/07TENOFOVIR DISOPROXIL FUMARATE

MATRIX LABORATORIES LTD,

F-4, F-12, MALEGAON MIDC

300MG TABLET (FILM COATED) 1X30 IN HDPE INDIA

PHILLIPS PHARMACEUTICALS

(U) LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{3CB08246-5A8C-4F27-91DC-C5572B50F7D6}

HETERO DRUGS LTD ZIDOLAM-N 6028/06/07LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE

HETERO DRUGS LTD, UNIT 111 22-110,

IDA JEEDIMETLA,

150MG + 300MG + 200MG

TABLET (FILM COATED) 1X60 HDPE INDIA ASTRA PHARMA

UGANDA LTD 17/12/09 RT28304 DATED 03/08/11

{14C6833D-2C94-4845-9EF1-3B68688FD407}

MATRIX LABORATORIES LTD

TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE

6030/06/07

TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE

MATRIX LABORATORIES LTD,

F-4, F-12, MALEGAON MIDC

300MG + 300MG TABLET (FILM COATED) 1X30 IN HDPE INDIA

PHILLIPS PHARMACEUTICALS

(U) LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{B34C455E-9F3F-4769-9B59-6B19F384E0E3}

AUROBINDO PHARMA LTD EFAVIRENZ 50MG 6033/06/07 EFAVIRENZ

AUROBINDO PHARMA LTD, UNIT

111, SURVEY NO 313, BACHUPALLY

VILLAGE, QUTUBULLAPUR ,

HYDERABAD

50MG CAPSULES (HARD GELATIN) 1X30 HDPE INDIA

GITPOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011{0F7C37C0-B2F6-428B-A51C-9D983F406743}

ABBOT LABORATORIES

SOUTH AFRICA (PTY) LTD

ALUVIA 100/25 6034/06/07 LOPINAVIR + RITONAVIR

ABBOT GMBH & CO., 50 KNOLLSTRASSE, 67061 LUDWIGSHA

100MG + 25MG TABLET ( F ILM COATED) 1*60 HDPE GERMANY MEDICAL ACCESS

UGANDA LTD

RT24732 DATED 25/02/2011. DOC.

REVIEW

RT28979 DATED 12/09/2011

{9EC488B4-8046-4F7A-9ABA-7AFA0D7236D3}

AUROBINDO PHARMA LTD

STAVUDINE FOR ORAL SOLUTION 6036/06/07 STAVUDINE

AUROBINDO PHARMA LTD, UNIT III, SURVEY NO 313

(P),

1MG/ML DRY POWDER FOR RECONSTITUTION 1X200ML IN HDPE INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011{F6019F81-1E17-43E7-970F-FF981EE0BF2E}

AUROBINDO PHARMA LTD

DIDANOSINE CHEWABLE/DISPERS

IBLE TABLETS6037/06/07 DIDANOSINE

AUROBINDO PHARMA LTD, UNIT III, SURVEY NO 313

(P),

200MG TABLET (UNCOATED) 1X60HDPE INDIAGITTOES

PHARMACEUTICALS LTD

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{F5568D5A-2AC4-4CBA-9900-

7D43EF6395BC}

MATRIX LABORATORIES LTD

ABACAVIR SULPHATE 6038/06/07 ABACAVIR

SULPHATE

MATRIX LABORATORIES LTD,

F-4, F-12, MALEGAON MIDC

300MG TABLET (FILM COATED) 1X60 IN HDPE INDIA

PHILLIPS PHARMACEUTICALS

(U) LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{38777EB1-7EBC-4613-8915-3F94D2F72EB1}

CENTAUR PHARMACEUTICALS

LTDSINAREST- FORTE 6040/25/07 MULTI INGREDIENT

CENTAUR PHARMACEUTICALS PVT LTD, PLT NO. 3,

TIVIM

MULTI INGREDIENT TABLETS (UNCOATED)

1X10X10 BLISTERS & 1X50X4 STRIPS INDIA GITTOES

PHARMACEUTICALS22/04/08 + RT24338

DATED 04/02/11RT28397 DATED

08/08/11

{9BCC96C5-E109-4C55-BE6D-

4A1B22AD7AA4}

JOHNSON&JOHNSON PTY LTD SINUTAB 3-WAY 6041/25/07

IBUPROFEN + PSEUDOEPHEDRINE

HCL

JOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794

200MG + 30MG TABLET (FILM COATED) 1X2X10 IN BLISTER SOUTH AFRICA ERIS LTD 03/08/2009 RT30480 DATED

18/10/2011

{7FFB3CD6-F16C-4371-98F6-

BFB9AFE8CCF4}

Page 74

Page 75: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CIRON DRUGS & PHARMACEUTICALS

PVT LTDPROTORANGE PLUS 6054/27/07 MULTI INGREDIENT

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

MULTI INGREDIENT SYRUP 1X200ML AMBER GLASS BOTTLE INDIA RENE PHARMACY

LTDRE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{1D7E00B6-F18A-41A6A8C5-CCC62886F819}

ARISTO PHARMACEUTICALS

PVT LTDAMBRODIL 6055/25/07 AMBROXOL HCLrt

ARISTO PHARMACEUTICALS

PVT LTD, NO. 208 NEW INDUST

30MG TABLET (UNCOATED) 1X10X10 IN BLISTER INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011

{F8BD0965-DCCD-44A5-9E8F-

A09390BB09A2}

ARISTO PHARMACEUTICALS

LTDAMBRODIL 6056/25/07 AMBROXOL

HYDROCHLORIDE

ARISTO PHARMACEUTICALS PVT LTD, PLOT NO

208, NEW I

30MG/5ML SYRUP 1X100ML IN AMBER PET BOTTLE INDIA NORVIK

ENTERPRISES LTD 18/03/2010 RT28634 DATED 19/08/2011

{1FC49C87-B7B2-48F7-8AEA-AE139D496C3A}

GEOFMAN PHARMACEUTICAL NURAMINE FORTE 6057/27/07 VITAMIN B1+B2+B12

GEOFMAN PHARMACEUTICAL,

20/23 KORANGI INDUSTRIAL A

100MG/200MG/200MCG

TABLET (FILM COATED) 1X10X10 PAKISTAN HEALTHCARE 27/02/09 RT31697 DATED

09/12/11

{BD1B7CB3-AD05-4E96-94C6-

798E623A8E2F}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

CIROVIN NASAL DROPS 6058/28/07 XYLEMETAZOLINE BP

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

0.1%W/V NASAL SOLUTION 1X1X10ML INDIA RENE PHARMACY LTD

RE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{28A1DE74-5468-44C8-B7C8-4DE1C0712B0A}

INTAS PHARMACEUTICALS

LTDHIFENAC-SR 6060/02/07

ACECLOFENAC SUSTAINED RELEASE

INTAS PHARMACEUTICALS

LTD, CAMP ROAD, SELAQUI,

DEHRADUN

200MG TABLET (FILM COATED) 1X5X10 BLISTERS INDIA NORVIK

ENTERPRISES LTD 18/02/10 RT29052 DATED 06/09/11

{A0B1381B-A096-4A9BADDF-77A62F0D45F6}

UNIVERSAL CORPORATION LTD DINAC-50 6061/02/07 DICLOFENAC

SODIUM

UNIVERSAL CORPORATION,

KIKUYU, NAIROBI50MG TABLET (UNCOATED) 1X10X10 BLISTER KENYA MATRIX (U) LTD 26/10/2009 RT30250 DATED

14/10/2011

{ADB4603D-EDD1-4183-A938-

5BFFA48591F7}

CIRON DRUGS & PHARMACEUTICALS

PVT LTDLUFENAC 6068/02/07 DICLOFENAC

SODIUM

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

25MG/ML LIQUID INJECTION 1X10X10X3ML AMPOULE INDIA RENE PHARMACY

LTDRE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{4DA7BFBD-4D42-4A9D-B9E6-

DCA4558E56CB}

DENK PHARMA GMBH & CO KG

METFORMIN DENK 850 6069/18/07 METFORMIN

HYDROCHLORIDE

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

850MG TABLET (FILM COATED) 1X8X15 BLISTERS GERMANY ERIS LTD 14/01/08 + RT27569

DATED 04/07/11RT28444 DATED

09/08/11

{B70D0D31-DA79-4839-93D2-

4D856DAE1B8A}

ARISTO PHARMACEUTICALS

PVT LTDBIGOMET 6070/18/07 METFORMIN HCL

ARISTO PHARMACEUTICALS

PVT LTD, NO. 208 NEW INDUST

500MG TABLET (UNCOATED) 1X10X1X0 IN BLISTER INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011{D69E4928-82C2-40AA888A-3F3AF86BE2BF}

CIRON DRUGS & PHARMACEUTICALS

PVT LTDERGOMETRINE 6072/22/07 ERGOMETRINE

MALEATE

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

0.5MG/ML LIQUID INJECTION 1X10X10X1ML AMPOULE INDIA RENE PHARMACY

LTDRE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{7286D764-A8DE-4384-B587-0815CB0D23FF}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

BENZYL BENZOATE APPLICATION 607513/07 BENZYL BENZOATE

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

25%W/V LOTION 1X100ML AMBER GLASS BOTTLE INDIA RENE PHARMACY

LTDRE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{93A8784D-CB96-4679-99A0-00CF6388C2EE}

GSK LTD CERVARIX 6079/19/07HUMAN PAPILLOMA

VIRUS VACCINE (rDNA)

GLAXOSMITHKLINE BIOLOGICALS S.S,

RUE DE L'INSTITUTE

TYPE 16 L1 PROTEIN + TYPE 18 L1

PROTEIN + 3-0-DESACYL-

4'MONOPHOSPHORYL LIPID A(MPL)

INJECTABLE SUSPENSION

1X10X0.5ML VIALS & 1X0.5ML PRE-FILLED SYRINGE WITH A 25

GAUGE NEEDLE.

BELGIUM ERIS LTD 04/10/07 + RE-AUDIT FEES (RT22504)

RT28825 DATED 27/08/11

{6CDA1119-BC7F-42B8-A1E5-

3BAB02DD3A32}

AEGIS LTD OXACID 200 6080/06/08 OFLOXACIN

AEGIS LTD, ERGATES

INDUSTRIAL AREA, P.O.BOX 28629,

200MG CAPSULE 1X1X10 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED

02/08/11{A3F98127-47A2-444B-B049-99A778528F96}

Page 75

Page 76: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

AEGIS LTD VIRUCID 400 6081/06/08 ACICLOVIR

AEGIS LTD, ERGATES

INDUSTRIAL AREA, P.O.BOX 28629,

400MG TABLET 1X3X10 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED

02/08/11{636EAD21-7625-461A-81A4-EBF33EEF71A3}

AEGIS LTD CLERON 500 6082/06/08 CLARITHROMYCIN

AEGIS LTD, ERGATES

INDUSTRIAL AREA, P.O.BOX 28629,

500MG TABLET 1X1X14 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED

02/08/11

{998DAB4B-A4BF-462B-880E-

3C301CEABE1C}

AEGIS LTD FLUCOZAL 150 6083/06/08 FLUCONAZOLE

AEGIS LTD, ERGATES

INDUSTRIAL AREA, P.O.BOX 28629,

150MG CAPSULE (HARD GELATIN) 1X1X1 BLISTER CYPRUS SURGIPHARM (U)

LTD 01/07/11 RT28278 DATED 02/08/11

{88EAD245-B706-4781-997C-D7247649BEAB}

AEGIS LTD VIPROLOX 500 6084/06/08 CIPROFLOXACIN

AEGIS LTD, ERGATES

INDUSTRIAL AREA, P.O.BOX 28629,

500MG TABLET 1X1X10 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED

02/08/11{314C4934-A33F-48F3-BD4B-A09087DCEF60}

AJANTA PHARMA LTD ZOLANAS-30 6085/17/08 LANSOPRAZOLEAJANTA PHARMA LTD, B-4-5-6, MIDC INDUSTRIAL AREA,

30MG CAPSULE 1X3X10 BLISTER INDIAAARON

PHARMACEUTICALS LTD

27/11/08 RT28086 DATED 26/07/11

{11AD70E6-AA6E-44788A89-97C48DA0E343}

ALEMBIC LTD LORMEG 6086/03/08 LORATADINEALEMBIC LTD PLOT

NO. 21-22 EPIP, PHASE 1 JHARMAJRI

10MG TABLET 1X3X10 BLISTER INDIAGITTOES

PHARMACEUTICALS LTD

28/06/2010 RT28449 DATED 10/08/2011

{8E78C6D7-132E-4343-A63C-AAC52C876901}

ARISTO PHARMACEUTICALS

PVT LTDQURE 500 6089/06/08 LEVOFLOXACIN

HEMIHYDRATE

ARISTO PHARMACEUTICALS

PVT LTD, PLOT NO.208, NEW I

500MG TABLET 1X10X10 BLISTER, 1*5*1*5 INDIA NORVIK

ENTERPRISES LTD 18/03/2010 RT28634 DATED 19/08/2011

{8F27B4E5-A3B6-4CA9-BD55-

B2AE3C6184D5}

ARISTO PHARMACEUTICALS

PVT LTDBIGOMET SR 500 6091/18/08 METFORMIN HCL

ARISTO PHARMACEUTICALS PVT LTD, PLOT NO.

208, NEW

500MG TABLET 1X3X10 INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011{E0A56E71-8C36-4BA29C04-86ADD0504D55}

ARISTO PHARMACEUTICALS

PVT LTDPIOSAFE MF 15/500 6092/18/08 PIOGLITAZONE +

METFORMIN

ARISTO PHARMACEUTICALS PVT LTD, PLOT NO.

208, NEW

15MG + 500MG TABLET 1X3X10 BLISTER INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011

{C3B2D483-A2C2-4F53-9044-

14F1A31EA271}

AUROBINDO PHARMA LTD ZIDOVUDINE USP 6093/06/08 ZIDOVUDINE

AUROBINDO PHARMA LTD, UNIT

111, SURVEY NO 313(P) B

100MG CAPSULE (HARD GELATIN) 1X100 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011{1160B05F-1C26-4291-AB8D-9CE126250C29}

CADILA HEALTH CARE LTD CIPROBID 6097/06/08 CIPROFLOXACIN

AHLCON PARENTERALS LTD,

SP-918, PHASE III, INDUSTR

0.3%W/V EYE DROP 1X5ML INDIA ABACUS PHARMA (A) LTD 21/02/2011 RT28660 DATED

19/08/2011{786D85CE-7114-4E85-8279-52BCAD92E908}

CENTAUR DRUG HOUSE PVT LTD OROGEL 6098/15/08

CHOLINE SALICYLATE+LIGNOC

AINE HCL+BENZALKONIUM

CHL

CENTAUR DRUG HOUSE PVT LTD,

PLOT NO. 39 TIVIN IND.

8.7%W/W+2%W/W+0.01%W/W GEL 1X10G TUBE INDIA

GITTOES PHARMACEUTICALS

LTD

26/04/08 + RT24344 DATED 04/02/11

RT28397 DATED 08/08/11

{D34499DD-5C4C-4430-95BA-

33AD8D3B03AF}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

IRON DEXTRAN INJECTION USP 6099/11/08 IRON DEXTRAN

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

50MG/ML INJECTION 1X10X10X2ML AMPOULES INDIA RENE PHARMACY

LTDRE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{92D24645-179F-4BDF-9D5B-77B66038C2DD}

DAWA PHARMACEUTICALS

LTDASCORBIC ACID 6104/27/08 ASCORBIC ACID

DAWA LIMITED, BABA DOGO ROAD RUARAKA, MOBIL

PLAZA,

100MG TABLET 1X1000 HDPE KENYA SUPER MEDIC LTD RT24080 DATED 27/01/2011

RT28507 DATED 12/08/2011

{BB8D1797-4718-410F-9B91-

FDC8CDFD42CA}

EMCURE PHARMACEUTICALS

LTDATAZOR-150 6105/06/08 ATAZANAVIR

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

150MG CAPSULE 1X60 HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{29F3C375-870C-40BD-BF33-221312014E48}

EMCURE PHARMACEUTICALS

LTDATAZOR-200 6106/06/08 ATAZANAVIR

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

200MG CAPSULE 1X60 HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{E4810042-70FD-44E1-88AE-CF70DA92832F}

EMCURE PHARMACEUTICALS

LTDATAZOR-100 6107/06/08 ATAZANAVIR

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

100MG CAPSULE 1X60 HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{670A7E80-50FD-4549-92A1-4E3DB8EFAB1E}

Page 76

Page 77: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

FLAMINGO PHARMACEUTICALS

LTDS-PRAZO 40 6109/17/08 ESOMEPRAZOLE

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

40MG TABLET 1X10X10 IN BLISTERS INDIA ABACUS PHARMA (A) LTD 17/09/09 RT28444 DATED

09/08/11

{D5C584AF-7D6E-4A1D-A222-

C70418FF2BB7}

FLAMINGO PHARMACEUTICALS

LTDFLAMOFENAC 6110/03/08 ACECLOFENAC

FLAMINGO PHARMACEUTICALS

LTD R-662, T.T.C INDUS

100MG TABLET 1X10X10 IN BLISTERS INDIA ABACUS (A) LTD 17/09/09 RT28444 DATED 09/08/11

{EA790AC4-7135-4115-930C-07CD900AE3C3}

GEOFMAN PHARMACEUTICALS

LTD

NURAMINE FORTE INJECTION 6112/27/08

VITAMIN B1 + VITAMIN B2 + VITAMIN B12

GEOFMAN PHARMACEUTICALS

LTD, 20/23 INDUSTRIAL AREA

100MG + 100MG + 1000MCG INJECTION 1X25X3ML AMBER

GLASS AMPOULES PAKISTAN HEALTH CARE LTD 27/02/09 RT31697 DATED 09/12/11

{B1C74B53-55B1-45DC-BECA-

054ADF095843}

GLENMARK PHARMACEUTICALS

LTDGLEVATE 6113/13/08 CLOBETASOL

GLENMARK PHARMACEUTICALS LTD, PLOT NO E-37,

39, D-

0.05%W/W CREAM 1X15G TUBE INDIASTAR

PHARMACEUTICALS LTD

29/09/2009 RT28761 DATED 24/08/2011

{BBB3DB8A-842F-44BD-ACDB-

12B8BA14937A}

LORDS HEALTH CARE LTD

BETADINE OINTMENT 10%W/W 6119/15/08 POVIDONE IODINE

USP

MUNDIPHARMA PHARMACEUTICALS LTD, 13 OTHELLOS

STREET DHALI INDUSTRIAL ZONE,

P.O.BOX 23661, 1685, NICOSIA

10%W/W OINTMENT 1X 1X 40G TUBE CYPRUS SURGIPHARM (U) LTD

RT28668 DATED 19/08/2011

{B7F80F07-9412-445F-99C2-F8BA6D5FE716}

LORDS HEALTHCARE LTD

BETADINE VAGINAL DOUCHE 6120/15/08 POVIDONE IODINE

MUNDIPHARMA PHARMACEUTICALS LTD, 13 OTHELLOS

STREE

10%W/W VAGINAL DOUCHE 1X1X250ML CYPRUS SURGIPHARM (U) LTD

{DD7DF2EA-2069-48B7-919D-

DC3C82461AEF}

MATRIX LABORATORIES LTD EFAVIRENZ 6129/06/08 EFAVIRENZ

MATRIX LABORATORIES LTD,

F-4, F-12, MALEGAON MIDC

600MG TABLET 1X1X30 IN HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{1F970666-F853-4B18-88D8-1CE4F3C53F11}

MATRIX LABORATORIES LTD LAMIVUDINE 6130/06/08 LAMIVUDINE

MATRIX LABORATORIES LTD,

F-4, F-12, MALEGAON MIDC

150MG TABLET 1X1X60 IN HDPE INDIAPHILLIPS

PHARMACEUTICALSLTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{5CD66A06-076A-4BFD-94D4-

12BD96C4697C}

MATRIX LABORATORIES LTD STAVUDINE 6131/06/08 STAVUDINE

MATRIX LABORATORIES LTD,

F-4, F-12, MALEGAON MIDC

30MG CAPSULE 1X1X60 IN HDPE INDIAPHILLIPS

PHARMACEUTICALSLTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{9466F88B-E1E3-462D-A999-908BA83E0DC7}

MATRIX LABORATORIES LTD

LOPINAVIR + RITONAVIR 6132/06/08 LOPINAVIR +

RITONAVIR

MATRIX LABORATORIES LTD,

F-4, F-12, MALEGAON MIDC

200MG + 50MG TABLET 1X120 IN HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{39EBC69A-326D-4EA0-AC58-

DEA609C9201C}

MERCK SHARP & DOHME B.V ATRIPLA 6137/06/08

EFAVIRENZ + EMTRICITABINE +

TENOFOVIR DF

MERCK SHARP & DOHME B.V,

WAARDENWEG 39 2031 BN, HAARLEM

600MG + 200MG + 300MG TABLET 1X30 HDPE NETHERLANDS PHILLIPS P'CALS (U)

LTD 29/06/11 RT29554 DATED 26/09/11

{3741E918-A393-455B-85F1-0EF6EE4B19A2}

MISSION PHARMA A/S ALBENDAZOLE 6138/06/08 ALBENDAZOLE

MEDICAMEN BIOTECHLTD, SP-

1192 A&B PHASE IV INDUSTRIAL AREA,

BHIWADI

400MG TABLET 1X500 IN HDPE INDIA JMS 27/06/2011 RT28773 DATED 25/08/2011

{8FCD1F42-1403-4FB0-B71C-98E36376A429}

NOVARTIS CONSUMER HEALTH PROCTO GLYVENOL 6143/17/08 TRIBENOSIDE +

LIDOCAINE HCL

NOVARTIS CONSUMER INC, CH-

1260, NYON5%W/W + 2%W/W CREAM 1X30G SWITZERLAND BETA HEALTH CARE

(U) LTD

{FBCCBAEC-9E92-4B84-B320-

2D2E8BC7ADD8}

NOVARTIS CONSUMER HEALTH VIBROCIL 6145/28/08

PHENYLEPHRINE+DIMETHENDENE

MALEATE

NOVARTIS CONSUMER INC, CH-

1260, NYON

0.25%W/V+0.025%W/V NASAL DROPS 1X15ML SWITZERLAND BETA HEALTH CARE

(U) LTD

{D21CCAC5-23EE-4474-8E7C-

674E02C60B62}

PFIZER LABORATORIES

(PTY) LTDBENYLIN FOR COLDS 6147/25/08 PSEUDOEPHEDRINE

HCL + IBUPROFEN

JOHNSON & JOHNSON, 241MAIN

ROAD, RETREAT, CAPE TOWN

30MG + 200MG TABLET 1X2X10 STRIP SOUTH AFRICA LABOREX (U) LTD RT30480 DATED 18/10/2011

{A3F712EE-DE5F-4632-AA20-

7AAF6D704A6D}

RENE INDUSTRIES LTD NITROFURANTOIN 6160/06/08 NITROFURANTOIN

RENE INDUSTRIES LTD, PLOT 680

KAMULI, KIREKA. P.O.

100MG TABLET 1X1000 IN HDPE UGANDA RENE INDUSTRIES LTD

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{F49BA17F-1EC6-4309-AE43-

CCA265A1EEA3}

Page 77

Page 78: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

RENE INDUSTRIES LTD AMOXIREN 6161/06/08 AMOXICILLIN

TRIHYDRATE

RENE INDUSTROES LTD, PLOT 680

KAMULI, KIREKA. P.O.

125MG/5ML POWDER FOR SUSPENSION 1X100ML UGANDA RENE INDUSTRIES

LTDANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011{172AFD32-70D5-4A04-B714-5A985D855FB5}

SINO AFRICA MEDICINES & HEALTH LTD

FUROSEMIDE INJECTION 6163/12/08 FUROSEMIDE

GREENFIELD PHARMACEUTICAL (JIANGSU) CO. LTD,

NO 38

10MG/ML INJECTION 1X10X2ML, 1*100*2ML AMPOULE CHINA

SINO AFRICA MEDICINES & HEALTH LTD

07/09/09 RT28343 DATED 04/08/11

{599AA6B4-F05C-4F33-816D-52242E9F542D}

SOLVAY PHARMACEUTICALS

BVDUSPATALIN 6164/20/08 MEBEVERINE HCL

SOLVAY PHARMACEUTICALS

BV, VEERVEG 12 8121 AA 01 S

135MG TABLET 1X10X5 BLISTER NETHERLANDSSTAR

PHARMACEUTICALS LTD

29/09/08 RT17421 DATED16/08/11

{4E5804FB-636A-4910-85B0-

D7D7C1FFD22D}

VENUS REMEDIES LTD RONEM 6169/06/08 MEROPENEM

TRIHYDRATE

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

1000MG POWDER FOR INJECTION 1X20MLX1G VIAL INDIA

AARON PHARMACEUTICALSL

TD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{62E18897-25CB-4A26-A8CE-5979B513B168}

AEGIS LTD CLERON 250 6171/06/08 CLARITHROMYCIN

AEGIS LTD, ERGATES

INDUSTRIAL AREA, P.O.BOX 28629,

250MG TABLET 2 * 7 BLISTER CYPRUS SURGIPHARM (U) LTD 01/07/11 RT28278 DATED

02/08/11

{3F369564-8DED-4C8A-B826-

E3EED252FD2A}

RENE INDUSTRIES LTD VITAREN SYRUP 6176/27/08

VITAMIN A + VITAMIN B2 + VITAMIN B1 +

VITAMIN B6 + VITAMIN C + VITAMIN

E + VITAMIN B3

RENE INDUSTRIES LTD, PLOT 680

KAMULI, KIREKA, KAMP

1500IU/5ML + 1MG/5ML + 1MG/5ML

+ 0.5MG/5ML + 20MG/5ML + 100

IU/5ML + 10MG/5ML

SYRUP1X1X100ML +

1X1X60ML AMBER GLASS BOTTLES

UGANDA RENE PHARMACY ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{E1246D6F-1302-4EE1-BC23-F3D1C2682665}

SINO AFRICA MEDICINES & HEALTH LTD

TETRACYCLINE CAPSULE BP 6180/06/08 TETRACYCLINE

HYDROCHLORIDE

GREENFIELD PHARMACEUTICALS No 38 TAIJIU ROAD

TAIZH

250MG CAPSULE 1*1000 HDPE, 1*500 HDPE CHINA

SINO AFRICA MEDICINES & HEALTH LTD

07/09/09 RT28343 DATED 04/08/11

{6A5DE46D-7E61-41F9-87DD-

FD4E68FDB3E3}

GLAXOSMITHKLINE LTD PROXIMEXA 6182/06/08 CEFUROXIME AXETIL

GLAXO OPERATIONS UK LTD, HARMIRE

RD, BARNARD CASTL

125MG/5ML ORAL SUSPENSION (GRANULES)

1*1*50ML AMBER GLASS BOTTLE UNITED KINGDOM ERIS LTD 18/08/09 RT28825 DATED

27/08/11

{F609E5FF-EB0F-4ABE-97F2-

0CFD5A93C9A9}

SINO AFRICA MEDICINES & HEALTH LTD

CHLORAMPHENICOL CAPSULE BP 6183/06/08 CHLORAMPHENICOL

GREENFIELD PHARMACEUTICALS No 38 TAIJIU ROAD

TAIZH

250MG CAPSULE 1*1000 HDPE, 1*500 HDPE CHINA

SINO AFRICA MEDICINES & HEALTH LTD

07/09/09 RT28343 DATED 04/08/11

{0C0C8653-066A-401D-80EC-253584D85373}

MEPHA LTD CO-AMOX MEPHA 156.25 6186/06/08 CO-AMOXICLAV LEK D.D, PREVALJE 125MG+31.25MG/ 5ML ORAL SUSPENSION

(POWDER)1*1*100ML IN AMBER

GLASS BOTTLE SLOVENIA GOODMAN INTERNATIONAL LTD 14/05/2009 RT28480 DATED

11/08/2011{609EA4E0-AE87-489B8F0C-15D42F416F0F}

MEPHA LTD CO-AMOX MEPHA 457 6187/06/08 CO-AMOXICLAV LEK D.D, PREVALJE 400MG+47MG/ 5ML ORAL SUSPENSION (POWDER)

1*1*70ML IN AMBER GLASS BOTTLE SLOVENIA GOODMAN

INTERNATIONAL LTD 14/05/2009 RT28480 DATED 11/08/2011

{D3123104-91CC-4615-8436-BE561C8DEED0}

ALEMBIC LTD AZITHRAL LIQUID-200 6188/06/08 AZITHROMYCINALEMBIC LTD, PLOT

NO 21/22, EPIP, PHASE 1, JHARMAJ

40MG/ML ORAL SUSPENSION 1*15ML AMBER GLASS BOTTLE INDIA

GITTOES PHARMACEUTICALSL

TD28/06/2010 RT28449 DATED

10/08/2011{5D822A67-4ABE-4F02BFCC-406F5BAF3677}

SINO AFRICA MEDICINES & HEALTH LTD

METOCLOPRAMIDE HYDROCHLORIDE

INJECTION6192/17/08 METOCLOPRAMIDE

HYDROCHLORIDE

GREENFIELD PHARMACEUTICALS No 38 TAIJIU ROAD

TAIZH

5MG/ML INJECTION 2ML AMBER GLASS AMPOULES X10 CHINA

SINO AFRICA MEDICINES & HEALTH LTD

07/09/09 RT28343 DATED 04/08/11

{0A6CF354-7B1D-4F4E-9672-

2889113FA245}

CADILA HEALTHCARE LTD FLUCOZYD-200 6193/06/08 FLUCONAZOLE

CADILA HEALTHCARE LTD, SARKHEJ-BAVLA N.H.NO 8A, MO

200MG CAPSULE (HARD GELATIN) 1*4*7 BLISTERS INDIA ABACUS PHARMA (A)

LDTRE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{121758B6-5B9C-4BDA-8986-

E1BA4748ED9D}

SINO AFRICA MEDICINES & HEALTH LTD

PROMETHAZINE INJECTION 6195/03/08 PROMETHAZINE

HYDROCHLORIDE

GREENFIELD PHARMACEUTICALS No 38 TAIJIU ROAD

TAIZH

25MG/ML INJECTION 2ML AMBER GLASS AMPOULES X10 CHINA

SINO AFRICA MEDICINES & HEALTH LTD

07/09/09 RT28343 DATED 04/08/11

{58FF106D-BCCE-48B0-9A3B-

005FD4A9A7F8}

AEGIS LTD TREDOL 50 6196/12/08 ATENELOL

AEGIS LTD, 17 ATHINON STREET,

ERGATES INDUSTRIAL A

50MG TABLET (UNCOATED) 1*2*10 BLISTER CYPRUS SURGIPHARM 01/07/11 RT28278 DATED 02/08/11

{ADB23243-161F-40BC-930B-

4C5D22491968}

Page 78

Page 79: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SINO AFRICA MEDICINES & HEALTH LTD

METRONINDAZOLE 6201/06/08 METRONINDAZOLE

GREENFIELD PHARMACEUTICALS No 38 TAIJIU ROAD

TAIZH

200MG TABLET 1*500 HDPE CHINASINO AFRICA MEDICINES & HEALTH LTD

07/09/09 RT28343 DATED 04/08/11

{BCBE7527-00B6-4D12-919D-

C6946BCF2AEA}

MERCK SHARP & DOHME

INTERPHARMASTOCRIN 200 6203/30/08 EFAVIRENZ

MERCK SHARP & DOHME,

WAADERWAG 39, POSTBUS 581. 2003

PC HAARLEM

200MG TABLET (FILM COATED) 1*90 HDPE NETHERLANDS PHILLIPS P'CALS (U)

LTD 29/06/11 RT29554 DATED 26/09/11

{A437C7B7-A591-48B7-83FF-C809967A09A4}

MATRIX LABORATORIES LTD

TENOFOVIR DF + EMTRICITABINE +

EFAVIRENZ6205/30/08

TENOFOVIR DF + EMTRICITABINE +

EFAVIRENZMATRIX LABORATc 300MG + 200MG +

600MGTABLET (FILM

COATED) 1*30 HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{F40D9029-C255-4AC2-9227-1A7DB7907F48}

MATRIX LABORATORIES LTD

ABACAVIR SULFATE + LAMIVUDINE +

ZIDOVUDINE6206/30/08

ABACAVIR SULFATE + LAMIVUDINE +

ZIDOVUDINE

MATRIX LABORATORIES LTD,

F-14, F-12, MALEGAON, MID

300MG + 150MG + 300MG

TABLET (FILM COATED) 1*60 HDPE INDIA

PHILLIPS PHARMACEUTICALS

LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{BCADB102-D30B-4743-9D08-

F3EFD86A5167}

MATRIX LABORATORIES LTD NEVIRAPINE 6207/30/08 NEVIRAPINE

MATRIX LABORATORIES LTD,

F-14, F-12, MALEGAON, MIDc

200MG TABLET (UNCOATED) 1*60 HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{82C9E0CA-2D36-4715-BB89-

F4383D76DDC3}

AUROBINDO PHARMA LTD

ABACAVIR SULPHATE 6208/30/08 ABACAVIR

SULPHATE

AUROBINDO PHARMA LTD, UNIT III SURVEY NO 313,

BACH

20MG/ML ORAL SOLUTION 240ML INDIAGITTOES

PHARMACEUTICALS LIMITED

20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{5B347A1D-44F6-4814-B180-88D4FD52E4E4}

MATRIX LABORATORIES LTD

EMTRICITABINE + TENOFOVIR DF 6209/30/08 EMTRICITABINE +

TENOFOVIR DF

MATRIX LABORATORIES LTD,

F-14, F-12, MALEGAON, MID

200MG + 300MG TABLET (FILM COATED) 1*30 HDPE INDIA

PHILLIPS PHARMACEUTICALS

LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{AA4E112F-D0FD-4487-8C8B-

6DA20AA0D58E}

MERCK SHARP & DOHME

INTERPHARMASTOCRIN 50 6211/30/08 EFAVIRENZ

MERCK SHARP & DOHME,

WAADERWAG 39, POSTBUS 581. 2003

PC HAARLEM

50MG TABLET (FILM COATED) 1*30 HDPE NETHERLANDS PHILLIPS P'CALS (U)

LTD 29/06/11 RT29554 DATED 26/09/11

{6D738A19-59EA-4848-AE22-E0DE295F17D5}

MATRIX LABORATORIES LTD

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

6212/30/08LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

MATRIX LABORATORIES LTD,

F-4, F-12 MALEGAON, MIDC,

150MG + 200MG + 300MG

TABLET (FILM COATED) 1*60 HDPE INDIA

PHILLIPS PHARMACEUTICALS

LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{3DBA3859-FAE0-475A-996E-

20FE56857F88}

MATRIX LABORATORIES LTD

LAMIVUDINE + STAVUDINE 6213/30/08 LAMIVUDINE +

STAVUDINE

MATRIX LABORATORIES LTD,

F-14, F-12, MALEGAON, MID

150MG + 30MG TABLET (UNCOATED) 1*60 HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{04B558C5-3B41-4BE2-B0B1-EF838B9D8945}

SINO AFRICA MEDICINES & HEALTH LTD

AMINOPHYLLINE 6214/25/08 AMINOPHYLLINE

GREENFIELD PHARMACEUTICALS No 38 TAIJIU ROAD

TAIZH

100MG TABLET 1*500 HDPE CHINASINO AFRICA MEDICINES & HEALTH LTD

07/09/09 RT28343 DATED 04/08/11

{14D0061C-49C3-45FE-8671-A1B33D228A56}

MACK BROWN PHARMACEUTICALS

PVT LTDWINDERM CREAM 6215/13/08

BECLOMETHASONE DIPROPRIONATE/ CLOTRIMAZOLE/ NEOMYCIN SO4

TORQUE PHARMACEUTICALS

LTD, ISSAPUR, DAPPAR 140506

0.025%W/W+1.0%W/W+0.5%W/W CREAM 1*1*15G INDIA SHURIK LTD 21/08/08 + RT28/07/11

DATED 28/07/11RT:28301 DATED

03/08/2011{8056AD40-0EB4-4804-AF3E-60FE6B06DA39}

UHMG SOFTSURE 6217/18/08 LEVONOORGESTRELFAMY CARE, UNIT II

PLOT 1608&1609 GIDC, SARIGAM, G

0.03MG TABLET (SUGAR COATED) 1*1*28 BLISTER INDIA

UGANDA HEALTH MARKETING

GROUP,UHMG03/09/09 RT28149 DATED

27/07/11{2D3C91C2-7642-41E1-B6D4-226856FED3C5}

SINO AFRICA MEDICINES & HEALTH LTD

INDOMETHACIN 6218/02/08 INDOMETHACIN

GREENFIELD PHARMACEUTICALS No 38 TAIJIU ROAD

TAIZH

25MG CAPSULE 1*1000 HDPE, 1*500 HDPE CHINA

SINO AFRICA MEDICINES & HEALTH LTD

07/09/09 RT28343 DATED 04/08/11

{6311D3DC-122C-448F-A967-

F02C8BF7330A}

IRAN MEDICAL GROUP COMPANY

FARAMOX CAPSULES 6224/06/08 AMOXICILIN

FARABI PHARMACEUTICAL CO., KM 15, SHIRAZ

ROAD,ISFAHAN, IRAN

500MG CAPSULE 1*10*10 BLISTERS IRANMORID

PHARMACEUTICAL LTD

31/05/2011 RT27930 DATED 19/07/2011

{F8D7ABFC-6E4F-413B-BB52-

8600571E5289}

IRAN MEDICAL GROUP COMPANY FARACILLIN 6225/06/08 PENICILLIN V

BENZATHINE

FARABI PHARMACEUTICAL CO., KM 15, SHIRAZ

ROAD,ISFAHAN, IRAN

200000IU/5ML ORAL POWDER FOR SUSPENSION

1*100ML IN AMBER GLASS BOTTLE IRAN

MORID PHARMACEUTICAL

LTD31/05/2011 RT27930 DATED

19/07/2011{061495B7-9010-4E51-B0D7-1CD761991EAE}

Page 79

Page 80: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

IRAN MEDICAL GROUP COMPANY CO-AMOXICLAV 6231/06/08 AMOXICILLIN/CLAVUL

ANIC ACID

FARABI PHARMACEUTICAL CO., KM 15, SHIRAZ ROAD,ISFAHAN, IRA

500MG/125MG TABLETS 1*5*4 STRIP IRANMORID

PHARMACEUTICAL LTD

31/05/2011 RT27930 DATED 19/07/2011

{FD6A46FF-586C-4DAE-98E9-

5AA58FD29E56}

UGANDA HEALTH MARKETING

GROUP,UHMGNEW FEM 6235/18/08

LEVONOGESTREL/ETHINYL

ESTRADIOL+FERROUS FUMERATE

FAMY CARE LTD, 1608/1609, GIDC SARIGAM-396155

VALS

0.15 MG/0.03MG + 75MG=24.37 MG TABLET 1*1*28 BLISTER INDA

UGANDA HEALTH MARKETING

GROUP,UHMG03/09/09 RT28149 DATED

27/07/11{4782FC30-6F53-4328-9389-B64F99DFA5C2}

SINO AFRICA MEDICINE 7 HEALTH

DICLOFENAC SODIUM 6250/02/08 DICLOFENAC

ZHEJIANG TIANFENG PHARMACEUTICAL

FACTORY,NO.518 DA75MG/3ML INJECTION 10*10*3ML AMPOULE CHINA SINO AFRICA

MEDICINES 11/09/08 RT28343 DATED 04/08/11

{F3370622-4E7B-4163-9407-D489AACD30C5}

SINO AFRICA MEDICINES & HEALTH LTD

VITAMIN B COMPLEX 6252/27/08

VIT B1+ VIT B2 +VIT B3 +

NICOTINAMID+PANTOTHENOL

GREENFIELD PHARMACEUTICALS No 38 TAIJIU ROAD

TAIZH

10MG +1MG +1MG +16MG +0.5MG INJECTION 1*10*2ML & 1*100

*2ML AMPOULES CHINASINO AFRICA MEDICINES & HEALTH LTD

07/09/09 RT28343 DATED 04/08/11

{3446160E-A9D2-404A-9F2F-49683CE44D91}

MEDICAL UNION P'CAL CO.

DEXAMETHASONE IM/IV 6265/03/08 DEXAMETHASONE

SODIUM PHOSPHATE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA8MG/2ML SOLUTION FOR

INJECTION 1*100*2ML AMPOULE EGYPTKARURI

PHARMACEUTICALS LTD

12/10/2009 RT27905 DATED 18/07/2011

{97738C89-43A8-4658-B181-08BCF5B190E7}

MODI-MUNDI PHARMA (PVT) LTD DILCONTIN XL 180 6266/12/08

DILTIAZEM HCL CONTROLLED

RELEASE

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

180MG TABLET (FILM COATED) 1*10*10 BLISTERS INDIA SURGIPHARM (U)

LTDRT24921 DATED

04/03/2011RT28666 DATED

19/08/2011{0EC8096F-EB75-4A49B39D-9B99BE52E6D2}

AUROBINDO PHARMA POZINE A 1000 6272/06/08 CEFEPIME

AUROBINDO PHARMA LTD, UNIT VI, SURVEY 329/47,

329/

1000MG INJECTION1*1 VIAL + 1*1AMP

WATER FOR INJECTION

INDIAGITTOES

PHARMACEUTICALS LTD

25/02/2010 RT28910 + RT28908 DATED 31/08/2011

{9B6E8188-0B1C-421E-A49A-

ACA4BB0AF5C2}

RENE INDUSTRIES LTD

ERYTHROREN SUSPENSION 6280/06/08 ERYTHROMYCIN

RENE INDUSTRIES LTD, PLOT 680

KAMULI KIREKA P.O.BO

125MG/5ML ORAL SUSPENSION 1*100ML AMBER GLASS BOTTLE UGANDA RENE PHARMACY ANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011{9128D52A-B14B-41E7-9BBF-9CFF356F24CA}

RENE INDUSTRIES LTD

AMCLOREN DRY SYRUP 6281/06/08 AMPICILLIN +

CLOXACILLIN

RENE INDUSTRIES LTD, PLOT 608

KAMULI, KIREKA

125MG/5ML + 125MG/5ML SYRUP 1*100 BOTTLE UGANDA RENE INDUSTRIES

LTDANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011

{32005D02-4C20-4EEC-8F90-

9E79C203BBCB}

MARCK BIOSCIENCES LTD HIPOFLOX 6283/06/08 OFLOXACIN

MARCK BIOSCIENCES LTD, PLOT 876, N.H.NO.8,

VIL: HARIYALA KHEDA, - 387411,

GUJARAT

0.2%W/V LVP 1*100ML LDPE INDIAKARURI

PHARMACEUTICALSLTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{12B4D624-0574-4AE9-AD71-1C175BA2E6EE}

VENUS REMEDIES LTD PARIN-E 6289/10/08 ENOXAPARIN

SODIUM

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

40MG/0.4ML INJECTION 1*2 PRE-FILLED SYRINGES INDIA

AARON PHARMACEUTICALS

LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{98061A46-1BAB-44D3-9114-2D63BF7FA43F}

TORRENT PHARMACEUTICAL

LTDLAMITOR 100 6290/05/08 LAMOTRIGINE

TORRENT PHARMACEUTICAL

LTD, INDRAD- 382721, DIST,

100MG TABLET (UNCOATED) 1*3*10 BLISTERS INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{A3F226C9-A0FC-4F48-A63D-

ACC549AF4189}

CADILA HEALTHCARE LTD FLUOXETINE 6291/24/08 FLUOXETINE HCL

CADILA HEALTHCARE LTD,

SARKHEJ- BARIA N.H NO 8A, M

20MG CAPSULE (HARD GELATIN)

1*3*10, 1*10*10 BLISTERS INDIA ABACUS PHARMA (A)

LTDRE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{5ED9F61E-D180-4138-8156-A7FF154E87EA}

BEIJING HOLLEY-COTEC

PHARMACEUTICAL CO., LTD

DIARRAFIN 6293/17/08 MONTMORILLONITE

BEIJING WANHUI, DOUBLE-CRANE

PHARMACEUTICAL CO. LT

3G ORAL POWDER 1*10*3G SACHETS CHINASUPER

PHARMACEUTICALS LTD

RT28435 DATED 14/07/2011 PAYMENT FOR RE-INSPECTION

RT28435 DATED 09/08/2011

{65C9125B-82AD-4D81-B6FF-

8B294AD658DE}

Page 80

Page 81: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

MARCK BIOSCIENCES LTD

ACCUMOL 0.5%W/V EYE DROPS 6304/21/08 TIMOLOL MALEATE

MARCK BIOSCIENCES LTD, PLOT NO 1876, N.H.

NO.8, VIL. HARIYALA, KHEDA - 387411,

GUJARAT

0.5%W/V EYE DROPS 1*1*5ML VIAL INDIAKARURI

PHARMACEUTICALS LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{EA41A9C4-B1F5-409A-BBDA-

49C475B83642}

ARISTO PHARMACEUTICALS

PVT LTDFEXOFEN 6305/03/08 FEXOFENADINE

ARISTO PHARMACEUTICALS PVT LTD, PLOT NO

208, NEW I

180MG TABLET (FILM COATED) 1*10*6 BLISTERS INDIA NORVIK

ENTERPRISES LTD 18/03/2010 RT28634 DATED 19/08/2011

{A7C48017-76B6-4666-ABC0-473AD8FE471E}

MATRIX (U) LTD ASMAFEN SYRUP 6308/03/08 KETOTIFEN

XEPA-SOUL PATTINSON

(MALAYSIA) SDN BHD, 1-5, CHENG

INDUSTRIAL ESTATE, 75250

MELAKA

1MG/5ML SYRUP 1*1*120ML AMBER PLASTIC BOTTLE MALAYSIA MATRIX (U) LTD 05/02/2009 RT28476 DATED

11/08/11

{159E636A-476C-4D5F-A3DD-

C80D41B27C7B}

ARISTO PHARMACEUTICALS

PVT LTDFEXOFEN 6309/03/08 FEXOFENADINE

ARISTO PHARMACEUTICALS PVT LTD, PLOT NO

208, NEW I

120MG TABLET (FILM COATED) 1*10*6 BLISTERS INDIA NORVIK

ENTERPRISES LTD 18/03/2010 RT28634 DATED 19/08/2011

{2AD1A249-F7AF-4264-86C5-725629ACF52F}

MEPHA LTD ZENUSIN-20 SR 6311/12/08 NIFEDIPINE

MEPHA LTD, DORNACHESTRASS

E 114 CH-4147, AESCH, BASEL

20MG TABLET (FILM COATED) 1*3*10 BLISTERS SWITZERLAND GOODMAN

INTERNATIONAL 19/08/2009 RT28480 DATED 11/08/2011

{30E9271E-F0C7-4670-AC10-F3F49640DF47}

TORRENT PHARMACEUTICALS

LTDVALZAAR-80 6312/12/08 VALSARTAN

TORRENT PHARMACEUTICALS LTD, INDRAD-382721, DISTRICT MEHSANA

80MG CAPSULE (HARD GELATIN) 1*3*10 STRIPS INDIA

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{9B166FBA-B2D5-42C3-96C4-

C40946B2D478}

DENK PHARMA GMBH & CO. KG AMLO-DENK 10 6314/12/08

AMLODIPINE MESILATE

MONOHYDRATE

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

10MG TABLET (UNCOATED) 1*5*10 BLISTERS GERMANY ERIS LTD 14/01/08 + RT27569 DATED 04/07/11

RT28444 DATED 09/08/11

{A17CE813-C4C8-486A-A770-

2BB6736C8A07}

DENK PHARMA GMBH & CO. KG AMLO-DENK 5 6315/12/08

AMLODIPINE MESILATE

MONOHYDRATE

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

5MG TABLET (UNCOATED) 1*5*10 BLISTERS GERMANY ERIS LTD 14/01/08 + RT27569 DATED 04/07/11

RT28444 DATED 09/08/11

{66583141-FFDD-4F15-9049-D1E59FB06986}

AEGIS LTD TREDOL 100 6317/12/08 ATENOLOL

AEGIS LTD, ARGATES

INDUSTRAIL AREA, P.O.BOX 28629

100MG TABLET (UNCOATED) 1*2*10 & 1*3*10 BLISTERS CYRPUS SURGIPHARM (U)

LTD 01/07/11 RT28278 DATED 02/08/11

{AB30A4A7-0970-42C2-9947-D64BF682611C}

DENK PHARMA GMBH & CO. KG ENA-DENK 6319/12/08 ENALAPRIL MALEATE

DENK PHARMA GmbH & Co.KG

PRINZREGENTESTR.79.81675

MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING

GER

10MG TABLET (UNCOATED) 1*3*10 BLISTERS GERMANY ERIS LTD 14/01/08 + RT27569 DATED 04/07/11

RT28444 DATED 09/08/11

{7F019003-FA70-4408-A82C-

6AABCD8E25E7}

VENUS REMEDIES LTD CARBOL 6327/08/08 CARBOPLATIN

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

450MG/45ML INJECTION 1*45 VIAL INDIAAARON

PHARMACEUTICALS LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{05024CA0-636F-4C0B-B771-FF88B057DC39}

Page 81

Page 82: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

VENUS REMEDIES LTD PAXOL 6329/08/08 PACLITAXEL

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

100MG/16.7ML SOLUTION FOR INJECTION 1*20ML VIAL INDIA

AARON PHARMCEUTICALS

LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{DA0C410B-26CD-4151-9DD0-

F8209B391313}

LORDS HEALTH CARE LTD

BETADINE SURGICAL SCRUB 6335/15/08 POVIDONE-IODINE

MUNDIPHARMA PHARMACEUTICALS LTD, 13 OTHELLOS

STREET DHALI INDUSTRIAL ZONE

P.O.BOX 23661, 1685 NICOSIA

7.5%W/V TOPICAL SOLUTION 1*500ML, 1*120ML HDPE CYPRUS SURGIPHARM (U)

LTDRT28668 DATED

19/08/2011

{ABDD070D-25E9-48E8-8EB0-

97E655958B8E}

LORDS HEALTH CARE LTD

BETADINE ANTISEPTIC SOLUTION

6337/15/08 POVIDONE-IODINE

MUNDIPHARMA PHARMACEUTICALS LTD, 13 OTHELLOS

STREET DHALI INDUSTRIAL ZONE

P.O.BOX 23661, 1685 NICOSIA

10%W/V TOPICAL SOLUTION 1*500ML, 1*125ML HDPE CYPRUS SURGIPHARM (U)

LTDRT28668 DATED

19/08/2011

{17D7C27E-9255-49DD-9842-

12B1BB0FD37E}

LORDS HEALTH CARE LTD

BETADINE MOUTH WASH GARGLE 6338/15/08 POVIDONE-IODINE

MUNDIPHARMA PHARMACEUTICALS LTD, 13 OTHELLOS

STREET DHALI INDUSTRIAL ZONE

P.O.BOX 23661, 1685 NICOSIA

1%W/V TOPICAL SOLUTION 1*125ML, 1*250ML HDPE CYPRUS SURGIPHARM (U)

LTDRT28668 DATED

19/08/2011

{067C80E3-CF9B-45BB-BBB4-

3A1C5A78FEDB}

CIRON DRUGS & PHARMACEUTICALS

PVT LTDCIRATRO 6340/04/08 ATROPINE

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

1MG/ML INJECTION 1*10*10*1ML AMPOULES INDIA RENE PHARMACY

LTDRE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{CFBDB8A1-8666-4199-BB44-

20C02928DC7C}

INTAS PHARMACEUTICALS

LTDRABITAS-20 6347/17/08 RABEPRAZOLE

SODIUM

INTAS PHARMACEUTICALS

LTD, PLOT NO 457458, MATODA-

382210, DIST AHMEDABAD

20MG TABLET (ENTERIC COATED) 1*2*10 BLISTERS INDIA NORVIK

ENTERPRISES LTD 06/09/09 RT29052 DATED 06/09/11

{A0A11FA6-EC7D-4420-8866-

B518BA3C937D}

HETERO DRUGS LTD NEVILAST-30 6350/06/08LAMIVUDINE + STAVUDINE + NEVIRAPINE

HETERO DRUGS LTD, UNIT 111, NO 22-

110, I.D.A, JEED

150MG + 30MG + 200MG TABLET (UNCOATED) 1*60 HDPE INDIA ASTRA PHARMA

UGANDA LTD 17/12/09 RT28304 DATED 03/08/11

{F3665553-E46A-41F7-B3CC-39F38FBC928D}

MATRIX LABORATORIES LTD

LAMIVUDINE + ZIDOVUDINE 6352/06/08 LAMIVUDINE +

ZIDOVUDINE

MATRIX LABORATORIES LTD,

F-4, F-12, MALEGAON MIDC

150MG + 300MG TABLET (FILM COATED) 1*60 HDPE (GOU) INDIA

PHILLIPS PHARMACEUTICALS

LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{4F309CA5-0B25-4CDF-A234-

48A56E76C42F}

MODI-MUNDI PHARMA (PVT) LTD

FECONTIN-Z CONTROLLED

RELEASE6361/10/08

FERROUS GLYCINE SULPHATE + ZINC

SULPHATE + FOLIC ACID

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

100MG + 61.8MG + 0.5MG

TABLET (FILM COATED) 1*10*10 BLISTERS INDIA SURGIPHARM (U)

LTDRT24921 DATED

04/03/2011RT28666 DATED

19/08/2011{99A44CB9-120D-4A51B4CF-1C6B00C32933}

IDA FERROUS SULPHATE + FOLIC ACID 6362/10/08 FERROUS SULPHATE

/ FOLIC ACID

BIO NOVA PHARM LTD C-66/1 OKHLA INDUSTIAL AREA

PHASE II NEW DEHLI

200MG + 0.4MG TABLET (SUGAR COATED) 1*1000 HDPE INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11{17E7786E-5616-4015-915A-B95A5974B76F}

MISSION PHARMA A/S

FERROUS SULPHATE + FOLIC ACID 6363/10/08 FERROUS SULPHATE

+ FOLIC ACID

BIO NOVA PHARM LTD C-66/1, OKHLA INDUSTIAL AREA

NEW DELHI

200MG + 0.25MG TABLET (SUGAR COATED) 1*1000 HDPE INDIA JMS 27/06/2011 RT28773 DATED

25/08/2011{89E4A8B4-2920-41B6-8A5F-C2898BC3713C}

Page 82

Page 83: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ALBERT DAVID LTDGLUCOSE

INTRAVENOUS INFUSION

6364/26/08 GLUCOSE

ALBERT DAVID LTD, B-12-13 MEERUT

ROAD INDUSTRIAL AREA GHAZIABAD

50%W/V INFUSION 1*100ML LDPE INDIA ANDYCO PHARMACY 03/04/2010 RT29208 DATED 12/09/2011

{C04D2C26-1143-497D-A9B3-A7B024B4910D}

IDA DEXTROSE 5% 6365/26/08 GLUCOSEALBERT DAVID LTD 15-CHITTARANJAN

AVE. KOLKATA5%W/V INJECTION INFUSION 1*500ML, 1*1000ML INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11

{BC5A7C3B-A0CD-46C8-BEBD-

E69D45BC7F43}

MODI MUNDI PHARMA PVT LTD. NITROCONTIN 6.4 6380/12/08 NITROGLYCERIN

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

6.4MG TABLET (SUSTAINED RELEASE) 1*25 HDPE INDIA SURGIPHARM (U)

LTDRT24921 DATED

04/03/2011RT28666 DATED

19/08/2011

{678D5E67-D9BC-4129-AA9C-

B42FBC869D3B}

AUROBINDO PHARMA LIMITED POZINEG 2000 6384/06/08 CEFEPIME

AUROBINDO PHARMA LIMITED 329/47 CHITKUL

VILLAGE A

2000MG PARENTERAL 1 * 20ML INDIA GITTOES P'CALS LTD 25/02/2010 RT28910 + RT28908 DATED 31/08/2011

{5028B856-9BB0-494F-BC19-

616CC2AAAFEA}

CADILA PHARMACEUTICALS

LIMITEDCEFICAD-2000 6387/06/08 CEFEPIME

CADILA PHARMACEUTICALS

LIMITED 1389 TRABAD ROAD DHOLKA 387810

AHMEDABAD GUJURAT.

2000 MG PARENTERAL 1*20ML VIAL INDIA KARURI P'CALS LTDRT24680 DATED

22/02/2011 RE-INSP FEE

RT29230 DATED 13/09/2011

{ECC0BB50-2B2A-4950-827C-

91D5F8E355CD}

MARCK BIOSCIENCES LTD

PARACETIN EYE DROPS 6391/21/08 CHLORAMPHENICOL

MARCK BIOSCIENCES, PLOT

NO 876 NH NO 8 HARIYALA KHEDA 387411GUJARAT

0.5% W/V EYE DROP 1 * 5ML AMPOULE, 1*10ML VIAL INDIA KARURI P'CALS LTD.

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{B23D1F61-3CCF-48E4-8D11-

5FC107AD261D}

UNICHEM LABORATORIES

LIMITEDCORBIS-10 6401/12/08 BISOPROLOL

UNICHEM LABORATORIES LIMITED UNIT -II,

VILLAGE BHATAULI , BADDI, 173205

DISTRICT SOLAN HIMACHAL PRADESH

10 MG TABLET 1*3*10 BLISTER INDIA NORVIK ENTERPRISES 22/11/10 RT29055 DATED

06/09/11{D2823347-9545-4BFA-AC87-BE549B69E0E0}

UNICHEM LABORATORIES

LIMITEDCORBIS-5 6404/12/08 BISOPROLOL

UNICHEM LABORATORIES LIMITED UNIT -II,

VILLAGE BHATAULI , BADDI, 173205

DISTRICT SOLAN HIMACHAL PRADESH

5 MG TABLET 1*3*10 STRIP INDIA NORVIK ENTERPRISES 22/11/10 RT29055 DATED

06/09/11

{B5F3DEF7-08B3-44CB-B6E6-

736E334BE3A7}

AJANTA PHARMA LIMITED ARTEFAN 6408/06/08 ARTEMETHER

/LUMEFANTRINE

AJANTA PHARMA LTD B-4/5/6 MIDC IND

AREA PAITHAN 4380MG/ 480MG TABLET 1*6 BLISTER INDIA AARON P'CALS LTD 27/11/08 RT28086 DATED

26/07/11

{BE0AB191-CB39-4DDD-AD5C-

B5C0935C2211}

VENUS REMEDIES LIMITED DOXOL 6418/08/08 DOCETAXEL

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

80MG/2ML PARENTERAL 1*20 ML INDIAAARON

PHARMACEUTICALS LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{91A72316-8A8F-46DF-AD44-3C9F86298935}

BAYER SCHERING PHARMA

NEO-PENOTRAN FORTE 6420/06/08 METRONIDAZOLE/

MICONAZOLE

EMBIL PHARMACEUTICAL

CO LTD, BOMONTI, BIHRAHAN

750MG/ 200MG PESSARY 7 * 1 TURKEY SURGIPHARM (U) LTD

{855B3314-F681-4427-BF88-3FC2D5857528}

Page 83

Page 84: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

INTAS PHARMACEUTICALS

LTDDOVERIN-40 6425/17/08 DROTAVERINE

HYDROCHLORIDE

INTAS PHARMACEUTICALS

LTD 7/3 GIDC ESTATE

VATRA,AHMEDABAD 382445

40MG TABLET 1*10*10 BLISTER INDIA NORVIK ENTERPRISES LTD 04/10/11 RT29052 DATED

06/09/11{5BC2BB95-07D5-41378EAD-A5824E007B06}

SOLVAY PHARMACEUTICALS

B.VDUSPATALIN 200 MG 6426/17/08 MEBEVERINE

SOLVAY PHARMACEUTICALS

VEERWEG 12 NL-8121 AA 01ST

200MG TABLET 1*3*10 BLISTER NETHERLANDS PHILLIPS P'CALS LTD 29/09/08 RT17421 DATED16/08/11

{5BCAF36C-FF24-4A06-BE0C-

F2038B566533}

DAWA LIMITED SABULIN SYRUP 6429/25/08 SALBUTAMOL SULPHATE

DAWA LIMITED BABA DOGO ROAD

RUARAKA2MG/5ML SYRUP 1*1*100ML KENYA SUPER MEDIC LTD RT24080 DATED

27/01/2011RT28507 DATED

12/08/2011{90A7B4B0-BB29-4341-B39E-DA1A547618EE}

MEDIPHARM SALES [E.A] LTD

COFFMED SOFT GEL CAPS 6436/25/08

GUIAPHENESINE/PSEUDOEPHEDRINE

HYDROCHLORIDE/DEXTRO

MEGA LIFESCIENCES LTD

384 PATTANA 3 ROAD BANGPOO

INDUSTRIAL ESTATE SUMUTPRAKAN

200MG/ 30MG/ 10MG SOFT GEL CAPS 1*3*10 BLISTER PACK THAILAND MEDIPHARM SALES

LTD 19/03/2011 RT29865 DATED 06/10/2011

{F363FA99-601C-4DAF-A613-

91903866C907}

EMCURE PHARMACEUTICALS

LIMITEDMOFILET-500 6444/08/08 MYCOPHENOLATE

MOFETIL

EMCURE PHARMACEUTICALS LIMITED. PLOT NO. IT

BT PAR

500MG TABLET 1*10 BLISTER INDIAPHILLIPS

PHARMACEUTICALS LTD

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{E1E921BA-8EAA-4EB8-B12B-

E2A9F25C63A7}

CACHET PHARMACEUTICALS

PVT. LTD .ESENVIT 6447/27/08

GLYCERIN/ ZINC SULPHATE/ SODIUM

MOLYBDATE/ MANGANESE

CHLORIDE/ LYSINE HCL

CACHET PHARMACEUTICALSPVT.LTD.415,SHAH

NAHAR,WORLI

5.0G/ 263.83MG/ 0.4035MG/ 57.66MG/

612MGSYRUP 1*60 ML, 1*100 ML INDIA VRUSHIK INVESMENT 30/09/11 RT30959 DATED

08/11/11

{34E87471-3DF2-4C84-9CE9-

DCC7F4793CDE}

FLAMINGO PHARMACEUTCALS ANALMIN 500 6449/02/08 MEFENAMIC ACID

FLAMINGO PHARMACEUTICALS LTD R-662,TTC IND

AREANAR

500MG CAPSULE 1*1*1000HDPE INDIA ABACUS (AFRICA) LTD 17/09/09 RT28444 DATED

09/08/11{6CA5B405-F8E2-4B16B419-674FC2FFC421}

RENE INDUSTRIES LTD IBUREN 6450/02/08 IBUPROFEN

RENE INDUSTRIES, PLOT 680 KAMULI-

KIREKA.200MG TABLET 1* 10 * 10 BLISTER UGANDA RENE PHARMACY ANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011{336A8942-AA74-48C1-8D2D-20500B3DF5E6}

CENTAUR PHARMACEUTICALS

PVT LTDESOREST 6453/17/08 ESOMEPRAZOLE

CENTAUR PHARMACEUTICALS PVT LTD.CENTAUR

HOUSE NEAR

20 MG TABLET 1*10*10 BLISTER INDIA GITTOES P'CALS LTD 22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{624B60D6-E1E4-4096-B042-426A0931D98F}

CENTAUR PHARMACEUTICALS

PVT LTDESOREST 6454/17/08 ESOMEPRAZOLE

CENTAUR PHARMACEUTICALS PVT LTD.CENTAUR

HOUSE NEAR

40 MG TABLET 1*10*10 BLISTER INDIA GITTOES P'CALS LTD 22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{222B5D02-DC77-4418-BDD8-

15B86F64CCAB}

CACHET PHARMACEUTICALS

PVT LTDCACHPAR 6456/02/09 PARACETAMOL

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANA BADD

125MG/5ML ORAL SUSPENSION 1*60ML, 1*100ML INDIA VRUSHIK INVESTMENTS LTD 30/09/11 RT30959 DATED

08/11/11

{8676B6D7-7EBA-492D-BC44-

06DC9CB3B832}

CACHET PHARMACEUTICALS

PVT LTDCACH-E-WORM 6459/06/09 MEBENDAZOLE

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANA BADD

100MG/5ML ORAL SUSPENSION 1*30ML HDPE BOTTLE INDIA VRUSHIK

INVESTMENTS LTD 30/09/11 RT30959 DATED 08/11/11

{55CC3EBA-A19C-49AA-8C52-

DED7599544D6}

CADILA HEALTHCARE LTD

ALZOLE SUSPENSION 6460/06/09 ALBENDAZOLE

SAKAR HEALTHCARE LTD,

PLOT NO. 10-13, SARKHEJ- BAV

200MG/5ML ORAL SUSPENSION 1*1*10ML AMBER GLASS BOTTLE INDIA ABACUS PHARMA (A)

LTDRE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{F3D30B1A-347D-4536-B2C3-53C2EB1230E2}

Page 84

Page 85: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

MODI MUNDI PHARMA PVT LTD UNICONTIN 400 6463/25/09

THEOPHYLLINE (CONTROLLED

RELEASE)

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

400MG TABLET (UNCOATED) 1*10*10 BLISTERS INDIA SURGIPHARM (U) LTD

RT24921 DATED 04/03/2011

RT28666 DATED 19/08/2011

{B5746524-EA40-4A5E-9B1E-4024CA66ED21}

MODI MUNDI PHARMA PVT LTD UNICONTIN 600 6464/25/09

THEOPHYLLINE (CONTROLLED

RELEASE)

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

600MG TABLET (UNCOATED) 1*10*10 BLISTERS INDIA SURGIPHARM (U) LTD

RT24921 DATED 04/03/2011

RT28666 DATED 19/08/2011

{82E07F04-9FAC-459F-AD89-5663A0C0D3C1}

SINO AFRICA MEDICINES & HEALTH LTD

BENZATHINE BENZYL PENICILLIN FOR

INJECTION6471/06/09 BENZATHINE BENZYL

PENICILLIN

SHIJIAZHUANG PHARMA GROUP,

ZHONGNUO PHARMACEUTICAL

2,400,00O IU POWDER FOR INJECTION 1*50 ,1*10 VIAL CHINA

SINO AFRICA MEDICINES & HEALTH LTD

10/11/08 RT28344 DATED 04/08/11

{B93DDA43-0ED0-4DD9-ADC0-

F5237592D818}

SINO AFRICA MEDICINES & HEALTH LTD

BENZYL PENICILLIN SODIUM 6473/06/09 BENZYL PENICILLIN

SODIUM

SHIJIAZHUANG PHARMA GROUP,

ZHONGNUO PHARMACEUTICAL

1,000,000 IU POWDER FOR INJECTION 1*50 ,1*10 VIAL CHINA

SINO AFRICA MEDICINES & HEALTH LTD

10/11/08 RT28344 DATED 04/08/11

{4350142B-5B82-457C-A17C-

FBBDAEA8DB3F}

SINO AFRICA MEDICINES & HEALTH LTD

CHLORAMPHENICOL SODIUM SUCCINATE

FOR INJECTION6474/06/09 CHLORAMPHENICOL

SODIUM SUCCINATE

SHIJIAZHUANG PHARMA GROUP,

ZHONGNUO PHARMACEUTICAL

1G POWDER FOR INJECTION 1*50*1G VIAL CHINA

SINO AFRICA MEDICINES & HEALTH LTD

10/11/08 RT28344 DATED 04/08/11

{547CCBDE-C723-4CB6-B78C-

B55341A2DFCF}

CADILA HEALTHCARE LTD CIPROBID INFUSION 6476/06/09 CIPROFLOXACIN

AHLCON PARENTERALS LTD,

SP-918, PHASE III, INDUSTR

200MG SOLUTION FOR INJECTION

1*1*1*100ML LDPE BOTTLE INDIA ABACUS PHARMA (A)

LTD 21/02/2011 RT28660 DATED 19/08/2011

{01B24B3F-7EA5-4D31AE94-7C6B1F3B9C1C}

AJANTA PHARMA LTD LEVOTOP 500 6477/06/09 LEVOFLOXACINAJANTA PHARMA LTD, B-4/5/6, MIDC INDUSTRIAL AREA,

500MG TABLET (FILM COATED) 1*1*10 BLISTER INDIA

AARON PHARMACEUTICALS

LTD27/11/08 RT28086 DATED

26/07/11

{4DF541EF-3EF7-45CB-AADE-

8D30672506A5}

RENE INDUSTRIES SULPHADIMIDINE 6478/06/09 SULPHADIMIDINERENE INDUSTRIES, PLOT 680, KAMULI,

KIREKA500MG TABLET (UNCOATED) 1*1000 HDPE UGANDA RENE INDUSTRIES ANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011{3BE5EBB6-9513-4982-AA87-0720F64536AF}

AJANTA PHARMA LTD ZAHA-500MG 6482/06/09 AZITHROMYCINAJANTA PHARMA LTD, B-4-5-6, MIDC INDUSTRIAL AREA,

500MG TABLET (FILM COATED) 1*1*3BLISTER INDIA

AARON PHARMACEUTICALS

LTD27/11/08 RT28086 DATED

26/07/11{6CE151EB-356B-4634-84CC-76788FFA1812}

VENUS REMEDIES LTD ROBOL 6483/06/09 DOXORUBIICN HCL

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

50MG/25ML SOLUTION FOR INJECTION

1*30ML AMBER GLASS VIAL INDIA

AARON PHARMACEUTICALS

LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{DF006FF9-A744-4E9B-8A6D-

500CE57EBADC}

MISSION PHARMA COTRIMOXAZOLE 960MG 6486/06/09 SULPHAMETHOXAZO

LE + TRIMETHOPRIM

MEDICAMEN BIOTECHLTD, SP-

1192 A&B PHASE IV INDUSTRIAL AREA,

BHIWADI

800MG + 160MG TABLET (UNCOATED) 1*1000 HDPE INDIA JMS 27/06/2011 RT28773 DATED 25/08/2011

{AC8BA218-BCBD-4E1A-8F31-

B12880E15BEE}

RENE INDUSTRIES LTD AMCLOREN 6491/06/09 AMPICILLIN +

CLOXACILLIN

RENE INDUSTRIES LTD, PLOT 680

KAMULI-KIREKA250MG + 250MG CAPSULE (HARD

GELATIN) 1*100 HDPE UGANDA RENE INDUSTRIES LTD

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{93FF43D3-E368-4B6D-AB6D-6F663E4DE17D}

EMCURE PHARMACEUTICALS

LTDLOMOH-60 6492/10/09 ENOXAPARIN

SODIUM

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

60MG/0.6ML SOLUTION FOR INJECTION

1*1ML PREFILLED GLASS SYRINGE INDIA

PHILLIPS PHARMACEUTICALS

LTD

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{3306608C-BD23-4105-9815-45CF2CD6823E}

EMCURE PHARMACEUTICALS

LTDLOMOH-40 6493/10/09 ENOXAPARIN

SODIUM

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

40MG/0.4ML SOLUTION FOR INJECTION

1*1ML PREFILLED GLASS SYRINGE INDIA

PHILLIPS PHARMACEUTICALS

LTD

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{384BDB8F-0BEB-4DAA-8428-

29F3889ACB1D}

Page 85

Page 86: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

TORRENT PHARMACEUTICALS

LTDSYSCAN-200 6498/06/09 FLUCONAZOLE

TORRENT PHARMACEUTICALS

LTD, INDRAD - 382721, DIST

200MG CAPSULE (HARD GELATIN) 1*1*4 BLISTER INDIA

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {323246ED-04A2-45D6-

9E75-34E7955F9D12}

RENE INDUSTRIES LTD DERMOREN 6500/06/09 GRISEOFULVIN

RENE INDUSTRIES LTD, PLT 680,

KAMULI, KIREKA500MG TABLET (UNCOATED) 1*10*10 BLISTERS UGANDA RENE PHARMACY ANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011

{E526C6D2-2873-44FD-B09E-

CEEFC155CB9B}

CLARIS LIFE SCIENCES LTD FLUCANOL 6501/06/09 FLUCONAZOLE

CLARIS LIFE SCIENCES LTD, CHACHARWADI-

VASANA, SAN

2MG/ML SOLUTION FOR INJECTION 1*1*100ML LDPE INDIA REDDY'S PHARMA

LTD 01/03/2010 RT31356 DATED 24/11/2011

{E097A2C9-6AA6-4FD2-925E-

DECE7654CE1A}

MARCK BIOSCIENCES LTD OCCUMOL 6503/21/09 TIMOLOL MALEATE

MARCK BIOSCIENCES LTD,

PLOT 876, N.H. NO. 8, VIL:

0.25%W/V EYE DROPS 1*5ML VIAL INDIAKARURI

PHARMACEUTICALS LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{963DA67C-4587-420C-A074-D7B3A77A2069}

CACHET PHARMACEUTICALS

PVT LTDCETPRO 6504/03/09 CYPROHEPTADINE

HYDROCHLORIDE

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANA BADD

2MG/5ML SYRUP 1*100ML AMBER PET BOTTLE INDIA VRUSHIK

INVESTMENTS LTD 30/09/11 RT30959 DATED 08/11/11

{9A8B2384-3E9F-4E69-9817-D373110945AE}

UNIMED INDIA DYNAPET SYRUP 6505/03/09CYPROHEPTADINE +

TRICHOLINE + SORBITOL

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

2MG/5ML + 2.75MG/5ML + 3.58MG/5ML

SYRUP 1*1*200ML INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{5367DAEC-AB66-4E81-8023-

F9E4549ABE97}

EMCURE PHARMACEUTICALS

LTDFOSEAL 400 6506/26/09 SEVELAMER HCL

EMCURE PHARMACEUTICALS LTD C-10(12) MIDC

BHOSAN PUNE

400MG TABLET (FILM COATED) 1*1*1*10 BLISTER INDIA

PHILIPS PHARMACEUTICALS

LTD

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{46455BB1-E7CC-41AC-AE3B-

818A439B4A7E}

TORRENT PHARMACEUTICALS

LTDLORVAS SR 6509/12/09 INDAPAMIDE

TORRENT PHARMACEUTICALS

LTD, INDRAD - 382721, MEHS

1.5MG TABLET (FILM COATED) 1*3*10 BLISTERS INDIA

KARURI PHARMACEUTICALSL

TD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{FBEF503A-E6E9-4FE3-8737-

86578E5FD95B}

ARISTO PHARMACEUTICALS

LTD

ARISTO TELVAS H 40/12.5 6512/12/09

TELMISARTAN + HYDROCHLOROTHIA

ZIDE

ARISTO PHARMACEUTICALS

LTD, PLOT NO208, NEW INDUST

40MG + 12.5MG TABLET (UNCOATED) 1*10*10 ALU-ALU STRIPS INDIA NORVIK

ENTERPRISES LTD 18/03/2010 RT28634 DATED 19/08/2011

{396479FE-7845-48D6-870C-D2D75837FD15}

BAYER SCHERING PHARMA NIMOTOP 30MG 6513/12/09 NIMODIPINE

BAYER HEALTHCARE AG, D-51368, LEVERKUSEN

30MG TABLET (FILM COATED)

1*10*10 ALU-ALU BLISTERS GERMANY SURGIPHARM (U)

LTD

{3BAC9C52-41A6-4D65-99E9-

C82ACBB1F16B}

NOVARTIS PHARMA AG

COARTEM DISPERSIBLE

TABLETS6515/06/09 ARTEMETHER +

LUMEFANTRINE

NOVARTIS PHARMACEUTICALS CORPORATION, 25

OLD MILL

20MG + 120MG TABLET (UNCOATED) 1*36*6, 1*30*6 BLISTERS USA SURGIPHARM (U)

LTD

{8EFD473D-2A5F-4DC0-A703-

50556E62B2AA}

UGANDA HEALTH MARKETING GROUP CLOVIREX 200 6528/06/09 ACYCLOVIR

CIPLA LTD, 33, MIDC PATALGANGA, DIST:

RAIG MAHARAS200MG TABLET (UNCOATED) 1*10*10 BLISTERS INDIA UGANDA HEALTH

MARKETING GROUP 20/03/08 + RT23058 RT28149 DATED 27/07/11

{CE59389D-22A6-42CE-AEDA-

1635A8DB088E}

UGANDA HEALTH MARKETING GROUP

CLOVIREX 400 (DISPERSIBLE) 6529/06/09 ACICLOVIR

CIPLA LTD, A-33, MIDC, PATALGANGA,

DIST. RAIGAD400MG TABLET (UNCOATED) 1*10*10 BLISTERS INDIA UGANDA HEALTH

MARKETING GROUP 20/03/08 + RT23058 RT28149 DATED 27/07/11

{DC1116AA-49F3-4D45-8758-

2CB704978E2E}

UGANDA HEALTH MARKETING GROUP CLOVIREX 6530/06/09 ACICLOVIR

CIPLA LTD, VERNA INDUSTRIAL

ESTATE, VERNA GOA, 403

5%W/W CREAM 1*5G &1*10G TUBES INDIA UGANDA HEALTH MARKETING GROUP 16/10/06 + JV09/357 RT28149 DATED

27/07/11

{13C1B74A-CE63-4FF0-8AD7-

4B7FE97BC375}

FLAMINGO PHARMACEUTICALS

LTDACICLOVIR 6531/06/09 ACICLOVIR

FLAMINGO PHARMACEUTICALS LTD, RABALE NAVI

MUMBAI

400MG TABLET (UNCOATED) 1*3*10 BLISTERS INDIA ABACUS PHARMA (A) LTD 17/09/09 RT28444 DATED

09/08/11{0287B120-937B-4F54-95F0-40F2B5503A79}

MATRIX LABORATORIES LTD

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

6532/30/09LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

MATRIX LABORATORIES LTD, F-4, F-12, MALEGAN,

MIDC,

30MG + 50MG + 60MG TABLET (UNCOATED) 1*60 HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{089CB021-0A00-4D3AB9BE-FE51604456D1}

HETERO DRUGS LTD ESTIVA-600 6533/30/09 EFAVIRENZHETERO DRUGS

LTD, UNIT-111, 22-110 I.D.A, JEEDIMET

600MG TABLET (FILM COATED) 1*30HDPE INDIA ASTRA PHARMA

UGANDA LTD 17/12/09 RT28304 DATED 03/08/11

{C80E928B-554C-4857-987D-4FA872142874}

Page 86

Page 87: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

MATRIX LABORATORIES LTD

LAMIVUDINE + ZIDOVUDINE 6534/30/09 LAMIVUDINE +

ZIDOVUDINE

MATRIX LABORATORIES LTD, F-4, F-12, MALEGAN,

MIDC,

30MG + 60MG TABLET (FILM COATED) 1*60 HDPE INDIA

PHILLIPS PHARMACEUTICALS

LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{198FAB56-2EC9-4909-84B6-A10E3F138CB5}

CACHET PHARMACEUTICALS

LTD,EASCOF 6536/25/09

BROMHEXIDINE HCL + SALBUTAMOL

SULPHATE + GUAIPHENESIN

CACHET PHARMACEUTICALS

LTD, VILLAGE- THANA, BADI,

24MG/100ML + 42MG/100ML + 1G/ML SYRUP 1*100ML BOTTLE INDIA

VRUSHIK INVESTMENTS (U)

LTD30/09/11 RT30959 DATED

08/11/11{18FF7330-EEB4-4F2F-9657-AA1B9E166DB9}

CACHET PHARMACEUTICALS

PVT LTDCACHFER 6537/10/09 IRON + FOLIC ACID +

VITAMIN B12

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANE, BAD

32MG/15ML + 0.5MG/15ML + 7.5MCG/15ML

ORAL SUSPENSION 1*1*100ML, 1*1*200ML PET BOTTLE INDIA

VRUSHIK INVESTMENTS (U)

LTD30/09/11 RT30959 DATED

08/11/11{D8C78314-16B1-4462-B520-30B71C1FB124}

SINO AFRICA MEDICINES & HEALTH LTD

DICLOFENAC SODIUM INJECTION 6541/02/09 DICLOFENAC

SODIUM

ZHEJIANG TIANFENG PHARMACEUTICAL FACTORY, NO 518 D

75MG/3ML SOLUTION FOR INJECTION 1*10*10 AMPOULES CHINA

SINO AFRICA MEDICINES & HEALTH LTD

11/09/08 RT28343 DATED 04/08/11

{6EBBB66B-400F-4EFA-9BEC-

0318D3D7DBB3}

FLAMINGO PHARMACEUTICALS

LTDPIROXICAM 6543/02/09 PIROXICAM

FLAMINGO PHARMACEUTICALS LTD, RABALE NAVI

MUMBAI

20MG CAPSULE (HARD GELATIN) 1*10*10 BLISTERS INDIA ABACUS PHARMA (A)

LTD 17/09/09 RT28444 DATED 09/08/11

{0B3EF7F8-C33F-4C9F-A852-

7E68D4D1294A}

SK AGE EXPORT DINAC GEL 6544/02/09 DICLOFENACS.KANT HEALTH CARE LTD, 1802-

1805, GIDC, PHASE III1%W/W GEL 1*20G ALUMINIUM

TUBE INDIA ABACUS PHARMA (A) LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{718C5605-6434-4C86-93F5-8ED74FD6D5EA}

SHANGHAI PHARMA INDUSTRIAL CO. LTD INDOMETACIN 6545/02/09 INDOMETHACIN

HOLLEY PARMACEUTICALS (CHONGQUING) CO

LTD NO ,18 1ST ROAD ,TONGXING INDUSTRIAL PARK,

CHINA

25MG CAPSULE (HARD GELATIN)

1*1000 HDPE, 1*10*10 BLISTER PACK CHINA ABACUS PHARMA (A)

LTD

RT27821 DATED 14/07/2011 RE-INSP

FEE

RT29181 DATED 09/07/2011

{83FC6695-828C-464D-8DDC-

8F67ED4D88BE}

SK AGE EXPORTS SILVER KANT 6550/13/09 SILVER SULPHADIAZINE USP

S KANT HEALTHCARE LTD,

1802-1805 GIDC PHASE 111, V

1%W/W CREAM 1*15G TUBE INDIA ABACUS PHARMA (A) LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{CBE06FD9-047E-4371-A55C-

E2C1E91197F6}

SK AGE EXPORTS HYDROKANT 6552/13/09 HYDROCORTISONE ACETATE

S KANT HEALTHCARE LTD,

1802-1805, GIDC PHASE 111,

1%W/W CREAM 1*1*15G TUBE INDIA ABACUS PHARMA (A) LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{87371BCC-8C4B-4BDA-A4CF-

AE036F4F868F}

DAWA LTD CURAMOL SUSPENSION 6556/02,09 PARACETAMOL

DAWA LTD, BABA DOGO ROAD,

RUARAKA120MG/5ML ORAL SUSPENSION 1*60ML & 1*100ML

BOTTLES KENYA SUPERMEDIC RT24080 DATED 27/01/2011

RT28507 DATED 12/08/2011

{6470F8F0-E71F-4B78-A836-2C9AAEE37689}

DAWA LTD WOMNIL 6557/06/09 ALBENDAZOLEDAWA LTD, PLOT

7879/8, BABA DOGO ROAD, RUARAKA

200MG/5ML ORAL SUSPENSION 1*10ML BOTTLE KENYA SUPER MEDIC RT24080 DATED 27/01/2011

RT28507 DATED 12/08/2011

{C2E7375F-41DA-4EB0-B6AA-

B09BD2DC542A}

MODI-MUNDI PHARMA PVT LTD NITROCONTIN 2.6 6561/12/09

NITROGLYCERINE (CONTROLLED

RELEASE)

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

2.6MG TABLET (UNCOATED) 1*25 HDPE INDIA SURGIPHARM (U) LTD

RT24921 DATED 04/03/2011

RT28666 DATED 19/08/2011

{585B7924-893E-4E17-B3DA-

CEFB258C1DFF}

CACHET PHARMACEUTICALS

LTDNEST 6562/25/09 AMINOPHYLLINE

CACHET PHARMACEUTICALS

LTD, VILLAGE THANA, BADDI,

100MG TABLET (UNCOATED) 1*1000 HDPE INDIAVRUSHIK

INVESTMENTS (U) LTD

30/09/11 RT30959 DATED 08/11/11

{1B588B2B-3247-4906-A9E5-EB73B8D04BE2}

CADILA PHARMACEUTICALS

LTDCEFICAD 1000 6566/06/09 CEFEPIME HCL

CADILA PHARMACEUTICALS LTD, 1389 DHOLKA ,

387810,

1000MG POWDER FOR INJECTION

1*1*1000MG *20ML VIAL INDIA

KARURI PHARMACEUTICALS

LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{DA4A6F1C-DA62-4BC5-8788-

B040172869F2}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

GENTAMYCIN EYE/EAR DROPS 6573/21/09 GENTAMYCIN

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

0.3%W/V EYE/EAR DROPS 1*10ML INDIA RENE PHARMACY LTD

RE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{EB792C1C-0ADC-4F5D-941F-

DA63657F14C1}

Page 87

Page 88: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

GLAXOSMITHKLINE LTD CLAVULIN 6574/06/09 AMOXICILLIN/CLAVUL

ANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICALS, CLAREDON ROAD, WORTHING WEST, SUSSEX, BN1480H

1000MG/200MG POWDER FOR INJECTION 1*10 VIALS UNITED KINGDOM ERIS LTD 19/08/09 RT28825 DATED

27/08/11

{8A8C099F-DFC8-4469-9BBC-

AC4F960224DF}

GLAXOSMITHKLINE LTD CLAVULIN 6575/06/09 AMOXICILLIN/CLAVUL

ANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICALS, CLAREDON ROAD, WORTHING WEST, SUSSEX, BN1480H

500MG/100MG POWDER FOR INJECTION 1*10 VIALS UNITED KINGDOM ERIS LTD 19/08/09 RT28825 DATED

27/08/11{43C405A2-61A9-4BFF-92B1-FF8E49F4B319}

VENUS RE,MEDIES LTD SULBACTOMAX 1.5G 6576/06/09 CEFTRIAXONE +

SULBACTAM

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

1G + 0.5G POWDER FOR INJECTION 1*20ML VIAL INDIA

AARON PHARMACEUTICALS

LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{3EBFCCDE-214C-4E4A-ABE7-

FE6F500E7C9D}

CACHET PHARMACEUTICALS

PVT LTDCAZITHRO 6577/06/09 AZITHROMYCIN

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANE, BADDI

200MG/5ML ORAL SUSPENSION 1*1*15ML BOTTLE + 1 DROPPER INDIA VRUSHIK

INVESTMENT (U) LTD 30/09/11 RT30959 DATED 08/11/11

{E9BDC778-A176-426F-955C-

EAD3E7599827}

MARCK BIOSCIENCES LTD

XCIPRO EYE/EAR DROPS 6579/21/09 CIPROFLOXACIN

MARCK BIOSCIENCES LTD, PLOT 870, NH NO.8,

KHEDA 38

0.3%W/V OPTHALAMIC SOLUTION 1*1*5ML VIAL INDIA

KARURI PHARMACEUTICALS

LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{9D76822A-4B79-4A87-8EB5-24AF0FD3857F}

AUROBINDO PHARMA LTD TRIAXONE 1000 6581/06/09 CEFTRIAXONE

AUROBINDO PHARMA LTD, UNIT VI, SY. NO 329/39,

329/

1000MG POWDER FOR INJECTION 1*1 VIAL INDIA

GITTOES PHARMACEUTICALS

LTD25/02/2010 RT28910 + RT28908

DATED 31/08/2011{4730DFB5-BA62-475A9BBF-EB89A4775371}

AUROBINDO PHARMA LTD

AMPICILLIN FOR INJECTION 6582/06/09 AMPICILLIN SODIUM

AUROBINDO PHARMA LTD, UNIT-

XII, SY. NO.314 BACHUPA

500MG/VIAL POWDER FOR INJECTION 1*500MG VIAL INDIA

GITTOES PHARMACEUTICALS

LTD17/05/2010 RT28910 + RT28908

DATED 31/08/2011

{7C743670-BEEA-4476-8B52-

BDDBD70C9F8D}

MEDICAL UNION P'CAL CO. MOXACIL 6586/06/09 AMOXYCILLIN

TRIHYDRATE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA125MG/5ML POWDER FOR ORAL

SUSPENSION 1*100ML EGYPTKARURI

PHARMACEUTICALS LTD

12/10/2009 RT27905 DATED 18/07/2011

{4D550715-FE5E-470D-96AC-0EF77DF6DC81}

SINO AFRICA MEDICINES & HEALTH LTD

STREPTOMYCIN 6587/06/09 STREPTOMYCIN SULPHATE

CSPC ZHONGNUO PHARMACEUTICAL

COMPANY LTD1G POWDER FOR

INJECTION 1*50 VIALS CHINASINO AFRICA MEDICINES & HEALTH LTD

10/11/08 RT28343 DATED 04/08/11

{5FDC631A-73CD-494D-9000-

DEFEEDB61DB9}

CADILA PHARMACEUTICALS

LTDFYTOBACT 6589/06/09 CEFOPERAZONE/SUL

BACTAM

CADILA PHARMACEUTICALS LTD, 1389 TRASAD

RD DHOLKA

604.96MG/570.03MG POWDER FOR INJECTION 1*1 VIAL INDIA

CADILA PHARMACEUTICALS

LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{8AEE2FA1-6AB6-4C50-824B-

89DB390039B4}

VENUS REMEDIES LTD PISA 6592/06/09 PIPERACILLIN +

TAZOBACTAM

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

4000MG/VIAL + 500MG/VIAL

POWDER FOR INJECTION 1*1*30ML VIAL INDIA

AARON PHARMACEUTICALS

LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{D7C89666-2350-466D-926A-1683C0B4E7D6}

VENUS REMEDIES LTD TREXOL 6601/08/09 METHOTREXATE

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

50MG SOLUTION FOR INJECTION 1*1*2ML VIAL INDIA

AARON PHARMACEUTICALS

LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{07AC41F6-4CBB-404B-A913-

BBD66528DD37}

Page 88

Page 89: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

VENUS RE,MEDIES LTD CITABOL 6602/08/09 GEMCITABINE

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

2MG/ML INJECTION 1*50ML VIAL INDIAAARON

PHARMACEUTICALS LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{6CF1690E-0FC5-4CBA-9017-

24CB73D09DEE}

VENUS REMEDIES LTD PARIN E 6604/10/09 ENOXAPARIN

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

80MG INJECTION 1*10*2 PRE-FILLED SYRINGE INDIA

AARON PHARMACEUTICALS

LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{1CEB8CBF-640B-4497-B031-

DBC697E9CDFB}

CACHET PHARMACEUTICALS

PVT LTDCAMET 6606/17/09 METOCLOPRAMIDE

HYDROCHLORIDE

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANE, BAD

10MG TABLET 1*10*10 BLISTERS INDIAVRUSHIK

INVESTMENTS (U) LTD

30/09/11 RT30959 DATED 08/11/11

{6C97F06B-AFC9-4E27-8D08-

481478BB5ADD}

TORRENT PHARMACEUTICALS

LTD

VALPARIN CHRONO 500 6607/05/09

SODIUM VLAPROATE (CONTROLLED

RELEASE)

TORRENT PHARMACEUTICALS

LTD, INDRAD- 382721, MEHSA

500MG TABLET (FILM COATED) 1*10*10 STRIPS INDIA

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{DB147EDF-CC18-4629-AF20-

CFC98178122C}

CACHET PHARMACEUTICALS

PVT LTDNICOSTAT 6609/06/09 KETOCONAZOLE

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANA, BAD

200MG TABLET (UNCOATED) 1*10*10 BLISTERS INDIAVRUSHIK

INVESTMENTS (U) LTD

30/09/11 RT30959 DATED 08/11/11

{3AD79282-7072-4CC4-9C6A-1808BC93A16A}

CADILA HEALTHCARE LTD LAMIFINE 250 6612/06/09 TERBINAFINE

CADILA HEALTHCARE LTD, SARKHEJ-BAVLA,

N.H. NO. 8A

250MG TABLET 1*14 BLISTERS INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{3CCB6F63-154C-4306-B05B-8F19C7C2F293}

DAWA LTD DAWASTIN 6616/06/09 NYSTATINDAWA LTD, PLOT

7879/8, BABA DOGO ROAD, RUARAKA

100,000IU/ML ORAL SUSPENSION 1*30ML BOTTLE KENYA SUPER MEDIC RT24080 DATED 27/01/2011

RT28507 DATED 12/08/2011

{93A6A391-314C-4BF1-ACA1-057664180EAB}

CACHET PHARMACEUTICALS

LTDCACHET 6617/03/09 CETIRIZINE HCL

CACHET PHARMACEUTICALS

LTD, VILLAGE-THANA, BADDI,

10MG TABLET (UNCOATED) 1*4*5*10 BLISTERS INDIAVRUSHIK

INVESTMENTS (U) LTD

30/09/11 RT30959 DATED 08/11/11

{17BA76E9-8D9E-4FC0-96F1-

40FE93BFCAEA}

DAWA LTD DAWA-PROM 6618/03/09 PROMETHAZINE HCLDAWA LTD, PLOT

7879/8, BABA DOGO ROAD, RUARAKA

25MG TABLET (SUGAR COATED) 1*1000 HDPE KENYA SUPER MEDIC RT24080 DATED

27/01/2011RT28507 DATED

12/08/2011{E01B4303-829D-41DEBF2B-B94C5AC77F17}

BAYER SCHERING PHARMA NIMOTOP 6629/12/09 NIMODIPINE

BAYER HEALTHCARE AG, D-51368 LEVERKUSEN

0.2MG/ML SOLUTION FOR INJECTION 1*50ML VIAL GERMANY SURGIPHARM (U)

LTD{FB8818DF-3557-4F7C-A696-C7784E2CAC53}

IDASODIUM

STIBOGLUCONATE INJECTION

6630/06/09 SODIUM STIBOGLUCONATE

ALBERT DAVID LTD 15-CHITTARANJAN

AVE. KOLKATA100MG/ML INJECTION

SOLUTION 1*30ML VIAL INDIA JOINT MEDICAL STORES

JV11/017 DATED 08/07/11

{3CCC7B66-78C0-46B3-8F36-

0B2C4908E94E}

MISSION PHARMA A/S

STERILE QUININE HYDROCHLORIDE CONCENTRATE BP

6631/06/09 QUININE HYDROCHLORIDE

GLAND PHARMA LTD, D.P PALLY

SURVEY NOS 143-148, 15

300MG/ML SOLUTION FOR INJECTION

1*10*10*2ML AMPOULES INDIA JMS 27/06/2011 RT28773 DATED

25/08/2011{65C89A1B-78A8-4BF6B95F-512B60A08B15}

MISSION PHARMA A/S QUININE SULPHATE 6632/06/09 QUININE SULPHATE

MEDICAMEN BIOTECHLTD, SP-

1192 A&B PHASE IV INDUSTRIAL AREA,

BHIWADI

300MG TABLET (FILM COATED) 1*1000 HDPE INDIA JMS 27/06/2011 RT28773 DATED

25/08/2011{F10F0590-EAA5-4D06-A7C0-55E6212FCE6B}

GLAXO SMITHKLINE LTD

AVAMYS NASAL SPRAY 6639/28/09 FLUTICASONE

FUROATE

GLAXO OPERATIONS UK LTD, HARMIRE ROAD, BERNARD

CASTLE

27.5 MCG / ACTUATION NASAL SPRAY 1*120 ACTUATIONS

(SPRAYS) UK ERIS LTD 18/08/09 RT28825 DATED 27/08/11

{61D3B29F-3883-4BDE-944C-

5089E96FEB2E}

Page 89

Page 90: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

STRIDES ARCOLAB LTD

RIFAMPICIN + ISONIAZID 6640/06/09 RIFAMPICIN +

ISONIAZID

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

150MG + 75MG TABLET (FILM COATED) 1*24*28 BLISTERS INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{85496661-78FA-4C7A-9D2B-7C7C42D1A416}

AUROBINDO PHARMA LTD ZOLCER 6641/17/09 OMEPRAZOLE

AUROBINDO PHARMA LTD, UNIT

111, NO. 313, BACHUPALL

20MG CAPSULE (HARD GELATIN) 1*10*10 STRIPS INDIA

GITTOES PHARMACEUTICALSL

TD20/05/2010 RT28910 + RT28908

DATED 31/08/2011{58489F60-B62A-468C-94C7-275D01F70E25}

STRIDES ARCOLAB LTD

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

6647/30/09LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

150MG + 200MG + 300MG

TABLET (FILM COATED) 1*60 HDPE INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{49D60EEE-8DF3-4AEB-B230-

43D229927234}

AUROBINDO PHARMA LTD

STAVUDINE + LAMIVUDINE + NEVIRAPINE

6651/30/09STAVUDINE + LAMIVUDINE + NEVIRAPINE

AUROBINDO PHARMA LTD, UNIT

111, SURVEY NO 313, BAC

30MG + 150MG + 200MG TABLET (UNCOATED) 1*1*60 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011

{27CEFB41-7FB7-4F3C-974F-

BA45A92B680E}

STRIDES ARCOLAB LTD

ABACAVIR SULPHATE TABLETS 6652/30/09 ABACAVIR

SULPHATE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

300MG TABLET (FILM COATED) 1*60 BOTTLE INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP.

RT30095 DATED 12/10/2011

{34F4884A-6D82-4666-9754-7D43CA2C3B53}

AUROBINDO PHARMA LTD

DIDANOSINE DELAYED -RELEASE 6653/30/09 DIDANOSINE

DELAYED -RELEASE

AUROBINDO PHARMA LTD, UNIT

111 SURVEY NO 313, BACH

250MG CAPSULES (HARD GELATIN) 1*30 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011{29D64296-4403-47E6-87A7-71B9F730A374}

AUROBINDO PHARMA LTD

EMTRICITABINE + TENOFOVIR DISOPROXIL

6654/30/09EMTRICITABINE +

TENOFOVIR DISOPROXIL

AUROBINDO PHARMA LTD, UNIT

111 SURVEY NO.313, BACH

200MG + 300MG TABLET (FILM COATED) 1*30 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011

{A504D4B7-EE89-48ED-B568-

8E51C46D1406}

AUROBINDO PHARMA LTD

DIDANOSINE DELAYED-RELEASE 6655/30/09 DIDANOSINE

AUROBINDO PHARMA LTD, UNIT

111 SURVEY NO.313, BACH

400MG CAPSULE (HARD GELATIN) 1*30 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011

{143FA430-0056-4A94-8DBF-

F74B63A0C2CE}

BAYER SCHERING PHARMA MIRENA 6658/18/09 LEVONORGESTREL

BAYER SCHERING PHARMA OY,

PANSLONTIE 47 20210 TURK

52MG IUD 1*1 IUD FINLAND SURGIPHARM (U) LTD

{06159B7B-CB8A-4D8F-916A-

F6638F6817BE}

ARISTO PHARMACEUTICALS

LTDAMBRODIL 6665/25/09 AMBROXOL HCL

ARISTO PHARMACEUTICALS PVT LTD, PLOT NO

208, NEW I

7.5MG/ML ORAL SOLUTION 1*15ML INDIA NORVIK ENTERPRISES LTD 18/03/2010 RT28634 DATED

19/08/2011{0014E715-6233-4560-9024-A8504F0A9566}

DAWA LTD DAWAVITE SYRUP 6667/27/09 MULTI-INGREDIENTDAWA LTD, BABA

DOGO ROAD, RUARAKA, NAIROBI

MULTI-INGREDIENT SYRUP 1*60ML, 1*100ML KENYA SUPERMEDIC LTD RT24080 DATED 27/01/2011

RT28507 DATED 12/08/2011

{73F7658F-093E-436A-A3CA-05D0D1202061}

MEDIPHARM SALES LTD GUFEN 400 6669/02/09 IBUPROFEN

MEGA LIFESCIENCES LTD

384 PATTANA 3 ROAD BANGPOO

INDUSTRIAL ESTATE SUMUTPRAKAN

400MG CAPSULE (SOFT GELATIN) 1*6*1*10 BLISTERS THAILAND MEDIPHARM SALES

LTD 19/03/2011 RT29865 DATED 06/10/2011

{5F1C5600-DD01-45B9-9B40-150A346D3E7B}

RENE INDUSTRIES LTD DICLOREN 6670/02/09 DICLOFENAC

SODIUM

RENE INDUSTRIES LTD, PLOT 680,

KAMULI, KIREKA50MG TABLET (ENTERIC

COATED) 1*10*10 BLISTERS UGANDA RENE INDUSTRIES LTD

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{619F1B89-3E84-4B65-A5EE-66935C65E77B}

CACHET PHARMACEUTICALS

PVT LTDARTIMED 6671/02/09 DICLOFENAC

SODIUM

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANA, BAD

50MG TABLET (ENTERIC COATED) 1*10*10 BLISTERS INDIA

VRUSHIK INVESTMENTS (U)

LTD30/09/11 RT30959 DATED

08/11/11{F53E45BF-1B15-4909-8870-0B61E32ED9D0}

DAWA LTD BENZYL BENZOATE LOTION 6679/13/09 BENZYL BENZOATE

DAWA LTD, BABA DOGO ROAD,

RUARAKA25%W/V LOTION 1*100 BOTTLE KENYA SUPER MEDIC LTD RT24080 DATED

27/01/2011RT28507 DATED

12/08/2011

{73DB53BC-E23F-4342-BFF9-

5408C6BC8084}

Page 90

Page 91: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

GLAXOSMITHKLINE LTD ROTARIX 6688/19/09 ROTAVIRUS VACCINE

GLAXOSMITHKLINE BIOLOGICALS S.A.,

RUE DE L'INSTITUTE1 MEGA CCID50

LYOPHILIZED POWDER FOR ORAL

SUSPENSION1*1 VIAL BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11{25618AAA-C636-4653-9983-FB3396022EF3}

MEDIPHARM SALES LTD MEDITROL 6690/27/09 CALCITROL

MEGA LIFESCIENCES LTD

384 PATTANA 3 ROAD BANGPOO

INDUSTRIAL ESTATE SUMUTPRAKAN

0.25MCG CAPSULE (SOFT GELATIN) 1*6*5 BLISTERS THAILAND MEDIPHARM SALES

LTD 19/03/2011 RT29865 DATED 06/10/2011

{96AA5B1F-CD01-4AAA-B548-

CC32EB15828B}

MISSION PHARMA A/S

ZINC SULPHATE TABLET USP 6694/27/09 ZINC SULPHATE

MEDICAMEN BIOTECHLTD, SP-

1192 A&B PHASE IV INDUSTRIAL AREA,

BHIWADI

20MG TABLET (DISPERSIBLE) 1*10*10 BLISTERS INDIA JMS 27/06/2011 RT28773 DATED

25/08/2011

{8F29CF83-3DFD-4F54-A4C6-

7FB8CBDFA8E4}

ARISTO PHARMACEUTICALS

PVT LTDMIKACIN 6708/06/09 AMIKACIN SULPHATE

ARISTO PHARMACEUTICALS LTD, PLOT NO 208,

NEW INDUS

500MG/2ML SOLUTION FOR INJECTION

1*5*8*2ML VIALS, 1*1*2ML VIALS INDIA

NORVIK ENTERPRISES (U)

LTD18/03/2010 RT28634 DATED

19/08/2011{C578F876-3662-4589-B4D2-DD3398A2D666}

CADILA HEALTHCARE LTD AZICIN-250 6710/06/09 AZITHROMYCIN

ALLY PHARMA OPTIONS PVT LTD, J-7, MIDC, TARAPUR IN

250MG TABLET (FILM COATED) 1*1*6 BLISTER INDIA ABACUS PHARMA (A)

LTD 28/02/2011 RT28660 DATED 19/08/2011

{30381A25-7683-42D0-8DEE-B9C107F5693A}

CADILA HEALTHCARE LTD AZICIN-500 6711/06/09 AZITHROMYCIN

ALLY PHARMA OPTIONS PVT LTD, J-7, MIDC, TARAPUR IN

500MG TABLET (FILM COATED) 1*1*3 BLISTER INDIA ABACUS PHARMA (A)

LTD 28/02/2011 RT28660 DATED 19/08/2011

{98672C7B-0728-4B36-9D00-B3AB11465CDC}

KAMPALA PHARMACEUTICAL INDUSTRIES (1996)

LTD

CEFTONE 6712/06/09 CEFTRIAXONE

ALKEM LABORATORIES LTD,

PLOT 333/1, KACHIGAM NANI DAMAN, 396210

(MANUFACTURING), KAMPALA

PHARMACEUTICAL INDUSTRIES (PACKAGING)

1G POWDER FOR INJECTION

1*1*1GVIAL + 1*10ML WATER FOR INJECTIONS

INDIA, UGANDA K.P.I ANNUAL RT29128 DATED 07/09/2011

{1B18AE98-581A-4E10-9021-B2E9A0FCEB20}

AEGIS LTD CLERON 125MG/5ML 6714/06/09 CLARITHROMYCIN

AEGIS LTD, ERGATES

INDUSTRIAL AREA, P.O.BOX 28629/

125MG/5ML POWDER FOR ORAL SUSPENSION 1*100ML BOTTLE CYPRUS SURGIPHARM (U)

LTD 01/07/11 RT28278 DATED 02/08/11

{0A90B02B-B8DD-4A05-880E-

5E31F12976E5}

MISSION PHARMA A/S

AMOXICILLIN ORAL SUSPENSION 6717/06/09 AMOXICILLIN

MEDICAMEN BIOTECHLTD, SP-

1192 A&B PHASE IV INDUSTRIAL AREA,

BHIWADI

125MG/5ML ORAL SUSPENSION 1*100ML HDPE INDIA JMS 27/06/2011 RT28773 DATED 25/08/2011

{C2AE7081-94BD-490B-A83E-

B0A3EFD6AC56}

BAYER SCHERING PHARMA XARELTO 10MG 6726/10/09 RIVAROXABAN

BAYER HEALTHCARE AG, D-51368, LEVERKUSEN,

GERMANY

10MG TABLET (FILM COATED) 1*1*10 BLISTER GERMANY SURGIPHARM (U)

LTD

{07CF2D71-BE38-41AF-8728-

549BD191FBA1}

TORRENT PHARMACEUTICALS

LTD

VALPARIN CHRONO 300 6730/20/09 SODIUM VALPROATE

TORRENT PHARMACEUTICALS

LTD, INDRAD- 382721, MEHSA

300MG TABLET (FILM COATED) 1*10*10 STRIPS INDIA

KARURI PHARMACEUTICALS

LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {38A5B9BD-44A0-4845-

A779-1848975081E2}

ALCON PHARMACEUTICALS

LTDAZOPT 6732/21/09 BRINZOLAMIDE

ALCON COUVREUR NV B-2870 PUURS

BELGIUM10MG/ML EYE DROP

SUSPENSION 1*5ML LDPE BELGIUM KARURI PHARMA. LTD

RT27350 DATED 27/06/2011

RT28865 DATED 29/08/2011

{599BAC72-3871-4B72-ACB2-

A6DB09D2F4EE}

ALCON PHARMACEUTICALS

LTDTRAVATAN 6733/21/09 TRAVOPROST

ALCON COUVREUR NV, RIJKSWEG 14, B-

2870 PUURS BELGIUM

4µG/ML EYE DROP SOLUTION 1*2.5ML LDPE BELGIUM KARURI PHARMA. LTD

RT27350 DATED 27/06/2011

RT28865 DATED 29/08/2011

{03784FEF-F0E7-40F4-A58B-F00510B7A2C7}

CADILA HEALTHCARE LTD RHIZIN 6734/03/09 CETIRIZINE

HYDROCHLORIDE

ALLY PHARMA OPTIONS PVT LTD, J-7, MIDC, TARAPUR IN

10MG TABLET 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD 28/02/2011 RT28660 DATED

19/08/2011{9A5BB9F2-B096-49AB8532-D9BE3546A39D}

Page 91

Page 92: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

UNICHEM LABORATORIES LTD LEZYNCET 6735/03/09 LEVOCETRIZINE

UNICHEM LABORATORIES LTD,

UNIT II, VILLAGE BHATANL

5MG TABLET (FILM COATED)

1*2*10, 5*2*10 BLISTERS , INDIA

NORVIK ENTERPRISES (U)

LTD22/11/10 RT29055 DATED

06/09/11

{1DB0B49F-DC89-4764-A876-

5D7FFF0D1F10}

ALCON PHARMACEUTICALS

LTDPATANOL 6736/03/09 OLOPTADINE

HYDROCHLORIDE

ALCON COUVREUR NV, RIJKSWEG 14, B-

2870 PUURS BELGIUM

1%W/V EYE DROP SOLUTION 1*5ML LDPE BELGIUM KARURI PHARMA. LTD

RT27350 DATED 27/06/2011

RT28865 DATED 29/08/2011

{25F96FCA-CB09-4765-BB5D-BB5721F2EB06}

EMCURE PHARMACEUTICALS

LTDMETPURE-XL 50 6737/12/09

METOPROLOL (EXTENDED

RELEASE TABLETS)

EMCURE PHARMACEUTICALS LTD, P-2 PHASE 11,

I.T PARK MIDC, HINJWADI, PUNE

411057

50MG TABLET (FILM COATED) 1*3*10 BLISTERS INDIA

PHILLIPS PHARMACEUTICALS

LTD

RE-INSP PAYMENT RT27849 DATED

14/03/2011

RT29885 DATED 07/10/2011

{6A684984-C776-4721-8C5B-EFE336CE1093}

CENTAUR PHARMACEUTICALS

PVT LTDGDICLOGENTA 6747/21/09

DICLOFENAC SODDIUM +

GENTAMICIN SULPHATE

CENTAUR PHARMACEUTICALS PVT LTD, PLOT NO 3,

TIVIM

1MG/ML + 3MG/ML EYEDROP 1*5ML GLASS AMPOULE INDIA

GITTOES PHARMACEUTICALS

LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{C4D90C06-5CE4-4449-B687-

0ABF2CB120F7}

AJANTA PHARMA LTD DAZEL KIT 6748/06/09FLUCONAZOLE + AZITHROMYCIN +

SECNIDAZOLE

AJANTA PHARMA LTD, B-4/5/6 MIDC

INDUSTRIAL AREA, P150MG + 1G + 1G

TABLET + TABLET (FILM COATED) +

TABLET (FILM COATED)

1*1*(2+1+1) COMBI-PACK BLISTER INDIA

AARON PHARMACEUTICALS

LTD27/11/08 RT28086 DATED

26/07/11

{FCD99A79-0E1F-4A38-B124-

0B1FD9E09376}

DAWA LTD STOPACID SUSPENSION 6762/17/09

MAGNESIUM TRISILICATE +

ALUMINIUM HYDROXIDE

DAWA LTD, BABA DOGO ROAD,

RUARAKA, NAIROBI

250MG/5ML + 120MG/5ML ORAL SUSPENSION 1*100ML BOTTLE KENYA SUPER MEDIC LTD RT24080 DATED

27/01/2011RT28507 DATED

12/08/2011{74D7D270-9A94-4010-866D-A11CEFC76B4A}

CADILA HEALTHCARE LTD ESPRA-20 6763/17/09 ESOMEPRAZOLE

MAGNESIUM

ALLY PHARMA OPTIONS PVT LTD, J-7, MIDC, TARAPUR IN

20MG TABLET (ENTERIC COATED) 1*1*10 BLISTER INDIA ABACUS PHARMA (A)

LTD 28/02/2011 RT28660 DATED 19/08/2011

{AC120ADB-7A00-44D5-AC08-

8D3DC1DD14F4}

CADILA HEALTHCARE LTD ESPRA-40 6770/17/09 ESOMEPRAZOLE

MAGNESIUM

ALLY PHARMA OPTIONS PVT LTD, J-7, MIDC, TARAPUR IN

40MG TABLET (ENTERIC COATED) 1*1*10 BLISTER INDIA ABACUS PHARMA (A)

LTD 28/02/2011 RT28660 DATED 19/08/2011

{030F83F4-189E-47ED-BF42-508280265FC2}

AEGIS LTD ZOLARAM 0.5 6771/24/09 ALPRAZOLAM

AEGIS LTD, ERGATES

INDUSTRIAL AREA, ERGATES

0.5MG TABLET 1*3*10 BLISTERS CYPRUS SURGIPHARM (U) LTD 01/07/11

RT28278 DATED 02/08/11. RT29152 DATED 08/09/2011

{88138C3F-0A0C-443D-8B68-7786EC727ABD}

MATRIX LABORATORIES LTD

TENOFOVIR DISOPROXIL FUMARATE +

LAMIVUDINE + EFAVIRENZ

6773/30/09

TENOFOVIR DISOPROXIL + LAMIVUDINE +

EFAVIRENZ

MATRIX LABORATORIES LTD,

F-4, F-12, MALEGAON MIDC SINNAR, NASHIK-

422113, MAHARASHTRA

300/300/600MG TABLETS 1*1*30 INDIAPHILLIPS

PHARMACEUTICALS (U) LTD

21/09/07 + RT21787 DATED 10/11/10

RT28546 DATED 15/08/11

{0338C470-E4C6-4D6A-B808-

F4533B7287F9}

AJANTA PHARMA LTD APFLU 6777/25/09CHLOROPHENERAMINE + PARACETAMOL

+ VITAMIN C

AJANTA PHARMA LTD, 31-0

INDUSTRIAL AREA CHIIKALTHA

0.5MG + 120MG + 50MG SYRUP 1*100ML BOTTEL INDIA

AARON PHARMACEUTICALS

LTD05/05/08 + RT26072 RT28086 DATED

26/07/11{C455C2BF-4B73-49F9-BB95-A2F5ABC8368C}

CADILA PHARMACEUTICALS

LTDSTPASE 6783/10/09 STREPTOKINASE

CADILA PHARMACEUTICALS LTD, 1389 DHOLKA GUJARAT STATE

1,500,000IUINJECTION

(LYOPHILIZED SOLIDS)

1*10ML VIAL INDIAKARURI

PHARMACEUTICALS LTD

RT24680 DATED 22/02/2011 RE-INSP

FEE

RT29230 DATED 13/09/2011

{E27BF9D9-427B-45AB-89D9-

713B8A061A82}

SURGIPHARM (U) LTD NAT-B 6785/27/09 MULTI-INGREDIENT

MEGA LIFE SCIENCES LTD. 384 PATTANA 3 ROAD

BANGPOO INDUSTRIAL ESTATE

SAMUTPRAKARN

MULTI-INGREDIENT CAPSULE (SOFT GELATIN) 1*3*10 BLISTERS THAILAND SURGIPHARM (U)

LTD

21/01/2009. NOTIFICATION SENT TO INSP FROM DAR

RT292218 & RT29217 DATED 12/09/2011

{C59C5DCC-E43A-4AA7-AD87-

F9B42D018C6C}

NEM LABORATORIES (PVT) LTD

LATONE MULTIVITAMIN 6787/27/09 MULTI-INGREDIENT

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

MULTI-INGREDIENT TABLET (UNCOATED) 1*3*10 BLISTERS INDIA RENE PHARMACY LTD. 06/09/2011 RT29395 DATED

20/09/2011

{58F856AE-130B-4D6D-8753-

430AD6A160AD}

Page 92

Page 93: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SURGIPHARM (U) LTD VITA CAP 6788/27/09 MULTI-INGREDIENT

MEGA LIFE SCIENCES LTD. 384 PATTANA 3 ROAD

BANGPOO INDUSTRIAL ESTATE

SAMUTPRAKARN

MULTI-INGREDIENT CAPSULE (SOFT GELATIN)

1*3*10, 1*10*10 BLISTERS THAILAND SURGIPHARM (U)

LTD

21/01/2009. NOTIFICATION SENT TO INSP FROM DAR

RT292218 & RT29217 DATED 12/09/2011

{52A9669D-3ED9-4D41-8816-

AE3EDD4B79C5}

SURGIPHARM (U) LTD LIVOLIN FORTE 6789/27/09 MULTI-INGREDIENT

MEGA LIFE SCIENCES LTD. 384 PATTANA 3 ROAD

BANGPOO INDUSTRIAL ESTATE

SAMUTPRAKARN

MULTI-INGREDIENT CAPSULE (SOFT GELATIN) 1*3*10 BLISTERS THAILAND SURGIPHARM (U)

LTD

21/01/2009. NOTIFICATION SENT TO INSP FROM DAR

RT292218 & RT29217 DATED 12/09/2011

{846B1C8D-6008-4028-929D-351096B92742}

CENTAUR PHARMACEUTICALS

LTDSINAREST 6790/25/09 OXYMETAZOLINE

HCL

CENTAUR PHARMACEUTICALS PVT LTD, PLOT NO 3,

TIVIM

0.05%W/V NASAL DROP 1*10ML VIAL INDIAGITTOES

PHARMACEUTICALS LTD

22/04/08 + RT24338 DATED 04/02/11

RT28397 DATED 08/08/11

{B7F1FF46-4840-41C6-8EE4-67BCE3848969}

SHELYS PHARMACEUTICALS

LTDACEFEN 6791/02/09 ACECLOFENAC

SHELYS PHARMACEUTICALS

LTD, NEW BAGAMOYO ROAD,

MWE

100MG TABLET (FILM COATED) 1*10(1*10) BLISTERS TANZANIA BETA HEALTH CARE

(U) LTD 26/01/09 RT28335 DATED 03/08/11

{DA97FC78-16C2-4F08-88CC-

9FE9D415A11C}

AJANTA PHARMA LTD ACTINAC 100 6793/02/09 ACECLOFENACAJANTA PHARMA LTD, B-4/5/6 MIDC

INDUSTRIAL AREA, P100MG TABLET (FILM

COATED) 1*10*2*10 BLISTERS INDIAAARON

PHARMACEUTICALS LTD

27/11/08 RT28086 DATED 26/07/11

{50AA963A-A1A0-4959-BCA4-85F7916E6C3E}

AJANTA PHARMA LTD ACTINAC PLUS 6794/02/09 ACECLOFENAC + PARACETAMOL

AJANTA PHARMA LTD, B-4/5/6 MIDC

INDUSTRIAL AREA, P100MG + 500MG TABLET (FILM

COATED) 1*2*10 BLISTERS INDIAAARON

PHARMACEUTICALS LTD

27/11/08 RT28086 DATED 26/07/11

{392E6F29-5CC1-4BB7-B697-

6D7B872C046D}

AEGIS LTD TRAMADEX 50 6797/02/09 TRAMADOL

AEGIS LTD, ERGATES

INDUSTRIAL AREA, P.O.BOX 28629/

50MG CAPSULE (HARD GELATIN) 1*3*10 BLISTERS CYPRUS SURGIPHARM (U)

LTD 01/07/11 RT28278 DATED 02/08/11

{A6954F69-1A6E-469E-A5F2-676932A0AC7B}

MODI MUNDU PHARMA PVT, LTD TRD-CONTIN 6798/02/09

TRAMADOL HYDROCHLORIDE

(CONTROLLED RELEASE)

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

100MG TABLET (FILM COATED) 1*5*10 BLISTERS INDIA SURGIPHARM (U)

LTDRT24921 DATED

04/03/2011RT28666 DATED

19/08/2011{8242555A-F851-4633-B499-0B1F08DA048C}

SK AGE EXPORTS SKAN-DID 6805/13/09 CLOTRIMAZOLE

S KANT HEALTHCARE, 1802-1805, GIDC PHASE

111, VAPI

1%W/W CREAM 1*1*15G TUBE INDIA ABACUS PHARMA (U) LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{C525769E-FBC7-4927-986D-FA4F12EA6765}

THEMIS MEDICARE EMAL 6810/06/09 ALPHA & BETA ARTEETHER

THEMIS MEDICARE LTD, SECTOR 6A, PLOT 16, 17 & 18

HARIDWAR

150MG/2ML INJECTION 1*3*2 ML INDIASTAR

PHARMACEUTICALS LTD

12/03/2009 RT29140 DATED 08/09/2011

{6865D002-59E0-4C9A-80C3-8EA5CD72F4C9}

SK AGE EXPORTS CIPROKANT-500 6815/06/10 CIPROFLOXACIN

S KANT HEALTHCARE LTD,

1802-1805, GIDC PHASE 111, VAPI- 396195, GUJARAT

500MG TABLET (FILM COATED) 1*10*10 BLISTERS INDIA ABACUS PHARMA (A)

LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{B62BDFD5-41B2-4CD9-9540-

EA03633259C2}

KARNATAKA ANTIBIOTICS &

PHARMACEUTICALS LTD

AMPICILLIN + CLOXACILLIN 6816/06/10 AMPICILLIN +

CLOXACILLIN

KARNATAKA ANTIBIOTICS &

PHARMACEUTICALS LTD, #14, II PHASE PIA, BANGALORE

560058

250MG + 250MG POWDER FOR INJECTION 1*10*500MG VIALS INDIA TATA (U) LTD RT28499 DATED

12/08/2011

{911A99BC-9FCC-4CC6-8447-

9B1D52F559F3}

KARNATAKA ANTIBIOTICS &

PHARMACEUTICALS LTD

CLOXACILLIN SODIUM 6819/06/10 CLOXACILLIN

SODIUM

KARNATAKA ANTIBIOTICS &

PHARMACEUTICALS LTD, #14, II PHASE PIA, BANGALORE

560058

500MG POWDER FOR INJECTION 1*10*500MG VIALS INDIA TATA (U) LTD

{D4B289CF-8983-40F7-99CD-

AE2CD770CE66}

Page 93

Page 94: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

KARNATAKA ANTIBIOTICS &

PHARMACEUTICALS LTD

AMPICILLIN SODIUM 6820/06/10 AMPICILLIN SODIUM

KARNATAKA ANTIBIOTICS &

PHARMACEUTICALS LTD, #14, II PHASE PIA, BANGALORE

560058

500MG POWDER FOR INJECTION 1*10*500MG VIALS INDIA TATA (U) LTD

{D2EECD6F-4A56-4ABB-B9AF-

603C84673D99}

DYNAPHARM (M) SDN BHD LOMODIUM 6822/17/10 LOPERAMIDE HCL

DYNAPHARM (M) SDN BHD, 2497, MK,

LORONG PERUSAHAAN BARU

5, KAWASAN, PERUSAHAAN,

PERAI 3, 13600,PULAU,

PINANG

2MG TABLET 1*1000 TIN, 1*10*10 BLISTERS MALAYSIA DYNA LABS 08/03/11 RT31603 DATED

06/12/11{794BE540-9444-4AD7-876B-370278E682C7}

MODI MUDIPHARMA PVT LTD INDICONTIN 6825/12/10 INDAPAMIDE

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

1.5MG TABLET (FILM COATED) 1*10*10 BLISTERS INDIA SURGIPHARM (U)

LTDRT24921 DATED

04/03/2011RT28666 DATED

19/08/2011

{CE1CA8CA-FAA5-4184-A2A6-

626C37C29379}

STRIDES ARCOLAB LTD

TENOFOVIR DISOPROXIL FUMARATE

6834/30/10TENOFOVIR DISOPROXIL FUMARATE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

300MG TABLET (FILM COATED) 1*30 HDPE INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{472829C6-DF87-4E2A-BBD7-76E289C4B372}

STRIDES ARCOLAB LTD LAMIVUDINE 6835/30/10 LAMIVUDINE

STRIDES ARCOLAB LTD 36/7

SURAJAKKANAHALLI INDLAVADI CROSS

ANEKAL TALUK BANGALORE

300MG TABLET (FILM COATED) 1*30 HDPE INDIA VEERAM

HEALTHCARE

RE-INSP FEE RT20564 DATED

17/08/2010. NOTIFICATION SENT

TO INSP

RT30095 DATED 12/10/2011

{5BC95F53-82DB-4283-9DDA-B03A747481B9}

KARNATAKA ANTIBIOTICS &

PHARMACEUTICALS LTD

HYDROCORTISONE SODIUM SUCCINATE 6838/03/10 HYDROCORTISONE

SODIUM SUCCINATE

KARNATAKA ANTIBIOTICS &

PHARMACEUTICALS LTD, #14, II PHASE PIA, BANGALORE

560058

100MG POWDER FOR INJECTION 1*10*100MG VIALS INDIA TATA (U) LTD {7BEA0A97-2893-4E7F-

958E-9231727DC28D}

DYNAPHARM (M) SDN BHD METFORMIN 6844/18/10 METFORMIN HCL

DYNAPHARM (M) SDN BHD, 2497, MK,

LORONG PERUSAHAAN BARU

5, KAWASAN, PERUSAHAAN,

PERAI 3, 13600,PULAU,

PINANG

500MG TABLET 1*100*10 BLISTERS, 1*10*10 BLISTERS MALAYSIA DYNA LABS 08/03/11 RT31603 DATED

06/12/11{2C2EB939-6990-42A2-B1B9-37C33444896B}

CACHET PHARMACEUTICALS

PVT LTDCACHEWORM 6857/06/10 MEBENDAZOLE

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANA, BADDI, HIMACHAL PRADESH

173205

100MG TABLET 1*10*10 BLISTERS, 1*1000 HDPE INDIA

VRUSHIK INVESTMENTS

UGNADA30/09/11 RT30959 DATED

08/11/11

{E1132BEC-D264-441B-9505-

86642405C54E}

MODI-MUNDIPHARMA PVT

LTDMONOCONTIN OD 6865/12/10

ISOSORBIDE MONONITRATE (CONTROLLED

RELEASE)

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

50MG TABLET (FILM COATED) 1*10*10 BLISTERS INDIA SURGIPHARM (U)

LTDRT24921 DATED

04/03/2011RT28666 DATED

19/08/2011{B9365882-CA01-4DF5-82A4-29347A8B829C}

Page 94

Page 95: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

MODI MUNDIPHARMA PVT LTD DILCONTIN XL90 6866/12/10

DILTIAZEM HCL (CONTROLLED

RELEASE)

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

90MG TABLET (FILM COATED) 1*10*10 BLISTERS INDIA SURGIPHARM (U)

LTDRT24921 DATED

04/03/2011RT28666 DATED

19/08/2011{0C64E4AB-7596-4BB7A809-991758AA2B43}

MODI MUNDIPHARMA (PVT) LTD DILCONTIN XL 120 6867/12/10

DILTIAZEM HBR (CONTROLLED

RELEASE)

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

120MG TABLET (FILM COATED0 1*10*10 BLISTERS INDIA SURGIPHARM (U)

LTYDRT24921 DATED

04/03/2011RT28666 DATED

19/08/2011

{EAAECA40-A289-4CD5-9426-

E4894137B22C}

MARCK BIOSCIENCES LTD

HIPOFLOX EYE/EAR DROPS 6871/21/10 OFLOXACIN

MARCK BIOSCIENCES LTD, PLOT NO. 876, N.H NO.8, HARIYALA, KHEDA - 387411,

GUJARAT

0.3%W/V EYE DROPS 1*5ML VIAL INDIAKARURI

PHARMACEUTICALS LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{974CFC4F-D31D-48E2-8E31-

FD465BE76BB9}

MARCK BIOSCIENCES LTD TRIX EYE DROPSD 6872/21/10 TOBRAMYCIN

MARCK BIOSCIENCES LTD, PLOT NO. 876, N.H NO.8, HARIYALA, KHEDA - 387411,

GUJARAT

0.3%W/V EYE DROPS 1*5ML VIAL INDIAKARURI

PHARMACEUTICALS LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{75752BCE-0A47-42DD-943E-

60304B7EE700}

FLAMINGO PHARMACEUTICALS

LTDBISEPTON 960 6874/06/10 SULPHAMETHOXAZO

LE + TRIMETHOPRIM

FLAMINGO PHARMACEUTICALS

LTD, R-622, T.T.C INDUSTRIAL AREA,

RABALE NAVI MUMBAI 460701

800MG + 160MG TABLET 1*500 HDPE INDIA ABACUS PHARMA (A) LTD 17/09/09 RT28444 DATED

09/08/11{9293E430-705B-46DC-9C10-E5A892280ACD}

GLAXO SMITHKLINE LTD CLAVULIN 1G 6875/06/10 AMOXICILLIN +

CLAVULANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICAL, CLARENDON ROAD, WORTHING WEST

SUSSEX, BN 148QH

875MG + 125MG TABLET (FILM COATED0 1*2*1*7 BLISTERS UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11{FE062F2A-7B97-4695-80E2-FCB566FF36AA}

GLAXO SMITHKLINE LTD

AUGMENTIN 457MG/5ML 6876/06/10 AMOXICILLIN +

CLAVULANIC ACID

SMITHKLINE BEECHAM

PHARMACEUTICAL, CLARENDON ROAD, WORTHING WEST

SUSSEX, BN 148QH

PER 5ML: 400MG+ 57MG

GRANULES FOR ORAL SUSPENSION 1*1*70ML BOTTLE UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11

{35243BFE-801C-42CA-BDD6-

2B288665BAA5}

SHANGHAI PHARMA INDUSTRIAL CO.LTD AMOCIN 6879/06/10 AMOXICILLIN

ZHEJIANG HOLLLEY NANHU

PHARMACEUTICAL CO.LTD, NO.205, YUNHAI ROAD,

ECONOMY DEVELOPMENT

ZONE, JIANXING, ZHEJIANG

125MG/5ML POWDER FOR ORAL SUSPENSION 1*1*100 BOTTLE CHINA ABACUS PHARMA (A)

LTD

RT27821 DATED 14/07/2011 RE-INSP

FEE

RT29181 DATED 09/07/2011

{2AA4F169-4092-4665-AE9D-2A3F6A044D32}

SHANGHAI PHARMA INDUSTRIAL CO.LTD AMOXICILLIN 6880/06/10 AMOXICILLIN

ZHEJIANG HOLLLEY NANHU

PHARMACEUTICAL CO.LTD, NO.205, YUNHAI ROAD,

ECONOMY DEVELOPMENT

ZONE, JIANXING, ZHEJIANG

250MG CAPSULE (HARD GELATIN)

1*1*10*10 BLISTERS, 1*1000 HDPE CHINA ABACUS PHARMA (A)

LTD

RT27821 DATED 14/07/2011 RE-INSP

FEE

RT29181 DATED 09/07/2011

{D5E1194D-80C9-4729-A2F9-A913A25D2BC6}

Page 95

Page 96: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SINO AFRICA MEDICINES & HEALTH LTD

AMOXICILLIN 6886/06/10 AMOXICILLIN TRIHYDRATE

SHIJIAZHUANG PHARMA GROUP

ZHANGNUO PHARMACEUTICAL

(SHIJIAZHUANG) CO, LTD, NO.6,HUAXING ROAD,SHIJIAZHUAN

G CITY

250MG CAPSULE (HARD GELATIN) 1*100 HDPE CHINA

SINO AFRICA MEDICINES & HEALTH LTD

10/11/08 RT28344 DATED 04/08/11

{713DB782-EF54-4F0E-8163-C4ABDF3A6E6F}

SINO AFRICA MEDICINES & HEALTH LTD

AMPICILLIN 6887/06/10 AMPICILLIN TRIHYDRATE

SHIJIAZHUANG PHARMA GROUP

ZHANGNUO PHARMACEUTICAL

(SHIJIAZHUANG) CO, LTD, NO.6,HUAXING ROAD,SHIJIAZHUAN

G CITY

250MG CAPSULE (HARD GELATIN) 1*100 HDPE CHINA

SINO AFRICA MEDICINES & HEALTH LTD

10/11/08 RT28344 DATED 04/08/11

{CBC9F1D6-F0B3-4058-8C9F-

6B7A531398E6}

VHB MEDI SCIENCES LTD SOLITAX 6889/06/10 CEFTRIAXONE

VHB MEDI SCIENCE LTD, PLOT NO. 20-22 & 49-51 11E, SECTOR-

5, SIDCUL, UTTARANCHAL

1G POWDER FOR INJECTION 1*10ML*1G VIAL INDIA RENE PHARMACY 01/04/2009 RT29401 DATED

20/09/2011{BBE86B75-FC76-46068F58-B3EE2EC19011}

SHELYS PHARMACEUTICALS

LTDLEVOZ 6890/06/10 LEVOFLOXACIN

SHELYS PHARMACEUTICALS

LTD, NEW BAGAMOYO ROAD, MWENGE, PLOT NO 696,BLOCK NO 32, P.O.BOX 3016, DAR

ES SALAAM

500MG TABLET (FILM COATED) 1*30*(1*5) BLISTERS TANZANIA BETA HEALTHCARE

(U) LTD 26/01/09 RT28335 DATED 03/08/11

{9FC068BB-BF42-46EE-9F54-

6318F7578956}

VENUS REMEDIES LTD RONEM 6893/06/10 MEROPENEM

VENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL

ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION),

BHATOLI KALAN, BADDI -HP

500MG POWDER FOR INJECTION 1*500G (10ML) VIAL INDIA

AARON PHARMACEUTICALS

LTD

RT17334 DATED 15/03/2010 PAYMENT FOR RE-INSPECTION

RT28897 DATED 31/08/2011

{AA8B9957-FEC8-460A-AD5C-

8A7FA780726E}

UNI-MED INDIA SIMATRIM FORTE 960 6896/06/10 SULPHAMETHOXAZOLE + TRIMETHOPRIM

UNIMED INDIA, UNI-MED HOUSE, 86, MAROL CO-OP.

INDUSTRIAL ESTATE, ANDHERI

(E) MUMBAI

800MG + 160MG TABLET 1*3*10 BLISTER INDIA META PRODUCTS (U) LTD

26/02/2009 REF:064/INS/NDA-

05/09

RT28869, RT28988 DATED 12/09/2011

{8BE0A738-5C4F-46CF-8D85-

9072ED7F7685}

MISSION PAHRMA A/S AMOXICILLIN 6898/06/10 AMOXICILLIN

TRIHYDRATE

CSPC ZHONGNUO PHARMACEUTICAL

(SHIJIAZHUANG) CO. LTD NO. 6 HYANXING

RD ZNONGHU SHIJIAZHUANG

250MG CAPSULE (HARD GELATIN) 1*1000 HDPE CHINA JMS 24/08/2009 RT28773 DATED

25/08/2011{FEF8F9ED-4966-43E2-B667-EAF6E5A0AAF5}

BAYER SCHERING PHARMA CIPROBAY 750 6902/06/10 CIPROFLOXACIN

BAYER HEALTHCARE AG, D-51368 LEVERKUSEN

750MG TABLET (FILM COATED) 1*1*10 BLISTER GERMANY SURGIPHARM (U)

LTD

{F7FCB278-6A7D-416D-BED7-

C65C0F5542C1}

EUROLIFE HEALTHCARE PVT

LTDLEVOLIFE 6904/06/10 LEVOFLOXACIN

EUROLIFE HEALTHCARE PVT LTD, KHASRA NO.

520, BHAGWANPUR ROAD, ROORKEE UTTARAKHAND

500MG/100ML LVP 1*100ML LDPE INDIA RENE PHARMACY03/04/2009.

NOTIFICATION SENT TO INSP. FROM DAR

RT29402 DATED 09/12/2011

{FB616403-86CF-4760-96BC-EC448F7F5A0F}

GLAXOSMITHKLINE LTD AUGMENTIN 6907/06/10

AMOXICILLIN + CLAVULANTE POTASSIUM

SMITHKLINE BEECHAM PLC,

WORTHING WEST SUSSEX BN14 8QH

875MG + 125MG TABLET (FILM COATED) 1*2*1*7 BLISTERS UK ERIS LTD 19/08/09 RT28825 DATED

27/08/11

{3E32EAB4-655C-4C3C-B931-

66B772B8F6DD}

Page 96

Page 97: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

EUROLIFE HEALTHCARE PVT

LTDEUROCIP 6910/06/10 CIPROFLOXACIN

EUROLIFE HEALTHCARE PVT LTD, KHASRA NO.

520, BHAGWANPUR ROAD, ROORKEE UTTARAKHAND

200MG/100ML LVP 1*100ML LDPE INDIA RENE PHARMACY03/04/2009.

NOTIFICATION SENT TO INSP. FROM DAR

RT29402 DATED 09/12/2011

{0B657062-942C-4ADD-B51B-

82C6762F8C18}

CHINA ASSOCIATES BENZATHINE BENZYLPENICILLIN 6911/06/10 BENZATHINE

BENZYLPENICILLIN

JIANGXI DONGFENG PHARMACEUTICAL LTD. 15 DONGFENG ROAD LEPING CITY JIANGXI PROVINCE

2.4 MEGA IU/VIAL POWDER FOR INJECTION

1*50*2.4 MEGA IU VIAL CHINA RENE PHARMACY

LTD 31/03/2011 RT29400 DATED 20/09/2011

{CCF09F05-B940-40AC-B411-

31AE2E5CD8AE}

MARCK BIOSCIENCES LTD GENTA EYE DROPS 6912/21/10 GENTAMYCIN

SULPHATE

MARCK BIOSCIENCES LTD,

PLOT NO. 876, HARIYALA, KHEDA, 387411, GUJARAT

0.3%W/V EYE DROPS 1*1*5ML VIAL INDIAKARURI

PHARMACEUTICALS LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{4A2E753B-2F58-4E13-8BD5-2C4C499F4732}

MARCK BIOSCIENCES LTD

NEODEX EYE/EAR DROPS 6914/21/10

NEOMYCIN SULPHATE +

DEXAMETHASONE SODIUM PHOSPHATE

MARCK BIOSCIENCES LTD,

PLOT NO. 876, HARIYALA, KHEDA, 387411, GUJARAT

0.35%W/V + 0.1%W/V EYE/EAR DROPS 1*1*5ML VIAL INDIAKARURI

PHARMACEUTICALS LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{767504DC-8E80-4701-B541-CE4A072D669C}

NAPROD LIFE SCIENCES PVT LTD VINROS A-1 6915/08/10 VINCRISTINE

SULPHATE

NAPROD LIFE SCIENCES PVT LTD,

G-17, MIDC, TARAPUR

INDUSTRIAL AREA, BIOSAR THANE,

MUMBAI

1MG LYOPHILISZED INJECTION 1*10ML*1MG VIAL INDIA

GITTOES PHARMACEUTICALS

LTD10/09/09 RT28451 DATED

10/08/11{35AD7B33-2457-4AE1-AC14-F574506CDD55}

AUROBINDO PHARMA LTD FINAGEN 6916/08/10 FINASTERIDE

AUROBINDO PHARMA LTD, UNIT

111 SURVEY NO 313, BACHUPALLY

VILLAGE, QUTHUBULLAPUR

MANDAL, R.R. DISTRICT, ANDHRA PRADESH, 500072

5MG TABLET (FILM COATED) 1*2*10 BLISTERS INDIA

GITTOES PHARMACEUTICALS

LTD20/05/2010 RT28910 + RT28908

DATED 31/08/2011{071FBAF9-8C59-468D-B24B-987C0E4307A4}

SHELYS PHARMACEUTICALS

LTDPEDZINC 6919/27/10 ZINC SULPHATE

SHELYS PHARMACEUTICALS

LTD, NEW BAGAMOYO ROAD,

MWENGE, PLOT NO. 696, BLOCK NO.32

20MG TABLET 1*10*(1*10) BLISTERS TANZANIA BETA HEALTH CARE LTD 26/01/09 RT28335 DATED

03/08/11{30358624-CFA6-49DE-8524-BA53FC969E97}

MERCK (PTY) LTD GLUCOPHAGE 6920/18/10 METFORMIN

MERCK SANTE S.A.S., 2, RUE DU PRESSOIR VERT, SEMOY & MERCK

PHARMACEUTICAL MANUFACTURING

PVT LTD, 259 DAVIDSON ROAD,

WADEVILLE, GERMISTON

1000MG TABLET (FILM COATED) 1*4*15 BLISTERS FRANCE & SOUTH

AFRICA

KARURI PHARMACEUTICALS

LTD19/10/09 JV11/077 DATED

11/08/11

{9DF0DB9C-3357-431E-B28A-

42BCD7634130}

MERCK (PTY) LTD GLUCOPHAGE 6922/18/10 METFORMIN

MERCK SANTE S.A.S., 2, RUE DU PRESSOIR VERT, SEMOY & MERCK

PHARMACEUTICAL MANUFACTURING

PVT LTD, 259 DAVIDSON ROAD,

WADEVILLE, GERMISTON

500MG TABLET (FILM COATED)

1*6*15 BLISTERS & 1*500 HDPE

FRANCE & SOUTH AFRICA

KARURI PHARMACEUTICALS

LTD19/10/09 JV11/077 DATED

11/08/11

{17CCB6E3-7A04-4C9D-B31A-

0FFF6C6E3E10}

DAWA LIMITED DAWA-PROM 6924/17/10 PROMETHAZINE HCLDAWA LIMITED,

BABA DOGO ROAD, RUARAKA

5MG/5ML ORAL SUSPENSION 1*60ML BOTTLE KENYA SUPER MEDIC LTD RT24080 DATED 27/01/2011

RT28507 DATED 12/08/2011

{D9310709-599D-4045-908A-F8099B774CE6}

Page 97

Page 98: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

INDOCO REMEDIES LTD NOSIC 6925/17/10

DOXYLAMINE SUCCINATE +

PYRIDOXINE HCL

INDOCO REMEDIES LTD, L-14, VERNA

INDUSTRIAL AREA, VERNA GOA - 403722

10MG + 10MG TABLET (ENTERIC COATED) 1*3*10 BLISTERS INDIA TATA (U) LTD 25/02/2008 RT29332 & JV11/148

DATED 16/09/11

{42A2B555-6D1D-4D4C-9D78-

DADB2443F75D}

MODI MUDIPHARMA PVT LTD, VALCONTIN 500 6926/05/10

SODIUM VALPROATE (CONTROLLED

RELEASE)

MODI MUNDIPHARMA

(PVT) LTD, MEERUT - MUZAFFARNAGAR

ROAD, MODIPURAM, UTTAR PRADESH

ESTATE

500MG TABLET (FILM COATED) 1*10*10 BLISTERS INDIA SURGIPHARM (U)

LTDRT24921 DATED

04/03/2011RT28666 DATED

19/08/2011

{86D5EC47-EDFC-41AC-9323-

4D78E8022754}

ARISTO PHARMACEUTICALS

PVT LTDTRANLOK 500 6927/10/10 TRANEXAMIC ACID

ARISTO PHARMACEUTICALS PVT LTD, PLOT NO.

208 NEW INDUSTRIAL AREA

NO 11, MANDIDEEP - 462046 (DISTRICT) - RAISEN, MADHYA

PRADESH

500MG/5ML SOLUTION FOR INJECTION 1*5*5ML AMPOULES INDIA NORVIK

ENTERPRISES LTD 18/03/2010 RT28634 DATED 19/08/2011

{2168CE1B-EF57-45C6-98B9-

2BF8163C7C05}

EUROLIFE HEALTHCARE PVT

LTDFLUCOLIFE 6928/06/10 FLUCONAZOLE

EUROLIFE HEALTHCARE PVT LTD, KHASRA NO.

520, BHAGWANPUR ROAD, ROORKEE UTTARAKHAND

200MG/100ML LVP 1*100ML LDPE INDIA RENE PHARMACY03/04/2009.

NOTIFICATION SENT TO INSP. FROM DAR

RT29402 DATED 09/12/2011

{4B981EA9-6869-4AF5-A8DD-F6E6B780F962}

S.A ALCON-COUVREUR N.V AZARGA 6932/21/10 BRINZOLAMIDE +

TIMOLOL

ALCON - COUVREUR N.V,

RIJKSWEG 14, 2870 PUURS

10MG/ML + 5MG/ML EYE DROPS 1*5ML VIAL BELGIUMKARURI

PHARMACEUTICALS LTD

RT27350 DATED 27/06/2011

RT28859 DATED 29/08/2011

{66CB729D-0150-4F69-A4C5-AF026BE60A68}

S.A.ALCON COUVREUR N.V DUOTRAV 6933/21/10 TRAVOPROST +

TIMOLOL MALEATE

S.A.ALCON COUVREUR N.V,

RIJSWEG, B-2870, PUURS

40MG/ML + 5MG/ML EYE DROP 1*1*2.5ML VIAL BELGIUMKARURI

PHARMACEUTICALS LTD

RT27350 DATED 27/06/2011

RT28859 DATED 29/08/2011

{34852CFC-493D-4CAF-A5FC-

91AF03F837CD}

FLAMINGO PHARMACEUTICALS

LTDFLAMOSEL-10 6938/03/10 LEVOCETIRIZINE

DIHYDROCHLORIDE

FLAMINGO PHARMACEUTICALS

LTD, R-662, T.T.C. INDUSTRIAL AREA,

RABALE, NAVI, MUMBAI 400701

10MG TABLET (FILM COATED) 1*10*10 BLISTERS INDIA ABACUS PHARMA (A)

LTD 17/09/09 RT28444 DATED 09/08/11

{A2C67CB4-6586-48AF-8483-

86BC9C4B949C}

ASTRAZENECA UK LTD CRESTOR 6940/12/10 RUSOVASTATIN

ASTRAZENECA UK LTD, SILK ROAD

BUSINESS PARK, MACCLESFIELD, SK

102NA

40MG TABLET (FILM COATED) 1*4*7 BLISTERS UK MACNAUGHTON 19/08/09 RT29484 DTED

22/09/11{88333193-C022-4244-A5F9-DE307A160D4E}

TORRENT PHARMACEUTICALS

LTDKARVIL 6946/12/10 CARVEDILOL

TORRENT PHARMACEUTICALS LTD, INDRAD - DIST.

MEHSANA

12.5MG TABLET 1*15 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011 {4CE5589F-1052-49B0-

95B2-ED1A4E9E29EC}

UNICHEM LABORATORIES LTD CORVADIL 10 6949/12/10 AMLODIPINE

BESILATE

UNICHEM LABORATORIES LTD,

UNIT 11, VILLAGE BHATAULI KALAN, BADDI, DISTRICT

SOLAN (H.P) - 173205

10MG TABLET 1*3*10 STRIP INDIA NORVIK ENTERPRISES LTD 22/11/10 RT29055 DATED

06/09/11

{F3BADC58-1479-47AF-A9D3-

9DF7778CC122}

BEIJING HOLLEY-COTEC

PHARMACEUTICAL CO.LTD

DUO-COTECXIN 6959/06/10DIHYDROARTEMISINI

N + PIPERAQUINE PHOSPHATE

ZHEIJIANG HOLLEY NANHU

PHARMACEUTICAL CO. LTD.

No.205,YUNHAI ROAD, JIAXING DEVELOPMENT ZONE, JIANXING CITY, ZHEJIANG

PROVINCE

20MG + 160MG TABLET (FILM COATED) 1*1*6 BLISTER CHINA

SUPER PHARMACEUTICALS

(U) LTD

RT28435 DATED 14/07/2011 PAYMENT FOR RE-INSPECTION

RT28435 DATED 09/08/2011

{823622CF-32F6-4683-B9EE-58E52D86F5B5}

Page 98

Page 99: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CACHET PHARMACEUTICALS

PVT LTDCACH-ART 20/120 6960/06/10 ARTEMETHER +

LUMEFANTRINE

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANA, BADDI, HIMACHAL PRADESH

173205

20MG + 120MG TABLET (FILM COATED) 1*3*8 BLISTERS INDIA

VRUSHIK INVESTMENTS

UGNADA30/09/11 RT30959 DATED

08/11/11

{E8EEAF24-9A24-400C-AB1E-

1D846146D7EF}

AJANTA PHARMA LTD RIDMAL 40/320 6962/06/10 DIHYDROARTEMISININ + PIPERAQUINE

AJANTA PHARMA LTD, B-4/5/6 MIDC

INDUSTRIAL AREA, PAITHAN 431128,

DIST. AURANGABAD, MAHARASTRA

40MG + 320MG TABLET (FILM COATED) 1*1*8 BLISTER INDIA AARON

PHARMACEUTICALS 27/11/08 RT28086 DATED 26/07/11

{2E14B58F-CA6D-446C-9FE5-

53193DE8AC2F}

INTAS PHARMACEUTICALS

LTDOBETAS - 120 6971/12/10 ORLISTAT

INTAS PHARMACEUTICALS

LTD, CAMP ROAD, SELAQUI - 248197,

DEHRADUN

120MG CAPSULE (HARD GELATIN) 1*2*10 BLISTERS INDIA NORVIK

ENTERPRISES LTD 18/02/10 RT29052 DATED 06/09/11

{8671AF83-12FC-4196-9F9F-

2FABD78CD5CC}

SURGIPHARM (U) LTD GILOBA 6972/24/10 GINKGO BILOBA

EXTRACT

MEGA LIFE SCIENCES LTD. 384 PATTANA 3 ROAD

BANGPOO INDUSTRIAL ESTATE

SAMUTPRAKARN

40MG CAPSULE (SOFT GELATIN) 1*3*10 BLISTERS THAILAND SURGIPHARM (U)

LTD

21/01/2009. NOTIFICATION SENT TO INSP FROM DAR

RT292218 & RT29217 DATED 12/09/2011

{365D9C8D-1798-42DD-8FB1-

F673FC31E31C}

FLAMINGO PHARMACEUTICALS

LTDFLAMOGREL 75 6974/10/10 CLOPIDOGREL

FLAMINGO PHARMACEUTICALS

LTD, R-662, T.T.C. INDUSTRIAL AREA,

RABALE, NAVI, MUMBAI 400701

75MG TABLET (FILM COATED) 1*10*10 BLISTERS INDIA ABACUS PHARMA (A)

LTD 17/09/09 RT28444 DATED 09/08/11

{34FEE17A-489D-4DDC-A029-

A089BE03D1BE}

EUROLIFE HEALTHCARE PVT

LTDMETLIFE 6976/06/10 METRONIDAZOLE

EUROLIFE HEALTHCARE PVT LTD, KHASRA NO.

520, BHAGWANPUR ROAD, ROORKEE UTTARAKHAND

500MG/100ML SOLUTION FOR INJECTION 1*100ML BOTTLE INDIA RENE PHARMACY

LTD

03/04/2009. NOTIFICATION SENT TO INSP. FROM DAR

RT29402 DATED 09/12/2011

{05CBE6D2-78DD-4AE1-A926-

29563B7D271E}

CACHET PHARMACEUTICALS

PVT LTDCACHTIN 500 6978/06/10 TINIDAZOLE

CACHET PHARMACEUTICALS PVT LTD, VILLAGE-

THANA, BADDI, HIMACHAL PRADESH

173205

500MG TABLET (FILM COATED) 1*1*4*25 BLISTERS INDIA

VRUSHIK INVESTMENTS

UGNADA30/09/11 RT30959 DATED

08/11/11

{C3D32B0F-760D-4B9F-AF0B-

339C58C3A541}

META PRODUCTS (U) LTD DREZ 6979/15/10 POVIDONE IODINE +

METRONIDAZOLE

STEDMAN PHARMACEUTICALS

PVT, C-4 SIDCO PHARMACEUTICAL

COMPLEX, ALATHUR,

THIRUPORUR, KANCHEEPURAM

DIST 603 110 TAMIL NADU

5%W/W + 1%W/W OINTMENT 1*10G, 1*30G, 1*250G INDIA META PRODUCTS (U) LTD 30/09/09 RT28466 DATED

11/08/11{5EE24EFE-99A6-4849-AC84-E2D4536077A7}

CADILA HELATHCARE LTD R-LOC 6985/17/10 RANITIDINE

CADILA HEALTHCARE LTD,

SAKHEJ-BAVIA, N.H.NO 8A,

MORAIYA, TAL: SANAND, DIST:

AHMEDABAD- 382210

25MG/ML SOLUTION FOR INJECTION 1*5*2ML AMPOULES INDIA ABACUS PHARMA (A)

LTDRE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{CDCD953D-9788-456B-B858-

1FCCFEE67EE7}

PFIZER LABORATORIES LTD CYTOTEC 6988/17/10 MISOPROSTOL

PIRAMAL HEALTHCARE LTD, WHALTON ROAD

MORPETH NORTHUMBERLAND

, NE 613YA

200MCG TABLET (FILM COATED) 1*2*14 BLISTERS UK LABOREX (U) LTD RT28810 DATED

26/08/2011

{6A352BDB-CAB5-4CC2-8E37-

805CD526A739}

Page 99

Page 100: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SK AGE EXPORTS OMESK 6990/17/10 OMEPRAZOLE

S KANT HEALTHCARE LTD,

1802-1805 GIDC PHASE 111, VAPI- 396195,GUJARAT

20MG CAPSULE (HARD GELATIN) 1*10*10 STRIPS INDIA ABACUS PHARMA (A)

LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{574AEDD3-DE15-4C24-BA01-

5670A8573720}

HETERO DRUGS LTD FLUVIR 6991/06/10 OSTELTAMIVIR PHOSPHATE

HETERO DRUGS LTD, UNIT 111, H22-

110, I.D.A, JEEDIMETLA,

HYDERABAD, 500055

75MG CAPSULE (HARD GELATIN) 1*10*10 BLISTERS INDIA ASTRA PHARMA (U)

LTD 17/12/09 RT28304 DATED 03/08/11

{39DC2140-509F-481B-AEBF-381B9D8FC95A}

HETERO DRUGS LTD NEVIRAPINE 6993/30/10 NEVIRAPINE

HETERO DRUGS LTD, UNIT 111, H22-

110, I.D.A, JEEDIMETLA,

HYDERABAD, 500055

200MG TABLET 1*60 HDPE INDIA ASTRA PHARMA (U) LTD 17/12/09 RT28304 DATED

03/08/11

{B507CC63-3EB0-40BA-8EF2-

D5A1F8B235E8}

HETERO DRUGS LTD EFAVIRENZ 6999/30/10 EFAVIRENZ

HETERO DRUGS LTD, UNIT 111, H22-

110, I.D.A, JEEDIMETLA,

HYDERABAD, 500055

600MG TABLET (FILM COATED) 1*30 HDPE INDIA ASTRA PHARMA (U)

LTD 17/12/09 RT28304 DATED 03/08/11

{452192D7-42AF-4DED-9E2C-

8B1CDBA891D1}

HETERO DRUGS LTD LAMIVUDINE 7000/30/10 LAMIVUDINE

HETERO DRUGS LTD, UNIT 111, H22-

110, I.D.A, JEEDIMETLA,

HYDERABAD, 500055

150MG TABLET (FILM COATED) 1*60 HDPE INDIA ASTRA PHARMA (U)

LTD 17/12/09 RT28304 DATED 03/08/11

{CCA2BB30-46B7-4748-AC1E-

E82EAD1F358B}

HETERO DRUGS LTD LAMIVUDINE + ZIDOVUDINE 7001/30/10 LAMIVUDINE +

ZIDOVUDINE

HETERO DRUGS LTD, UNIT 111, H22-

110, I.D.A, JEEDIMETLA,

HYDERABAD, 500055

150MG + 300MG TABLET (FILM COATED) 1*60 HDPE INDIA ASTRA PHARMA (U)

LTD 17/12/09 RT28304 DATED 03/08/11

{34DD764C-EEA0-42ED-AB57-

E2F4B9149F5B}

WIN-MEDICARE PVT LTD UDIHEP FORTE 7002/06/10 URSODEOXYCHOLIC

ACID

WIN-MEDICARE PVT LTD, MEERUT,

MUZAFFAR NAGAR ROAD, MODIPURAM

250110 UP

300MG TABLET 1*5*10 BLISTERS INDIA SURGIPHARM (U) LTD

RE-INSP FEE RT13839 DATED

MARCH 2011

RT28733 DATED 23/08/2011

{D830DC0B-329B-4EEC-9DBC-

630F0312225D}

DAWA LTD DACOLD SYRUP 7005/25/10

PARACETAMOL + PSEUDOEPHEDRINE

HCL + CHLORPHENIRAMINE

MALEATE

DAWA LTD, BABA DOGO ROAD,

RUARAKA, NAIROBI

PER 5ML: 120MG + 10MG + 2MG SYRUP 1*100ML BOTTLE KENYA SUPER MEDIC RT24080 DATED

27/01/2011RT28507 DATED

12/08/2011

{6760CE13-2CBB-46FD-831B-

78F2D7BE07F9}

SHELYS PHARMACEUTICALS

LTDCOLDRIL 7006/25/10

PARACETAMOL + CHLORPHENIRAMINE

MALEATE + PSEUDOEPHEDRINE

HCL

SHELYS PHARMACEUTICALS

LTD, NEW BAGAMOYO ROAD

MWENGE, PLOT NO. 696, BLOCK 32 #

3016, DAR ES SALAAM

500MG + 30MG + 2MG CAPSULE (HARD GELATIN)

1*12*(1*2*10) , 1*10*10 BLISTERS, TANZANIA BETA HEALTH CARE

LTD 26/01/09 RT28335 DATED 03/08/11

{A1E7A92D-8427-4459-9D08-70026D7AEB14}

META PRODUCTS (U) LTD CONTUS-650 7007/25/10

CHLORPHENIRAMINE + PHENYLEPHRINE +

PARACETAMOL

STEDMAN PHARMACEUTICALS PVT LTD, C-4, SIDCO PHARMACEUTICAL

COMPLEX, THIRUPORUR,

603110, TAMIL, NADU

2MG + 5MG + 650MG TABLET 1*50*1(1*6), 1*10*10 BLISTERS INDIA META PRODUCTS (U)

LTD 30/09/09 RT28466 DATED 11/08/11

{F4672CB5-4DAF-4273-B25D-61D51023F5AB}

Page 100

Page 101: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SHELYS PHARMACEUTICALS

LTDCOLDRIL SYRUP 7009/25/10

PARACETAMOL + CHLORPHENIRAMINE

+ PSEUDOEPHEDRINE

SHELYS PHARMACEUTICALS

LTD, NEW BAGAMOYO ROAD, MWENGE, PLOT NO 696,BLOCK NO 32, P.O.BOX 3016, DAR

ES SALAAM

MG/5ML 120 + 1 + 10 SYRUP 1*100ML BOTTLE TANZANIA BETA HEALTHCARE

(U) LTD 26/01/09 RT28335 DATED 03/08/11

{8F98F8AF-A5E9-497C-98C1-9B047B3A3189}

HEALTHCARE LTD POSTINOR 2 7010/18/10 LEVONORGESTREL

GEDEON RICHTER PLC, 1103

BUDAPEST GYOMROI UT 19-21

0.75MG TABLET 1*1*2 BLISTERS HUNGARY HEALTHCARE LTD 15/04/201 RT30074 DATED 12/10/2011

{E9DFAD10-8ED4-48F1-8242-

7BC67F0C0756}

PFIZER LABORATORIES

(PTY) LTDSAYANA 7013/18/10 MEDROXYPROGEST

ERONE ACETATE

PFIZER MANUFACTURING

NV/NA, RIJKSWEG 12 2870, PUURS

105MG/0.65ML SUSPENSION FOR INJECTION

1*1*0.65ML SYRINGE + NEEDLE BELGIUM LABOREX (U) LTD RT28810 DATED

26/08/2011{05F8782F-2FB3-47B5-8590-BF9F6C9962BF}

SHELYS PHARMACEUTICALS

LTD

MUCOLYN PAEDIATRIC SYRUP 7017/25/10 MULTI-INGREDIENT

SHELYS PHARMACEUTICALS LTD, PLOT NO. 696, NEW BAGOMOYO ROAD, MWENGE, DAR- ES-SALAAM

MULTI-INGREDIENT 1*1*100ML BOTTLE SYRUP TANZANIA BETA HELATHCARE (U) LTD 26/01/09 RT28335 DATED

03/08/11{C690016C-1D68-4535-A31B-943E4ABCF767}

INDOCO REMEDIES LTD

TUSPRESS COUGH SUPPRESSANT 7018/25/10 MULTI-INGREDIENT

INDOCO REMEDIES LTD, L-14 VERNA

INDUSTRIAL ESTATE, VERNA

GOA 403722

MULTI-INGREDIENT 1*1*100ML BOTTLE SYRUP INDIA TATA (U) LTD 25/02/2008 RT29332 & JV11/148 DATED 16/09/11

{83D1D023-9D62-473E-98E9-4325B9836BF4}

SHELYS PHARMACEUTICALS

L.TD

MUCOLYN - ASTHALIN SYRUP 7020//25/10 SALBUTAMOL +

BROMHEXINE

SHELYS PHARMACEUTICALS L.TD, PLOT NO. 696, NEW BAGOMOYO ROAD, MWENGE, DAR-ES-SALAAM

PER 5ML: 2MG + 4MG SYRUP 1*100ML BOTTLE TANZANIA BETA HEALTHCARE

(U) LTD 26/01/09 RT28335 DATED 03/08/11

{6EA04549-CEF4-4D2C-A0B2-

0EB488ACD539}

MARCK BIOSCIENCES LTD MANNITOL 7021/16/10 MANNITOL

MARCK BIOSCIENCES LTD, PLOT NO. 876, N.H NO. 8, HARIYALA,

KHEDA 387411

20%W/V INFUSION 1*100ML BOTTLE INDIAKARURI

PHARMACEUTICALS LTD

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{A35D8CCB-8612-4EF8-89DC-

B421CDF83CF1}

MEDIPHARM SALES LTD PROMUNE 50 7025/08/10 CYCLOSPORINE

MEGA LIFESCIENCES LTD

384 PATTANA 3 ROAD BANGPOO

INDUSTRIAL ESTATE SUMUTPRAKAN

50MG CAPSULE (SOFT GELATIN) 1*10*5 BLISTERS THAILAND SURGIPHARM (U)

LTD 19/03/2011 RT29865 DATED 06/10/2011

{DEC417F1-1C95-4F78-BFC8-

882DEC5C587C}

EUROLIFE HEALTHCARE PVT

LTDGLUCOLIFE 7027/26/10 GLUCOSE

EUROLIFE HEALTHCARE PVT LTD, KHASRA NO.

520, BHAGWANPUR ROAD, ROORKEE UTTARAKHAND

5%W/V LVP 1*100ML LDPE INDIA RENE PHARMACY03/04/2009.

NOTIFICATION SENT TO INSP. FROM DAR

RT29402 DATED 09/12/2011

{3B665CCF-AC36-4C60-8489-

49923171AFB4}

EUROLIFE HEALTHCARE PVT

LTDMANNILIFE 7028/26/10 MANNITOL

EUROLIFE HEALTHCARE PVT LTD, KHASRA NO.

520, BHAGWANPUR ROAD, ROORKEE UTTARAKHAND

20MG/100ML LVP 1*100ML LDPE INDIA RENE PHARMACY03/04/2009.

NOTIFICATION SENT TO INSP. FROM DAR

RT29402 DATED 09/12/2011

{ABD161D8-8677-45DA-B9B7-

85F077451931}

SK AGE EXPORTS VITAMAKS 7029/27/10 MULTI-INGREDIENT

S KANT HEALTHCARE LTD,

1802-1805 GIDC PHASE 111, VAPI- 396195,GUJARAT

MULTI-INGREDIENT 1*100ML BOTTLE SYRUP INDIA ABACUS PHARMA (A) LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{34DAF048-582B-4687-88A5-B75ADFB9C46B}

Page 101

Page 102: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

STEDMAN PHARMACEUTICALS

PVT LTDSTEDNAC 7037/02/10 ACECLOFENAC

STEDMAN PHARMACEUTICALS PVT LTD, C-4, SIDCO PHARMACEUTICAL

COMPLEX ALATHUR, THIRUPORUR 603110

TAMIL NADU

100MG TABLET (FILM COATED) 1*1*10 BLISTER INDIA META PRODUCTS (U)

LTD 30/09/09 RT28431 DATED 09/08/11

{BA0756E9-259C-481D9AF7-16E65AE7136F}

BAYER SCHERING PHARMA MICROLUT 7042/18/10 LEVONORGESTREL

SCHERING GMBH & CO., PRODUKTIONS

KG DOBEREINERSTRAS

SE 20, D-99427 WEIMER

0.03MG TABLET (SUGAR COATED) 1*3*35 BLISTER GERMANY SURGIPHARM (U)

LTD

{5C786B3A-6EE6-4CAC-B97B-

B9C493851E9A}

BAYER SCHERING PHARMA YASMIN 7043/18/10 DROSPIRENONE +

ETHINYLESTRADIOL

SCHERING GMBH & CO., PRODUKTIONS

KG DOBEREINERSTRAS

SE 20, D-99427 WEIMER

3MG + 0.03MG TABLET 1*1*21 BLISTER GERMANY SURGIPHARM (U) LTD

{9D86FE48-5B36-4CC2-898F-

ABAA893DDC1B}

UGANDA HEALTH MARKETING GROUP

(UHMG)RESTORS 7044/26/10

ANHYDROUS GLUCOSE + SODIUM CHLORIDE + SODIUM

CITRATE + POTASSIUM CHLORIDE

FDC LTD, B-8 MIDC WALUJ, DIST.

AURANGABAD, 431136

13.5G + 2.6G + 2.9G + 1.5G

POWDER FOR ORAL SOLUTION 1*20.5G SACHET INDIA

UGANDA HEALTH MARKETING GROUP

(UHMG)19/01/09 RT28149 DATED

27/07/11{E1812EC3-272B-4F24-9A56-4805FA36805D}

MISSIONPHARMA A/S TRICLOVERA 7045/18/10 MEDROXYPROGESTERONE ACETATE

PT TUNGGAI IDAMAN ABDI, J1.JEND.YANI

NO.7 JAKARTA TIMUR

150MG/ML SUSPENSION FOR INJECTION 1*20*1ML VIALS INDONESIA JMS 09/11/2012 RT28773 DATED

25/08/2011

{38ACB7C8-05C7-474C-B08C-

21A9F13DE776}

SK AGE EXPORTS KETOZ 7049/13/10 KETOCONAZOLE

S KANT HEALTHCARE LTD,

1802-1805 GIDC PHASE 111, VAPI- 396195,GUJARAT

2%W/W CREAM 1*30G TUBE INDIA ABACUS PHARMA (A) LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{DC06C2D9-F7DB-4ECE-AF20-

CDA9F6E3FF41}

NEM LABORATORIES PRIVATE LTD

PAINGO MEDICATED CREAM 7050/13/10

METHYL SALICYLATE + CAPSICUM OLEORESIN +

TUPENTINE OIL

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

15% + 1% + 1.47% CREAM 1*2*15G TUBE INDIA RENE PHARMACY LTD 06/09/2011 RT29395 DATED

20/09/2011{73633D62-093B-41E4-AE08-928FD4CC51C8}

SK AGE EXPORTS SK DERM 7051/13/10BETAMETHASONE + CLOTRIMOXAZOLE +

GENTAMYCIN

S KANT HEALTHCARE LTD,

1802-1805 GIDC PHASE 111, VAPI- 396195,GUJARAT

0.05%W/W + 1%W/W + 0.1%W/W CREAM 1*15G + 1*30G TUBES INDIA ABACUS PHARMA (A)

LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{8DC75AED-7ED6-4167-807A-

5B32EAEBD355}

SK AGE EXPORTS BETAD 7052/13/10 BETAMETHASONE DIPROPRIONATE

S KANT HEALTH CARE LTD, 1802-

1805, GIDC PHASE 111, VAPI - 306195,

GUJARAT

0.05%W/W CREAM 1*1*15G, 1*1*30G TUBES INDIA ABACUS PHARMA (A)

LTD

13/12/07 + RE-AUDIT FEES -RT24301 DATED 03/02/11

RT30803 DATED 31/10/11

{7BF92A84-562C-46F7-A656-89D7885E9B5B}

GLAXO SMITHKLINE SYNFLORIX VACCINE 7054/19/10

PNEUMOCOCCAL POLYSACCHARIDE

CONJUGATE PROTEIN D VACCINE

GLAXO SMITHKLINE BIOLOGICALS S.A

RUE DE L'INSTITUT, 89 B-1330

RIXENSART

1 DOSE (0.5ML), 2DOSES (1.0ML)

SUSPENSION FOR INJECTION

1 DOSE IN PREFILLED SYRINGE BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11

{DEAE9A9C-7D71-4A84-A7AA-

78EFF1B719E9}

GLAXO SMITHKLINE PRIORIX VACCINE 7056/19/10 MEASLES + MUMPS + RUBELLA

GLAXO SMITHKLINE BIOLOGICALS S.A

RUE DE L'INSTITUT, 89 B-1330

RIXENSART

103.0CCID50 + 103.7CCID50 + 103.0CCID50

LYOPHILIZED POWDER FOR

RECONSTITUTION1*0.5ML AMPOULE BELGIUM ERIS LTD 04/10/07 + RE-AUDIT

FEES (RT22504)RT28825 DATED

27/08/11

{FECE832C-92C7-401B-84C8-

7F9F5052D516}

INDOCO REMEDIES LTD ALOHA LIQUID 7058/27/10 MULTI-INGREDIENT

INDOCO REMEDIES LTD, B-20 MIDC,

WALUJ, AURANGABAD,

431136

MULTI-INGREDIENT 1*200ML BOTTLE ORAL SUSPENSION INDIA TATA (U) LTD 10/05/2010 RT29332 & JV11/148 DATED 16/09/11

{34F92C2A-95B7-4A80-9C35-ED181088D0A1}

Page 102

Page 103: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CIRON DRUGS PHARMACEUTICALS

PVT LTDLIDOCAINE HCL 7062/01/10 LIDOCAINE HCL

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

20MG/ML INJECTION 1*20ML GLASS VIAL INDIA RENE PHARMACY RE-INSP RT18638 DATED 14/05/2010

RT29396 DATED 20/09/2011

{D339BC7D-8D70-42DE-B2AB-

9679C74095B2}

GLAXO SMITHKLINE PANADOL ADVANCE 7064/02/10 PARACETAMOL

GLAXOSMITHKLINE LTD, LIKONI ROAD, INDUSTRIAL AREA, VIWANDANI 00507,

NAIROBI

500MG TABLET1*2*10, 1*10*10

BLISTERS, 1*11*10 BLISTER

KENYA ERIS LTD23/06/08 + RE-AUDIT

FEES-JV11/190 DATED

RT28825 DATED 27/08/11

{87B2915E-4AEE-4E04B906-F891936B48ED}

DAWA LTD STOPACID 7065/17/10

MAGNESIUM TRISILICATE +

ALUMINIUM HYDROXIDE

DAWA LTD, BABA DOGO ROAD,

RUARAKA250MG/120MG TABLET 1*10*10 BLISTER KENYA SUPERMEDIC RT24080 DATED

27/01/2011RT28507 DATED

12/08/2011{6840E1E3-721F-496E-A429-36B59D4DD406}

SINO AFRICA MEDICINES & HEALTH LTD

GENTAMICIN INJECTION 7074/06/10 GENTAMICIN

SULPHATE

ZHEJIANG RUIXIN PHARMACEUTICAL

CO LTD, KAIFA ROAD,

1*100*2ML AMPOULE 40MG/ML CHINASINO AFRICA

MEDICINES AND HEALTH

16/11/09 RT28343 DATED 04/08/11

{65CA4DA6-EBD0-4237-9D99-

C7E7B58ADA33}

IDA CO-TRIMOXAZOLE 480MG 7076/06/10 CO-TRIMOXAZOLE

MEDOPHARM NO 1 34-B INDUSTRIAL

AREA MALUR KARNATAKA

480MG TABLET 1*10*100 BLISTER INDIA JOINT MEDICAL STORES

JV11/017 DATED08/07/11

{71E18966-EEE3-4AA2AE9F-3861CF05EF7B}

DAWA LIMITED TRIMOXOL SUSPENSION 7077/06/10 CO-TRIMOXAZOLE

DAWA LTD BABA DOGO ROAD

RUARAKA200MG/40MG / 5ML SUSPENSION

1*60ML,1*100ML AMBER GLASS

BOTTLEKENYA SUPER MEDIC RT24080 DATED

27/01/2011RT28507 DATED

12/08/2011{CC541507-849D-41E5-B888-CD9541B25139}

MARCK BIOSCIENCES LTD TRIM-DM EYE DROP 7079/21/10 TOBRAMYCIN/

DEXAMETHASONE

MARCK BIOSCIENCES LTD, PLOT NO 876 NH NO 8 HARIYALA KHEDA

GUJARAT

0.3/0.1% W/V SOLUTION (EYE DROPS) 1*5ML INDIA KARURI P'CALS

28/08/08 + RE-AUDIT FEES RT31149 DATED 16/11/11

RT30431 DATED 17/10/11

{015300D7-A809-4F0E-B6FE-8CEA72A82921}

ASTRA ZENECA LTD ZOLADEX LA 7084/08/10 GOSERELIN ACETATE

ASTRA ZENECA LTD,SILK ROAD

BUSINESS PARK, MACCLESFIELD, CHESHIRE SK 10

2NA

10.8MG IMPLANT 1*10.8MG SYRINGE UK MACNAUGHTONUGANDA 19/08/09 RT29484 DTED

22/09/11

{8B6DD7E9-D951-48F6-BC00-

ECD43DB1A080}

NAPROD LIFE SCIENCES PVT LTD, NAPRODOX-10 7085/08/10 DOXORUBICIN HCL

NAPROD LIFE SCIENCES PVT LTD,

G-17 MIDC, TARAPUR

INDUSTRIAL AREA, BIOSAR,THANE

MUMBAI

100MG/VIAL POWDER FOR INJECTION 1*5ML INDIA GITTOES P'CALS 10/09/09 RT28451 DATED

10/08/11{374952AC-8333-49C1-86E8-E945F7834FBD}

VHB MEDI SCIENCE LTD DOMAXIN-RD 10MG 7086/08/10 DOXORUBICIN HCL

VHB MEDI SCIENCE LTD, PLOT NO.20-22 VHB MEDI SCIENCE LTD, PLOT NO. 20-22 & 49-51 11E, SECTOR-

5, SIDCUL, UTTARANCHAL

10MG POWDER FOR INJECTION 1*10MG VIAL INDIA RENE PHARMACY 01/04/2009 RT29401 DATED

20/09/2011{160BB013-7670-4DFC-B8A7-0A11B6D49D62}

INTAS PHARMACEUTICALS

LTDDIVAA OD 500 7088/05/10 DIVALPROEX

INTAS PHARMACEUTICALS

LTD, CAMP ROAD, SELAQUI,

DEHRADUN

500MG TABLET 1*3*10 BLISTER INDIA NORVIK ENTERPRISES 18/02/10 RT29052 DATED

06/09/11{9E08964C-26B4-491B-8638-D19F0B1DF30F}

CIRON DRUGS PHARMACEUTICAL

PVT LTDMETOCLOPRAMIDE 7096/17/10 METOCLOPRAMIDE

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

5MG/ML AMPOULE FOR INJECTION 1*10*10*2MLS INDIA RENE PHARMACY RE-INSP RT18638

DATED 14/05/2010RT29396 DATED

20/09/2011

{E5E3EB43-3DE8-4F8C-AED8-

9BA2DBE0A3D4}

CACHET PHARMACEUTICALS

PVT.LTDCETPRO 7103/03/10 CYPROHEPTADINE

HCL

CACHET PHARMACEUTICALS PVT.LTD 415, SHAH

NAHAR, WORLI, MUMBAI 400 018

4MG TABLET 1*2*5*10 BLISTER INDIA VRUSHIK INVESTMENTS 30/09/11 RT30959 DATED

08/11/11

{5D3D21D5-D844-4C77-BF1D-

406197D29345}

Page 103

Page 104: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

RANBAXY LABORATORIES LTD

STARVAL HCT, 80+12.5 7105/12/10

VALSARTAN/ HYDROCHLOROTHIA

ZIDE

RANBAXY LABARATORIES LTD, PAONTA SAHIB DIST

SIRMOUR H.P

80/12.5MG TABLET 1*3*10 BLISTER INDIA SURGIPHARM LTD 20/05/2011 RT29222 DATED 12/09/2011

{71D1CF92-6274-4248-8478-A8A813B8AB1B}

RANBAXY LABORATORIES LTD STARVAL 7106/12/10 VALSARTAN

RANBAXY LABOATORIES LTD, PAONTA SAHIB DIST

SIRMOUR H.P-173025

160MG TABLET 1*3*10 BLISTER INDIA SURGIPHARM 20/05/2011 RT29222 DATED 12/09/2011

{DA70B2AD-6F50-45A4-93CC-

7DEE16D753C0}

RANBAXY LABORATORIES LTD, STARVAL 80 7110/12/10 VALSARTAN

RANBAXY LABATORIES LTD,

PAONTA SAHIB DIST SIRMOUR H.P

80MG TABLET 1*3*10 BLISTER INDIA SURGIPHARM 20/05/2011 RT29222 DATED 12/09/2011

{88695AD8-CE0E-4C83-9EBD-

765E1319FA36}

ASTRA ZENECA SEROQUEL 25MG 7117/24/10 QUETIAPINE FUMARATE

ASTRA ZENECA UK LIMITED SILK ROAD

BUSINESS PARK, MACCLES

FIELD,CHESHIRE SK 10 2NA, UK

25MG TABLET 1*1*30 & 1*1*60 BLISTER UNITED KINGDOM MACNAUGHTON 19/08/09 RT29484 DTED

22/09/11

{59FD0A65-5EBB-46A0-8564-

ABE0026E1282}

ASTRA ZENECA SEROQUEL 200MG 7118/24/10 QUETIAPINE FUMARATE

ASTRAZENECA UK LIMITED SILK ROAD

BUSINESS PARK, MACCLES

FIELD,CHESHIRE SK 10 2NA,

200MG TABLET 1*1*30 & 1*1*60 BLISTER UNITED KINGDOM MACNAUGHTON 19/08/09 RT29484 DTED

22/09/11{268A92FB-C809-4F89-9159-980A70D5C280}

ASTRA ZENECA SEROQUEL 100MG 7119/24/10 QUETIAPINE FUMARATE

ASTRA ZENECA UK LIMITED SILK ROAD

BUSINESS PARK, MACCLESFIELD, CHESHIRE SK 10

2NA

100MG TABLET 1*1*30 & 1*1*60 BLISTER UNITED KINGDOM MACNAUGHTON 19/08/09 RT29484 DTED

22/09/11

{0EF15B1F-7DDE-4D3E-871F-

59CE2AD1E8D2}

ASTRA ZENECA SEROQUEL 300MG 7120/24/10 QUETIAPINE FUMARATE

ASTRA ZENECA UK LIMITED SILK ROAD

BUSINESS PARK, MACCLESFIELD,CHE

SHIRE SK 10 2NA

300MG TABLET 1*1*30 & 1*1*60 BLISTER UNITED KINGDOM MACNAUGHTON 19/08/09 RT29484 DTED

22/09/11{94BF7672-3A24-487D-86C3-EFF913ACB06C}

STEDMAN PHARMACEUTICALS DREZ POWDER 7122/06/10 POVIDONE IODINE &

METRONIDAZOLE

STEDMAN PHARMACEUTICALS

COMPLEX, ALATHUR,

THIRUPORUR TAMIL NADU

1.0% W/W & 5.0% W/W POWDER 100G INDIA META PRODUCTS 30/09/09 RT28431 DATED

09/08/11{7497B27C-3511-4CFC-8277-10CD67EAA5A0}

STEDMAN PHARMACEUTICALS DREZ 7123/06/10

IODINATED POVIDONE &

METRONIDAZOLE

STEDMAN PHARMACEUTICAL

COMPLEX, ALATHUR,

THIRUPORUR TAMIL NADU

1.0% W/V & 5.0% W/V TOPICAL SOLUTION 1*30ML, 1*60ML, 1*100ML 1*500ML INDIA META PRODUCTS 30/09/09 RT28431 DATED

09/08/11{38EB92B4-5588-490C-B81C-8F227A74E732}

ASTRAZENECA NEXIUM 40MG IV 7125/17/10 ESOMEPRAZOLE

ASTRA ZENECA, KVARNBERGAGATA

N12, SE-151 SODERTALIJE

40MG/5ML POWDER FOR INJECTION

1*1*5ML & 1*10*5ML VIAL SWEDEN MACNAUGHTON 30/06/10 RT29484 DATED

22/09/11{9F0A14E8-9F2A-45FA-AF47-B123DCC81A6B}

NEM LABORATORIES PRIVATE LTD BISALAX 7136/17/10 BISACODYL

NEM LABORATORIES PVT LTD, 133 VASAI

RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

1*5MG TABLET 1*1000 HDPE JAR INDIA RENE PHARMACY 06/09/2011 RT29395 DATED 20/09/2011

{03E05967-248B-412E-BD4F-8B4FC3E934C6}

ASTRA ZENECA CRESTOR 7137/12/10 ROSUVASTATIN CALCIUM

ASTRA ZENECA ALDERLEY PARK, MACCLESFIED,

CHESHIRE SK10TG

10MG TABLET 1*2*14 BLISTER UK MACNAUGHTON 19/08/09 RT29484 DTED 22/09/11

{956925A5-F0B3-4B72-A4D5-92C1FA3D995A}

ASTRA ZENECA CRESTOR 7139/12/10 ROSUVASTATIN CALCIUM

ASTRA ZENECA ALDERLEY PARK, MACCLESFIED,

CHESHIRE SK10TG

20MG TABLET 1*2*14 BLISTER UK MACNAUGHTON 19/08/09 RT29484 DTED 22/09/11

{FCFA10B7-5501-4FB5-A7AA-624F9DC8B2F0}

Page 104

Page 105: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ASTRA ZENECA CRESTOR 7140/12/10 ROSUVASTATIN CALCIUM

ASTRA ZENECA ALDERLEY PARK, MACCLESFIED,

CHESHIRE SK10TG

5MG TABLET 1*2*14 BLISTER UK MACNAUGHTON 19/08/09 RT29484 DTED 22/09/11

{7B0A6573-7D86-41D3-A1A6-21FCD943A3EC}

GLAXOSMITHKLINE TRACIUM INJECTION 7142/20/10 ATRACIUM BESYLATE

GLAXOSMITHKLINE Spa FLEMING 2, 37135 PARMA

10MG/ML INJECTION 1*2.5ML, 1*5ML, 1*10ML AMPOULE ITALY ERIS LTD 29/09/08 RT28825 DATED

27/08/11

{FED82FB7-47E6-41C6-BB7A-

7532CDB6B976}

RENE INDUSTRIES LTD ALZOL 7153/06/10 ALBENDAZOLE

RENE INDUSTRIES LTD, PLOT NO. 680,

KAMULI, KIREKA400MG TABLET 1*500 HDPE UGANDA RENE INDUSTRIES

LTDANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011

{DC4720D6-2E5B-492E-84B7-

B2B6B6CED093}

MISSION PHARMA A/S

DOXYCYCLINE CAPSULES BP 7159/06/10 DOXYCYCLINE

MEDICAMEN BIOTECHLTD, SP-

1192 A&B PHASE IV INDUSTRIAL AREA,

BHIWADI

100MG CAPSULES !*1000 HDPE INDIA JMS 27/06/2011 RT28773 DATED 25/08/2011

{1B4BC1C2-FDDC-41A2-91CC-

4E41D7F56B2F}

MISSION PHARMA A/S

PHENOXYMETHYLPENICILLIN TABLETS BP 7161/06/10 PHENOXYMETHYLPE

NICILLIN

MEDICAMEN BIOTECHLTD, SP-

1192 A&B PHASE IV INDUSTRIAL AREA,

BHIWADI

250MG TABLET 1*1000 HDPE INDIA JMS 27/06/2011 RT28773 DATED 25/08/2011

{0F8A06AC-55B1-4F6A-819A-

3113972982CF}

MISSION PHARMA A/S

ERYTHROMYCIN STEARATE TABLETS

BP7162/06/10 ERYTHROMYCIN

MEDICAMEN BIOTECHLTD, SP-

1192 A&B PHASE IV INDUSTRIAL AREA,

BHIWADI

100MG TABLET 1*1000 HDPE INDIA JMS 27/06/2011 RT28773 DATED 25/08/2011

{861E06B1-027D-43A0-AEFC-

7C3B2C45AD12}

PFIZER LABORATORIES

(PTY) LTDUNASYN 1.5 7163/06/10 AMPICILLIN /

SULLBACTAM

HAUPT PHARMA LATINA S.R.L,

STRADA STATALE 156KM, BORGO SAN

MICHELE

1000MG/ 500MG PARENTERAL 1*1*1.5G VIAL ITALY LABOREX (U) LTD RT28810 DATED 26/08/2011

{081FDF35-47CF-4345-BB5F-BC54E2BA1488}

VHB MEDI SCIENCE LTD DOMAXIN-RD 7164/08/10 DOXORUBICIN

VHB MEDI SCIENCE LTD, PLOT NO. 20-22 & 49-51 11E, SECTOR-

5, SIDCUL, UTTARANCHAL

50MG PARENTERAL 1*1*50MG VIAL INDIA RENE PHARMACY 01/04/2009 RT29401 DATED 20/09/2011

{771C7F09-A74C-4794-802C-A9647B315665}

VHB MEDI SCIENCE LTD MTX-VHB 7165/08/10 METHOTREXATE

VHB MEDI SCIENCE LTD, PLOT NO. 20-22 & 49-51 11E, SECTOR-

5, SIDCUL, UTTARANCHAL

50MG/2ML PARENTERAL 1*1*2ML VIAL INDIA RENE PHARMACY 01/04/2009 RT29401 DATED 20/09/2011

{071BCBF0-87CF-4C5B-B289-

D0D3A499BEC9}

CADILA HEALTHCARE LTD DOMPERIDONE 7167/17/10 DOMPERIDONE

CADILA HEALTHCARE LTD, SARKHEJ-BAVLA

N.H. NO. 8A, MORAIYA TAL: SANAND, DIST: AHMEDABAD

10MG TABLET !*10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{29507169-65C8-4CDE-B9EB-

5FC202DC37D3}

AUROBINDO PHARMA LTD NOVATIN 7169/05/10 GABAPENTIN

AUROBINDO PHARMA LTD, UNIT III, SURVEY NO. 313,

BACHUPALLY VILLAGE,

QUTHUBULLAPUR

300MG CAPSULE 1*3*10 BLISTER INDIA GITTOES P'CALS 20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{801EC443-FF90-4DBA-ABF5-

ED50D697CE28}

RENE INDUSTRIES LTD KETOREN 7170/06/10 KETOCONAZOLE

RENE INDUSTRIES LTD, PLOT NO. 680,

KAMULI, KIREKA200MG TABLET 1*3*10 BLISTER &

1*10*10 BLISTER UGANDA RENE INDUSTRIES LTD

ANNUAL WITH PERIODIC REVIEW

RT29394 DATED 20/09/2011

{CF1D6B3A-EF20-460A-B8F7-

34D68146C8FC}

GENO P'CALS LTD VERTIGON 7171/17/10 CINNARAZINE

GENO P'CALS LTD, TIVIM INDUSTRIAL

ESTATE, KARASWADA, MAPUSA, GOA

25MG TABLET 1*4*5*10 BLISTER INDIA PHILLIPS P'CALS 27/04/09 RT28544 DATED 15/08/11

{A477AF9A-CCA7-4420-9020-

79543DF1ED3C}

CADILA HEALTHCARE LTD LOSACAR 7178/12/10 LOSARTAN

POTASSIUM

CADILA HEALTHCARE LTD, SARKHEJ-BAVLA

N.H. NO. 8A, MORAIYA TAL: SANAND, DIST: AHMEDABAD

100MG TABLET 1*10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{65686377-0EE7-480E-8147-6B11856791EF}

Page 105

Page 106: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ASTRA ZENECA (UK) LTD ATACAND 8MG 7179/12/10 CANDESARTAN

CILEXETILASTRA ZENECA AB,

SODERTALJE 8MG TABLET 1*14*2 BLISTER SWEDEN MACNAUGHTON (U) LTD 30/06/10 RT29484 DATED

22/09/11

{4ED859E3-A9FC-4143-9C5B-

F380933D6926}

CADILA HEALTHCARE LTD

PERINDOPRIL ERBUMINE/

INDAPAMIDE7180/12/10

PERINDOPRIL ERBUMINE/

INDAPAMIDE

CADILA HEALTHCARE LTD, SARKHEJ-BAVLA

N.H. NO. 8A, MORAIYA TAL: SANAND, DIST: AHMEDABAD

4MG/ 1.25MG TABLET 1*1*10 BLISTER INDIA ABACUS PHARMA (A) LTD

RE-INSP RT24185 DATED 31/01/2011

RT28660 DATED 19/08/2011

{DC1B63C3-D504-431C-8600-

B198A62154C7}

ASTRA ZENECA (UK) LTD ATACAND PLUS 7181/12/10

CANDESARTAN CILEXETIL/

HYDROCHLOROTHIAZIDE

ASTRA ZENECA AB, SODERTALJE 16MG/ 12.5MG TABLET 1*14*2 BLISTER SWEDEN MACNAUGHTON (U)

LTD 30/06/10 RT29484 DATED 22/09/11

{355EE631-9356-482F-9C4C-

38D8DADAE877}

ASTRA ZENECA (UK) LTD ATACAND 16MG 7182/12/10 CANDESARTAN

CILEXETILASTRA ZENECA AB,

SODERTALJE 16MG TABLET 1*14*2 BLISTER SWEDEN MACNAUGHTON (U) LTD 30/06/10 RT29484 DATED

22/09/11{9F1B2FC1-0247-478A-A31D-A28224E5B9D5}

RENE INDUSTRIES LTD LUMAREN 7187/06/10 ARTEMETHER/

LUMEFANTRINE

RENE INDUSTRIES LTD, PLOT NO. 680,

KAMULI, KIREKA20MG/ 120MG TABLET 1*3*8 BLISTER UGANDA RENE INDUSTRIES

LTDANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011

{B5A968F8-7E1D-47FA-8240-

72B48F0D816D}

HETERO DRUGS LTD TENOFOVIR/ LAMUVIDINE 7192/30/10

TENOFOVIR DISOPROXIL FUMARATE/ LAMUVIDINE

HETERO DRUGS LTD, UNIT III, NO 22-

110 I.D.A, JEEDIMETLA, HYDERABAD

300MG/ 300MG TABLET 1*30 HDPE INDIA ASTRA PHARMA (U) LTD 17/12/09 RT28304 DATED

03/08/11

{24CB93A4-8CE4-406F-A067-

F5D2DA37E395}

AUROBINDO PHARMA LTD

LOPINAVIR/ RITONAVIR 7194/30/10 LOPINAVIR/

RITONAVIR

AUROBINDO PHARMA LTD. UNIT III, SURVEY NO. 313.

BACHUPALLY VILLAGE,

QUTHUBULLARPUR MANDAL

200MG/ 50MG TABLET 1*120 HDPE INDIA GITTOES P'CALS LTD 20/05/2010 RT28910 + RT28908 DATED 31/08/2011

{9E3E8CFD-8278-43CC-8033-

022CF4B61F8C}

JOHNSON & JOHNSON (PTY) LTD

SINUTAB ALLERGY CONGESTION 7197/25/10

PARACETAMOL/ CHLORPHENIRAMINE

/ EPHEDRINE

JOHNSON & JOHNSON, 241MAIN

ROAD, RETREAT, CAPE TOWN

500MG/ 2MG/ 30MG TABLET 1*2*10 BLISTER SOUTH AFRICA LABOREX (U) LTD 03/08/2009 RT30480 DATED 18/10/2011

{4F8F4853-6E54-443A-92E6-54F70D889333}

MEDICAL UNION P'CAL CO. NIGHT & DAY -N 7198/25/10

PARACETAMOL/ DIPHENHYDRAMINE

CHLORIDE + PARACETAMOL/

PSEUDOEPHEDRINE

MEDICAL UNION P'CAL CO., ABU

SALTAN, ISMALIA

500MG/ 25MG + 500MG/ 90MG TABLET 1*1 (5+5) BLISTER EGYPT KARURI P'CALS LTD 12/10/2009 RT27905 DATED

18/07/2011

{7BDDB7BE-5841-44DF-A645-

AADF19332A34}

DAWA LTD DAWASOLONE 7201/18/10 PREDNISOLONE DAWA LTD, BABA DOGO RD, RUARAKA 5MG TABLET 1*1000 HDPE KENYA SUPER MEDIC RT24080 DATED

27/01/2011RT28507 DATED

12/08/2011{93D4F91B-FEE4-4033-84B2-6D07268FF40A}

CIRON DRUG & P'CALS PVT LTD CIRIX 7204/16/10 FUROSEMIDE

CIRON DRUGS PHARMACEUTICAL

PVT LTD, N-118 MIDC TARAPUR BOOSAR

THANE

10MG/ML PARENTERAL 1*10*10*2ML AMPOULE INDIA RENE PHARMACY RE-INSP RT18638

DATED 14/05/2010RT29396 DATED

20/09/2011{7E8E128E-6905-40EF-A96C-2607D2511C6C}

RENE INDUSTRIES LTD

MULTIVITAMIN TABLETS 7207/27/10 MULTI-INGREDIENT

RENE INDUSTRIES LTD, PLOT NO. 680,

KAMULI, KIREKAMULTI-INGREDIENT TABLET 1*1000 HDPE UGANDA RENE INDUSTRIES

LTDANNUAL WITH

PERIODIC REVIEWRT29394 DATED

20/09/2011

{33AE7F91-0705-4FAD-B90C-

4DDEBA005D7E}

CACHET P'CALS PVT LTD IBUCACH 200 7212/02/10 IBUBROFEN

CACHET P'CALS PVT LTD, VILLAGE

THANA, BADDI, HIMACHAL PRADESH

200MG TABLET 1*10*10 BLISTER & 1*1000 HDPE INDIA VRUSHIK

INVESTMENTS 30/09/11 RT30959 DATED 08/11/11

{18552C25-2FB9-4281-8DF8-671F7B2D505C}

MISSION PHARMA A/S

ORAL REHYDRATION SALTS BP 7217/17/10 MULTI-INGREDIENT

MEDICAMEN BIOTECHLTD, SP-

1192 A&B PHASE IV INDUSTRIAL AREA,

BHIWADI

2.6G/ 1.5G/ 2.9G/ 13.5G

POWDER FOR ORAL SOLUTION 1*100*20.5G INDIA JMS 27/06/2011 RT28773 DATED

25/08/2011

{D5619EA4-A4D9-40C0-B67C-

14A15D346575}

PLETHICO PHARMACEUTICALS

LIMITEDCOOLZ 7218/17/11

DRIED ALUMINIUM HYDROXIDE/ MAGNESIUM TRISILICATE/ MAGNESIUM HYDROXIDE/

SIMETHICONE

PLETHICO PHARMACEUTICALS

LIMITED VILLAGE DHARAVARA

KALARIA, DIST INDORE

300MG/ 50MG/ 25MG/ 10MG SUSPENSION 1*200ML INDIA

STAR PHARMACEUTICALS

(U) LTD

{ACA6F8A1-CCE1-4DC8-938F-

3DB1C5DD2D0A}

Page 106

Page 107: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

DENK PHARMA GMBH & CO SIMVA-DENK 7219/12/11 SIMVASTATIN

DENK PHARMA GMBH & CO.GK GOII

STR.1 84529 TIHMONING

20MG TABLET 1*3*10 BLISTER GERMANY ERIS LTD{0DF403B9-6A27-

4C5B-8808-3C8ECC339858}

MICRO LABS LTD ARBITEL-H 7220/12/11TELMISARTAN /

HYDROCHLOROTHIAZIDE

MICRO LABS LTD 92, SIPCOT INDUSTRIAL

COMPLEX,HOSUR 635 126, (T.N)

40MG /12.5MG TABLETS 1*3*10 STRIP INDIAPHILIPS

DISTRIBUTORS (U) LTD

{66F8B2A0-9911-4590-A3DD-5A2C372E02FB}

CIPLA LTD ASTHALIN ECOPACK INHALER CFC FREE 7221/25/11

SALBUTAMOL PRESSURISED INHALATION BP

CIPLA LTD PLOT 9& 10 PHARMA ZONE PHASE 11 INDORE S.E.Z. PITHAMPUR

100MCG INHALATION AEROSOL 1*1*300MD INDIA QUALITY CHEMICALS

LTD{2B21E5B0-8029-4A33-95FC-A991560D9832}

CADILA PHARMACEUTICALS

LTDLOSIUM 50 7222/12/11 LOSARTAN

POTASSIUM

CADILA PHARMACEUTICALS

LTD 1389 TRABAD ROAD DHOLKA-38810 DISTRICT

AHMEDABAD

50MG TABLET 1*2*1*14 BLISTER INDIAKARURI

PHARMACEUTICALS LTD

{6EDACC08-0DCF-411B-9533-

2CC106820E15}

WIN MEDICARE PRIVATE LTD URGENDOL P 7223/02/11 TRAMADOL/

PARACETAMOL

WIN MEDICARE PRIVATE LTD MODIPURAM

BUTTAR PRADESH

37.5MG/ 325MG TABLET 1*10*10 BLISTER INDIA SURGIPHARMRE-INSP FEE

RT13839 DATED MARCH 2011

RT28733 DATED 23/08/2011

{1A54D597-EA69-4D97A643-

EAC3D0D8CF2C}

TROIKAA PHARMACEUTICALS

LTDPANURON 7224/20/11 PANCURONIUM

TROIKAA PHARMACEUTICALS

LTD, THOL, DIST MEHSANA, 382728,

GUJARAT, AHMEDABAD

2MG/ML INJECTION 1*5*2ML AMPOULE INDIA ANDYCO PHARMACY {E1DE50B2-2696-48AFB9EB-A1908CF9AD59}

CADILA HEALTHCARE LTD

PERINDOPRIL ERBUMINE TABLETS 7225/12/11 PERINDOPRIL

ERBUMINE

CADILA HEALTH CARE LTD SARKHEJ

BAVLA N.H.NO 8A MORAIYA TAL SANAND DIST AHMEDABAD

4MG TABLET 1*1*10 BLISTER INDIA ABACUS PHARMA AFRICA LTD

{B39923AA-C587-4F77-A202-DB3C1A5806C7}

IPCA LABORATORIES LTD GLYCINORM MR 30 7226/18/11 GLICLAZIDE

IPCA LABORATORIES LTD

P .O. JEJAVTA 457002, DIST.

RATLAM MADHYA PRADESH

30MG TABLET 1*3*10 BLISTER INDIA ABACUS PHARMA AFRICA LTD

{62640208-DA07-4212-B5FB-AAE9723D8BF3}

IPCA LABORATORIES LTD ZITRAM SR 100 7227/02/11 TRAMADOL

IPCA LABORATORIES LTD PLOT 255/1 ATHAL SILVASSA 396 320

100MG TABLET 1*2*10 BLISTER INDIA ABACUS PHARMA AFRICA LTD

{268915CB-97B9-42B3-9DC8-7E91DF901EF2}

AGOG PHARMA LTD PROPAN 7228/12/11 PROPANOLOL

AGOG PHARMA LTD PLOT NO 33 SECTOR II THE VASAI TALUKA IND. CO.OP EST LTD

VASAI (E)

40MG TABLET 1*10*10 BLISTER, 1*1000 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD

{5550518E-9A5B-44C6-BE53-72B31B45E8F3}

SHANGHAI PHARMA INDUSTRIAL CO LTD ARTERAQUIN 7229/06/11 DIHYDROARTEMISINI

N / PIPERAQUINE

HOLLEY PHARMACEUTICALS CHONGQING CO LTD

NO 8, 1ST ROAD INDUSTRIAL PARK, TONGJIAXI TOWN,

BEIBEI ZONE CHONGQUIG

40MG / 320MG TABLET 1*1*9 BLISTER INDIA ABACUS PHARMA AFRICA LTD

{0DE17F50-8CA3-44D4-B78E-

1ADA030697FD}

TROIKAA PHARMACEUTICALS

LTDBENZOSED 7230/05/11 MIDAZOLAM

TROIKAA PHARMACEUTICALS

LTD, THOL, DIST MEHSANA, 382728,

GUJARAT, AHMEDABAD

1MG/ML INJECTION 1*1*5ML VIAL INDIA ANDYCO PHARMACY{BFF7D2A9-1A87-

422B-B605-50EFB1317751}

Page 107

Page 108: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ASTRA ZENECA UK LTD ATACAND 7231/12/11 CANDESARTAN

ASTRA ZENECA SWEDEN

OPERATIONS, TABLET

PRODUCTION SE-151 85,

GARTUNAVAGEN, SODERTALJE

32MG TABLET 1*2*14 BLISTER SWEDEN MAC NAUGHTON (U) LTD

{29890476-C18E-46B2-817A-6C665D6E84DF}

UNICHEM LABORATORIES LTD LOSA-H 7232/12/11

LOSARTAN / HYDROCHLOROTHIA

ZIDE

UNICHEM LABORATORIES LTD

UNIT II,VILLAGE BHATAULI

KALAN,BADDI DIST SOLAN HIMACHAL PRADESH 173205

50MG / 12.5MG TABLET 1*3*10 BLISTER INDIA NORVIK ENTERPRISES LTD

{82D79F72-519F-473C-A2DD-

4D437CC6E193}

TROIKAA PHARMACEUTICALS

LTDKETAMAX-50 7233/01/11 KETAMINE

TROIKAA PHARMACEUTICALS

LTD, THOL, DIST MEHSANA, 382728,

GUJARAT, AHMEDABAD

50MG/ML INJECTION 1*10ML VIAL INDIA ANDYCO PHARMACY{6C5E5A2F-C3D3-

46AC-A44E-8057A1927F46}

ASTRA LIFECARE ASDOL 7234/02/11 TRAMADOL

ASTRA LIFECARE (I) PVT PLOT NO.57/P SARKHEJ BAVLA RAJODA 382220

TALUKA BAVLA DIST AHMEDABAD

50MG CAPSULE 1*10*10 BLISTER INDIA ASTRA PHARMA (U) LTD

{2DF2E72D-7196-4324-9546-8EF89638964F}

ASTRA LIFECARE ASCET 7235/03/11 CETIRIZINE

ASTRA LIFECARE (I) PVT PLOT NO.57/P SARKHEJ BAVLA RAJODA 382220

TALUKA BAVLA DIST AHMEDABAD

10MG TABLET 1*10*10 BLISTER INDIA ASTRA PHARMA (U) LTD

{851EEBBE-52D6-4A6C-B6AA-

7CDBCEAF8B1A}

DYNAPHARM (M) SDN.BHD DYNAFUCIN 7236/06/11 GRISEOFULVIN

DYNAPHARM (M) SDN.BHD 2497 MKI

LORONG PERUSAHAAN BARU

N 5 KAWASAN PERUSAHAAN PERAI

3 13600

500MG TABLET 1*500 HDPE, 1*10*10 BLISTERS MALAYSIA

DYNA LAB PHARMACEUTICALS

LTD

{F32418AF-0807-459A-972C-2BB32DBC1B09}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

SUXAMETHONIUM CHLORIDE

INJECTION B.P7237/20/11 SUXAMETHONIUM

CHLORIDE

CIRON DRUGS & PHARMACEUTICALS

PVT LTD N-118 N-119 MIDC TARAPUR

BOISAR DIST THANE-401 506

MAHARASHTRA

50MG/ML INJECTION 1*10*10*2ML GLASS AMPOULE INDIA RENE PHARMACY {A992AB79-03B0-4BF5-

928F-F0426346BA86}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

THIOPENTAL SODIUM INJECTION 7238/01/11 THIOPENTAL SODIUM

CIRON DRUGS & PHARMACEUTICALS

PVT LTD N-118 N-119 MIDC TARAPUR

BOISAR DIST THANE-401 506

MAHARASHTRA

1GM / VIAL INJECTION 1*50*1GM GLASS VIAL INDIA RENE PHARMACY {C7B3D815-77A9-47F2-

B282-B9B87E6252AB}

CIRON DRUGS & PHARMACEUTICALS

PVT LTDCIROGAN 7239/03/11 PROMETHAZINE

CIRON DRUGS & PHARMACEUTICALS

PVT LTD N-118 N-119 MIDC TARAPUR

BOISAR DIST THANE-401 506

MAHARASHTRA

25M / ML INJECTION 1*10*10*2ML AMBER GLASS AMPOULE INDIA RENE PHARMACY

{D94BF5AF-0FF3-482E-84E3-

53CFE0A39DF3}

GITTOES PHARMACEUTICALS

LTD

CHLORPROMAZINE INJECTION 7240/24/11 CHLORPROMAZINE

NINGBO DAHONGYING

PHARMACEUTICAL CO LTD NO 396 MINZHU ROAD NINGBO CITY

ZHEJIANG

25M / ML INJECTION 1*10*2ML GLASS AMPOULE CHINA

GITTOES PHARMACEUTICALS

LTD

{F1895A0A-AB94-4995-B035-AF2AE53410FD}

Page 108

Page 109: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SURGIPHARM (U) LTD ACNOTIN 7241/13/11 ISOTRETINOIN

MEGA LIFE SCIENCES LTD 384

SOIB PATTANA 3 RD BANGPOO

INDUSTRIAL ESTATE SAMUTPRAKARN

10280

10MG CAPSULE 1*3*10 BLISTER THAILAND SURGIPHARM (U) LTD

{838BD057-0BC5-4703-A81D-51ED9D30F0A0}

SURGIPHARM (U) LTD ACNOTIN 7242/13/11 ISOTRETINOIN

MEGA LIFE SCIENCES LTD 384

SOIB PATTANA 3 RD BANGPOO

INDUSTRIAL ESTATE SAMUTPRAKARN

10280

20MG CAPSULE 1*3*10 BLISTER THAILAND SURGIPHARM (U) LTD

{149205E6-1E3B-4DC191C2-F085C8DFE20E}

ROYAL GROUP CHLORAMPHENICOL CAPSULES BP 7244/06/11 CHLORAMPHENICOL

JIANGSU PENGYAO PHARMACEUTICALS

69 LONGHI ROAD YIXING CITY

JIANGSU

250MG CAPSULE 1*1000 HDPE, 1*10*10 BLISTER CHINA ABACUS PHARMA (A)

LTD

{DFE1C7FB-EC31-48E7-ADBE-

1118B1C25938}

SEV PHARMACEUTICALS

LTDCOUGH LINCTUS 7245/25/11 CHLORPHENIRAMINE

SEV PHARMACEUTICALS

LTD PLOT 100 NALUKOLONGO MASAKA ROAD

2MG/5ML SYRUP 1*200ML BOTTLE UGANDASEV

PHARMACEUTICALS LTD

{71D8BB98-2D58-4D0E-B60B-

5CD613B177DD}

SQUARE CEPHALOSPORINS

LTDFORCE 7246/06/11 CETPIROME

SQUARE CEPHALOSPORINS

LTD, KALIAKOIR GAZIPUR

1G/VIAL POWDER FOR INJECTION

1*1G VIAL + 1*10ML AMPOULE WATER

FOR INJECTIONBANGLADESH

WIDE SPECTRUM ENTERPRISES (U)

LTD

{8DE2E75B-5A7F-4C36-8600-

06163696D7B4}

LINCOLN PHARMACEUTICALS

LTDSOLUDINE-M 7247/13/11 POVIDONE IODINE /

METRONIDAZOLE

LINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE

KHATRAJ KALOL, GUJARAT

5%W/W/ 1%W/W OINTMENT 1*20G ,1*125G INDIAMETRO

PHARMACEUTICALS LTD

{75D303E8-FEC8-45AE-AA2D-

9FB2C60C5552}

RANBAXY LABORATORIES LTD STARVAL 7248/12/11

VALSARTAN / HYDROCHLOROTHIA

ZIDE

RANBAXY LABORATORIES LTD

PAONTA SAHIB SIRMOUR 173 025

160MG / 25MG TABLET 1*3*10 BLISTER INDIA SURGIPHARM (U) LTD

{830E6173-D998-443A-B7B9-DC5AE3779A26}

PLETHICO PHARMACEUTICALS

LTDPLEOM 7249/17/11 OMEPRAZOLE

PLETHICO PHARMACEUTICALS

LTD DHARAVARA KALARIA 453 001

INDORE M.P

20MG CAPSULE 1*10 & 1*10*10 BLISTER INDIA

STAR PHARMACEUTICALS

LTD

{551E1238-D8BD-4AEB-B575-

B7E58538B4AE}

RANBAXY LABORATORIES

LIMITEDCEPODEM 7250/06/11 CEFPODOXIME

RANBAXY LABORATORIES

LIMITED INDUSTRIAL AREA- 3 DEWAS

100MG TABLET 1*1*10 STRIP INDIASTAR

PHARMACEUTICALS LTD

{FAB20C98-4765-412A-B018-4C16C90696BD}

MEDINOMICS HEALTHCARE LTD AMINOFER 7251/27/11 MULTI-INGREDIENT

THE MADRAS PHARMACEUTICALS 137-B OLD MAHABALI

PURAM RD KARAPAKKAM

CHENNAI 600096

MULTI-INGREDIENT SYRUP 1*1*200ML INDIAGITTOES

PHARMACEUTICALS LTD

{BC40832B-3202-4AAEB448-E65867884DF0}

MODI MUNDIPHARMA PVT LTD FECONTIN-F 7252/10/11

FERROUS GLYCINE SULPHATE/ FOLIC

ACID

MODI MUNDIPHARMA PVT

LTD MODIPURAM 250 110 UTTAR

PRADESH STATE

100MG/ 0.5MG TABLET 1*10*10 BLISTER INDIA SURGIPHARM (U) LTD

{C647BA99-6A3B-449C-9EDC-

6F64FAA72CDA}

Page 109

Page 110: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

AUROBINDO PHARMA LTD

TENOFOVIR DISOPROXIL FUMARATE

7253/30/11TENOFOVIR DISOPROXIL FUMARATE

AUROBINDO PHARMA LTD UNIT III

SURVEY NO 313 & 314 BACHUPALLY

VILLAGE QUTUBULLAPAR

MANDAL R.R DISTRICT ANDHRA

PRADESH

300MG TABLET 1*30 HDPE INDIAGITTOES

PHARMACEUTICALS LTD

{43B4006D-705F-4FF0-826B-E728F8087A5D}

ALKEM LABORATORIES LTD ZINC SULPHATE 7254/27/11 ZINC SULPHATE

ALKEM LABORATORIES LTD

PLOT 167/2 M.G UDYOG NAGAR DABHEL DAMAN

20MG TABLET 1*10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

{89F7DA64-EE27-4D53-A179-

49AD2AAD0301}

GITTOES PHARMACEUTICALS

LTD

AMPICILLIN SODIUM FOR INJECTION BP 7255/06/11 AMPICILLIN SODIUM

CSPC ZHONGNUO (SHIJIAZHUANG)

PHARMACEUTICAL CO.LTD NO 188

GONGNONG ROAD SHIJIAZHUANG

500MG POWDER FOR INJECTION 1*10*500MG VIAL CHINA

GITTOES PHARMACEUTICALS

LTD

{01B46BC8-B978-4D99A847-CC302591BA96}

CADILA HEALTHCARE LTD NUDOXA 7256/08/11

DOXORUBICIN HYDRO LIPOSOME

CHLORIDE

CADILA HEALTHCARE

LIMITED PLOT NO. 203-213 KUNDAIM

INDUSTRIAL ESTATE GOA 403115

2MG/ML SOLUTION FOR INJECTION 1*1*10ML GLASS VIAL INDIA ABACUS PHARMA (A)

LTD

{E9A11DFB-29B5-464C-92C4-

3ABBB483DFEC}

LINCOLN PHARMACEUTICALS

LTDDIOLIN-M 7257/18/11 GLIBENCLAMIDE/

METFORMIN

LINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE,

KHATRAJ KALOL GUJARAT

5MG / 500MG TABLET 1*10*10 STRIP INDIAMETRO

PHARMACEUTICALS LTD

{97BBD6D3-95D2-4558-A3E2-

EAAA71D715ED}

LINCOLN PHARMACEUTICALS

LTDOMLINK-20 7258/17/11 OMEPRAZOLE

LINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE

KHATRAJ KALOL, GUJARAT

20MG CAPSULE 1*10*10 BLISTER INDIAMETRO

PHARMACEUTICALS LTD

{1B88575E-30E0-4E09-AFC2-8E554BE6375C}

DENK PHARMA GMBH & CO SIMVA-DENK 7259/12/11 SIMVASTATIN

DENK PHARMA GMBH & CO.GK

GOLL STR.184529 TIHMONING, GERMANY

40MG TABLET 1*3*10 BLISTER GERMANY ERIS LTD {FB045FDF-3919-49A0-B20C-38D12889596A}

IPCA LABORATORIES LTD EMNORM ER 7260/18/11 METFORMIN

IPCA LABORATORIES LTD

SEJAVTA 457002 DIST RATLAM

MADHYA PRADESH

500MG TABLETS 1*3*10 BLISTER INDIA ABACUS PHARMA AFRICA LTD

{34A9D7CA-1191-40C5-9C3B-

113DC16992D6}

MEDREICH PLC BIOZOLE 7261/06/11 METRONIDAZOLE

MEDREICH LTD 4/3 AVALAHALI

ANJANPURA POST BANGALORE

125MG/5ML SUSPENSION 1*100ML AMBER GLASS BOTTLE INDIA SURGIPHARM

{47EFA41D-1BE4-49BC-91BB-

4098C77E46CF}

CACHET PHARMA PVT LTD CACHLOX 7262/06/11 CIPROFLOXACIN

CACHET PHARMA PVT LTD VILLAGE

THANA BADDI HIMACHAL PRADESH

500MG TABLET 1*10*10 BLISTER INDIA VRUSHIK INVESTMENTS LTD

{24F4E153-D618-4226-B4D8-54B884F6D04D}

CACHET PHARMA PVT LTD CAZITHRO 7263/06/11 AZITHROMYCIN

CACHET PHARMA PVT LTD VILLAGE

THANA BADDI HIMACHAL PRADESH

250MG TABLET 1*1* 6 BLISTER INDIA VRUSHIK INVESTMENTS LTD

{6F501916-5623-4D6E-9C93-2597B930E893}

CACHET PHARMA PVT LTD CAZITHRO 7264/06/11 AZITHROMYCIN

CACHET PHARMA PVT LTD VILLAGE

THANA BADDI HIMACHAL PRADESH

500MG TABLET 1*1*3 BLISTER INDIA VRUSHIK INVESTMENTS LTD

{3871CB0A-3041-4778-9ADF-0A038F809AB2}

Page 110

Page 111: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

LINCOLN PHARMACEUTICALS

LTDNEPIN-SR-20 7265/12/11 NIFEDIPINE

LINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE KHATRAP GUJARAT

20MG TABLET 1*3*10 &1*10*10 BLISTER INDIA

METRO PHARMACEUTICALS

LTD

{AF83BD69-9C3A-4C10-97A9-

CE6CE11923BD}

STRIDES ARCOLAB LTD STRICORT 7266/18/11 HYDROCORTISONE

STRIDES ARCOLAB LTD OPP.IIM, BILEKAHALLI,

BANNERGHATTA ROAD BANGALORE

500MG POWDER FOR INJECTION

1*1*500MG CLEAR GLASS VIAL INDIA VEERAM

HEALTHCARE

{E503C328-3BA4-4EAE-8E43-

E72EEA583AD3}

F.HOFFMANN LA ROCHE LTD KYTRIL 7267/17/11 GRANISETRON

F.HOFFMANN LA ROCHE LTD BASEL

GRENZA CHERSTRASSE 124

4070

3MG/3ML SOLUTION FOR INJECTION

1*5*1ML, 1*5*3ML SWITZERLAND LABOREX (U) LTD {72D23457-8653-4A8A-

BA67-0725BDBF2986}

FLAMINGO PHARMACEUTICALS

LTDPANZOL 7268/17/11 PANTOPRAZOLE

FLAMINGO PHARMACEUTICALS

LTD R-662 T.T,C INDUSTRIAL AREA

RABALE NAVI MUMBAI

40MG TABLET 1*10*10 BLISTER INDIA ABACUS PHARMA AFRICA LTD

{A52D5AD8-8E81-4848A436-2814DF783C19}

CIRON DRUGS & PHARMACEUTICALS

PVT LTD

CHLORPROMAZINE INJECTION B.P 7269/24/11 CHLORPROMAZINE

INJECTION B.P

CIRON DRUGS & PHARMACEUTICALS

PVT LTD N-118 N-119 MIDC TARAPUR

BOISAR DIST THANE-401 506

MAHARASHTRA

25MG/ML INJECTION 1*10*10*2ML INDIA RENE PHARMACY {117D47CE-59E9-4E578DF3-B6CD521941E4}

ASTRA PHARMA (U) LTD ASID 7270/17/11 OMEPRAZOLE

ASTRA LIFECARE PVT LTD, 57/P

RAJODA 382220 BAVLA AHMEDABAD

20MG CAPSULE 1*10*10 BLISTER INDIA ASTRA PHARMA (U) LTD

{DE234E5E-3F1C-43FE-BF14-

9EE49D806C44}

CACHET PHARMACEUTICALS

PVT LTDMETROCACH 7271/06/11 METRONIDAZOLE

CACHET PHARMACEUTICALS

PVT LTD VILLAGE THANA BADDI

HIMACHAL PRADESH 173205

200MG TABLET 1*10*10 BLISTER INDIA VRUSHIK INVESTMENTS LTD

{7E63BD87-A758-475E-8073-F106CFD1837E}

MATRIX LABORATORIES LTD

LOPINAVIR / RITONAVIR 7272/30/11 LOPINAVIR /

RITONAVIR

MATRIX LABORATORIES LTD

F-4, F-12, MALEGAON MIDC

100MG / 25MG TABLET 1*120 HDPE INDIAPHILLIPS

PHARMACEUTICALS LTD

{416CECE6-81A0-48F6-8B52-

304F9FB14A27}

MEDRIECH PLC ZOXON 1000 7273/06/11 CEFTRIAXONE

MEDREICH CEPHTECH PVT LTD

45 A & B ,ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK

DISTRICT

1000MG INJECTION 1*1000MG CLEAR GLASS VIAL INDIA SURGIPHARM (U)

LTD{10C53825-BA90-409F-8B37-D6B235932009}

ALKEM LABORATORIES LTD ZOCEF 7274/06/11 CEFUROXIME

ALKEM LABORATORIES LTD

VILLAGE THANA BADDI TEHSIL

NALAGARH DIST SOLAN HIMACHAL

125MG/5ML DRY POWDER FOR SUSPENSION 1*60ML HDPE INDIA ABACUS PHARMA

AFRICA LTD{2378E7ED-7EF3-4204-8625-F516AF329927}

CADILA HEALTHCARE LTD DOCETAXEL 7275/08/11 DOCETAXEL

ZYDUS HOSPIRA ONCOLOGY PVT LTD PHARMEZ SPECIAL ECONOMIC ZONE MATODA SARKHEJ BAVLA HIGHWAY

AHMEDABAD

80MG/ 8ML INJECTION 1*1*1G VIAL INDIA ABACUS PHARMA AFRICA LTD

{7BD10A86-EBE0-46899550-D0633A3D584B}

Page 111

Page 112: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CACHET PHARMACEUTICALS

LTDCACHCOLD PLUS 7276/25/11

PARACETAMOL/ CAFFEINE/

PHENYLEPHRINE/ CHLORPHENIRAMINE

CACHET PHARMACEUTICALS LTD VILLAGE THANA

BADDI HIMACHAL PRADESH 173205

500MG/ 30MG/ 5MG/ 2MG TABLETS 1*50*4 STRIPS INDIA

VRUSHIK INVESTMENTS (U)

LTD

{6431695C-79B3-4709-AA30-B8654A4EF15C}

ROYAL GROUP INDOMETHACIN 7277/01/11 INDOMETHACIN

JIANGSU PENGYAO PHARMACEUTICALS

69 LONGHI ROAD YIXING CITY

JIANGSU

25MG CAPSULES 1*10*10 BLISTETR, 1*1000 HDPE CHINA ABACUS PHARMA

AFRICA LTD{579B1C26-16DF-4FF0-A468-1A3889F6C87A}

SK AGE EXPORTS DERM 7278/13/11ECONAZOLE/

TRIAMCINOLONE/ GENTAMYCIN

S.KANT HEALTH CARE LTD 1802 -1805 GIDC PHASE III VAPI

396195 GUJARAT

1%/0.1%/0.1% CREAM 1*15G INDIA ABACUS PHARMA AFRICA LTD

{0EE6E7A5-6F1F-46C7-A4CD-

B3EF1BAAAB4B}

CADILA HEALTHCARE LTD ALDREN 7279/04/11 ALENDRONATE

CADILA HEALTHCARE LTD SARKHEJ BAVLA

N.H. NO 8A MORAIYA TAL SANANO DIST:

AHMEDABAD

70MG TABLET 1*4 BLISTER INDIA ABACUS PHARMA AFRICA LTD

{62EC40B8-F784-41F4-91D1-8272506919E4}

CACHET PHARMACEUTICALS

PVT LTDERYTHROCACH 250 7280/06/11 ERYTHROMYCIN

CACHET PHARMACEUTICALS

PVT LTD VILLAGE THANA BADDI

HIMACHAL PRADESH 173205

250MG TABLET 1*10*10 BLISTER INDIAVRUSHIK

INVESTMENTS (U) LTD

{57273B61-0DA8-43B7-BC9B-3F364421270F}

AJANTA PHARMA LTD MEFLAM 7281/02/11 MEFENAMIC ACID

AJANTA PHARMA LTD 31-0, MIDC

INDUSTRIAL AREA CHIKALTHANA

431210 DIST AURANGABAD

MAHARASHTRA STATE

50MG/5ML SUSPENSION 1*1*100ML AMBER GLASS BOTTLE INDIA ABACUS PHARMA

AFRICA LTD

{7F8C8B6C-0BCB-46E7-B5B6-

F641F4ED473E}

WIDE SPECTRUM ENTERPRISES (U)

LTDEPIFASI 7282/18/11 HUMAN CHORIONIC

GONADOTROPHIN

EGYPTIAN INTERNATIONAL

PHARMACEUTICAL INDUSTRIES CO

(EIPICO) 10TH OF RAMADAN CITY

FIRST INDUSTRIAL AREA

5000 I.U INJECTION

1 LYOPHILISED AMPOULE + 1 AMPOULE OF

SOLVENT OF 0.9% SODIUM CHLORIDE

EGYPTWIDE SPECTRUM ENTERPRISES (U)

LTD

{55D2E572-E221-48AC8C42-B0EF2775AEF3}

WIDE SPECTRUM ENTERPRISES (U)

LTDDOSIN 7283/12/11 DOXAZOCIN

EGYPTIAN INTERNATIONAL

PHARMACEUTICAL INDUSTRIES CO

(EIPICO) 10TH OF RAMADAN CITY

FIRST INDUSTRIAL AREA

2MG TABLET 1*2*10 BLISTER EGYPTWIDE SPECTRUM ENTERPRISES (U)

LTD

{4D0559EB-9A42-46FBA1F6-D65A6C698022}

NORVIK ENTERPRISES LTD MEDOMOX 250 7284/06/11 AMOXICILLIN

MEDOPHARM (PVT) LTD NO.50

KAYARAMBEDU VILLAGE

GUDUVANCHERY

250MG CAPSULES 1*10*10 BLISTERS, 1*1000 HDPE INDIA NORVIK

ENTERPRISES LTD{317C17EF-141F-44AA-A052-33F281EEDE74}

ALKEM LABORATORIES LTD BROADICLOX 7285/06/11 AMPICILLIN/

CLOXACILLIN

ALKEM LABORATORIES LTD

SURVEY NO 333/1 KACHIGAM DAMAN

500MG POWDER FOR INJECTION 1*1*500MG VIAL INDIA ABACUS PHARMA (A)

LTD

{9A21A472-C1BD-4B2C-BD51-

B3D8AFCD51CF}

SK AGE EXPORTS ERYTHROKANT 7286/06/11 ERYTHROMYCIN

S.KANT HEALTHCARE LTD

1802-1805 GIDC PHASE III VAPI

GUJARAT

250MG TABLET 1*10*10 BLISTER INDIA ABACUS PHARMA AFRICA LTD

{54CBADAD-A303-45BE-A949-

32D31A387331}

Page 112

Page 113: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

FLAMINGO PHARMACEUTICALS

LTD

AMOXICILLIN ORAL SUSPENSION 7287/06/11 AMOXICILLIN

FLAMINGO PHARMACEUTICALS

LTD R-662 T.T.C INDUSTRIAL AREA

RABALE NAVI MUMBAI 440 701

125MG/5ML SUSPENSION 1*100ML PET BOTTLE INDIA ABACUS PHARMA AFRICA LTD

{70D6F91A-6B1B-458A8253-05B3E9052873}

CADILA HEALTHCARE LTD DOCETAXEL 7288/08/11 DOCETAXEL

ZYDUS HOSPIRA ONCOLOGY PVT LTD PHARMEZ SPECIAL ECONOMIC ZONE MATODA SARKHEJ BAVLA HIGHWAY

AHMEDABAD

160MG/ 16ML INJECTION 1*1*1G VIAL INDIA ABACUS PHARMA AFRICA LTD

{6A332F39-DEC7-4861-B572-6E63FF92F27C}

PLETHICO PHARMACEUTICALS

LTDAZIPAR 7289/06/11 AZITHROMYCIN

PLETHICO PHARMACEUTICALS

LTD A.B ROAD MONGLIA 453 771

INDORE MP

200MG/5ML SUSPENSION 1*1*30ML INDIASTAR

PHARMACEUTICALS LTD

{81C40622-16E7-4E09-808A-C9C5A339B16E}

SK AGE EXPORTS QUININE SULPHATE TABLETS BP 7290/06/11 QUININE SULPHATE

SKANT HEALTH CARE LTD 1802-1805 GIDC PHASE III VAPI

GUJARAT

300MG TABLET 1*1000 HDPE INDIA ABACUS PHARMA (A) LTD

{2EDC668A-E598-4C7A-9122-

D247C7C0516B}

MARKSANS PHARMA LTD CLAVMARK-625 7291/06/11

AMOXICILLIN + POTASSIUM

CLAVULANATE

MEDOPHARM PVT LTD 50

KAYARAMBEDIL VILLAGE GUDU

VANCHERY

625MG TABLET 1*1*6 BLISTER INDIA ABACUS PHARMA (A) LTD

{BB9263F7-3781-46BB-9943-057EEAF45C4E}

WIDE SPECTRUM ENTERPRISES LTD EPICEPHIN 7292/06/11 CEFTRIAXONE

EGYPTIAN INTERNATIONAL

PHARMACEUTICAL INDUSTRIES Co (EIPICO) 1Oth OF RAMADAN CITY

FIRST INDUSTRIAL AREA

1G POWDER FOR INJECTION

1*1G VIAL + 2 PLASTIC AMPOULES

OF WFIEGYPT WIDE SPECTRUM

ENTERPRISES LTD{9746FEE3-EE15-4C3981F8-7053DB4617D4}

NEM LABORATORIES PVT LTD

AMINOPHYLLINE TABLETS 7293/25/11 AMINOPHYLLINE

NEM LABORATORIES PVT LTD 133

KRISHINA INDUSTRIAL ESTATE VASAI ROAD (EAST)

DIST. THANE

100MG TABLET 1*1000 HDPE INDIA RENE PHARMACY{9CBF67EF-F085-4F44-

BBAF-B0BBF651ADE7}

TORRENT PHARMACEUTICALS

LTDNEBICARD 5 7294/12/11 NEBIVOLOL

TORRENT PHARMACEUTICALS LTD INDRAD, DIST

MEHSANA

5MG TABLET 1*10*10 BLISTER INDIA KARURI PHARMACEUTICALS

RE-INSP RT26309 DATED 06/05/2011 RT28746 24/08/2011

{3C35DCD8-746E-43FC-B61D-

BDF5AD3EB8CE}

DYNAPHARM (M) SDN.BHD AMOXYCILLIN 7295/06/11 AMOXYCILLIN

DYNAPHARM (M) SDN.BHD 2497 MKI

LORONG PERUSAHAAN BARU

5 KAWASAN PERUSAHAAN

500MG CAPSULE 1*500 HDPE, 1*10*10 BLISTERS MALAYSIA

DYNA LAB PHARMACEUTICALS

LTD

{6F3FCCA6-EE08-4497-AE5C-

B11052331297}

NAPROD LIFE SCIENCES PVT LTD AMBROSE 2 7296/08/11 CHLORAMBUCIL

NAPROD LIFE SCIENCES PVT LTD

G 17 MIDC TARAPUR INDUSTRIAL AREA

BIOSAR THANE MUMBAI

2MG TABLET 1* 10 HDPE BOTTLE INDIAGITTOES

PHARMACEUTICALS LTD

{B950A41A-CDB9-47AF-90BC-

C2351BBCBDC9}

GENO PHARMACEUTICALS

LTDFLUNER-5 7297/03/11 FLUNARIZINE

GENO PHARMACEUTICALS

LTD TIVIM INDUSTRIAL ESTATE

KARASWADA, MAPUSA, GOA

5MG TABLET 1*2*5*10 BLISTER INDIAPHILLIPS

PHARMACEUTICALS (U) LTD

{722CDE7A-C8CD-43E9-A354-

86E83C743324}

Page 113

Page 114: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

GENO PHARMACEUTICALS

LTDFUSIGEN 7298/13/11 SODIUM FUSIDATE

GENO PHARMACEUTICALS

LTD TIVIM INDUSTRIAL ESTATE

KARASWADA, MAPUSA, GOA

20MG/G OINTMENT 1*1*10G INDIAPHILLIPS

PHARMACEUTICALS (U) LTD

{2696A8EB-F5CA-4AFF-A9AB-

5F4AE392475B}

RENE INDUSTRIES LTD COMBIFEN 7299/02/11 IBUPROFEN /

PARACETAMOL

RENE INDUSTRIES LTD PLOT 680 KAMULI ROAD

KIREKA

400MG/500MG TABLET 1*10 BLISTER UGANDA RENE INDUSTRIES LTD

{B9A2B413-60B1-4FFC-9C06-

E27F763F6A30}

WIDE SPECTRUM ENTERPRISES (U)

LTD

COLOSPASMIN FORTE 7300/17/11 MEBEVERINE

EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO

(E.I.P.C.O)

135MG TABLETS 1*1*20 BLISTER EGYPTWIDE SPECTRUM ENTERPRISES (U)

LTD

{7F7754A1-DBC0-435F-A440-85BC89CFE823}

GETZ PHARMA PVT LTD LARINEX 7301/03/11 DESLORATIDINE

GETZ PHARMA PVT LTD 29-30/27

KORANGI INDUSTRIAL AREA,

KARACHI 74900

5MG TABLET 1*1*10 BLISTER PAKISTAN TATA (U) LTD {33662D39-BCC6-4908-9A9C-D0555985A016}

CADILA HEALTHCARE LTD GEMCITABINE 7302/08/11 GEMCITABINE

ZYDUS HOSPIRA ONCOLOGY PVT LTD PHARMEZ SPECIAL ECONOMIC ZONE MATODA SARKHEJ BAVLA HIGHWAY

AHMEDABAD

1G INJECTION 1*1VIAL INDIA ABACUS PHARMA AFRICA LTD

{FBFE6CCA-D2BA-40D2-A723-

5683173DA711}

CIPLA LTD STAVUDINE 7303/30/11 STAVUDINE

CIPLA LTD PLOT NO M-61, M-62 & M-63

VERNA INDUSTRIAL ESTATE ,VERNA

GOA

1MG/ML ORAL SOLUTION 1*200ML INDIA QUALITY CHEMICALS{325CD0D5-FB18-

48CB-8D93-A4C991AF24EF}

GETZ PHARMA PVT LTD CYTOPAN 7304/02/11 DICLOFENAC /

MISOPROSTOL

GETZ PHARMA PVT LTD 29-30/27

KORANGI INDUSTRIAL AREA,

KARACHI

75MG/200MCG TABLET 1*2*10 BLISTER PAKISTAN TATA (U) LTD {B37CFDB7-5315-46F3-BDD7-A5B176B92D77}

MACK BROWN PHARMACEUTICALS

PVT LTDAZZY 7305/06/11 AZITHROMYCIN

TORQUE PHARMACEUTICALS PVT LTD PO DAPPAR

VILL ISSAPUR PUNJAB

500MG TABLET 1*3 BLISTER INDIA SHURIK{056DD471-DAFE-

4B24-BDD4-831D0E0328A5}

MEDINOMICS HEALTHCARE LTD AMINOSENG 7306/27/11 MULTI-INGREDIENT

SOFT GEL HEALTH CARE PVT LTD SURVEY 20/1 VANDALUR

PUDUPAKKAM VILLAGE

KANCHEPURAM DIST CHENNAI

600013

MULTI-INGREDIENT CAPSULE 1*3*10 BLISTER INDIAGITTOES

PHARMACEUTICALS LTD

{97DE1DD2-CE6C-47FB-9B9F-

3BA836B49749}

ORTIN LABORATORIES LTD MULTIVIT 7307/27/11 MULTI-INGREDIENT

ORTIN LABORATORIES LTD

PLOT 275 & 278 (PART) CHEMICAL

ZONE IDA POSHAMYLARAM MEDAK DISTRICT

(A.P)

MULTI-INGREDIENT TABLET 1*1000 HDPE INDIA META PRODUCTS (U) LTD

{8521D397-1D24-4D1F-BB19-

439D46D5EDDF}

SANOFI PASTEUR VAXIGRIP 7308/19/11 H1N1/ H3N2/ B/FLORIDA/4/2006

SANOFI PASTEUR CAMPUS MERIEUX

1541 AVENUE MARCEL MERIEUX

69280 MARCY LETOILE

15MCG/ 15MCG/ 15MCG INJECTION 1*0.5ML FRANCE LABOREX (U) LTD

{6AC9F656-CABF-4780-AD1F-

3E1A9C732AF7}

Page 114

Page 115: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

PHARMACARE LTD PREZISTA 7309/30/11 DARUNAVIR

JANSSEN ORTHO LLC STATE ROAD 933 KM 0.1 MAMEY

WARD GURABO PUERTO RICO

600MG TABLET 1*60 HDPE USA MEDICAL ACCESS{6BBB73DE-A92D-

4A75-A972-0BBB4EDE2D55}

GETZ PHARMA PVT LTD CYTOPAN 7310/02/11

DICLOFENAC SODIUM /

MISOPROSTOL

GETZ PHARMA PVT LTD 29-30/27

KORANGI INDUSTRIAL AREA

KARACHI 74900

50MG/ 200MCG TABLET 1*2*10 BLISTER PAKISTAN TATA (U) LTD {07EDF805-2E20-4463-86DD-6274EC3534EE}

GENO PHARMACEUTICALS

LTDLOBAK 7311/02/11

DICLOFENAC/PARACETAMOL/CHLORZOX

AZONE

GENO PHARMACEUTICALS

LTD TIVIM INDUSTRIAL ESTATE

KARASWADA, MAPUSA, GOA

50MG/325MG/250MG TABLET 1*10 BLISTER INDIA PHILLIPS PHARMACEUTICALS

{1271693F-2C0D-42F5-9A58-EBFB6E2F9578}

KAMPALA PHARMACEUTICALS INDUSTRIES (1996)

LTD

CARDIPAC 7312/12/11 AMLODIPINE

KAMPALA PHARMACEUTICALS INDUSTRIES (1996)

LTD PLOT NO. M444B STRETCHER ROAD,

NTINDA

5MG TABLETS 1*10!10 BLISTER UGAND

KAMPALA PHARMACEUTICALS INDUSTRIES (1996)

LTD

{68B794F7-D07F-49B3-9944-3569EC92CD4C}

MEDINOMICS HEALTHCARE LTD AMINOSOFT 7313/27/11 MULTI-INGREDIENT

THE MADRAS PHARMACEUTICALS 137-B OLD MAHABALI

PURAM RD KARAPAKKAM

CHENNAI 600096

MULTI-INGREDIENT SYRUP 1*1*200ML INDIAGITTOES

PHARMACEUTICALS LTD

{C405FF51-073C-420A-BFCE-

9A7EAFE9735A}

AGOG PHARMA LTD CHLOZINE 7314/24/11 CHLORPROMAZINE

AGOG PHARMA LTD PLOT NO.33 SECTOR II THE VASI TALUKA INDL CO-OP ESTATE LTD VASAI (E) DIST -

THANE

100MG TABLETS 1*10*10 BLISTER, 1*1000 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD

{7A3163A5-F3F0-4F88-A92D-2B16FB37F7A0}

SEARLE PAKISTAN LTD LOMOTIL 7315/17/11 DIPHENOXYLATE

/ATROPINE

SEARLE PAKISTAN LTD F-319 S.I.T.E

KARACHI2.5MG/0.025MG TABLETS 1*25*20 , 1*4

BLISTERS PAKISTAN HEALTHCARE LTD{9F7E6D7B-57AD-

42F1-A859-6C2DA751FDB0}

PHARMACARE LTD CARDIVEL 7316/12/11 CARVEDILOL

TORRENT PHARMACEUTICALS LTD INDRAD 382 721

DIST MEHSANA

25MG TABLET 1*3*10 BLISTER INDIA ERIS{E6BCE859-751C-

4CFF-B9C3-9DD88A5DD45B}

ALKEM LABORATORIES LTD ZAXTER 7317/06/11 MEROPENEM

ALKEM LABORATORIES LTD

VILLAGE THANA BADDI TEHSIL

NALAGARH DIST SOLAN (HP) INDIA-

173205

1GM INJECTION 1*1G VIAL INDIA ABACUS PHARMA AFRICA LTD

{0A885E2C-D187-4BB9-84BD-

BE5F12C31C16}

INTAS PHARMACEUTICALS

LTDCARCA 12.5 7318/12/11 CARVEDILOL

INTAS PHARMACEUTICALS

LTD SELAQUI DEHRADUN 248197

12.5 MG TABLETS 1*3*10 BLISTER INDIA NORVIK ENTERPRISES LTD

{CDB5F329-5E35-46A8-AEDF-

20AEEF48C94D}

CIPLA LTD AMICIP 7319/06/11 AMIKACIN

CIPLA LTD M-61, M-62 &M-63 UNIT IX

VERNA INDUSTRIAL ESTATE, VERNA,

SALCETTE GOA 403 722

500MG/2ML INJECTION 5 VIALS OF 2ML INDIA QUALITY CHEMICALS{45E1E5E7-7DAE-

41ED-AB08-193E7DFB47A7}

SHELYS PHARMACEUTICALS

LTDMUCOLYN SYRUP 7320/25/11

AMMONIUM CHLORIDE/

CHLORPHENIRAMINE/

DEXTRMETHORPHAN/ BROMOHEXINE

SHELYS PHARMACEUTICALS

LTD NEW BAGAMOYO ROAD, MWENGE PLOTNO

696 BLOCK 32

50MG/2MG/5MG/4MG SYRUP 1*1*100ML TANZANIA BETE HEALTH CARE UGANDA LTD

{182F32BD-2879-4734-9B1A-

A3A8DBFDEE36}

Page 115

Page 116: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

PLETHICO PHARMACEUTICALS

LTDANGISARTAN 7321/12/11 LOSARTAN

PLETHICO PHARMACEUTICALS

LTD DHARAVARA KALARIA 453 001

(MP)

50MG TABLETS 1*2*14 BLISTER INDIASTAR

PHARMACEUTICALS LTD

{43A859E9-6B1D-43C49ED6-3D70F63574B5}

FLAMINGO PHARMACEUTICALS

LTDAMOXY 250 7322/06/11 AMOXICILLIN

FLAMINGO PHARMACEUTICALS

LTD R622 T.T.C INDUSTRIAL AREA

RABALE NAVI MUMBAI 400 701

250 MG CAPSULES 1*10*10 BLISTER INDIA ABACUS PHARMA AFRICA LTD

{48948CC6-D5E0-4DB9-8E99-

9B2AEAC839A5}

MERCK SHARP & DOHME BV ISENTRESS 7323/30/11 RALTEGRAVIR

ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD XUNQIAE LINHAI ZHIJIANG

400MG TABLETS 1*60 CHINA PHILLIPS P'CALS (U) LTD

{808ECE5E-C772-4701B460-1C4F01063162}

KUNMING PHARMACEUTICAL

CORPORATIONARCO 7324/06/11 ARTEMESININ /

NAPTHOQUINE

KUNMING PHARMACEUTICAL

CORPORATION 650100 QIGONGLI WEST SUBURB

KUNMING YUNNAN PROVINC

250MG /100MG TABLETS 1*4 BLISTER CHINA SINO AFRICA MEDICINES LTD

{A71BFF87-D812-4115-A615-3CE93E4BB5CB}

SWISS PARENTERALS PVT

LTDSWISSCILLIN 7325/06/11 AMPICILLIN

SWISS PARENTERALS PVT LTD 809 KERALA IND ESTATE GIDC NEAR

BAVLA DIST AHMEDABAD 382

22O GUJARAT

500MG POWDER FOR INJECTION 1*500MG VIAL INDIA

SHREEJI PHARMACEUTICALS

LTD

{8AA571E2-2B9A-4BA9-B5B4-

8DC54F4C3140}

QUALITY CHEMICALS INDUSTRIES LTD LUMARTEM 7326/06/11 ARTEMETHER

/LUMEFANTRINE

QUALITY CHEMICALS

INDUSTRIES LTD LUZIRA INDUSTRIAL

PARK PLOT 1-7

20MG /120MG TABLET 1*30*24 BLISTER UGANDA QUALITY CHEMICALS INDUSTRIES LTD

{68FC8918-2E82-4AAAB93E-

AFADD9B791E3}

FRESENIUS KABI ONCOLOGY LTD INTAXEL 7327/08/11 PACLITAXEL

FRESENIUS KABI ONCOLOGY LTD

VILLAGE KISHANPURA P.O.

GURU MAJRA TEHSIL NALARGGH

DIST SOLAN(H.P) 174 101

6MG/ML INJECTABLESOLUTION

1*1*2OML, 1*1*43.4ML,

1*1*16.7ML, 1*1*25ML, 1*1*5ML GLASS VIALS

INDIA NORVIK ENTERPRISES LTD

{8096AC1B-B18B-4B80B328-50CFB68279A7}

SK AGE EXPORTS HYOSCINE BUTYLBROMIDE 7328/17/11 HYOSCINE

BUTYLBROMIDE

S KANT HEALTH CARE LTD 1802-1805 GIDC PHASE III VAPI

396195 GUJARAT

10MG TABLETS 1*100*10 BLISTER PACK INDIA ABACUS PHARMA

AFRICA LTD

{FD4B036F-E15D-44CB-9BF9-

96F5D887B915}

ABACUS PARENTERAL DRUGS

LTDX-BETA 7329/28/11 BETAMETHASONE

ABACUS PARENTERAL

DRUGS LTD BLOCK 191 PLOT NO114 KNGA MUKONO

0.1W/V EYE/EAR/NASAL DROPS 1*1*10ML LDPE VIAL UGANDA

ABACUS PARENTERAL DRUGS

LTD

{740D2083-8A1D-407C-822F-1930E7BDE2F2}

ROYAL GROUP TETRACYCLINE 7330/06/11 TETRACYCLINE

JIANGSU PENGYAO PHARMACEUTICALS

69 LONGHI ROAD YIXING CITY

JIANGSU

250MG CAPSULES 1*10*10 BLISTER, 1*1000 HDPE CHINA ABACUS PHARMA

AFRICA LTD{4C7C4866-3232-45FA-8E2D-392AE7537649}

SANOFI AVENTIS MAALOX 7331/17/11

MAGNESIUM HYDROXIDE +

ALUMINIUM HYDRXIDE

WINTHROP PHARMACEUTICALS

(PYT) 315, WALTALOO PRETORIA

200MG + 200MG TABLET 1*10, 1*5*10 BLISTER SOUTH AFRICA LABOREX (U) LTD{2F15EE83-5767-442F-

BCA1-AA148FA27EC1}

SANOFI AVENTIS MAALOX PLUS 7332/17/11

MAGNESIUM HYDROXIDE +

ALUMINIUM HYDRXIDE +

SIMETHICONE

WINTHROP PHARMACEUTICALS

(PYT) 315, WALTALOO PRETORIA

200MG + 200MG + 25MG TABLET 1*10, 1*5*10 BLISTER SOUTH AFRICA LABOREX (U) LTD

{2FE1D48F-A6F2-4921-9025-

5ADBADCAA10E}

Page 116

Page 117: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

MARCK BIOSCIENCES LTD

MAGNESIUM SULPHATE 7333/05/11 MAGNESIUM

SULPHATE

MARCK BIOSCIENCES LTD PLOT 876 NH NO 8 HARIYALA KHEDA 387411 GUJARAT

50%W/V INJECTION 1*50*10ML INDIAKARURI

PHARMACEUTICALS LTD

{F7635599-972F-4F6D-BC25-ADA85BF82511}

ABACUS PARENTERAL DRUGS

LTD

ABNAL NASAL DROPS 7334/28/11 SODIUM CHLORIDE

ABACUS PARENTERAL

DRUGS LTD BLOCK 191 PLOT NO114 KINGA MUKONO

0.9%W/V NASAL DROPS 1*10ML LDPE VIAL UGANDAABACUS

PARENTERAL DRUGS LTD

{0BB1B737-0F64-4434-A45F-20B3421628B0}

CIPLA LTD LUMARTEM 7335/06/11 ARTEMETHER + LUMEFANTRINE

CIPLA LTD PLOT NO.9 & 10 PHARMA

ZONE PHASE II INDORE SPECIAL ECONOMIC ZONE PITHAMPUR (M.P)

454 775

20MG /120 MG TABLETS

1*1*24, 1*1*6, 1*1*12, 1*1*18, 1*30*6,

1*30*12, 1*30*18 & 1*30*24 BLISTER

PACKS

INDIA QUALITY CHEMICALS LTD

{5DA6F040-1E34-43F2-988C-636868B22CCD}

ASTRA ZENECA UK LTD

PULMICORT NEBULISER 7336/25/11 BUDESONIDE

ASTRA ZENECA SWEDEN

OPERATIONS LIQUID PRODUCTION

KVARNBERGAGATANLZ SE-151 -85 SODERTAJJE

0.25MG/ML SUSPENSION 1*4*5*2ML AMPOULES SWEDEN MACNAUGHTON LTD

{2B9DB954-F58E-41D8-9293-

F39E54EB9060}

ASTRA ZENECA UK LTD

PULMICORT NEBULISER 7337/25/11 BUDESONIDE

ASTRA ZENECA SWEDEN

OPERATIONS LIQUID PRODUCTION

KVARNBERGAGATANLZ SE-151 -85 SODERTAJJE

0.5MG/ML SUSPENSION 1*4*5*2ML AMPOULES SWEDEN MACNAUGHTON LTD

{05B56C70-DC53-43D0-BFB0-

A58620B80AC4}

AGOG PHARMA LTD TENA-50 7338/12/11 ATENOLOL

AGOG PHARMA LTD PLOT NO 33 SECTOR II THE VASAI TALUKA INDL. CO-OP ESTATE LTD VASAI (E) DIST

THAN

50MG TABLETS 1*3*10, 1*28, 1*10*10 BLISTERS INDIA

GITTOES PHARMACEUTICALS

LTD

{7BE4C129-5D7F-4CDB-B4C0-

F94725053D86}

GITTOES PHARMACEUTICALS

LTD

CLOXACILLIN SODIUM INJECTION

BP7339/06/11 CLOXACILLIN

SODIUM

CSPC ZHONGNUO (SHIJIAZHUANG)

PHARMACEUTICAL CO LTD NO.188

GONGNONG ROAD SHIJIAZHUANG

500MG POWDER FOR INJECTION 1*10*500MG VIALS CHINA

GITTOES PHARMACEUTICALS

LTD

{D012088D-876E-4BE3A1B6-0155796D1000}

GITTOES PHARMACEUTICALS

LTD

RANITIDINE INJECTION USP 7340/17/11 RANITIDINE

NINGBO DAHONGYING

PHARMACEUTICAL LTD NO.396 MINZHU

ROAD NINGBO ZHEJIANG

25MG/ML INJECTION 1*1*10*2ML AMPOULES CHINA

GITTOES PHARMACEUTICALS

LTD

{F42BD61C-9A7F-4CC7-BAF4-

728ABE339C7F}

GITTOES PHARMACEUTICALS

LTD

CEFTRIAXONE SODIUM 7341/06/11 CEFTRIAXONE

SODIUM

CSPC ZHONGNUO (SHIJIAZHUANG)

PHARMACEUTICAL CO LTD NO.188

GONGNONG ROAD SHIJIAZHUANG

1G POWDER FOR INJECTION 1*1G VIAL CHINA

GITTOES PHARMACEUTICALS

LTD

{2E29834E-384C-4761-A171-

8D16DCDCFA52}

MACLEODS PHARMACEUTICALS

LTDTRENAXA 500 7342/10/11 TRANEXAMIC ACID

MACLEODS PHARMACEUTICALS LTD PLOT NO 25-27

SURVEY NO 366 PREIER IND ESTATE KACHIGAM DAMAN

500MG TABLETS 1*5*6 INDIA NORVIK ENTERPRISES LTD

{13574747-C944-4BBB-9A75-28AEB3108764}

ABACUS PARENTERAL DRUGS

LTDX-SONE-N 7343/06/11 DEXAMETHASONE +

NEOMYCIN

ABACUS PARENTERAL

DRUGS LTD BLOCK 191 PLOT NO 114 KINGA MUKONO

0.1W/V + 0.35W/V EYE/EAR DROPS 1*10ML LDPE VIAL UGANDAABACUS

PARENTERAL DRUGS LTD

{232A8694-4D8D-4CB3-A5C8-

2C2009A7FD9B}

Page 117

Page 118: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SWISS PARENTERALS PVT

LTDARTI 7344/06/11 ARTEMETHER

SWISS PARENTERALS PVT

LTD 809, KERALA IND ESTATE ,GI.D.C, NR

BAVLA DIST AHMEDABAD

GUJARAT

80MG/ML SOLUTION FOR INJECTION 1*7*1ML INDIA

SHREEJI PHARMACEUTICALS

LTD

{5200A2C0-EA49-4858-8741-074AE3C70F2C}

SHANGHAI PHARMA INDUSTRIAL CO LTD METRONIDAZOLE 7345/06/11 METRONIDAZOLE

HOLLEY PHARMACEUTICALS

(CHONGQING) CO.LTD NO.8 1ST ROAD TONGJIAXI

TOWN BEIBEI ZONE CHONGQING

200MG TABLETS 1*1000HDPE CHINA ABACUS PHARMA (A) LTD

{642D2A15-E97A-4F55-A118-F71CA8935F56}

PLETHICO PHARMACEUTICALS

LTDGYNO KIT 7346/06/11

SECNIDAZOLE + ZITHROMYCIN + FLUCONAZOLE

PLETHICO PHARMACEUTICALS

LTD A.B ROAD MANGLIA 453 771

(MP)

1G+1G+150MG TABLETS 1*(2+1+1) INDIASTAR

PHARMACEUTICALS LTD

{E75172F2-4A09-4643-A16B-AB77A5C5AF9A}

UNIQUE PHARMACEUTICALS

LABORATORIESIFICIPRO OD 1000 7347/06/11 CIPROFLOXACIN

EXTENDED RELEASE

J.B CHEMICALS AND PHARMACEUTICALS

LTD 128 / G.I.D.C INDUSTRIAL AREA

ANKLESHWAR GUJARAT 393002

1000MG TABLETS 1*5 BLISTER INDIA TATA (U) LTD{6B933A9D-9FED-

4683-8BEF-0DF7FAE7A1E3}

SVIZERA EUROPE BV RIAMPICIN / ISONIAZID 7348/06/11 RIAMPICIN /

ISONIAZID

SVIZERA LABS PVT LTD PLOT D 16/6 TTC

INDUSTRIAL AREA MIDC TURBHE NAVI

MUMBAI

60MG /30MG TABLETS 1*1000 HDPE, 1*24*28 BLISTERS INDIA

PHILLIPS PHARMACEUTICALS

LTD

{8AB85775-10A3-4CE6-804C-F81E0B5F0D47}

IND SWIFT LTD CAPLOR 7349/10/11 CLOPIDOGREL

IND SWIFT LTD GBU JAWAHARPUR OFF NH-21 DERABASSI

DIST MOHALI

75MG TABLETS 1*3*10 BLISTER INDIA META PRODUCTS (U) LTD

{801F252B-B26F-4E75-BB9D-5843E90C6467}

IND SWIFT LTD ATSTAT 7350/12/11 ATORVSASTATIN

IND SWIFT LTD GBU JAWAHARPUR OFF NH-21 DERABASSI

DIST MOHALI

100MG TABLETS 1*3*10 BLISTER INDIA META PRODUCTS (U) LTD

{D62C54F3-6731-4B86-B715-3D24CF52F3C7}

SHANGHAI PHARMA INDUSTRIAL CO LTD TETRACYCLINE 7351/06/11 TETRACYCLINE

HOLLEY PHARMACEUTICALS ( CHONGQING) CO

LTD NO .8 1ST ROAD TONGXING

INDUSTRIAL PARK TONGJAXING TOWN

BEIBEI ZONE CHONGQING

250MG CAPSULES 1*1000 HDPE CHINA ABACUS PHARMA (A) LTD

{31EF0F1C-4BA8-474D-A625-

2D35F5B7A14A}

IPCA LABORATORIES LTD ZITRAM SR 200 7352/02/11 TRAMADOL

IPCA LABORATORIES LTD

PLOT NO. 255/1 ATHAL SILVASSA 396

320 DADRA AND NAGAR HAVELI

200MG TABLETS 1*2*10 BLISTER INDIA ABACUS PHARMA (A) LTD

{E9B86CBA-1A35-42389934-B163E15FC481}

INGELHEIM PHARMACEUTICALS

(PTY) LTDBUSCOPAN PLUS 7353/17/11 HYOSCINE /

PARACETAMOL

BOEHRINGER INGELHEIM PHARMA

GMBH & CO, KG INGELHEIM AM

RHEIN

10MG /500MG TABLETS 1*5*10 BLISTER GERMANY SURGIPHARM {531E3152-33B6-4320-94C3-7B6F285B687E}

Page 118

Page 119: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

AGOG PHARMA LTD AZ-250 7354/06/11 AZITHROMYCIN

AGOG PHARMA LTD PLOT NO.33 SECTOR II THE VASAI TALUKA INDL CO-OP ESTATE LTD VASAI (E) DIST

THANE

250MG TABLETS 1* 6 INDIAGITTOES

PHARMACEUTICALS LTD

{B7711715-0A2C-4993-85AE-61B60F08CAB4}

AGOG PHARMA LTD AGOFORMIN 7355/18/11 METFORMIN

AGOG PHARMA LTD PLOT NO.33 SECTOR II THE VASAI TALUKA INDL CO-OP ESTATE LTD VASAI (E) DIST

THANE

500MG TABLETS 1*10*10 BLISTER, 1*1000 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD

{A3EAC93F-4ECD-474B-B9C5-

C8D093BE2705}

SWISS PARENTERALS PVT

LTDS-CHLOR 7356/06/11 CHLORAMPHENICOL

SWISS PARENTERALS PVT LTD 809 KERALA IND

ESTATE GIDC NR BAVLA DIST

AHMEDABAD

1G POWDER FOR INJECTION 1* 1G INDIA

SHREEJI PHARMACEUTICALS

LTD

{63B1B324-DD1B-4683B1BC-7B3080AC206A}

SOFTGEL HEALTH CARE PVT LTD LIV-COD 1000 7357/27/11 COD LIVER OIL

SOFTGEL HEALTH CARE PVT LTD

SURVEY NO 20/1 VANDALUR

KELAMBAKKAM DIST TAMIL NADU 603 103

1000MG CAPSULES 1*30 HDPE INDIAGITTOES

PHARMACEUTICALS LTD

{69A2DC22-F7AF-4FB3-8463-

DD84E30BE09F}

UNIQUE PHARMACEUTICAL

LABORATORIESIFIMOL 7358/02/11 PARACETAMOL

UNIQUE PHARMACEUTICAL LABORATORIES (A

DIVISION OF J.B CHEMICALS AND

PHARMACEUTICALS LTD) PLOT 4 PHASE

IV GIDC PANLI 394116 GUJURAT

10MG/ML INTRAVENOUS INFUSION 1*100ML INDIA TATA (U) LTD {9DBA5022-A308-43AB

87F5-43D4A8F8CCF9}

MACLEODS PHARMACEUTICALS

LTDZIDOVUDINE 7359/30/11 ZIDOVUDINE

MACLEODS PHARMACEUTICALS LTD PLOT NO.25-27

SR NO.366 PREMIERE INDL

ESTATE KACHIGAM DAMAN

300MG TABLETS 1*60 HDPE BOTTLE INDIA NORVIK ENTERPRISES LTD

{18325F60-24C4-4C44-B8DA-0073DAD6F982}

NIRMA LTD HEALTHCARE

DIVISIONMANNITOL INFUSION 7360/16/11 MANNITOL

NIRMA LTD HEALTHCARE

DIVISION SACHANA VIRAMGAM

AHMEDABAD

20%W/V INTRAVENOUS INFUSION 1*100ML LDPE INDIA

PHILLIP PHARMACEUTICALS

(U) LTD

{80C8AF3E-E024-4F79-A39D-B81B50F41EA5}

SINOCHEM JIANSU CORPORATION

BENZYL PENICILLIN SODIUM 7361/06/11 BENZYL PENICILLIN

SODIUM

REYOUNG PHARMACEUTICAL

.CO LTD ERLANGSHAN ROAD

YIYUAN COUNTRY SHANDONG

PROVINCE P.R

1,000,000 I.U POWDER FOR INJECTION 1*50 VIALS CHINA FAMILY PHARMACY

LTD

{F3DCE5D5-F282-4394-A579-

CD431D4AB0B0}

MICRO LABS LTD ARBITEL-80 7362/12/11 TELMISARTAN

MICRO LABS LTD 92 SIPCOT INDUSTRIAL

COMPLEX HOSUR 635 126 (T.N)

80MG TABLETS 1*3*10 BLISTER INDIAPHILLIPS

DISTRIBUTORS (U) LTD

{1F879C52-57B1-4669-9269-

DFEDC81BAC85}

MACLEODS PHARMACEUTICALS

LTDEFAVIRENZ 7363/30/11 EFAVIRENZ

MACLEODS PHARMACEUTICALS LTD PLOT NO.25-27

SR. NO .366 PREMIERE INDL

ESTATE KACHIGAM DAMAN

600MG TABLETS 1*30 HDPE INDIA NORVIK ENTERPRISES LTD

{860226A6-1916-4790-B94B-DDA201991FC6}

Page 119

Page 120: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

AVENTIS INTERCONTINENTAL ORELOX 7364/06/11 CEFPODOXIME

AVENTIS INTERCONTINENTAL

56 ROUTE DE CHOISY AU BAC

60200 COMPIENGNE

40MG/ 5ML GRANULES FOR SUSPENSION

1*50ML, 1*100ML AMBER GLASS

BOTTLEFRANCE LABOREX (U) LTD {D892849E-7C46-468A-

BA99-91FFC57B6414}

IPCA LABORATORIES LTD LARITEM 7365/06/11 ARTEMETHER /

LUMEFANTRINE

IPCA LABORATORIES LTD

SEJAVTA RATLAM 4570002 MADHYA

PRADESH

40MG /240MG TABLETS 1*10*2*6 BLISTER INDIA ABACUS PHARMA (A) LTD

{415660AF-8F7B-434B-AD24-9A499E15767B}

CIPLA LTD FUNGICIP 7366/13/11 CLOTRMAZOLE CREAM USP

CIPLA LTD L139 TO L-146 VERNA

INDUSTRIAL ESTATE VERNA SALCETTE

GOA 403 722

1%W/W CREAM 1*20G INDIA QUALITY CHEMICALS LTD

{2783BEA9-8482-4CC999A3-A15985B8A560}

SWISS PARENTERALS PVT

LTDMERO 7367/06/11 MEROPENEM

SWISS PARENTERALS PVT

LTD 809, KERALA IND ESTATE ,GI.D.C, NR

BAVLA DIST AHMEDABAD

GUJARAT

1G POWDER FOR INJECTION 1*1G VIAL INDIA

SHREEJI PHARMACEUTICALS

LTD

{8CE3F0F3-990A-48F9-B54D-F39FD6E08997}

IPCA LABORATORIES REVELOL XL 7368/12/11METOPROLOL

SUCCINATE EXTENDED RELEASE

IPCA LABORATORIES LTD

SEJAVTA RATLAM MADHYA PRADESH

25MG TABLETS 1*3*10 BLISTER INDIA ABACUS PHARMA (A) LTD

{4743DC83-6C93-4BD1-861D-

7084BD12F2FB}

IPCA LABORATORIES LTD LARINETE 7369/06/11 ARTESUNATE

IPCA LABORATORIES LTD SEJAVTA DISTRICT

RATLAM 457 002 (M.P)

60MG INJECTION

I*60MG VIAL DRY POWDER OF

ARTESUNATE, 1*5ML SODIUM CHLORIDE

INJ, 1*1ML AMPOULE OF SODIUM

BICARBONATE INJ

INDIA ABACUS PHARMA (A) LTD

{FB29A7B6-0BF1-46E198C0-F27BF64E512A}

ASTRA ZENECA UK LTD DIPRIVAN 7370/01/11 PROPOFOL

CORDEN PHARMA SPA VIALE DELL

INDUSTRIA 3 REPAR TO VIA GAB'LEI

1720040 LOPONAGO MILAN

20MG/ML EMULSION FOR INJECTION 1*50ML VIAL ITALY MACNAUGHTON LTD

{07AAAD15-625F-434C-9AC5-

C83DF0E82028}

IPCA LABORATORIES LTD LARITEM 7371/06/11 ARTEMETHER /

LUMEFANTRINE

IPCA LABORATORIES LTD

SEJAVTA RATLAM 457002 MADHYA

PRADESH

80MG/480MG TABLETS 1*10*1*6 BLISTER INDIA ABACUS PHARMA (A) LTD

{278D86FB-A202-4EF8-8862-5B4658A3E5A6}

MACLEODS PHARMACEUTICALS

LTD

LAMIVUDINE/ STAVUDINE/

NEVIRRAPINE7372/30/11

LAMIVUDINE/ STAVUDINE/

NEVIRRAPINE

MACLEODS PHARMACEUTICALS LTD PLOT NO.25-27

SR NO. 366 PREMIERE

KACHIGAM DAMAN

150MG/ 30MG/ 200MG TABLETS 1*60 HDPE INDIA NORVIK ENTERPRISES LTD

{034B52BB-D037-4209-BD92-2673FD212A8A}

ASTRA ZENECA UK LTD DIPRIVAN 7373/01/11 PROPOFOL

CORDEN PHARMA SPA VIALE DELL

INDUSTRIA 3 REPAR TO VIA GAB'LEI

1720040 LOPONAGO MILAN

10MG/ML EMULSION FOR INJECTION

1*1*50ML VIALS, 1*5*20ML AMPOULES ITALY MACNAUGHTON LTD

{773037CE-5DCD-4B9E-AD99-

A089EC0A3D93}

MARKSANS PHARMA LTD AMPIMARK 7374/06/11 AMPICILLIN

SPARSH BIOTECH PVT LTDPLOT NO.

1SURVEY NO.242/243/244

LAKHABVAD JAMNAGAR 361 006

250MG CAPSULES 1*10*10 BLISTER INDIA ABACUS PHARMA (A) LTD

{B7928D6F-C15C-453B-8C27-

875B3E8F33D9}

Page 120

Page 121: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ABACUS PHARMA (A) LTD TRIXONE 7375/06/11 CEFTRIAXONE

REYOUNG PHARMACEUTICAL

CO.LTD ERLANGSHAN ROAD

YIYUAN COUNTRY SHANDONG P.R

1G POWDER FOR INJECTION 1*1*1G CHINA ABACUS PHARMA (A)

LTD{3621AF15-4C7B-46D1-B607-6CB671FF9C66}

ABACUS PARENTERAL DRUGS

LTDXBETA-N 7376/28/11 BETAMETHASONE +

NEOMYCIN

ABACUS PARENTERAL

DRUGS LTD BLOCK 191 PLOT NO.114 KINGA MUKONO

0.1%W/V + 0.5%W/V EAR/ EYE DROPS 1*1*10ML LDPE VIAL UGANDAABACUS

PARENTERAL DRUGS LTD

{43F96586-DFE2-4AAC-92C4-

BEB24F8496E0}

P.T NOVELL PHARMACEUTICAL

LABORATORIESNOTRIXUM 7377/20/11 ATRACURIUM

P.T NOVELL PHARMACEUTICAL LABORATORIES JL. WANAHERANG NO. 35 TLAJUNG UDIK GUNUNG PUTRI BOGOR 16962

10MG/ML INJECTION 1*5*5ML INDONESIA MEDIPHARM SALES LTD

{679732EC-A1B6-4324-80C1-695ED56684C9}

DAR AL DAWA DEVELOPMENT AND

INVESTMENT CO. LTD

FORMIT 7378/18/11 METFORMINDAR AL DAWA NA UR PLANT AMMAN

JORDAN850MG TABLETS 1*3*10 BLISTER JORDANK KIMSY MEDS LTD {E5D373F8-892B-431E-

A23A-AC9CF3FB3673}

FLAMINGO PHARMACEUTICALS

LTDTETRA 500 7379/06/11 TETRACYCLINE

FLAMINGO PHARMACEUTICALS

LTD R-662 TTC INDUSTRIAL AREA

RABALE NAVI MIUMBAI 400 701

500MG CAPSULES 1*10*10 BLISTER INDIA ABACUS (A) LTD{B16F9A7D-F40C-

41B7-B8FE-543889029480}

P.T NOVELL PHARMACEUTICAL

LABORATORIESCIVELL 7380/06/11 CIPROFLOXACIN

P.T NOVELL PHARMACEUTICAL LABORATORIES JL. WANAHERANG NO. 35 TLAJUNG UDIK GUNUNG PUTRI BOGOR 16962

500MG TABLETS 1*3*10 INDONESIA MEDIPHARM SALES LTD

{9F96A910-C466-4839-9F20-0812EA002DA7}

ABACUS PHARMA (A) LTD AMPIMAX-1 7381/06/11 AMPICILLIN

REYOUNG PHARMACEUTICAL

CO LTD ERLANGSHAN ROAD

YIYUAN COUNTRY SHANDONG

PROVICE P.R

1G POWDER FOR INJECTION 1*50*1G CHINA ABACUS PHARMA (A)

LTD

{91AF0A8A-6CC4-4F5C-857D-

6B27892D3208}

MATRIX UGANDA LTD CLOMIPHENE 7382/18/11 CLOMIPHENE

Y.S.P INDUSTRIES (M) SDN BDH LOT 3,5 & 7 P/7 SECTION 13

KAWASAN PERINDUSTRIAN BANDAR BARU

BANGI 43000 KAJANG SELANGOR

DARUL EHSAN

50MG TABLETS 1*10*10 BLISTERS MALAYSIA MATRIX UGANDA LTD {018F7A24-2B1A-481D-9065-7B348D317FD2}

MICRO LABS LTD COTRIMOXAZOLE 7383/06/11 COTRIMOXAZOLE

MICRO LABS LTD 92 SIPCOT INDUSTRIAL

COMPLEX HOSUR 635126 (T.N)

960MG TABLETS 1*1000 HDPE INDIA LABOREX (U) LTD {90AA6A52-0483-4458-90D4-83519E102B4F}

MATRIX UGANDA LTD PORO 7384/02/11 PARACETAMOL

Y.S.P INDUSTRIES (M) SDN BDH LOT 3,5 & 7 P/7 SECTION 13

KAWASAN PERINDUSTRIAN BANDAR BARU

BANGI 43000 KAJANG SELANGOR

DARUL EHSAN

120MG CHEWABLE TABLETS 1*50*10 BLISTER MALAYSIA MATRIX UGANDA LTD{EF3C3271-2BB5-

4DEC-B133-0DCE896822F6}

Page 121

Page 122: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

P.T NOVELL PHARMACEUTICAL

LABORATORIESRYVEL 7385/03/11 CETIRIZINE

P.T NOVELL PHARMACEUTICAL LABORATORIES JL. WANAHERANG NO. 35 TLAJUNG UDIK GUNUNG PUTRI BOGOR 16962

10MG TABLETS 1*3*10 BLISTER INDONESIA MEDIPHARM SALES LTD

{7F5DF089-7B67-4FFB-B27B-

0C4C33DBFC33}

P.T NOVELL PHARMACEUTICAL

LABORATORIESRYVEL 7386/03/11 CETIRIZINE

P.T NOVELL PHARMACEUTICAL LABORATORIES JL. WANAHERANG NO. 35 TLAJUNG UDIK GUNUNG PUTRI BOGOR 16962

1MG/ML SYRUP 1*60ML INDONESIA MEDIPHARM SALES LTD

{C7E5BC78-A5D3-4EBB-9A6F-

8C750703918E}

P.T NOVELL PHARMACEUTICAL

LABORATORIESNOTRIXUM 7387/20/11 ATRACURIUM

P.T NOVELL PHARMACEUTICAL LABORATORIES JL. WANAHERANG NO. 35 TLAJUNG UDIK GUNUNG PUTRI BOGOR 16962

10MG/ML INJECTION 1*1*5*2.5ML AMPOULES INDONESIA MEDIPHARM SALES

LTD{F0AF8BF4-59B3-4641-83DB-55DD81D56A1E}

SEV PHARMACEUTICALS

LTDSURGICAL SPIRIT 7389/15/11 METHYL SALICYLATE

SEV PHARMACEUTICALS

LTD PLOT 100 MASAKA ROAD NALUKOLONGO

KAMPALA

0.5%V/V SOLUTION 1*100ML UGANDASEV

PHARMACEUTICALS LTD

{DABCE0D8-C711-44A2-98A6-

239DD79DE4AF}

MERCK SHARP & DOHME

INTAPHARMAROTATEQ 7390/19/11

ROTAVIRUS LIVE REASSORTANT

VIRUS G1, G2,G3,G4 & P1

MERCK & CO.INC SUMNEY TOWN PIKE

P.O BOX 4 WEST POINT

PENNSYLVANIA U.S 19486 USA

G1 2.2M IU/DOSE G2 2.8M IU/DOSE G3 2.2M IU/DOSE G4 2.0M IU/DOSE P1 2.3M IU/DOSE

ORAL SOLUTION 1*10ML USA PHILLIPS P'CALS (U) LTD

{F9959D8E-0D2F-46AC-A0AE-

B419273EAF3F}

PHILLIPS PHARMACEUTICALS

LTDCAPSIFENAC GEL 7391/02/11

CAPSAICIN/ DICLOFENAC/

LEVOMENTHOL/ METHYL SALICYLATE

STEDMAN PHARMACEUTICALS PVT LTD C-4 SIDCO PHARMACEUTICAL

COMPLEX ALATHUR THRUPORUR 603 110

TAMIL NADU

0.438G/ 0.355G/ 0.315G/ 0.918G TOPICAL GEL 1*1*10G, 1*1*20G INDIA

PHILLIPS PHARMACEUTICALS

LTD

{9736A055-8101-4BD7-8DA3-

BDC2FCEC39AC}

HETERO LABS LTD LOPINAVIR / RITONAVIR 7392/30/11 LOPINAVIR /

RITONAVIR

HETERO LABS LTD, 22-110, 1.D.A, JEEDIMETLA HYDERABAD

200MG /50MG TABLETS 1*120 HDPE INDIA ASTRA PHARMA (U) LTD

{A9D6F13A-42E0-4C21-88E1-

DDED6D6E33EB}

ABBOTT LABORATORIES

SOUTH AFRICA (PTY) LTD

ULTANE 7393/01/11 SEVOFLURANE

AESICA QUEENBOROUGH

LTD QUEENBOROUGH KENT ME 11 5EL

UNITED KINGDOM

100%W/W LIQUID 1*250ML UNITED KINGDOM LABOREX (U) LTD {3BE482BF-52C5-4F00-BEAF-851762F8934D}

SANOFI PASTEUR MENACTRA 7394/19/11

MENINGOCOCCAL (GROUPS A,C,Y & W-

135) POLYSACCHARIDE DIPTHERIA TOXOID

CONJUGATE VACCINE

SANOFI PASTEUR,INC

DISCOVERY DRIVE SWIFTWATER

PENNSYLVANIA 183370-0187

MENINGOCOCCAL GROUPS 4MCG

EACH, DIPHTHERIA TOXOID PROTEIN

48MCG

STRERILE INJECTABLE

VACCINE SOLUTION1*0.5ML VIAL U.S.A LABOREX (U) LTD {1E2B7BD2-657D-4878

A587-BCF258218653}

FLAMINGO PHARMACEUTICALS

LTDLEXIN 125 7395/06/11 CEPHALEXIN

FLAMINGO PHARMACEUTICALS

LTD R-662 T.T.C INDUSTRIAL AREA

RABALE NAVI MUMBAI

125MG/5ML POWDER FOR ORAL SUSPENSION

1*100ML AMBER PET BOTTLE INDIA ABACUS (A) LTD

{DE390BE6-2D17-4DC3-856B-

63A47B3593F9}

Page 122

Page 123: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ALKEM LABORATORIES LTD MEGAPIME 7396/06/11 CEFEPIME

ALKEM LABORATORIES LTD

167/2 MAHATMA GANDHI UDYOG NAGAR DABHEL

AMALIYA DAMAN 396 210

1G POWDER FOR INJECTION 1*1*1G VIAL INDIA ABACUS (A) LTD {2CC82926-936E-48E3-

A1E2-4A07D24A57D3}

IDA AMOXICILLIN/ CLAVULANIC ACID 7397/06/11 AMOXICLAV

MICRO LABS LTD VEERASANDRA

ANEKAL BANGALORE KARNATAKA

156.25MG/ 5ML ORAL SUSPENSION POWDER 1*100ML INDIA JOINT MEDICAL

STORESJV11/017 DATED

08/07/11

{9A2AE9D7-A9C5-4DF5-96A1-

DC5E18E193E7}

CADILA HEALTHCARE LTD IPRAMIST 7398/25/11 IPRATROPIUM

CADILA HEALTHCARE LTD

SARKHEJ BAVLA N.H NO 8A MORAIYA TAL

SANAND DIST AHMEDABAD 282 210

0.06%W/V NASAL SPRAY 1*15ML HDPE BOTTLE INDIA ABACUS PHARMA (A)

LTD

{4365BD39-7AC4-48DA-8980-

5F92155C2790}

CACHETPHARMACEUTICALS PVT LTD CACH-ART DS 7399/06/11 ARTEMETHER /

LUMEFANTRINE

CACHETPHARMACEUTICALS PVT LTD VILLAGE THANA

BADDI HIMACHAL PRADESH 173 205

80MG/ 480MG TABLET 1*6 BLISTER INDIAVRUSHIK

INVESTMENTS (U) LTD

{F3893DD6-E181-4198-9045-31415750BCB0}

MEGA LIFESCIENCE AUSTRALIA PTY LTD BAROLE 20 7400/17/11 RABERPRAZOLE

INVENTIA HEALTHCARE PVT

LTD F1-F1/1 ADDITIONAL

AMBERNATH (EAST) DISTRICT THANE 421 0506 MAHARASHTRA

20MG CAPSULES 1*3*10 BLISTERS INDIA MEDIPHARM SALES LTD

{9389051A-B47F-4F79-9D48-3C7DF119770B}

GUILIN PHARMACEUTICAL

CO LTDARTESUN 7401/06/11 ARTESUNATE

GUILIN PHARMACEUTICAL

CO LTD NO.43 QILIDIAN ROAD GUILIN 541002

GUANGXI

120MG POWDER FOR INJECTION

1*1VIAL OF 12O MG ARTESUNATE

POWDER,1 *2ML AMPOULE OF 5%

SODIUM BICARBONATE

SOLUTION, 1*10ML AMPOULE OF 0.9% SODIUM CHLORIDE

CHINASTAR

PHARMACEUTICALS LTD

{E3CF8357-3182-4428-A88A-DF45EF532096}

ARISTO PHARMACEUTICALS

PVT LTDALSARTAN-AM 7402/12/11 LOSARTAN/

AMLODIPINE

ARISTO PHARMACEUTICALS

PVT LTD PLOT NO.208 NEW

INDUSTRIAL AREA II MANDIDEEP DIST

RAISEN 462062 MADHTA PRADESH

50MG/ 5MG TABLET 1*4*7 BLISTER INDIA NORVIK ENTERPRISES LTD

{01B9F51C-ADD1-4EDA-BC87-

6B3267F254B6}

LEBEN LABORATORIES LTD KELVIN 7403/02/11 PARACETAMOL

LEBEN LABORATORIES LTD L-4 PHASE 111 MIDC

AKOLA 444104 MAHARASTRA

500MG TABLETS1*10*10 BLISTER, 1*100*10 BLISTER,

1*1000 HDPEINDIA

ANDYCO PHARMACEUTICALS

LTD

{2E2ACFDF-B10F-4AB3-800A-

86B2E87AFCC6}

SHELLYS PHARMACEUTICALS

LTDCO -MALATHER 7404/06/11 ARTEMETHER /

LUMEFANTRINE

SHELLYS PHARMACEUTICALS LTD PLOT 693-6 NEW

BAGAMOYO ROAD MWENGE DAR

ESALAAM

20MG/ 120MG TABLETS 1*3*8 BLISTER TANZANIA BETA HEALTH CARE UGANDA LTD

{8B014E29-BAB7-4BF09DC8-19BFEB00BEF7}

ZHUHAI UNITED LABORATORIES

(ZHONGSHAN) CO LTD

MICONICE 7405/13/11 MICONAZOLE

ZHUHAI UNITED LABORATORIES

(ZHONGSHAN) CO LTD NO.12 JIALIAN

RD TANZHOU TOWN ZHONGSHAN

GUANGDONG 528467 P.R

2%W/W CREAM 1*10*1*15G CHINA AARON PHARMACEUTICALS

{49DF75AB-9A2F-4AD6-9A75-

38760EC25D31}

Page 123

Page 124: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

LEBEN LABORATORIES PVT

LTDBECLOMIN 7406/13/11 BECLOMETHASONE /

MICONAZOLE

LEBEN LABORATORIES PVT LTD L-4 PHASE 111 MIDC AKOLA 444104

MAHARASTRA

0.025%W/V / 2.0%W/V LOTION 1*1*15 ML HDPE INDIA ANDYCO PHARMACY {070F392F-7593-4612-

98A9-D5D4484640D6}

ZHUHAI UNITED LABORATORIES

(ZHONGSHAN) CO LTD

MELOSTONE 7407/13/11 BETAMETHASONE / NEOMYCIN

ZHUHAI UNITED LABORATORIES

(ZHONGSHAN) CO LTD NO.12 JIALIAN

RD TANZHOU TOWN ZHONGSHAN

GUANGDONG 528467 P.R

0.1%W/W / 0.5%W/W CREAM 1*15G CHINA AARON PHARMACEUTICALS

{20F101C6-5CC4-4BFE-A482-

E134A8693A9C}

BODENE (PTY) LTD PETOGEN-FRESEMIOS 7408/18/11 MEDROXYPROGEST

ERONE

BODENE (PTY) LTD TRADING AS

INTRAMED 6-GIBAUD ROAD KORSTEN ELIZABETH 6001

150MG/ML INJECTION 1*100*1ML VIALS SOUTH AFRICA SURGIPHARM UGANDA LTD

{AC2C795A-2ED5-4D8A-8683-

F05E358915DD}

CADILA HEALTHCARE LTD DOCETAXEL 7409/08/11 DOCETAXEL

ZYDUS HOSPIRA ONCOLOGY PVT LTD PHARMEZ SPECIAL ECONOMIC ZONE MATODA SARKHEJ BAVLA HIGHWAY

AHMEDABAD 382 213

10MG/ML INJECTION 1*2ML INDIA ABACUS PHARMA (AFRICA) LTD

{A99251A0-3492-485D-96A7-DF7064E4F904}

GUILIN PHARMACEUTICAL

CO. LTDARTESUN PLUS 7410/06/11 ARTESUNATE /

AMODIAQUINE

GUILIN PHARMACEUTICAL

CO. LTD NO 17 SHANGHAI ROAD GUILIN GUANGXI

100MG / 270MG TABLETS 1*20*3 , 1*20*6 BLISTER CHINA

STAR PHARMACEUTICALS

LTD

{61F94F1C-3BFB-4659-9A02-E879615BEF90}

CADILA HEALTHCARE LTD MONTELUKAST 7411/25/11 MONTELUKAST

CADILA HEALTHCARE LTD

SARKHEJ BAVLA N.H NO 8A MORAIYA TAL

SANAND DIST AHMEDABAD 282 210

4MG CHEWABLE TABLETS 1*3*10 BLISTER INDIA ABACUS PHARMA (AFRICA) LTD

{56DF8D8B-ED03-4F35-8F2F-

6789DCBC08F4}

LEBEN LABORATORIES PVT

LTDALCLOX 7412/06/11 CLOXACILLIN

LEBEN LABORATORIES PVT LTD L-4 PHASE 111 MIDC AKOLA 444104

MAHARASTRA

250MG CAPSULES 1*10*10 BLISTER, 1*1000 HDPE INDIA ANDYCO PHARMACY {917696B1-1394-4BF2-

99BC-44B9C89B87F9}

MATRIX LABORATORIES LTD RITONAVIR 7413/30/11 RITONAVIR

MATRIX LABORATORIES LTD F-4, F-12 MALEGAON

MIDC SINNAR NASHIK 422113 MAHARASHTRA

STATE

100MG TABLETS 1*120 HDPE INDIAPHILLIPS

PHARMACEUTICALS (U) LTD

{0F4B5978-9D60-44B3-958A-CD46FF78C59E}

UNIVERSAL CORPORATION LTD CLOBIT 7414/13/11 CLOBETASOL

UNIVERSAL CORPORATION LTD PLOT 13777 KIKUYU

TOWN

0.05%W/W CREAM 1*1*30G KENYA MATRIX (U) LTD {D4851532-BC24-4875-AE3D-F1A8317BE3EE}

LEBEN LABORATORIES PVT

LTDLAMPY 7415/06/11 AMPICILLIN

LEBEN LABORATORIES PVT LTD L-4 PHASE 111 MIDC AKOLA 444104

MAHARASTRA

250MG CAPSULES 1*10*10 BLISTERS ,1* 1000 HDPE INDIA ANDYCO PHARMACY {034822CF-FA24-4D84-

A964-65B48D1FF9F7}

Page 124

Page 125: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

BAYER SCHERING PHARMA MICROGYNON ED Fe 7416/18/11 LEVONOGESTROL /

ETHINYLESTRADIOL

DEL PHARM LILLE S.A.S ZONE

INDUSTRIELLE DE ROUBAIX EST RUE DE TOUFFLERS BP

50070 59452 LYS LEZ LANNOY

0.15MG / 0.03MG TABLETS 1*3*(21+7) BLISTER FRANCE SURGIPHARM (U) LTD

03/04/2009. NOTIFICATION SENT TO INSP. FROM DAR

RT29402 DATED 09/12/2011

{E664991F-2099-4FBC-B932-AF3A1FC7E57D}

RIVA PHARMA ZITHRORIV 7417/06/11 AZITHROMYCINRIVA PHARMA FREE

ZONE NASR CITY CAIRO

200MG/5ML POWDER FOR ORAL SUSPENSION 1*22.5 ML HDPE EGYPT WIDE SPECTRUM

ENTERPRISES LTD{72DE46A3-241B-42FA879C-7C621F13166A}

RIVA PHARMA DIARIV 7418/06/11

DI-IODO HYDROXYQUINOLINE

/ PHTHALYL SULPHATHIAZOLE/

HOMATROPINE / STREPTOMYCIN

RIVA PHARMA SAE FREE ZONE NASIR

CITY

125MG/ 150MG/ 1MG/ 100MG

POWDER FOR SUSPENSION 1*60ML EGYPT WIDE SPECTRUM

ENTERPRISES LTD{BC589225-551A-4BAA89BF-159887610558}

PFIZER LABORATORIES LTD PREVENAR 13 7419/19/11

PNEUMOCOCCAL POLYSACCHARIDE

CONJUGATE VACCINE (13-

VALENT.ADSORBED)

WYETH PHARMACEUTICALS

INC 401 N MIDDLETOWN RD PEARL RIVER NY

10965

2.2MCG OF POLYSACCHARIDE FOR SEROTYPES

1,3,4,5,6A,7F.9V,14,18C,23F,AND 4.4MCG FOR SEROTYPE 6B

STERILE LIQUID 1*0.5ML U.S.A LABOREX (U) LTD{19C114DA-89AB-

438C-9612-226667BCB24A}

PANACEA BIOTEC LTD POLPROTEC 7420/19/11

POLIOMYELITIS VACCINE

INACTIVATED

PANACEA BIOTEC LTD MALPUR BADDI TEHSIL NALAGARH DIST SOLAN (H.P)

173 205

0.5ML PER SINGLE DOSE

SUSPENSION FOR INTRAMUSCULAR

INJECTION

1*0.5ML PREFILLED SYRINGE INDIA

STAR PHARMACEUTICALS

LTD

{9DCE40EA-F803-47CA-9935-

2EA0DD36EABB}

SANOFI PASTEUR TETRAXIM 7421/19/11

DIPHTERIA/ TETANUS/

PERTUSSIS (ACELLULAR, COMPONENT)

POLIOMYELITIS (INACTIVATED)

VACCINE (ADSORBED)

SANOFI PASTEUR CAMPUS MERIEUX

1541 AVENUE MARCEL MERIEUX

69280 MARCY L'ETOILE

301IU/ 401IU/ 25MCG/ POLIOMYELITIS -

40DU (TYPE 1)/ 8DU TYPE 2/ 32DU TYPE 3

STERILE SUSPENSIONFOR

INJECTION

1*0.5MLPREFILLED SYRINGE FRANCE LABOREX (U) LTD

{8B8B4B35-1F63-4481-AB45-

AFC8EBC689FF}

SANOFI PASTEUR DULTAVAX 7422/19/11

DIPHTERIA/ TETANUS/ AND (INACTIVATED) POLIOMYELITIS

VACCINE (ADSORBED)

SANOFI PASTEUR CAMPUS MERIEUX

1541 AVENUE MARCEL MERIEUX

69280 MARCY L'ETOILE

2 IU/ 20IU/ POLIOMYELITIS

(40DU/ 8DU/ 32DU)

STERILE SUSPENSIONFOR

INJECTION

1*0.5MLPREFILLED SYRINGE FRANCE LABOREX (U) LTD {A29770D9-E25F-433E-

B8D1-26729FECAF24}

SANOFI PASTEUR AVAXIM 80U PAEDIATRIC 7423/19/11

INACTIVATED HEPATITIS A

VACCINE ADSORBED

SANOFI PASTEUR CAMPUS MERIEUX

1541 AVENUE MARCEL MERIEUX

69280 MARCY L'ETOILE

80 ANTIGEN UNITS SUSPENSION FOR INJECTION

1*0.5MLPREFILLED SYRINGE FRANCE LABOREX (U) LTD

{FCC382D0-9FD5-4927-944C-

BED5F0E48CAF}

SANOFI PASTEUR AVAXIM 160U 7424/19/11INACTIVATED HEPATITIS A

VACCINE ADSORBED

SANOFI PASTEUR CAMPUS MERIEUX

1541 AVENUE MARCEL MERIEUX

69280 MARCY L'ETOILE

160 ANTIGEN UNITS SUSPENSION FOR INJECTION

1*0.5MLPREFILLED SYRINGE FRANCE LABOREX (U) LTD {66930216-4A66-481E-

9A11-2EA66E2AB7D3}

MACLEODS PHARMACEUTICALS

LTDCOTRIM 120 7425/06/11 COTRIMOXAZOLE

MACLEODS PHARMACEUTICALS LTD PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN

(U.T) 396401

120MG TABLETS 1*10*10 BLISTER, 1*1000 HDPE INDIA NORVIK ENTERPRIES

LTD{9F678AAB-39AB-4094-B93B-D2E01472535E}

AGOG PHARMA LTD AZ-250 7426/06/11 AZITHROMYCIN

AGOG PHARMA LTD PLOT NO.33 SECTOR II THE VASAI TALUKA INDL CO;OP ESTATE LTD VASAI (E) DIST

THANE

250MG CAPSULES 1*1*6 BLISTER INDIAGITTOES

PHARMACEUTICALS LTD

{976D69B1-E8FA-44CF-8F68-

9FB2480125E6}

Page 125

Page 126: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

MEDINOMICS HEALTHCARE PVT

LTDDIPI (ADULT) 7427/06/11 DIHYDRARTEMISININ

/ PIPERAQUINE

THE MADRAS PHARMACEUTICALS

137 B OLD MAHABALIPURAM

ROAD KARAPAKKAM CHENNAI

40MG /320MG TABLETS 1*9 BLISTERS INDIAGITTOES

PHARMACEUTICALS LTD

{2DFA0265-CAC6-4FC2-92F0-

46F8A7FA551F}

SANCE LABORATORIES PVT

LTDSANCEPH DS 7428/06/11 CEPHALEXIN

SANCE LABORATORIES PVT

LTD PB NO 2 ELAPPUNKAL

JUNCTION KOZLUVANAL 686 523 KOTTAYANA

DISTRICT KERALA

125MG/5ML POWDER FOR ORAL SUSPENSION

1*100ML HDPE BOTTLE INDIA DELMAW

ENTERPRISES LTD

{3B023B86-F5EA-4ED5-BD4F-

F9A2FCA2C0E0}

AGOG PHARMA LTD TENA-100 7429/12/11 ATENOLOL

AGOG PHARMA LTD PLOT NO.33 SECTOR II THE VASAI TALUKA INDL CO;OP ESTATE LTD VASAI (E) DIST

THANE

100MG TABLETS 1*10*10, 1*3*10, 1*2*14 BLISTER INDIA

GITTOES PHARMACEUTICALS

LTD

{4D324442-AFA3-47AD-937D-

0881080784E1}

MICRO LABS LTD RIMONID EYE DROP 7430/21/11 BRIMONIDINE

MICRO LABS LTD PLOT NO 113-116

4TH PHASE K.I.A.D.B BOMMASANDRA

INDUSTRIAL AREA BANGALORE 560 099

0.15%W/V OPHTHALMIC SOLUTION 1*1*5ML INDIA

PHILLIPS DISTRIBUTORS (U)

LTD

{95378497-D1DE-459A-B05B-623635EBAECE}

LINCOLN PHARMACEUTICALS

LTDDOMI 10 7431/17/11 DOMPERIDONE

LINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE KHATRAJ TAL KALOL

GUJARAT

10MG TABLET 1*10*10 BLISTER INDIAMETRO

PHARMACEUTICALS LTD

{1988E060-D3EF-44AC-A89D-

C031E2DCB0BF}

WOCHARDT LTD WEPOX 2000 7432/10/11RECOMBINANT

HUMAN ERYTHROPOIETIN

WOCHARDT LTD BIOTECH PARK

H14/2 MIDC WALUJ AURANGABAD 431

136

2000IU SOLUTION FOR INJECTION

0.5ML (IN 1ML SYRINGE) INDIA

STAR PHARMACEUTICALS

LTD

{498E3822-F7BB-4749-B7B7-5870A7191DBC}

CADILA HEALTHCARE LTD GEMCITABINE 7433/08/11 GEMCITABINE

ZYDUS HOSPIRA ONCOLOGY PVT LTD PHARMEZ SPECIAL

ZONE MATODA SARKHEJ BAVLA

HIGHWAY AHMEDABAD 382 213

200MG POWDER FOR INJECTION 1*200MG VIAL INDIA ABACUS PHARMA

AFRICA LTD{9FD40D27-EB97-4F19-8D45-532B723575A6}

NIRMA LTD HEALTHCARE

DIVISIONNIRPID 7435/26/11 INTRAVENOUS FAT

EMULSION

NIRMA LTD HEALTHCARE

DIVISION SACHANA VIRAMGAM

AHMEDABAD

20%W/V INFUSION 1*500ML GLASS BOTTLE INDIA

PHILLIPS PHARMACEUTICALS

LTD

{56C343EA-16BA-4560-8015-C6C3C1BB9E21}

DYNAPHARM (M) SDN BHD DYANIL 7436/18/11 GLIBECLAMIDE

DYNAPHARM (M) SDN BHD 2497 MKI

LORONG PERUSAHAAN BARU

5 KAWASAN PERUSAHAAN PERAI

3 13600 PALAU PENANG

5MG TABLET 1*1000 HDPE, 1*10*10 BLISTERS MALAYSIA

DYNA LAB PHARMACEUTICALS

UGANDA LTD

{B1F175DB-6382-45ED-82CF-

2B7B6F125FC1}

UNIVERSAL CORPORATION LTD QUININE 7437/06/11 QUININE

UNIVERSAL CORPORATION LTD CLUB ROAD PLOT NO. 13777 KIKUYU

300MG TABLET 1*10*10 BLISTER ,1*1000 HDPE KENYA MATRIX (U) LTD {F64A9A22-024B-4411-

8BEB-5D14B7FE8B52}

Page 126

Page 127: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

UNIVERSAL CORPORATION LTD NELZOLE 7438/06/11 METRONIDAZOLE

UNIVERSAL CORPORATION LTD CLUB ROAD PLOT NO. 13777 KIKUYU

200MG/5ML SUSPENSION 1*60ML, 1*100ML AMBER PET BOTTLE KENYA MATRIX (U) LTD

{F1E10152-1184-4F96-80D1-

C7AAA3A9DB13}

CIPLA LTD VIRADAY 7439/30/11TENOFOVIR/

EMTRICITABINE/ EFAVIRENZ

CIPLA LTD PLOT NO. S-103 TO S-105, S-

107 TO S-112 , L-147 TO L-147-1 VERNA

INDUSTRIAL ESTATE VERNA GOA

300MG/ 200MG/ 600MG TABLET 1*30 HDPE INDIA QUALITY CHEMICALS

LTD{CB95E597-1151-4C64-878E-88F2A12D329D}

SQUARE CEPHALOSPORINS

LTDCEFTRON 7440/06/11 CEFTRIAXONE

SQUARE CEPHALOSPORINS

LTD KALIAKOR GAZIPUR

1G POWDER FOR INJECTION

1*1G VIAL + 1*10 ML AMPOULE WATER

FOR INJECTIONBANGLADESH

WIDE SPECTRUM ENTERPRISES (U)

LTD

{7D99AF30-2199-4F8B-B412-611EDC2E223B}

UNITED PHARMACEUTICAL

COMPANY LTDRUXID 300 7441/06/11 ROXITHROMYCIN

UNITED PHARMACEUTICAL COMPANY LTD P.O

BOX 69 AMMAN 11591 JORDAN

NUZHAT SAHAB AL RAQEEM NEAR

PUBLIC SECURITY HOUSING

300MG TABLETS 1*7 BLISTER JORDAN MEDICAL ACCESS (U) LTD

{7D932CF9-ED78-40C8-8910-

46B6EFFA84E0}

CACHET PHARMACEUTICALS

PVT LTDCACID-O 7442/17/11 OMEPRAZOLE

CACHET PHARMACEUTICALS

PVT LTD VILLAGE THANA BADDI

HIMACHAL PRADESH 173205

20MG CAPSULES 1*10*10 STRIPS INDIA VRUSHIK INVESTIMENTS LTD

{49964224-9F1D-487D-B829-2F58733C99CC}

INTAS PHARMACEUTICALS

LTDRISDONE-2 7446/24/11 RISPERIDONE

INTAS PHARMACEUTICALS

CAMP ROAD SELAQUI DEHRADUN

248197

2MG TABLETS 1*5*10 BLISTER INDIA NORVIK ENTERPRISES LTD

{E50D69B6-D97D-48DD-AF49-

0682CC1BEDFC}

RENE INDUSTRIES LTD REQUIN FC 7447/06/11 QUININE

RENE INDUSTRIES LTD PLOT 680

KAMULI KIREKA P.O BOX 6034 KAMPALA

300MG TABLETS 1*1000 HDPE UGANDA RENE INDUSTRIES LTD

{E671F2DA-C8C7-48FC-B3FF-

E4D522DCCF34}

GITTOES PHARMACEUTICALS

LTDLIDOCAINE 7448/01/11 LIDOCAINE

NINGBO DAHONGYING

PHARMACEUTICAL CO LTD NO.396 MINGZHU ROAD

NINGBO CITY ZHEJIANG

2%W/V INJECTION 1*10*2ML AMPOULES CHINAGITTOES

PHARMACEUTICALS LTD

{79A11AF0-17A9-4BA7-A75B-9C337D0F8789}

ALKEM LABORATORIES LTD ZAXTER 7449/06/11 MEROPENEM

ALKEM LABORATORIES LTD

VILLAGE THANA BADDI TEHSIL-

NALAGARH DIST SOLAN (HP) 173205

500MG POWDER FOR INJECTION 1*1 GLASS VIAL INDIA ABACUS PHARMA (A)

LTD{D012DA40-19C2-490F-A041-59D204A8A50F}

CACHET PHARMACEUTICALS

PVT LTDCACHTRIM 480 7450/06/11 COTRIMOXAZOLE

CACHET PHARMACEUTICALS

PVT LTD VILLAGE THANE BADDI

HIMACHAL PRADESH

480MG TABLETS 1*10*10 BLISTER , 1*1000 HDPE INDIA

VRUSHIK INVESTMENT UGANDA LTD

{92E0B35B-F2CB-48B0-8C5F-

90733BC2E04B}

NIRMA LTD HEALTHCARE

DIVISIONFLUCANIR 7451/06/11 FLUCONAZOLE

NIRMA LTD HEALTHCARE

DIVISION SACHANA VIRAMGAM

AHMEDABAD

2MG/ML INFUSION 1*100ML INDIA PHILLIPS PHARMACEUTICALS

{D6C61A8B-996D-461C-9C1B-

C913E287D1A2}

Page 127

Page 128: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SWISS PARENTERALS PVT

LTDSWISSCLOXA 7452/06/11 AMPICILLIN /

CLOXACILLIN

SWISS PARENTERALS PVT LTD 809 KERALA IND

ESTATE GIDC NR BAVLA DIST

AHMEDABAD GUJARAT

250MG / 250MG POWDER FOR INJECTION

1*500MG IN 7.5ML VIAL INDIA

SHREEJI PHARMACEUTICALS

LTD

{A473EADA-045B-484F-901A-

442312358910}

PHARM ACCESS AFRICA LTD MISOCLEAR 7453/22/11 MISOPROSTOL

ACME FORMULATION PVT

LTD ROPAR RD NALAGARH DIST

SOLAN HIMACHAL

200MCG TABLETS 1*10 BLISTER INDIA MEDICAL ACESS UGANDA LTD

{73F72BEC-6F9F-4765-8EDE-

3B0ED6CCF077}

SINOCHEM JIANGSU CORPORATION PERAZONE 7454/06/11 CEFOPERAZONE /

SULBACTAM

REYOUNG PHARMACEUTICAL

CO/LTD ERLANGSHAN ROAD

YIYUAN COUNTRY SHANDONG

PROVINCE P.R

0.5G / 0.5G POWDER FOR INJECTION 1*50*1G VIALS CHINA FAMILY PHARMACY

LTD

{CD55F99A-4E7F-4CA9-A96C-

0C9B19A71B60}

PHILLIPS PHARMACEUTICALS

(U) LTDLMW-ENOX 7455/10/11 ENOXAPARIN

GLAND PHARMA LTD D.P PALLY DUNDIGAL

QUTHUBULLAPUR MANDAL RANGA

REDDY HYDERABAD

80MG / 0.8ML INJECTION 1*1*0.8ML INDIAPHILLIPS

PHARMACEUTICALS (U) LTD

{3B4A5103-1F66-4A39-8BC2-B8E6D1982650}

PHILLIPS PHARMACEUTICALS

(U) LTDLMW-ENOX 7456/10/11 ENOXAPARIN

GLAND PHARMA LTD D.P PALLY DUNDIGAL

QUTHUBULLAPUR MANDAL RANGA

REDDY HYDERABAD

40MG / 0.4ML INJECTION 1*1*0.4M.L INDIAPHILLIPS

PHARMACEUTICALS (U) LTD

{0810CBF6-3DE8-4E10-A25A-

AF6F07F4EC62}

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

CLAVODAR 7457/06/11 AMOXICILLIN / CLAVULANIC ACID

DAR AL DAWA DEVELOPMENT AND

INVESTMENT COMPANY LTD NAUR PLANT

AMMAN JORDAN

500MG / 125 MG TABLETS 1*2*7 BLISTERS JORDAN KIMSY MEDS{86DE9E08-CA9E-

4F6E-B0D2-E3A276A793E5}

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

LIPODAR 10 7458/12/11 ATOVARSTATIN

DAR AL DAWA DEVELOPMENT AND

INVESTMENT COMPANY.LTD NA'UR PLANT

AMMAN JORDAN

10MG TABLET 1*3*10 BLISTERS JORDAN KIMSY MEDS{9121284C-C6C0-

4AC3-9EA8-EFF7ADD56581}

TORRENT PHARMACEUTICALS

LTDGABATOR 7459/05/11 GABAPENTIN

TORRENT PHARMACEUTICALS LTD INDRAD 382 721

DIST MEHSANA

300MG CAPSULES 1*3*10 BLISTERS INDIA KARURI PHARMACEUTICALS

{3EDC625A-B1A7-417B-BD0B-

334AF1DD3FCE}

GUILIN PHARMACEUTICALS

LTDARTESUN PLUS 7460/06/11 ARTESUNATE /

AMODIAQUINE

GUILIN PHARMACEUTICAL

CO LTD NO.17 SHANGHAI ROAD

GUILIN GUANG CHINA

25MG / 67.5MG TABLET 1*1*3*20 BLISTERS CHINASTAR

PHARMACEUTICALS LTD

{A2300D34-4818-4C30-8CEB-11EDE3A42761}

ASTRA PHARMA (U) LTD

STREPTOMYCIN SULPHATE FOR

INJECTION7461/06/11 STREPTOMYCIN

SULPHATE

CSPC ZHONGUO (SHIJIAZHUANG)

PHARMACEUTICAL CO.LTD NO. 188

GONGNONG

1G POWDER FOR INJECTION

1*5*1*10 GLASS VIALS CHINA ASTRA PHARMA (U)

LTD{5FF05726-9E77-4FEF-B7B4-A82820DAF24D}

IDA FOUNDATION NYSTATIN 7462/06/11 NYSTATIN

MEDIORALS LABORATORIES PVT LTD SATARA ,J-4/2 ADDITIONAL MIDC ,SATARA 415004

100.000 IU/ML ORAL SUSPENSION 1*30ML INDIA JOINT MEDICAL STORES

{01AB20F8-7F6C-41B7-8097-CCA2A1807527}

Page 128

Page 129: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CLARIS LIFE SCIENCES LTD SUCROFER 7463/10/11 IRON SUCROSE

CLARIS LIFE SCIENCES LTD

CHARCHARWADI VASANA SANAND

AHMEDABAD GUJARAT 382 213

20MG/ML INTRAVENOUS INJECTION

1*5*5*5ML AMBER GLASS VIALS INDIA REDDY'S PHARMA

LTD{9D7A83A2-E374-45C69C34-3FAAAB1D9BF1}

ABACUS PHARMA (A) LTD AMPIMAX-500 7464/06/11 AMPICILLIN

REYOUNG PHARMACEUTICALS

CO LTD NO.6 ERLANGSHAN ROAD

YIYUAN COUNTY SHANDONG PROVINCE

500MG POWDER FOR INJECTION 1*50 VIALS CHINA ABACUS PHARMA (A)

LTD{B773419C-5672-46A5-81C3-108C7EBA085E}

CADILA HEALTHCARE LTD OLMY 20 7465/12/11 OLMESARTAN

CADILA HEALTHCARE LTD

KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401

20MG TABLETS 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{A7722B3D-D44B-41B5-9B5D-

A9F30EA3C5F3}

TROIKAA PHARMACEUTICALS

LTDANTIPLATT 7466/12/11 CLOPIDOGREL

TROIKAA PHARMACEUTICALS

LTD THOL DIST MEHSANA PIN 382

728 GUJARAT AHMEDABAD

75MG TABLETS 1*10*10 BLISTERS INDIA ANDYCO PHARMACY{CC7A28D9-B22C-

4614-81AD-989D57CC4259}

SWISS PARENTERALS PVT

LTDSWISS QUIN 7467/06/11 QUININE

SWISS PARENTERALS PVT

LTD 809 KERALA INDUSTRIAL ESTATE

G.I.D.C NR BAVLA DIST AHMEDABAD

300MG/ML SOLUTION FOR INJECTION 1*10*2ML AMPOULES INDIA

SHREEJI PHARMACEUTICALS

LTD

{742C9FC9-D657-4493-BCB1-0E860BC05B6A}

MICRO LABS LTD TRAVO 7468/21/11 TRAVOPROSTMICRO LABS LTD

92,SIPCOT HOSUR 635126 TAMIL NADU

40MCG/ML OPHTHALMIC SOLUTION

1*1*3ML LDPE BOTTLE INDIA LABOREX (U) LTD {BB099B2F-6607-4934-

8B55-03280F47F37E}

SHELYS PHARMACEUTICALS

LTDSAVE 7469/26/11

GLUCOSE /NaCl / TRISODIUM CITRATE

/ KCl

SHELYS PHARMACEUTICALS

LTD NEW BAGAMOYO ROAD MWENGE DAR-ES-

SALAAM

13.5g / 2.6g /2.9g / 1.5g ORAL POWDER 1*20.5G SACHETS TANZANIA BETA HEALTHCARE LTD

{D3D98D7A-7B5E-4A07-944F-

B15936BC246C}

MICRO LABS LTD MELMET-500 SR 7470/18/11METFORMIN SUSTAINED

RELEASE

MICRO LABS LTD 92,SIPCOT HOSUR

635126 TAMIL NADU500MG TABLETS 1*10*10 BLISTER INDIA

PHILLIPS DISTRIBUTORS (U)

LTD

{2FD2710F-CED0-4E6F-B49B-

B479437AA20A}

GITTOES PHARMACEUTICALS

LTDHYOSCINE 7471/17/11 HYOSCINE

NINGBO DAHONGYING

PHARMACEUTICAL CO LTD NO.3986 MINZHU ROAD NINGBO CITY

ZHEJIANG

20MG/ML INJECTION 1*10*1ML AMPOULES CHINAGITTOES

PHARMACEUTICALS LTD

{F8A09678-2ED9-4B03-84B4-24AA85FD1CF9}

LINCOLN PHARMACEUTICALS

LTDFLUCAN-200 7472/06/11 FLUCONAZOLE

LINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE

KHATRAJ KOLOL GUJARAT

200MG TABLETS 1*10*1*1 BLISTERS INDIAMETRO

PHARMACEUTICALS LTD

{831C2BB2-5C2A-47CC-8D4F-

8920112302C2}

M.J BIOPHARM PVT LTD CEFUROXIME-MJ 7473/06/11 CEFUROXIME

M.J BIOPHARM PVT LTD L-7 MIDC

INDUSTRIAL AREA TALOJA NAVI

MUMBAI

750MG POWDER FOR INJECTION 1*10ML VIAL INDIA TATA (U) LTD

{8238EEB1-96DC-4ED0-9864-

B19A2BE9CA3B}

AGOG PHARMA LTD AMKINE 7474/24/11 AMITRIPTYLINE

AGOG PHARMA LTD PLOT NO. 33

SECTOR II THE VASAI TALUKA

INDUSTRIAL CO-OP ESTATE LTD VASAI

(E) DIST THANE

25MG TABLETS 1*1000 HDPE INDIAGITTOES

PHARMACEUTICALS LTD

{DCABC6EA-BD15-4DFD-8949-

C48F054C4049}

Page 129

Page 130: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ORTIN LABORATORIES LTD CONIL-X 7475/25/11

PARACETAMOL/ CHLORPHENAMINE/ PHENYLEPHRINE/

CAFFEINE

ORTIN LABORATORIES LTD PLOT PLOT NO. 275

& 278 IND PASHAMYLARAM

MEDAK DIST 502 307 A.P

400MG/ 2MG/ 5MG/ 15MG TABLETS 1*25*1*4 BLISTERS INDIA META PRODUCTS (U)

LTD{9EFA6628-2E76-4BD0A1BB-28FF1B870046}

AGOG PHARMA LTD CEZIN 7476/03/11 CETRIZINE

AGOG PHARMA LTD PLOT NO. 33

SECTOR II THE VASAI TALUKA

INDUSTRIAL CO-OP ESTATE LTD VASAI

(E) DIST THANE

5MG/5ML SYRUP 1*30ML, 1*60ML, 1*100ML INDIA

GITTOES PHARMACEUTICALS

LTD

{8C0D84A5-231B-4C8C-A173-

3AB4BE5958CE}

HETERO DRUGS LTD VALOVIR 7477/30/11 VALACYCLOVIR

HETERO DRUGS LTD UNIT III 22-110 IDA

JEEDIMATLA HYDERABAD ZIP 500

055

500MG TABLETS 1*10*10 BLISTERS INDIA ASTRA PHARMA (U) LTD

{F90E098C-12B5-4E84-803C-7D95F0B73CBD}

SUN PHARMACEUTICALS

INDUSTRIESPROLOMET XL 100 7478/12/11 METOPROLOL

SUN PHARMACEUTICALS

INDUSTRIES SURVEY NO. 259/15

DADRA 396 191 UNION TERRITORY

OF DADRA AND NAGAR HAVELI

100MG TABLETS 1*5*10 BLISTERS INDIA SURGIPHARM (U) LTD

{6D751719-F1EE-4BB7A993-B332C4C92733}

SWISS PARENTERALS PVT

LTDD-FEN 7479/02/11 DICLOFENAC

SODIUM

SWISS PARENTERALS PVT

LTD 809 KERALA INDUSTRIAL ESTATE GIDC NEAR BAVLA DIST AHMEDABAD

GUJARAT

25MG/ML SOLUTION FOR INJECTION 1*5*3ML AMPOULES INDIA

SHREEJI PHARMACEUTICALS

LTD

{EBEB49A3-6F84-433C-85B1-

7AF9E3A9E2A0}

UNITED PHARMACEUTICAL

COMPANY LTDDICLOFEN 25 7480/02/11 DICLOFENAC

UNITED PHARMACEUTICAL COMPANY LTD P.O

BOX 69 AMMAN 11591 JORDAN

NUZHAT SAHAB RAQEEM NEARPUBLI SECURITY HOUSING

25MG SUPPOSITORY 1*10 JORDAN MEDICAL ACCESS UGANDA

{70888D82-3D6F-4E54-AD2C-37867453421D}

NAPROD LIFE SCIENCES PVT LTD NAPRODOX-50 7481/08/11 DOXORUBICIN

NAPROD LIFE SCIENCES PVT LTD

G-17, MIDC TARAPUR

INDUSTRIAL AREA BIOSAR THANE

MUMBAI

50MG LYOPHILISED INJECTION 1*50MG*25ML VIAL INDIA

GITTOES PHARMACEUTICALS

LTD

{06B41783-E554-4312-85A3-AA3FD4378102}

AGOG PHARMA LTD SATISFIL -100 7482/18/11 SILDENAFIL

AGOG PHARMA LTD PLOT NO.33 SECTOR II THE VASAI TALUKA INDUSTRIAL CO-OP ESTATE LTD VASAA

(E) DIST THANE INDIA

100MG TABLETS 1*4 BLISTERS INDIAGITTOES

PHARMACEUTICALS LTD

{924C051B-A27E-4640-B24E-0C8BE4698D7E}

NAPROD LIFE SCIENCES (PVT) LTD NAPROBLEO 7483/08/11 BLEOMYCIN

NAPROD LIFE SCIENCES (PVT) LTD

PLOT G-17 MIDC TARAPUR

INDUSTRIAL AREA BIOSAR THANE

MUMBAI

I5 UNITS LYOPHILIZED INJECTION 1*1 VIAL INDIA

GITTOES PHARMACEUTICALS

LTD

{1B867454-72D9-4A30-AE1A-89DB3616DB9A}

Page 130

Page 131: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SUN PHARMACEUTICAL INDUSTRIES LTD

IROVEL 300 7484/12/11 IRBESARTAN

SUN PHARMACEUTICAL INDUSTRIES LTD SURVEY NO. 214

PLOT NO. 20 GOVT IND AREA PHASE II

SILVASSA 390230 U.T OT DADRA & NAGAR

HAVELI

300MG TABLETS 1*5*10, 1*3*10 STRIPS INDIA SURGIPHARM (U) LTD

{1E7C1A80-9EEE-41E4-9464-

77173B8EDC1B}

SANOFI SYNTHELABO

CO.LTDNOSPALGIN 7485/02/11

PARACETAMOL/ DROTAVERINE/

CODEINE

CHINOIN PHARMACEUTICAL

AND CHEMICAL WORKS H2112 VERESEGYHAZ

LEVAI U 5

500MG/ 40MG/ 8MG TABLET 1*2*6 BLISTERS HUNGARY SURGIPHARM (U) LTD

{36B5F5BF-67A5-4CB5-AD0F-

2E3F3F4D97AC}

SUN PHARMACEUTICAL INDUSTRIES LTD

PANTOCID 7486/17/11 PANTOPRAZOLE

SUN PHARMACEUTICAL INDUSTRIES LTD SURVEY NO. 214

PLOT NO.20 GOVT IND SILVASS 390230

U.T OF DADRA & NAGAR HAVELI

40MG TABLETS 1*3*10 STRIPS INDIA SURGIPHARM (U) LTD

{51C8A0A5-ADD4-48CA-977D-

16D970B97E56}

LUPIN LTD RIFAMPICIN / ISONIAZID 7487/06/11 RIFAMPICIN /

ISONIAZID

LUPIN LTD A-28 MIDC CHIKALTHANA

AURANGABAD 431210

MAHARASHTRA

150MG / 75MG TABLETS 1*24*28 BLISTERS INDIASTAR

PHARMACEUTICALS LTD

{30FC7901-8936-4C66-970A-4916C90F00F4}

DAFRA PHARMA LTD DAFRACLAV 7488/06/11AMOXICILLIN / POTASSIUM CLAVUNATE

BILIM PHARMACEUTICALS

ISLETMESI 59501 CERKEZKOY TEKIRDAG

400MG / 57MG POWDER FOR ORAL SUSPENSION 1*70ML TURKEY SURGIPHARM (U)

LTD

{14CDD900-C2F4-47C1-BCB9-

39FFEBAFD6FD}

ARISTO PHARMACEUTCALS

PVT LTDVISCO 7489/17/11

ALGINIC ACID/ MAGNESIUM HYDROXIDE/ ALUMINIUM

HYDROXIDE/ SIMETHICONE

ARISTO PHARMACEUTCALS

PVT LTD PLOT NO.208 NEW

INDUSTRIAL AREA NO.II MANDIDEEP

462046 RAISEN MADHYA PRADESH

100MG, 400MG/ 200MG/ 50MG TABLETS 1*4*6 GLASSINE

POLY FOIL INDIA NORVIK ENTERPRISES LTD

{768AB83B-1A59-4699-AE7F-1D3B99F06C53}

ARISTO PHARMACEUTCALS

PVT LTDVISCO LIQUID 7490/17/11

ALGINIC ACID/ MAGNESIUM HYDROXIDE/ ALUMINIUM

HYDROXIDE/ SIMETHICONE

ARISTO PHARMACEUTCALS

PVT LTD PLOT NO.208 NEW

INDUSTRIAL AREA NO.II MANDIDEEP

462046 RAISEN MADHYA PRADESH

100MG, 250MG/ 125MG/ 50MG SUSPENSION 1*1*200ML AMBER

PET BOTTLE INDIA NORVIK ENTERPRISES LTD

{51F0FB16-D6DB-4076-B0AC-

0E239B1BD1BC}

PT NOVELL PHARMACEUTICAL

LABORATORIESEPIVEN 7491/05/11 GABAPENTIN

PT NOVELL PHARMACEUTICAL LABORATORIES JI

WANAHERANG NO.35 TLAJUNG UDIK GUNUNG

PUTRI BONGOR

300MG CAPSULES 1*3*10 BLISTERS INDONESIA ECHO PHARMACY{801681A5-92C0-4C1A-

B8FC-0EC86D0AC016}

GITTOES PHARMACEUTICALS

LTDBENDRO 7492/16/11 BENDROFLUMETHIA

ZIDE

AGOG PHARMA LTD PLOT NO.33 SECTOR II THE VASAI TALUKA INDUSTRIAL CO-OP ESTATE LTD VASAI

(E) DIST THANE INDIA

5MG TABLETS 1*10*10 BLISTERS, 1*1000 HDPE INDIA AGOG PHARMA LTD

{3413D7ED-488B-4C46-A3FB-

EC5BDAEB5FA6}

Page 131

Page 132: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

RANBAXY LABORATORIES LTD AVOCOMB-N KID 7493/30/11

LAMIVUDINE/ NEVIRAPINE/ ZIDOVUDINE

RANBAXY LABS LTD PAONTA SAHIB DIST SIRMOUR HIMACHAL

PRADESH 173 025

30MG/ 50MG/ 60MG TABLETS FOR ORAL SOLUTION 1*60 HDPE INDIA SURGIPHARM (U)

LTD

{3690E128-D7C2-4C33-854D-

CC5292EA7EAB}

MICRO LABS LTD FLURISONE 7494/21/11 FLUROMETHALONE

MICRO LABS LTD 4TH PHASE KIADB BOMMASANDRA

INDUSTRIAL AREA ANEKAL TALUK

BANGAALORE 560 099

0.1%W/V EYE DROPS 1*1*5ML VIAL INDIAPHILLIP

DISTRIBUTORS (U) LTD

{234DEE73-016B-4D19A9A7-676C3A67FBB3}

INTAS PHARMACEUTICALS

LTDCARCA-6.25 7495/12/11 CARVEDILOL

INTAS PHARMACEUTICALS

LTD SELAQUI FEHRADUN 248197

6.25MG TABLET 1*3*10 BLISTERS INDIA NORVIK ENTERPRISES LTD

{39B8E2D1-C08C-4C6D-A097-

CBE73A7EE9F7}

IDA FOUNDATION ERYTHROMYCIN 7496/06/11 ERYTHROMYCINMICRO LABS 92

SIPCOT HOSUR 635 126 TAMIL NADU

250MG TABLET 1*1000 HDPE INDIA JOINT MEDICAL STORES

{DB07AA11-8F6D-4FA7-90BA-

B01A60F95C26}

TORRENT PHARMACEUTICALS

LTDROSUCOR 7497/12/11 ROSUVASTATIN

TORRENT PHARMACEUTICALS LTD INDRAD 382 721

TAL AHMEDABAD

20MG TABLET 1*3*10 BLISTERS INDIAKARURI

PHARMACEUTICALS LTD

{06BA5FD8-38C5-4E86-BEB3-

6E55BCB846A0}

PHARMACARE LIMITED HYCORCIN 7498/18/11 HYDROCORTISONE

STRIDES ARCOLAB LTD OPP IIM BILEKAHALLI

BANNERGHATTA ROAD BANGALORE

560 076

100MG POWDER FOR INJECTION 1*10 VIALS INDIA ERIS LTD {57D12374-25CF-4B59-

B587-D6BA20BBF920}

INCEPTA PHARMACEUTICALS

LTDOROCLEAN 7499/06/11

EUCALYPTOL / THYMOL / MENTHOL / METHYL SALICYLATE

INCEPTA PHARMACEUTICALS LTD DEWAN IDRIS

ROAD BARA RANGAMATIA

ZIRABO SAVAH DHAKA

BANGLADESH

0.092% / 0.054% / 0.042% / 0.06% W/V MOUTH WASH 1*250ML BANGLADESH ABACUS PHARMA (A)

LTD

{DFF3CEF1-AF22-48F2-BD5E-

01BFB0B776CA}

GLAXOSMITHKLINE LTD ZENTEL 7500/06/11 ALBENDAZOLE

GLAXOSMITHKLINE SOUTH AFRICA (PTY)

LTD HAWKINS AVENUE EPPING

7460

400MG TABLETS 1*1 BLISTERS SOUTH AFRICA ERIS LTD {4F59FFE3-51F3-4EFD-8BFD-3462CA9FE46F}

ALKEM LABORATORIES LTD RAPEED-20 7501/17/11 RABEPRAZOLE

ALKEM LABORATORIES LTD

VILLAGE THAN BADDI TEHSIL

NALAGARH DIST SOLAN HIMACHAL

PRADESH

20MG TABLETS 1*1*10 STRIP INDIA ABACUS PHARMA (A) LTD

{3ED5CC3B-8F34-4EE2-99CC-

74DDDCC451A7}

WOCKHARDT LTD WEPOX 4000 7502/10/11RECOMBINANT

HUMAN ERYTHROPOIETIN

WOCKHARDT LTD BIOTECH PARK H-14/2 MIDC WALIJ AURANGABAD

431136

4000IU SOLUTION FOR INJECTION

O.4ML FILLED IN 1ML SYRINGE INDIA

STAR PHARMACEUTICALS

LTD

{080D859C-40EE-4A6B-9BA9-

7AABF50F019C}

ABACUS PARENTERAL DRUGS

LTDP-FLOX 7503/06/11 PEFLOXACIN

AXA PARENTERALS LTD KISHANPUR

JAMALPUR ROORKEE 247667

400MG/100ML PARENTERAL SOLUTION 1*100ML INDIA ABACUS PHARMA (A)

LTD

{F23BEBD9-39F7-4B34-867D-

E0504CF209AA}

INTAS PHARMACEUTICALS

LTDLOSARTAS-HT 7504/12/11

LOSARTAN POTASSIUM /

HYDROCHLOROTHIAZIDE

INTAS PHARMACEUTICALS

LTD SELAQUI DEHRADUN 248197

50MG /12.5MG TABLETS 1*3*10 BLISTERS INDIA NORVIK ENTERPRISES LTD

{10FB5BD6-4CCC-41DA-B5D9-

F6DEBB32943E}

Page 132

Page 133: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

CADILA HEALTH CARE LTD AZEP 7505/28/11 AZELTASTINE

CADILA HEALTH CARE LTD SARKHEJ

BAVLA N.H NO.8A MORAIYA TAL

SANDAND DIST AHMEDABAD 382210

1MG/ML NASAL SPRAY 1*30ML HDPE BOTTLE INDIA ABACUS PHARMA (A)

LTD

{8C769F99-1233-4834-A7A2-

3C9D73B9FC2C}

INGELHEIM PHARMACEUTICALS

(PTY) LTDMOBIC 7506/02/11 MELOXICAM

BOEHRINGER INGELHEIM ELLAS

5TH PEANIAS MARKOPOULOU AVENUE 19400

KOROPI

15MG TABLETS 1*10 BLISTERS GREECE SURGIPHARM (U) LTD

{73227D82-A1BB-43AF8D97-

A954CABDD4B1}

FLAMINGO PHARMACEUTICALS

LTDKEFUROX 7507/06/11 CEFUROXIME

FLAMINGO PHARMACEUTICALS

LTD R-662 TTC INDUSTRIAL AREA

RABALE NAVI MUMBAI 400701

500MG TABLETS 1*10*1*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{15E3DA3D-D20F-43E0-8443-

47420BC677DB}

ABACUS PARENTERAL DRUGS

LTDAB-TOL 7508/16/11 MANNITOL

AXA PARENTERALS LTD KISHANPUR

JAMALPUR ROORKEE 247667

200MG/ML INTRAVENOUS INFUSION

1*100ML LDPE BOTTLE INDIA

ABACUS PARENTERAL DRUGS

LTD

{7C31DCBD-F003-48D2-965C-

1ECCFAFE73A0}

LEBEN LABORATORIES LTD FOLIBEN 7509/10/11 FOLIC ACID

LEBEN LABORATORIES LTD L-4 PHASE III MIDC

AKOLA 444 104 MAHARASTRA

5MG TABLETS 1*10*20 BLISTERS, 1*1000 HDPE INDIA

ANDYCO PHARMACEUTICALS

LTD

{9805751D-D424-43FA-9D46-A7F9334A77BA}

CADILA HEALTH CARE LTD OXALIPLATIN 7510/08/11 OXALIPLATIN

ZYDUS HOSPIRA ONCOLOGY PVT LTD PHARMEZ SPECIAL ECONOMIC ZONE MATAODA SARKEJ BAVLA HIGHWAY

AHMEDABAD 232 213

5MG/ML INJECTION 1*1 VIAL INDIA ABACUS PHARMA (A) LTD

{1172D935-FABE-40DB-A027-

9823E05505DF}

MACLEODS PHARMACEUTICALS

LTDALIVA 7511/25/11 LEVODROPROPIZINE

MACLEODS PHARMACEUTICALS LTD PLOT NO 1 & 2

MAHIM ROAD PALGHAR (W) DIST

THANE MAHARASHTRA

401404

30MG/5ML SYRUP 1*120ML INDIA NORVIK ENTERPRISES LTD

{DB6D9860-4ABE-4126-887D-

B2A13682BA74}

STEDMAN PHARMACEUTICALS

PVT LTDMICOBACT POWDER 7512/06/11 MICONAZOLE /

CHLORHEXIDINE

STEDMAN PHARMACEUTICALS PVT LTD C-4 SIDCO PHARMACEUTICAL

COMPLEX ALATHUR THIRUPORUR 603110

TAMIL NADU

2% W/W / 0.5%W/W POWDER 1*30G, 1*50G, 1*75G, 1*100G HDPE INDIA VEERAM

HEALTHCARE (U) LTD

{C9DBD460-DD6A-41FC-876C-

AE383990E9BF}

ALKEM LABORATORIES LTD GEMFOS 7513/04/11 RISEDRONATE

SODIUM

ALKEM LABORATORIES LTD

162/2 MAHTMA GANDHI UDYOG NAGAR DABHEL DAMAN 396 210

35MG TABLETS 1*4 BLISTERS INDIA ABACUS PHARMA (A) LTD

{3AC0C4BC-ED1E-47EC-B575-

17AE179FEDA8}

ABACUS PARENTERAL DRUGS

LTDCIFIN 7514/06/11 CIPROFLOXACIN

AXA PARENTERALS LTD KISHANPUR

JAMALPUR ROORKEE- 247667

0.2%W/V INJECTION 1*100ML INDIA ABACUS PHARMA (A) LTD

{8020DFF8-D347-4930-BADA-

45D423AFA0DB}

Page 133

Page 134: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

STEDMAN PHARMACEUTICALS

PVT LTD

CONTUS PLUS PAEDIATRIC

SUSPENSION7515/28/11

CHLORPHENAMINE / PHENYLEPHRINE /PARACETAMOL

STEDMAN PHARMACEUTICALS PVT LTD C-4 SIDCO PHARMACEUTICAL

COMPLEX ALATHUR THIRUPORUR 603110

TAMIL NADU

IMG /5MG /160MG SUSPENSION 1*50ML INDIA VEERAM HEALTHCARE (U) LTD

{8C7899CC-676C-49D6-A0AC-

F4DEDE431AD9}

METRO PHARMACEUTICALS

LTDDICLOFENAC 7516/02/11 DICLOFENAC

CSPC OUYI PHARMACEUTICAL

CO.LTD NO.276 WEST ZHONGSHAN

ROAD SHIJIAZHUANG

25MG/ML INJECTION 1*10*10*3ML CHINAMETRO

PHARMACEUTICALS LTD

{FFBE6E08-0887-412F-8EB2-B6C041CD754A}

CADILA HEALTHCARE LTD TRAMAZAC ER 100 7517/02/11 TRAMADOL

CADILA HEALTHCARE LTD

KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401

100MG TABLET 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{84A7E300-9EE0-4B42-B331-F5B9860475C6}

CADILA HEALTHCARE LTD TRAMAZAC ER 150 7518/02/11 TRAMADOL

CADILA HEALTHCARE LTD

KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401

150MG TABLET 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{8E15C0C3-1458-4AE79311-4111AB0403FE}

MEDIPHARM INDUSTRIES (E.A)

LTDORALYTE ORANGE 7519/26/11

GLUCOSE/ NaCl / TRISODIUM CITRATE

/ KCl

MEDIPHARM INDUSTRIES (E.A)

LTD PLOT 65 KAKAJJO ROAD BWEYOGERRE

KAMPALA

13.5G/ 2.6G/ 2.9G/ 1.5G POWDER 1*20.8G SACHET UGANDA

MEDIPHARM INDUSTRIES (E.A)

LTD

{00FB9E84-C7A6-4D4E-91FB-

F50B19ACDEA7}

CADILA HEALTHCARE LTD NEOLORIDIN 7520/03/11 DESLORATADINE

CADILA HEALTHCARE LTD

KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401

5MG TABLETS 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{2C0C3254-2376-4A5A-8E5D-1E3AF33E47E6}

ABACUS PARENTERAL DRUGS

LTDG-FLOX 7521/06/11 GATIFLOXACIN

AXA PARENTERALS LTD KISHANPUR

JAMALPUR ROORKEE- 247667

200MG / 100ML PARENTERAL SOLUTION 1*100ML LDPE INDIA ABACUS PHARMA (A)

LTD

{CC4EA2B1-627B-4531-9D54-

B94B0D6679CF}

METRO PHARMACEUTICALS

LTD

GENTAMICIN SULPHATE 7522/06/11 GENTAMICIN

SULPHATE

CSPC OUYI PHARMACEUTICAL

CO.LTD NO.276 WEST ZHONGSHAN

ROAD SHIJIAZHUANG

40MG/ML INJECTION 1*10*10*2ML CHINAMETRO

PHARMACEUTICALS LTD

{194B32D7-6A3C-4B839A0B-189C89D2A97E}

ASTRA PHARMA (U) LTD

CLOXACILLIN SODIUM 7523/06/11 CLOXACILLIN

SODIUM

CSPC ZHONGNUO PHARMACEUTICAL

CO. LTD NO.188 GONGNONG

FENGSHOU ROAD SHIJIAZHUANG

500MG POWDER FOR INJECTION 1*5*10 VIALS CHINA ASTRA PHARMA (U)

LTD{2197134C-40C5-4CE6-ADE3-CBA56A04094E}

FLAMINGO PHARMACEUTICALS

LTDAMOXICILLIN 7524/06/11 AMOXICILLIN

FLAMINGO PHARMACEUTICALS

LTD R-662 TTC INDUSTRIAL AREA

RABALE NAVI MUMBAI

500MG CAPSULES 1*10*10 INDIA ABACUS PHARMA (A) LTD

{80942977-96B3-48B3-AEAC-

D7E5DBC07516}

IDA FOUNDATION AZITHROMYCIN 7525/06/11 AZITHROMYCINCIPLA LTD VERNA INDUSTRIAL GOA

403 722250MG CAPSULES 1*6 BLISTERS INDIA JOINT MEDICAL

STORES

{D0027D1A-8B61-4EE7-9BAD-

9AFFC30924BA}

Page 134

Page 135: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SWISS PARENTERALS PVT

LTDHYCORT 7526/03/11 HYDROCORTISONE

SWISS PARENTERALS PVT

LTD 809 KERALA INDUSTRIAL ESTATE GIDC NEAR BAVLA DIST AHMEDABAD

GUJARAT

100MG POWDER FOR INJECTION

1*10*7.5ML GLASS VIALS INDIA

SHREEJI PHARMACEUTICALS

LTD

{C7B30ACB-65BE-47A9-82EC-

03DB6B98ACD9}

SWISS PARENTERALS PVT

LTDCEFONE 7527/06/11 CEFTRIAXONE

SWISS PARENTERALS PVT

LTD 809 KERALA INDUSTRIAL ESTATE GIDC NEAR BAVLA DIST AHMEDABAD

GUJARAT

1G POWDER FOR INJECTION 1*1G *10ML VIAL INDIA

SHREEJI PHARMACEUTICALS

LTD

{A1F6419B-AF87-45D9-90D9-1A7D83B45724}

ABACUS PHARMA (A) LTD FORTIWIN-4 7528/06/11

FORTIFIED PROCAINE

PENICILLIN SODIUM

REYOUNG PHARMACEUTICALS

CO LTD NO.6 ERLANGSHAN ROAD

YIYUAN COUNTY SHANDONG PROVINCE

4 MEGA POWDER FOR INJECTION

1*50*4MEGA GLASS VIALS CHINA ABACUS PHARMA (A)

LTD{111C57A3-CF74-4646-A1DF-597C3F917511}

GUILIN PHARMACEUTICAL

CO LTDGLINTHER 7529/06/11 ARTEMETHER

GUILIN PHARMACEUTICAL

CO LTD NO 43 QILIDIAN ROAD GUILIN 541002,

GUANGXI

80MG/ML INJECTION 1*6*1ML CHINASTAR

PHARMACEUTICALS LTD

{2B4D8578-11CA-40A8A82D-597029ABC066}

MEDINOMICS HEALTHCARE PVT

LTDAMINOSOFT 7530/27/11 MULTIVITAMINS AND

AMINO ACIDS

SOFTGEL HEALTH CARE PVT LTD

SURVEY NO 20/1 VANDALUR

KELAMBAKKAM ROAD PADUPAKKAM

VILLAGE KANCHEPURAM

DIST TAMIL NADU 600013

MULTIINGREDIENT CAPSULES 1*30 INDIAGITTOES

PHARMACEUTICALS LTD

{4B663089-2F62-49FA-A5F1-1BF75BDACA90}

ZYDUS CADILA HEALTHCARE LTD

DESPRESS NASAL SPRAY 7531/28/11 DESMOPRESSIN

CADILA HEALTHCARE LTD

SARKHEJ BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT

AHMEDABAD 382210

0.1MG/ML NASAL SPRAY 1*5ML VIAL INDIA ABACUS PHARMA (A) LTD

{86713134-675E-4351-A579-AB4F1BEB28E0}

PHARMEDIC LABORATORIES PVT

LTDMALASAN 7532/06/11 ARTEMETHER

PHARMEDIC LABORATORIES PVT LTD 16KM MULTAN

ROAD LAHORE

80MG/ML INJECTION 1*5*1ML AMPOULES PAKISTAN HEALTHCARE LTD {E300FFD7-5568-4C8F-AEF2-3D99828384AC}

CIPLA LTD COMBIMUNE 7533/30/11 ABACAVIR / LAMIVUDINE

CIPLA LTD A-33 & A-37/2/2 MIDC

PATALGANGA 410220600MG /300MG TABLETS 1*30 HDPE INDIA QUALITY CHEMICALS

LTD{BF639CE0-414F-492A-A8FD-AA5243248BF6}

AGOG PHARMA LTD AGOCLOX 7534/06/11 CLOXACILLIN

ELYSIUM PHARMACEUTICALS

LTD DABHASA PADRA VADODARA

391440 GUJARAT

125MG/5ML POWDER FOR ORAL SUSPENSION 1*100ML PET BOTTLE INDIA

GITTOES PHARMACEUTICALS

LTD

{67BAAD8E-79E5-4AA9-9B71-

5B5D8A9BBC69}

IDA FOUNDATION PARACETAMOL 7535/02/11 PARACETAMOLMICRO LABS LTD

92,SIPCOT HOSUR 635126 TAMIL NADU

500MG TABLETS 1*100*10 BLISTERS, 1*1000 HDPE INDIA JOINT MEDICAL

STORES{17037B2C-0A55-42C9-A14C-08EB28C6C4B2}

Page 135

Page 136: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ASTRA LIFECARE (INDIA) PVT LTD FLUCAS 7536/06/11 FLUCONAZOLE

ASTRA LIFECARE (INDIA) PVT LTD PLOT NO 57/P

SARKEJ BAVLA HIGHWAY RAJODA

AHMEDABAD

200MG CAPSULES 1*4 STRIPS INDIA ASTRA PHARMA (U) LTD

{ED0BA189-2ABA-4D4F-A037-

ABF13FEDAE3E}

ASTRA LIFECARE (INDIA) PVT LTD DIAS 7537/18/11 GLIBENCLAMIDE

ASTRA LIFECARE (INDIA) PVT LTD PLOT NO 57/P

SARKEJ BAVLA HIGHWAY RAJODA

AHMEDABAD

5MG TABLETS 1*10*10 BLISTERS INDIA ASTRA PHARMA (U) LTD

{FA9AFB22-D38B-4F61-BC2F-

E16EAE4B8D9B}

ASTRA LIFECARE (INDIA) PVT LTD BENDAS 7538/06/11 ALBENDAZOLE

ASTRA LIFECARE (INDIA) PVT LTD PLOT NO 57/P

SARKEJ BAVLA HIGHWAY RAJODA

AHMEDABAD

200MG TABLETS 1*1*2 STRIP INDIA ASTRA PHARMA (U) LTD

{5B07B8B3-9A52-486C-9BDD-

DAF34AA383F0}

MEDLEYPHARMACEUTICALS LTD ATORIN 7539/12/11 ATORVASTATIN

MEDLEYPHARMACEUTICALS LTD PLOT

18 & 19 SURVEY NO. 378/7 ,379/2 & 3 ZARI CAUSEWAY ROAD KACHIGAM DAMAN

10MG TABLETS 1*3*10 BLISTERS INDIA SUPERMEDIC LTD {0450C8FF-47A6-4398-B0D3-C3A46F163FF1}

LINCOLN PHARMACEUTICALS

LTDACICLOVIR 7540/30/11 ACICLOVIR

LINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE KHATRAJ TAL KALOL

GUJARAT

5% W/W CREAM 1*10G INDIAMETRO

PHARMACEUTICALS LTD

{CB4A769D-710E-43CD-8D59-

92EC1514B5E2}

ASTRA LIFECARE (INDIA) PVT LTD FLUCAS 7541/06/11 FLUCONAZOLE

ASTRA LIFECARE (INDIA) PVT LTD PLOT NO 57/P

SARKEJ BAVLA HIGHWAY RAJODA

AHMEDABAD

150MG CAPSULES 1*1 BLISTERS INDIA ASTRA PHARMA (U) LTD

{4D5854B5-223F-42AE-BC58-C44A693EE9D7}

GUILIN PHARMACEUTICAL

CO LTDARTESUN- PLUS 7542/06/11 ARTESUNATE /

AMODIAQUINE

GUILIN PHARMACEUTICAL

CO LTD NO.17 SHANGHAI ROAD GUILIN GUANXI

50MG / 135MG TABLETS 1*1*3*20 BLISTERS CHINASTAR

PHARMACEUTICALS LTD

{68D8877A-CB86-4859-9A58-BD738B070E29}

ABACUS PHARMA (A) LTD EXPEN 7543/06/11 BENZYLPENICILIN

REYOUNG PHARMACEUTICALS

CO LTD NO.6 ERLANGSHAN ROAD

YIYUAN COUNTY SHANDONG PROVINCE

1 MEGA POWDER FOR INJECTION

1*50*1MEGA GLASS VIALS CHINA ABACUS PHARMA (A)

LTD

{FF2C94E3-68C3-4D17-BDFB-

1C35E70D2649}

ABACUS PARENTERAL DRUGS

LTDABGYL 7544/06/11 METRONIDAZOLE

AXA PARENTERALS LTD KISHANPUR

JAMALPUR ROORKEE- 247667

500MG SOLUTION FOR INJECTION 1*1*100ML INDIA

ABACUS PARENTERAL DRUGS

LTD

{B137BD8E-25FD-45D3-9B3C-

9959DC23C7DD}

SK AGE EXPORTS DICLOKANT 7545/02/11 DICLOFENAC

S KANT HEALTHCARE

LTD1802-1805 GIDC PHASE III VAPI

396195 GUJARAT

50MG TABLETS 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{D0B0BB35-2574-4FB788C0-1DB176EE4274}

DAFRA PHARMA LTD DAFRACLAV 7546/06/11 AMOXICILLIN / CLAVULANIC ACID

BILIM PHARMACEUTICALS

ISLETMESI 59501 CERKEZKOY TEKIRDAG

875MG /125 MG TABLETS 1*2*5 BLISTERS TURKEY SURGIPHARM (U) LTD

{E699D959-86D9-467C-83F8-10CA886829B8}

Page 136

Page 137: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ASTRA PHARMA (U) LTD BENDAS-400 7547/06/11 ALBENDAZOLE

ASTRA LIFECARE (INDIA) PVT LTD PLOT NO 57/P

SARKEJ BAVLA HIGHWAY RAJODA

AHMEDABAD

400MG TABLETS 1*1 BLISTERS INDIA ASTRA PHARMA (U) LTD

{2F1C5D3F-6D72-48B5-B20C-

98F21B44A718}

SWISS PARENTERALS PVT

LTDLECOLE 7548/17/11 PANTOPRAZOLE

SWISS PARENTERALS PVT

LTD 809 KERALA INDUSTRIAL ESTATE GIDC NEAR BAVLA DIST AHMEDABAD

GUJARAT

40MG POWDER FOR INJECTION

1* 40MG* 10ML VIAL + 1*10ML 0.9% Nacl INDIA

SHREEJI PHARMACEUTICALS

LTD

{756E5845-D119-45BE-90F1-FC6B86500F20}

CADILA HEALTHCARE LTD MONTELUKAST 7549/25/11 MONTELUKAST

CADILA HEALTHCARE LTD

SARKHEJ BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT

AHMEDABAD 382210

CHEWABLE TABLETS 1*3*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{69624371-C138-452B-B378-6982BE22F423}

IDA FOUNDATION CEFTRIAXONE 7550/06/11 CEFTRIAXONE

OKASA PHARMA PVT LTD L-2 ADDITIONAL

MIDC SATARA 415004

MAHARASHTRA

1G POWDER FOR INJECTION 1*10 VIALS INDIA JOINT MEDICAL

STORES{2279B3BE-6739-4D9D8235-90AFBE531448}

CADILA HEALTHCARE LTD TRAMAZAC ER 200 7551/02/11 TRAMADOL

EXTENDED RELEASE

CADILA HEALTHCARE LTD

KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401

200MG TABLETS 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{08AF3C80-8353-4997-935E-

EEDB7B8DD58A}

CADILA HEALTHCARE LTD VALAZYD 7552/12/11 VALSARTAN

CADILA HEALTHCARE LTD

KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401

80MG TABLETS 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{47E1A5E4-8ED9-42A09533-FFB0CF60B0FE}

PHARMACARE LTD RAMPIL 7553/12/11 RAMIPRIL

TORRENT PHARMACEUTICALS

LTD AHMEDABAD INDRAD 382 721 DIST

MEHSANA

5MG CAPSULES 1*2*15 BLISTERS INDIA ERIS LTD{C6FAA77E-221B-

41A5-842F-BE5651E7CA38}

MICRO LABS LTD TOROLAC 7554/21/11 KETOROLAC TROMETHANMINE

MICRO LABS LTDPLOT 113-116

4TH PHASE BOMMASANDRA

INDUSTRIAL AREA BANGALORE 560 099

0.5%W/V OPHTHALMIC SOLUTION 1*1*5ML BOTTLE INDIA LABOREX (U) LTD

{3A2AD5A1-01F6-4C08-966C-

D6D3EC33D7D6}

AMOUN PHARMACEUTICAL

COMPANYANTINAL 7555/06/11 NIFUROXAZIDE

AMOUN PHARMACEUTICAL

COMPANY 1ST INDUSTRIAL ZONE

EL-OBOUR CITY

220MG/5ML ORAL SUSPENSION 1*60 ML EGYPTBOOTS

PHARMACEUTICALS LTD

{E4F5496A-B291-4AA7-A5E9-40572A867180}

NAPROD LIFE SCIENCES PVT LTD SUXAMETHONIUM 7556/20/11 SUXAMETHONIUM

NAPROD LIFE SCIENCES PVT LTD

G-17 MIDC TARAPUR INDUSTRIAL AREA

BIOSAR THANE

500MG/10ML INJECTION 1*10ML VIAL INDIA GITTOES PHARMACEUTICALS

{2E5426C4-0A18-4B21-AD69-4A3B5EEAB316}

Page 137

Page 138: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

DYNAPHARM (M) SDN BHD DYNA CALCIUM 7557/24/11 CALCIUM LACTATE

DYNAPHARM (M) SDN BHD 2497 MK 1

LORONG PERUSAHAAN BARU

5 KAWASAN PERUSAHAAN PERAI 313600 PERAI PALAU

PINANG

300MG TABLETS 1*100*10 BLISTERS MALAYSIADYNALAB

PHARMACEUTICALS (U) LTD

{F3CA122D-7DDF-41DE-BC68-

C76145D7D0DD}

MICRO LABS LTD OFLACIN 7558/06/11 OFLOXACIN

MICRO LABS LTD PLOT NO 113-116 4TH PHASE KIADB BOMMASANDRA

INDUSTRIAL AREA BANGALORE 560 099

0.3%W/V EYE / EAR DROPS 1*1*5ML INDIA LABOREX (U) LTD {2545460E-EC50-4B51-B626-BBB48ADF30A9}

ALKEM LABORATORIES LTD ONDEM 7559/17/11 ONDANSETRON

ALKEM LABORATORIES LTD PLOT NO. 167/2 M.G

UDYOG NAGAR DABHEL DAMAN 396

210

8MG SOLUTION FOR INJECTION 1*10*4ML AMPOULES INDIA ABACUS PHARMA (A)

LTD{B7E376F8-660E-469B-8DFA-C8F14D369353}

ABACUS PHARMA (A) LTD BENZALIN 7560/06/11

BENZATHINE BENZYLPENICILLIN

SODIUM

REYOUNG PHARMACEUTICALS

CO. LTD NO.6 ERLANGSHAN ROAD

YIYUAN COUNTY SHANDONG PROVINCE

2.4MEGA/ VIAL POWDER FOR INJECTION 1*50 GLASS VIALS CHINA ABACUS PHARMA (A)

LTD{381E1974-04C6-47D7-98BE-84B7E4370BA0}

CIPLA LTD EFAVIRENZ 7561/30/11 EFAVIRENZ

CIPLA LTD PLOT S-103 TO S-105, S-107 TO S-112 AND L-147 TO L-147-1 VERNA

INDUSTRIAL ESTATE GOA

200MG CAPSULES 1*90 HDPE INDIA QUALITY CHEMICALS LTD

{D69F6F48-D4F4-41A3-9AE7-617596C720F6}

TORRENT PHARMACEUTICALS

LTDGABATOR 400 7562/05/11 GABAPENTIN

CAPSULES USP

TORRENT PHARMACEUTICALS LTD INDRAD 382721

DIST MEHSANA

400MG CAPSULES 1*3*10 BLISTERS INDIAKARURI

PHARMACEUTICALS LTD

{B424C612-AA67-483A-BB41-6B08CAB74EFB}

CIPLA LTD LAMIVUDINE 7563/30/11 LAMIVUDINE

CIPLA LTD PLOT NO. L-139 TO L-146

VERNA INDUSTRIAL ESTATE GOA 403 722

30MG TABLETS 1*60 HDPE INDIA QUALITY CHEMICALS LTD

{C2A3D88F-FBDC-429C-BDDF-

5FC192FFC517}

ALKEM LABORATORIES LTD ODEM 7564/17/11 ONDANSETRON

ALKEM LABORATORIES LTD PLOT NO. 167/2 M.G

UDYOG NAGAR DABHEL DAMAN 396

210

4MG SOLUTION FOR INJECTION 1*10*2ML AMPOULES INDIA ABACUS PHARMA (A)

LTD

{CE0F8CAF-AD1B-46AD-BA51-

9DF21BCD69CF}

LEBEN LABORATORIES PVT

LTDCIPIUM 7565/03/11 CHLORPHENIRANMIN

E

LEBEN LABORATORIES PVT

LTD L-4 PHASE III MIDC AKOLA 444 104

MAHARASHTRA

2MG/5ML SYRUP 1*60ML, 1*100ML AMBER PET BOTTLE INDIA ANDYCO PHARMACY {70743693-8725-4908-

AB98-9CE7E0F47349}

DYNAPHARM (M) SDN.BHD AMOXYCILLIN 7566/06/11 AMOXYCILLIN

DYNAPHARM (M) SDN.BHD 2497 MK 1,

LORONG PERUSAHAAN BARU

5 KAWASAN PERUSAHAAN PERAI

3, 13600 PERAI ,PULAU PINANG

250MG CAPSULES 1*1000 HDPE MALAYSIA DYNA LABS LTD {10122BAA-A75F-4C928BAC-58D8B434F136}

Page 138

Page 139: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

PLETHICO PHARMACEUTICALS

LTDAMOD-5 7567/12/11 AMLODIPINE

PLETHICO PHARMACEUTICALS

LTD VILLAGE DHARAVARA

INDORE MADHYA PRADESH

5MG TABLETS 1*10 BLISTERS INDIASTAR

PHARMACEUTICALS LTD

{6593CB36-1473-4442-B757-

B3AEBDCC16BF}

UMEDICA LABORATORIES PVT

LTDRILIF-SR 7568/02/11

ACECLOFENAC SUSTAINED RELEASE

UMEDICA LABORATORIES PVT LTD PLOT 221 GIDC II PHASE VAPI 396195

GUJARAT

200MG TABLETS 1*3*10 BLISTERS INDIAGITTOES

PHARMACEUTICALS LTD

{C5A4C30F-BBFE-4887-8614-

2E78D8F61599}

PLETHICO PHARMACEUTICALS

LTDAMOD-10 7569/12/11 AMLODIPINE

PLETHICO PHARMACEUTICALS

LTD VILLAGE DHARAVARA

INDORE MADHYA PRADESH

10MG TABLETS 1*10 BLISTERS INDIASTAR

PHARMACEUTICALS LTD

{BFE69096-410F-4FFD-AD83-F3B0A3EA7550}

INTAS PHARMACEUTICALS

LIMITEDZENOXA-300 7570/05/11 OXCARBAZEPINE

INTAS PHARMACEUTICALS

LIMITED 7/3 GIDC ESTATE VATVA

AHMEDABAD 382 445

300MG TABLETS 1*5*10 BLISTERS INDIA NORVIK ENTERPRISE LTD

{BAF5902F-38A0-4FB6-93B7-4807F03BA3B6}

HETERO DRUGS LTDLAMIVUDINE/ NEVIRAPINE/ STAVUDINE

7571/30/11LAMIVUDINE/ NEVIRAPINE/ STAVUDINE

HETERO DRUGS LTD UNIT III 22-110 IDA

JEEDIMETLA HYDERABAD

150MG/ 200MG/ 30MG TABLETS 1*60 HDPE INDIA ASTR PHARMA (U) LTD

{DF547D3D-C537-4612-B8E8-

786A1933CEAE}

WOCKHARDT LTD NADOXIN 7572/06/11 NADIFLOXACIN

WOCKHARDT LTD VILLAGE KUNJHAL P.O BAROTIWALA

DIST SOLAN HIMACHAL PRADESH

1%W/W CREAM 1*10G INDIASTAR

PHARMACEUTICALS LTD

{BE20263A-13DC-4947AB44-5E6D72782A7D}

GUILIN PHARMACEUTICAL

CO LTD

SULFAMETHOXAZOLE / TRIMETHOPRIM 7573/06/11 SULFAMETHOXAZOL

E / TRIMETHOPRIM

GUILIN PHARMACEUTICAL

CO LTD NO.43 QILIDIAN ROAD

GUILIN

400MG/ 80MG TABLETS 1*10*10 BLISTERS INDIASTAR

PHARMACEUTICALS LTD

{7F10F985-EBDF-418F-AA5D-A4B70393E947}

GUILIN PHARMACEUTICAL

CO LTD

SULFAMETHOXAZOLE / TRIMETHOPRIM 7574/06/11 SULFAMETHOXAZOL

E / TRIMETHOPRIM

GUILIN PHARMACEUTICAL

CO LTD NO.17 SHANGHAI ROAD

GUILIN 541002 GUANGXI

800MG /100MG TABLETS 1*10*10 BLISTERS CHINASTAR

PHARMACEUTICALS LTD

{A7DD7D32-DE0F-4BCB-816D-

D5E0402D2D30}

REMEDICA LTD OVA-MIT 7575/18/11 CLOMIFENE

REMEDICA LTD AHARNON STREET

LIMASSOL INDUSTRIAL

ESTATE, 3056 LIMASSOL

50MG TABLETS 1*1*10 BLISTERS CYPRUS GOODMAN INTERNATIONAL LTD

{0EFAA8AF-56A8-449A-99EA-

23C45A13FECF}

LEBEN LABORATORIES PVT

LTDLIBITUS PLUS SYRUP 7576/25/11

TERBUTALIN/ BROMHEXINE/ GUAIPHENESIN

LEBEN LABORATORIES PVT

LTD L-4 PHASE III MIDC AKOLA 444 104

MAHARASHTRA

1.25MG/ 4MG/ 50 MG SYRUP 1*100ML AMBER PET BOTTLE INDIA ANDYCO PHARMACY {D33F7B82-F48A-42A5-

A70F-423177ADD225}

PACIFIC PHARMACEUTICALS

LTDTYZORIN 7577/06/11 TIBEZONIUM IODIDE

PACIFIC PHARMACEUTICALS LTD 30KM MULTAN ROAD P.O BOX 399

LAHORE

5MG LOZENGES 1*4*6 PAKISTAN HEALTHCARE LTD {32F51953-55CC-4F46-A39F-032A5B36CF8D}

TROIKAA PHARMACEUTICALS

LTD

CHLORAMPHENICOL SODIUM SUCCINATE 7578/06/11 CHLORAMPHENICOL

SODIUM SUCCINATE

TROIKAA PHARMACEUTICALS

LTD THOL DIST MEHSANA 382 728

GUJARAT AHMEDABAD

1G/ VIAL POWDER FOR INJECTION 1*10*1G INDIA ANDYCO PHARMACY {8F84B118-F9FC-42B1-

AD67-2ABBC9124A42}

Page 139

Page 140: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

DENK PHARMA GmbH & Co.KG LOSAR-DENK 7579/12/11 LOSARTAN

DENK PHARMA GmbH & Co.KG

GOLLESTR 1 84529 TITTMONING

50MG TABLETS 1*2*14 BLISTERS GERMANY ERIS LTD{D9578EDC-7F0C-

493A-A1C0-8D19677F3EFE}

DENK PHARMA GmbH & Co.KG METFORMIN-DENK 7580/18/11 METFORMIN

DENK PHARMA GmbH & Co.KG

GOLLESTR 1 84529 TITTMONING

1000MG TABLETS 1*2*15 BLISTERS GERMANY ERIS LTD{C36328B5-61E8-491D-

9BBF-BBCACA63FBB7}

DENK PHARMA GmbH & Co.KG

COLOSA-DENK 50/12.5 7581/12/11

LOSARTAN / HYDROCHLOROTHIA

ZIDE

DENK PHARMA GmbH & Co.KG

GOLLESTR 1 84529 TITTMONING

50MG/ 12.5MG TABLETS1*2*14 BLISTER,

MEDICAL SAMPLES (1*14 )

GERMANY ERIS LTD{63BAB455-1BA4-

45EE-B8A7-B3842A7063B6}

DENK PHARMA GmbH & Co.KG LOSAR-DENK 7582/12/11 LOSARTAN

DENK PHARMA GmbH & Co.KG

GOLLESTR 1 84529 TITTMONING

100MG TABLETS 1*2*14 BLISTER GERMANY ERIS LTD{61653CE7-8A9B-

4DC8-98E7-9EA5091D0FBF}

AJANTA PHARMA LIMITED AMPOD-100/270 7583/06/11 ARTESUNATE /

AMODIAQUINE

AJANTA PHARMA LIMITED B-4/5/6 MIDC

INDUSTRIAL AREA PAITHAN 431128 AURANGABAD

100MG/ 270MG TABLETS 1*1*3 (CHILD) 1*1*6 (ADULT) BLISTERS INDIA ABACUS PHARMA (A)

LTD

{8CD7E6A0-7DCE-4E32-9A5C-

DE07ADA60045}

AGOG PHARMA LTD AGOCLOX-250 7584/06/11 CLOXACILLIN

ELYSIUM PHARMACEUTICALS

LTD DABHASA PADRA VADODARA 391 440 GUJARAT

250MG CAPSULES 1*10*10 BLISTERS INDIAGITTOES

PHARMACEUTICALS LTD

{A1F89EBD-239E-4188858F-67995A90DDCF}

IDA FOUNDATION PARAMOMYCIN 7585/06/11 PARAMOMYCIN

GLAND PHARMA LTD D.P PALLY

DUNDIGAL POST QUTBULLAPUR

MANDAL RANGA REDDY DISTRICT

HYDERABAB 500043

375MG/ML SOLUTION FOR INJECTION

1*10*2ML AMBER GLASS AMPOULES INDIA JOINT MEDICAL

STORES{257D73D3-05F8-4796-8D86-04D39E2EBDF4}

LEBEN LABORATORIES LTD

LEBASMA ORAL SOLUTION 7586/25/11 SALBUTAMOL

LEBEN LABORATORIES LTD L-4 PHASE III MIDC

AKOLA 444 104 MAHARASHTRA

2MG/5ML ORAL SOLUTION 1*100 ML AMBER PET BOTTLE INDIA ANDYCO PHARMACY

{6CE4DBEE-4419-4757-BC32-

F695E676A5DC}

CIPLA LTD PHOTERICIN B 7587/06/11 AMPHOTERICIN B

CIPLA LTD M-61, M-62 & M-63, VERNA

INDUSTRIAL ESTATE VERNA GOA

50MG POWDER FOR INJECTION 1*50MG GLASS VIALS INDIA QUALITY CHEMICALS

LTD

{CF8E01AA-E05F-448E-8751-

1BF99941FAEC}

CADILA PHARMACEUTICALS

LTDALLERSTAT 120 7588/03/11 FEXOFENAMIDE

CADILA PHARMACEUTICALS

LTD 1389 DHOLKA DISTRICT

AHMEDABAD GUJARAT

120MG TABLETS 1*1*10 BLISTERS INDIAKARURI

PHARMACEUTICALS LTD

{09A702B4-6200-4146-A396-BCAE27FA170B}

INGELHEIM PHARMACEUTICALS

LTDCO-MICARDIS 7589/12/11

TELMISARTAN/ HYDROCHLOROTHIZI

DE

BOEHRINGER INGELHEIM PHARMA

GmbH & Co.KG INGELHEIM AM

RHEIN

80MG/ 12.5MG TABLETS 1*4*7 BLISTERS GERMANY SURGIPHARM (U) LTD

{32D788B2-03BE-4808-AAC8-

BB0B5BBF83AD}

GUILIN PHARMACEUTICAL

CO.LTDARTESUN 7590/06/11 ARTESUNATE

GUILIN PHARMACEUTICAL

CO.LTD NO.43 QILIDIAN ROAD GUILIN 541002

GUANGXI

30MG POWDER FOR INJECTION

1*30MG VIAL + 1*0.5 ML SODIUM

BICARBONATECHINA

STAR PHARMACEUTICALS

LTD

{2AD63498-9536-4E11-9602-F6268779C956}

Page 140

Page 141: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

SWISS PARENTERALS PVT

LTDABT 7591/06/11 ALPHA-BETA

ARTEETHER

SWISS PARENTERALS PVT

LTD 809 KERALA INDUSTRIAL ESTATE

GIDC NR BABVLA DIST AHMEDABAD

GUJARAT

75MG/ML SOLUTION FOR INJECTION

1*3*2ML AMBER GLASS AMPOULES INDIA

SHREEJI PHARMACEUTICALS

LTD

{18FFAD96-D592-48A4-BD33-A239BF384368}

PHARMACARE LTD BIDOGREL 7592/10/11 CLOPIDOGREL

TORRENT PHARMACEUTICALS

LTD AHMEDABAD MEHSANA INDRAD

382721

75MG TABLETS 1*3*10 BLISTERS INDIA ERIS LTD{2BBC7707-704F-

4CFC-84BB-10834CF9C785}

PT NOVELL PHARMACEUTICAL

LABORATORIESNOPRENIA 7593/24/11 RISPERIDONE

PT NOVELL PHARMACEUTICAL LABORATORIES JI

WANAHERANG NO.35 TLAJUNG UDIK GUNUNG

PUTRI BONGOR

2MG TABLETS 1*3*10 BLISTERS INDONESIA ECHO PHARMACY{41E9DAB9-C3DB-

4546-A68C-B26FF804CD2D}

AUROBINDO PHARMA LTD

LAMIVUDINE / ZIDOVUDINE/ NEVIRAPINE

7594/30/11LAMIVUDINE / ZIDOVUDINE/ NEVIRAPINE

AUROBINDO PHARMA LTD UNIT

VII SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P

PLOT NO S1 ( PART) SPECIAL ECONOMIC

ZONE GREEN INDUSTRIAL PARK

POLEPALLY VILLAGRE ANDHRA PRADESH 509302

150MG /300MG /200MG TABLETS 1*60 HDPE INDIA

GITTTOES PHARMACEUTICALS

LTD

{05946A27-736B-481F-8D08-9330F1DF558F}

AUROBINDO PHARMA LTD LAMIVUDINE 7595/30/11 LAMIVUDINE

AUROBINDO PHARMA LTD UNIT

VII SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P

PLOT NO S1 ( PART) SPECIAL ECONOMIC

ZONE GREEN INDUSTRIAL PARK

POLEPALLY VILLAGRE ANDHRA PRADESH 509302

150MG TABLETS 1*60 HDPE INDIAGITTTOES

PHARMACEUTICALS LTD

{3AF48593-152C-4C7D-84D5-8F4B11B80A46}

ALKEM LABORATORIES LTD ONDEM 7596/17/11 ONDANSETRON

ALKEM LABORATORIES LTD

VILLAGE THANA BADDI TEHSIL

NALAGARH DIST SOLAN (HP) 173205

8MG TABLETS 1*1*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{E8C95E33-B55B-47FB-B24F-

F269C81F1229}

ALKEM LABORATORIES LTD ONDEM 7597/17/11 ONDANSETRON

ALKEM LABORATORIES LTD

VILLAGE THANA BADDI TEHSIL

NALAGARH DIST SOLAN (HP) 173205

4MG TABLETS 1*1*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{36F4B59E-7C30-4F68-A0F4-E214C7255CE3}

DENK PHARMA GmbH & CO.KG

AMOXICLAV-DENK 1000/125 7598/06/11

AMOXICILLIN TRIHYDRATE / POTASSIUM

CLAVULANATE

PENCEF PHARMA GmbH

BRITENBACHSTR ASSE 13 D-13509

BERLIN

1000 MG/ 125MG POWDER FOR ORAL SUSPENSION 1*8*3G SACHETS GERMANY ERIS LTD

{124B4C9E-3C3C-4387-9C87-

3099AFA71F0B}

Page 141

Page 142: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

DENK PHARMA GmbH & CO.KG

AMOXICLAV-DENK 500/62.5 7599/06/11

AMOXICILLIN TRIHYDRATE / POTASSIUM

CLAVULANATE

PENCEF PHARMA GmbH

BRITENBACHSTR ASSE 13 D-13509

BERLIN

500MG/ 62.5MG TABLETS 1*2*8 BLISTERS GERMANY ERIS LTD{6C3F2BD0-21D0-

418F-BD9C-1FDBF0833AF7}

ALKEM LABORATORIES LTD MOBENAC-P 7600/02/11 ACECLOFENAC/

PARACETAMOL

ALKEM LABORATORIES LTD

VILLAGE THANA BADDI TEHSIL

NALAGARH DIST SOLAN (HP) 173205

100MG /500MG TABLETS 1*1*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{73B4DF61-D6A0-4562-A28B-

7D55BC76D0EA}

UNITED PHARMACEUTICAL MANUFACTURING

COMPANY LTD

UNICAST 7601/25/11 MONTELUKAST

UNITED PHARMACEUTICAL MANUFACTURING

COMPANY LTD NUZHAT SAHAB AL-

RAQEEM NEAR PUBLIC SECURITY

HOUSING REG NO.2161 P.O BOX 69

AMMAN 11591 JORDAN

10MG CHEWABLE TABLETS 1*3*10 BLISTERS JORDAN MEDICAL ACCESS (U) LTD

{BA1080F7-2A5E-49BD-AA44-

5A8CF4A1CDD7}

MEDICAL UNION PHARMACEUTICALS HEPATICUM 7602/25/11 SILYMARIN

MEDICAL UNION PHARMACEUTICALS

CO. ABU SULTAN ISMAILIA

140MG CAPSULE 1*5*2 BLISTERS EGYPTKARURI

PHARMACEUTICALS LTD

{D0FE070D-BF6C-43A9-A53E-

9223CD0FBA13}

AJANTA PHARMA LTD COFORM-AX 7603/25/11AMBROXOL

/SULBUTAMOL / GUAIFENESIN

AJANTA PHARMA LTD 31-0 MIDC

INDUSTRIAL AREA CHIKALTHANA

431210 DIST AURANGABAD

MAHARASHTRA STATE

15/ 1MG/ 50MG SYRUP 1*100 ML INDIA ABACUS PHARMA{4C5BAFBF-B24D-

4066-9198-4B42733ED4E7}

INDUS PHARMA PVT LTD EXLOR 7604/06/11 CEFACLOR

INDUS PHARMA PVT LTD PLOT NO 64, 65, 66 & 67 SECTOR-27

KORANGI INDUSTRIAL AREA

KARACHI 74900

125MG/ML POWDER FOR ORAL SUSPENSION 1*100ML PAKISTAN MAVID

PHARMACEUTICALS

{8E2FE2D6-D0B0-4414-B855-

CC7809854672}

IDA FOUNDATION CIPROFLOXACIN 7605/06/11 CIPROFLOXACIN

MICRO LABS LIMITED 92 SIPCOT

HOSUR 635 126 TAMIL NADU

500MG TABLETS 1*10*10 BLISTERS, 1*100 HDPE INDIA JOINT MEDICAL

STORES

{A5D22DAA-359B-449C-871B-

1059DDFDC9C5}

PT SANBE FARMA SANBE CLANEKSI 7606/06/11 AMOXICILLIN /CLAVULANIC ACID

PT SANBE FARMA JI LEUWIGAJAH NO.162

CIMINDI CIMAHI WEST JAVA INDONESIA

1000MG/ 200MG POWDER FOR INJECTION 1*6 GLASS VIALS INDONESIA ABACUS PHARMA (A)

LTD{0996D450-9C0A-46C1-9A2A-5FAB50DEE882}

AJANTA PHARMA LTD LEOCAL SYRUP 7607/27/11

CALCIUM CARBONATE /MAGNESIUM

HYDROXIDE /ZINC SULPHATE/

COLECALCIFERAL

AJANTA PHARMA LTD 31-0 MIDC

INDUSTRIAL AREA CHIKALTHANA

431210 DIST AURANGABAD

MAHARASHTRA STATE

375 MG/ 60MG / 4MG /17.5MG /4MG SYRUP 1*120 ML INDIA ABACUS PHARMA (A)

LTD{54233724-0E01-4661-AF7B-6717717957D4}

INCEPTA PHARMACEUTICALS

LTDPROVITEIN A-Z 7608/27/11

MULTIVITAMIN & MINERAL

SUPPLEMENT

INCEPTA PHARMACEUTICALS LTD DEWAN IDRIS

ROAD BARA RANGAMATIA

ZIRABO SAVAH DHAKA

MULTI-INGREDIENT TABLETS 1*15 HDPE BANGLADEDESH ABACUS PHARMA (A) LTD

{B5669E4C-0840-4A4C923F-FFEB069413B9}

MICRO LABS LTD LANCID KIT 7609/06/11AMOXICILLIN

/LANSOPRAZOLE /CLARITHROMYCIN

MICRO LABS LTD VEERASANDRA

INDUSTRIAL AREA BANGLORE 560 100

500MG/ 30MG/ 500MG TABLETS 1*7*1 (4+2+2) BLISTERS INDIA LABOREX (U) LTD {26977111-5003-46B6-

958B-DA442CA37BB0}

Page 142

Page 143: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

AUROBINDO PHARMA LTD ABACAVIR 7610/30/11 ABACAVIR

AUROBINDO PHARMA LTD UNIT-VII SEZ PLOT NO S1 SPECIAL ECONOMIC

ZONE GREEN INDUSTRIAL PARK

POLEPALLY VILLAGE

300MG TABLETS 1*1*60 HDPE INDIAGITTOES

PHARMACEUTICALS LTD

{78E89991-9BA2-40AC-BA71-C049F8A286F0}

WIDE SPECTRUM ENTERPRISES LTD ZITHRORIV 7611/06/11 AZTHROMYCIN

RIVA PHARMA FREEZONE NASR

CITY EGYPT500MG CAPSULES 1*3 BLISTERS EGYPT WIDE SPECTRUM

ENTERPRISES LTD

{ACA201FA-E86D-4FFE-833C-

CE7A6F24390A}

ABACUS PARENTERAL DRUGS

LTDD50 7612/24/11

GLUCOSE INTRAVENOUS

INFUSION

AXA PARENTERALS LTD KISHANPUR

JAMALPUR ROORKEE 247667 UTTARAKHAND

50%W/V SOLUTION FOR INJECTION 1*1*100ML INDIA ABACUS PHARMA (A)

LTD{6726C848-E4F7-424F-A244-F5CE9C6639DD}

VENUS REMEDIES LTD ZYDOTUM 7613/06/11 CEFTAZIDIME /

SULBACTAM

VENUS REMEDIES LTD UNIT II HILL TOP INDUSTRIAL ESTATE

JHARMAJRI EPIP PHASE I BHATOLI

KALAN BADDI (H.P)

1000MG / 500MG POWDER FOR INJECTION 1*1.5G IN 20ML VIALS INDIA

AARON PHARMACEUTICALS

LTD

{AC4770E5-B658-4E2AB158-0775AEEC9F89}

VENUS REMEDIES LTD LASTINEM 7614/06/11 IMIPENEM /

CILASTATIN

VENUS REMEDIES LTD UNIT II HILL TOP INDUSTRIAL ESTATE

JHARMAJRI EPIP PHASE I BHATOLI

KALAN BADDI (H.P)

500 MG /500MG INJECTION 1*10ML INDIAAARON

PHARMACEUTICALS LTD

{435124F4-BE7B-4FDD-A5B5-

31AE94D0F1E3}

BAYER SCHERING PHARMA COMBINATION 3 7615/18/11

ETHINYLESTRADIOL/ LEVONORGERSTERE

L/ FERROUS SULPHATE

DELPHARMA SAS ZONE INDUSTRIELLE

DE ROUBAIX EST RUE DE TOUFFLERS BP 50070 59452 LYS LEZLANNOY CEDEX

0.03MG/ 0.15MG / 75MG TABLETS 1*1000*(21+7) FRANCE SURGIPHARM (U)

LTD

{AD969EE7-FE1F-40C7-AA81-

3E7284243A0F}

NORVARTIS PHARMA AG SYNTOCINON 7616/22/11 OXYTOCIN

NORVARTIS PHARMA STEIN LTD SCHAFFHAUSESTRA

SSE 4332 STEIN

10 I.U/ML SOLUTION FOR INJECTION 1*10*1ML AMPOULES SWITZERLAND SURGIPHARM (U)

LTD

{661D3B49-CE1E-410C-9D7A-

F58F27A73E24}

ASTRA ZENECA UK LTD RHINOCORT AQUA 7617/25/11 BUDESONIDE

ASTRA ZENECA SWEDEN

OPERATIONS LIQUID PRODUCTION 151-85

SODAERTAJJE

32 MCG NASAL SPRAY 1*120 DOSES SWEDEN MACNAUGHTON LTD {966007C4-F574-4EC6-B0F0-A908A5BF531B}

AGOG PHARMA LTD AZ-500 7618/06/11 AZITHROMYCIN

AGOG PHARMA PLOT NO. 33

SECTOR II THE VASAI TALUKA

ESTATE DIST THANE

500MG TABLETS 1*3 BLISTER INDIAGITTOES

PHARMACEUTICALS LTD

{4A810560-88D2-4FB2-9449-C49BC761EF41}

LINCOLN PHARMACEUTICALS

LTDNEOVAG 7619/06/11 NYSTATIN

LINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE KHATRAJ CHOKADI

KHATRAJ 382721 GHANDHINAGAR

GUJARAT

100.000 1U OINTMENT 1*30G INDIAMETRO

PHARMACEUTICALS LTD

{CA6ECCAA-8162-4073-BD95-

D1B7B70D09BB}

Page 143

Page 144: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

BLISS GVS PHARMA LTD TODAY PESSARY 7620/06/11 NONOXYNOL-9

BLISS GVS PHARMA LTD PLOT NO. 10 SURVEY NO.381 DEWAN UDYOG NAGAR ALIYALI

VILLAGE PALGHAR DIST THANE

MAHARASHTRA

5%W/W PESSARY 1*5 BLISTER INDIA DELMAW ENTERPRISES LTD

{D9A42CA6-75CA-4F2B-B857-

30AD2A55931B}

ASTRA ZENECA UK LTD BRILINTA 7621/10/11 TICAGRELOR

ASTRA ZENECA AB GARTUNAVGEN SE

151 58 SODAERTAJJE

90MG TABLETS 1*4*14 BLISTER SWEDEN MACNAUGHTON (U) LTD

{9633FBC9-0BCA-480D-BC7C-

178CD5E43F21}

SUN PHARMACEUTICAL INDUSTRIES LTD

PIOGLIT 15 7622/18/11 PIOGLITAZONE

SUN PHARMACEUTICAL INDUSTRIES LTD SURVEY NO214

PLOT NO 20 GOVT INDUSTRIAL AREA PHASE II PIPARIA SILVASSA 396230

15MG TABLETS 1*3*10 INDIA SURGIPHARM (U) LTD

{D258D472-0953-4F28-94C6-F8FEE9DA0058}

AGOG PHARMA LTD TOPHEN 7623/05/11 PHENYTOIN

AGOG PHARMA LTD PLOT NO. 33

SECTOR II THE VASAI TALUKA

ESTATE DIST THANE

100MG CAPSULES 1*10*10 BLISTER, 1*100 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD

{A9D343F4-C5AC-4522-9C15-

6ED5F324A10D}

AGOG PHARMA LTD AGOPEN 7624/06/11 PHENOXYMETHYL PENICILLIN SODIUM

ELYSIUM PHARMACEUTICALS

LTD DHBHASA PADRA VADODARA 391 440 GUJARAT

125MG/ML POWDER FOR ORAL SUSPENSION

1*100ML AMBER PET BOTTLE INDIA

GITTOES PHARMACEUTICALS

LTD

{244F128F-8C58-4B65-9680-DD8EC1D73815}

SHELYS PHARMACEUTICALS

LTDHEMOVIT SYRUP 7625/10/11

IRON/ FOLIC ACID/ PYRIDOXINE/

CYANOCOBALAMIN/ ZINC

SHELYS PHARMACEUTICALS

LTD NEW BAGAMOYO ROAD MWENGE DAR-ES-

SALAAM

200MG/ 1.5MG/ 0.5MG/ 50 MCG/

2.33MGSYRUP 1*200ML AMBER

GLASS BOTTLE TANZANIA BETA HEALTH CARE (U) LTD

{65A8DC49-E4A3-462C-B5B9-

B1D0A8C2EB3E}

ASTRA LIFECARE INDIA PVT LTD ASMOX 7626/06/11 AMOXICILLIN

ASTRA LIFECARE INDIA PVT LTD PLOT

NO 57/P SARKEJ BAVLA HIGHWAY

RAJODA AHMEDABAD

500MG CAPSULES 1*10*10 BLISTER INDIA ASTRA PHARMA (U) LTD

{E3C05755-B058-4903-95D1-54A99FD9FA40}

MICRO LABS LTD DIAPRIDE 7627/18/11 GLIMEPRIDE

MICRO LABS LTD 92 SIPCOT INDUSTRIAL

COMPLEX HOSUR 635 126 TAMIL NADU

2MG TABLETS 1*3*10 BLISTER INDIA LABOREX (U0 LTD {52B57EF7-7E96-4A3F-9273-FFF978A56233}

AGOG PHARMA LTD AZ-500 7628/06/11 AZITHROMYCIN

AGOG PHARMA LTD PLOT NO. 33

SECTOR II THE VASAI TALUKA

ESTATE DIST THANE

500MG CAPSULES 1*3 BLISTER INDIAGITTOES

PHARMACEUTICALS LTD

{08220FAF-8910-4E47-94C5-BBD49C41FC27}

ABACUS PARENTERALS

DRUGS LTDFLUZOL 7629/06/11 FLUCONAZOLE

AXA PARENTERALS LTD KISHANPUR

JAMALPUR ROORKEE 247667 UTTARAKHAND

200MG SOLUTION FOR INJECTION 1*100ML INDIA

ABACUS PARENTERALS

DRUGS LTD

{D3F35EEE-3C66-42CA-8AC8-

E034620EB0F0}

SK AGE EXPORTS MDOPAKANT-250 7630/12/11 METHYLDOPA

S KANT HEALTHCARE LTD

1802-1805 GIDC PHASE III VAPI

396195 GUJARAT

250MG TABLETS 1*1000 INDIA ABACUS PHARMA (A) LTD

{9A79BA9D-45BF-45EA-B182-

8CCDB6D2BDEA}

Page 144

Page 145: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

AGOG PHARMA LTD AGOHAL 7631/24/11 HALOPERIDOL

AGOG PHARMA LTD PLOT NO. 33

SECTOR II THE VASAI TALUKA

ESTATE DIST THANE

10MG TABLETS 1*10*10 BLISTERS INDIAGITTOES

PHARMACEUTICALS LTD

{F88216ED-BD70-4C3D-BE39-

930A89AD919A}

SWISS PARENTERALS PVT

LTDDIAZI 7632/24/11 DIAZEPAM

SWISS PARENTERALS PVT

LTD 809 KERALA INDUSTRIAL ESTATE

GIDC NR BAVLA DIST AHMEDABAD

5MG/ML SOLUTION FOR INJECTION 1*10*2ML INDIA

SHREEJI PHARMACEUTICALS

LTD

{018ED633-5F0F-4A21-BD7D-

A960C0B1B02C}

LEBEN LABORATORIES PVT

LTDCIPIUM 7633/03/11 CHLORPHENIRAMINE

LEBEN LABORATORIES PVT

LTD L-4 PHASE III MIDC AKOLA 444 104

MAHARASHTRA

4MG TABLETS 11*10*20 BLISTER , 1*1000 HDPE INDIA

ANDYCO PHARMACEUTICALS

LTD

{5F868C5D-BFEA-4B9A-AC6C-

83856C7EAAB8}

INTAS PHARMACEUTICAL

LTDEMBETA XR-50 7634/12/11 METOPROLOL

INTAS PHARMACEUTICAL

LTD SELAQUI DEHRADUN 248 197

50MG TABLETS 1*10*10 BLISTERS INDIA NORVIK ENTERPRISES LTD

{CD2E38B5-13BB-42E6-A258-

3842F0986070}

ABACUS PHARMA (A) LTD AMPIMAX-250 7635/06/11 AMPICILLIN

REYOUNG PHARMACEUTICAL

CO. LTD NO.6 ERLANGSHAN ROAD

YIYUAN COUNTRY SHANDONG PROVINCE

250MG CAPSULES 1*10*10 BLISTERS, 1*1000 HDPE INDIA ABACUS PHARMA (A)

LTD

{D0105A81-A44D-4C23-87A7-

7AFD200C7508}

ABACUS PHARMA (A) LTD AMOXYN-250 7636/06/11 AMOXICILLIN

REYOUNG PHARMACEUTICAL

CO. LTD NO.6 ERLANGSHAN ROAD

YIYUAN COUNTRY SHANDONG PROVINCE

250MG CAPSULES 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{794255E8-1B6E-4B68-883A-6BBC0EC5D712}

RANBAXY LABORATORIES LTD ROSUVAS 20 7637/12/11 ROSUVASTATIN

RANBAXY LABORATORIES LTD POANTA SAHIB DIST SIRMOUR HIMACHAL

PRADESH 173025

20MG TABLETS 1*2*7 BLISTERS INDIA SURGIPHARM (U) LTD

{EBEED942-BFFB-4E10-BE12-

CD55695EC22A}

CIPLA LTD CLOSERINE 7638/06/11 CYCLOSERINECIPLA LTD VERNA

INDUSTRIAL ESTATE GOA 403722

250MG CAPSULES 1*40 HDPE INDIA QUALITY CHEMICALS{59DFCB8F-687A-

42A4-B526-EDD63146A32C}

AGOG PHARMA LTD AGOMPICLOX 7639/06/11 AMPICILLIN/ CLOXACILLIN

ELYSIUM PHARMACEUTICALS

LTD DHBHASA PADRA VADODARA 391 440 GUJARAT

250MG/ 250MG CAPSULES 1*10*10 BLISTER INDIA GITTOES

PHARMACEUTICALS LTD

{2AB65D89-5819-4F75-A1E7-50C53938C71D}

UNIVERSAL CORPORATION LTD NELADOL 7640/02/11 PARACETAMOL

UNIVERSAL CORPORATION LTD

KIKUYU ROAD KIKUYU TOWN

120MG/5ML ORAL SUSPENSION 1*60ML, 1*100ML BOTTLES KENYA MATRIX (U) LTD {9C9F53A4-10B5-4387-

A87D-805149CBC002}

STEDMAN PHARMACEUTICALS

PVT LTDDREZ-V 7641/06/11 MICONAZOLE /

METRONIDAZOLE

STEDMAN PHARMACEUTICALS PVT LTD C-4 SIDCO PHARMACEUTICALS COMPLEX ALATHUR THIRUPORUR 603110

TAMIL NADU

2.0%W/W / 1.0%W/W GEL 1*30MG INDIA VEERAM HEALTHCARE (U) LTD

{55111984-D9FB-4224-B23D-

8BEB60FA8D2C}

Page 145

Page 146: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ASTRA ZENECA UK LTD RHINOCORT AQUA 7642/25/11 BUDESONIDE

ASTRA ZENECA SWEDEN

OPERATIONS LIQUID PRODUCTION 151-85

SODAERTAJJE

64MCG/DOSE NASAL SPRAY 1*120 DOSES SWEDEN MACNAUGHTON (U) LTD

{DFB6E255-69AE-403C-99B4-

EF3B7115BCB2}

ALKEM LABORATORIES LTD MAGTAM 7643/06/11 CEFOPERAZONE /

SULBACTAM

ALKEM LABORATORIES LTD

VILLAGE THANA BADDI TEHSIL

NALAGARH DIST SOLAN (HP) 173205

500MG / 500MG POWDER FOR INJECTION 1*1G VIALS INDIA ABACUS PHARMA (A)

LTD

{82F6AA23-FB8E-4F4B-9DF4-

A9740DC1503A}

CADILA HEALTHCARE LTD OXALIPLATIN 7644/08/11 OXALIPLATIN

ZYDUS HOSPIRA ONCOLOGY PVT LTD PHARMEZ SPECIAL ECONOMIC ZONE MATODA SARKHEJ BAVLA HIGHWAY,

AHMEDABAD 382 213

5MG/ML INJECTION 1*20ML VIAL INDIA ABACUS PHARMA (A) LTD

{8D20E8B2-0C94-4C0F-80A7-

ED14C512DBA3}

PACIFIC PHARMACEUTICALS

LTD

PACIFIC'S JACK & JILL CHILDREN'S

FORMULA COUGH LIQUID

7645/25/11DEXTROMETHORPHA

N + CHLORPHENIRAMINE

PACIFIC PHARMACEUTICALS LTD 30KM MULTAN

ROAD LAHORE

10MG + 2MG / 5ML ORAL LIQUID 1*120ML PAKISTAN HEALTHCARE LTD {82C1C602-AA05-4F88-AC96-A244577D550D}

ALEMBIC LTD ULGEL 7646/17/11 MAGALDRATE / SIMETHICONE

ALEMBIC LTD PLOT NO 21/22 PHASE I

THARMAJRI BADDI DIST SOLAN HP

173205

400MG/ 20MG TABLETS 1*30*8 BLISTERS INDIAGITTOES

PHARMACETICALS LTD

{2654036D-0E3C-4CE9-9656-

1C35A8656E5B}

ALEMBIC LTD ULGEL 7647/17/11 MAGALDRATE / SIMETHICONE

ALEMBIC LTD PLOT NO 21/22 PHASE I

THARMAJRI BADDI DIST SOLAN HP

173205

400MG/ 20MG ORAL SUSPENSION 1*170ML AMBER GLASS BOTTLE INDIA

GITTOES PHARMACETICALS

LTD

{15668D5C-13CB-41FA-A5C0-

65B612FAF70A}

ALKEM LABORATORIES LTD CLAVAM 7648/06/11 CO-AMOXICLAV

ALKEM LABORATORIES LTD

PLOT NO. 167 MAHATMA GANDI UDYOG NAGAR

DABHEL DAMAN 396 210

600MG POWDER FOR INJECTION

1*1*600MG IN A 10ML VIAL INDIA ABACUS PHARMA (A)

LTD{45CB444F-8255-47D3-9C72-2067CF41DD05}

ABACUS PHARMA (A) LTD CLOXCIN-250 7649/06/11 CLOXACILLIN

REYOUNG PHARMACEUTICAL

CO LTD NO. 6 ERLANGSHAN ROAD

YIYUAN COUNTY SHANDONG PROVINCE

250MG CAPSULES 1*10*10 BLISTERS CHINA ABACUS PHARMA (A) LTD

{96B4F184-5A17-4164-80E8-ABFB26570360}

STEDMAN PHARMACEUTICALS

PVT LTD

CONTUS PAEDIATRIC LINCTUS 7650/25/11

CHLORPHENIRAMINE / PHENYLEPHRINE /

DEXTROMETHORPHAN

STEDMAN PHARMACEUTICALS PVT LTD C-4 SIDCO PHARMACEUTICAL

COMPLEX ALATHUR THIRUPORUR 603 110 TAMIL NADU

1MG/ 5MG/ 10MG LINCTUS 1*50ML INDIA VEERAM HEALTHCARE (U) LTD

{5965C435-286C-44A4-B673-4743165E6EE4}

SUN PHARMACEUTICAL INDUSTRIES LTD

PANTOCID 7651/17/11 PANTOPRAZOLE POWDER

SUN PHARMACEUTICAL INDUSTRIES LTD HALOL- BARODA HIGH WAY HALOL 389 350 GUJARAT

40MG POWDER FOR INJECTION

1*1*20MG + 1 AMPOULE OF WFI INDIA SURGIPHARM (U)

LTD

{ADED7EF3-A949-47AA-881E-

40BF9C6563C8}

Page 146

Page 147: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ASTRA LIFECARE INDIA PVT LTD AZY-500 7652/06/11 AZITHROMYCIN

ASTRA LIFECARE INDIA PVT LTD PLOT

NO. 57/P SARKEJ BAVLA HIGHWAY

RAJODA AHMEDABAD

500MG TABLETS 1*3 BLISTER INDIA ASTRA PHARMA (U) LTD

{D3F2D512-6BA0-4C1C-98B7-

6A8B2E2644FF}

MERCK CONSUMER HEALTHCARE ILIADIN 7653/28/11 OXYMETAZOLINE

MERCK PHARMACEUTICAL MANUFACTURING

(PTY) LTD 259 DAVIDSON WADEVILLE GERMISTON

0.05% NASAL SPRAY 1*20ML SOUTH AFRICA MEDIPHARM SALES LTD

{CD8D16BA-F236-4567-8474-

59261EED0ABA}

AGOG PHARMA LTD SATISFIL 7654/18/11 SILDENAFIL

AGOG PHARMA LTD PLOT NO. 33

SECTOR II THE VASAI TALUKA

INDUSTRIAL CO-OP ESTATE LTD VASAI

(E) DIST THANE

50MG TABLETS 1*1*4 BLISTER INDIAGITTOES

PHARMACEUTICALS LTD

{73F44AEE-D658-4595-B4B9-2F5FAC234E0D}

STRIDES ARCOLAB LTD PYRAZINAMIDE 7655/06/11 PYRAZINAMIDE

STRIDES ARCOLAB LTD 36/ 7

SURAGAJAKKANAHALI BANGALORE

562106

400MG TABLETS 1*28 BLISTER INDIA VEERAM HEALTHCARE (U) LTD

{7E4D32E6-8350-4B29-AC12-

3DF1C37D32EB}

DYNA PHARM (M) SDN BHD PREDSOLONE 7656/03/11 PREDNISOLONE

DYNA PHARM (M) SDN BHD 2497 MK

LORONG PERUSAHAAN BARU

5 KAWASAN PERUSAHAAN PERAI

3 13600 PERAI PULAU PINANG

5MG TABLETS 1*1000 HDPE MALAYSIA DYNA LABS {10698EA5-1345-4E70-A340-DD694830BBBD}

FLAMINGO PHARMACEUTICALS

LTDCEFADROXIL 7657/06/11 CEFADROXIL

FLAMINGO PHARMACEUTICALS

LTD R-662 T.T.C INDUSTRIAL AREA

RABALE NAVI MUMBAI 400 701

500MG CAPSULES 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{752E5129-32DB-4097-BE48-FF20B11301D9}

ASTRA LIFECARE INDIA PVT LTD AZY-250 7658/06/11 AZITHROMYCIN

ASTRA LIFECARE INDIA PVT LTD PLOT

NO. 57/P SARKEJ BAVLA HIGHWAY

RAJODA AHMEDABAD

250MG TABLETS 1* 6 BLISTERS INDIA ASTRA PHARMA (U) LTD

{210CEEEF-EF60-4002-9AC6-

7706B8C264E4}

FLAMINGO PHARMACEUTICALS

LTDBISACODYL 7659/17/11 BISACODYL

FLAMINGO PHARMACEUTICALS

LTD R-662 T.T.C INDUSTRIAL AREA

RABALE NAVI MUMBAI 400 701

5MG TABLETS 1*10*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{48803601-E087-40A1-819D-598321C83D79}

ASTRA LIFECARE INDIA PVT LTD ASTAGRA-50 7660/18/11 SILDENAFIL

ASTRA LIFECARE INDIA PVT LTD PLOT

NO. 57/P SARKEJ BAVLA HIGHWAY

RAJODA AHMEDABAD

50MG TABLETS 1*10 (1*4) BLISTERS INDIA ASTRA PHARMA (U) LTD

{185E2A9E-BF5A-42AE-AC70-

AAE3A7FD48EC}

SOFTGEL HEALTHCARE PVT LIV-COD 300 7661/27/11 COD LIVER OIL

SOFTGEL HEALTHCARE PVT

LTD SURVEY NO 20/1 VANDALUR

KELAMBAKKAM DIST TAMIL NADU

300MG SOFT GELATIN CAPSULES 1* 30 HDPE INDIA

GITTOES PHAMACEUTICALS

LTD

{617FBE02-4670-4F8F-8258-A2FBE35DD05E}

ABACUS PARENTERAL DRUGS

LTD

DARROWS SOLUTION (HALF

STRENGTH)7662/26/11

POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM

LACTATE

ABACUS PARENTERAL

DRUGS LTD BLOCK 191 PLOT NO.114 KINGA MUKONO

0.13% / 0.20% / 0.30%. INTRAVENOUS INFUSION 1*500ML UGANDA

ABACUS PARENTERAL DRUGS

LTD

{BDE8D746-BBBD-44C1-A582-

40D00561B42E}

Page 147

Page 148: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

AJANTA PHARMA LTD NURIFER JUNIOR SYRUP 7663/10/11

FERROUS FUMARATE/

CYANOCOBALAMIN/ FOLIC ACID

AJANTA PHARMA LTD 31-0 MIDC

INDUSTRIAL AREA CHIKALTHANA DIST

AURANGABAD MAHARASTHTRA

STATE

100MG/ 5MG/ 0.5MG SYRUP 1*100 AMBER GLASS BOTTLE INDIA ABACUS PHARMA (A)

LTD{D8E68AB8-164C-4923B983-3E20F38B3ED5}

UNIVERSAL CORPORATION

LIMITEDUNIBROL 7664/06/11 AMINOSIDINE

UNIVERSAL CORPORATION

LIMITED CLUB ROAD PLOT NO. 13777

KIKUYU

125MG/ML SYRUP 1*1*60ML AMBER GLASS BOTTLE KENYA MATRIX (U) LTD

{C620AEC2-CBD8-44FE-B57C-

5F78E8858DCB}

ABCON INTERNATIONAL

L.L.C

THERASIL SORE THROAT FORMULA

(ORANGE FLAVOUR)7665/06/11

AMYLMETACRESOL / DICHLOROBENZYL

ALCOHOL

PLETHICO PHARMACEUTICALS

LTD DHARAVARA POST KALARIA 453001 INDORE

MADHYA PRADESH

0.6MG/ 1.2MG LOZENGES 1*250 PET JAR INDIASTAR

PHARMACEUTICALS LTD

{5CE57430-4AD2-4564-9EDB-

CD84218A3DE1}

ABCON INTERNATIONAL

L.L.C

THERASIL SORE THROAT FORMULA (HONEY & LEMON)

7666/06/11AMYLMETACRESOL / DICHLOROBENZYL

ALCOHOL

PLETHICO PHARMACEUTICALS

LTD DHARAVARA POST KALARIA 453001 INDORE

MADHYA PRADESH

0.6MG/ 1.2MG LOZENGES 1*250 PET JAR INDIASTAR

PHARMACEUTICALS LTD

{4EC610FC-9F6B-458A-9F39-

F683CF66A859}

ABCON INTERNATIONAL

L.L.C

THERASIL SORE THROAT FORMULA (BLACK CURRANT)

7667/06/11AMYLMETACRESOL / DICHLOROBENZYL

ALCOHOL

PLETHICO PHARMACEUTICALS

LTD DHARAVARA POST KALARIA 453001 INDORE

MADHYA PRADESH

0.6MG/ 1.2MG LOZENGES 1*250 PET JAR INDIASTAR

PHARMACEUTICALS LTD

{9CA50C84-A04F-4DD6-9A28-

E09EA7126BF0}

DAFRA PHARMA LTD DAFRACLAV 7668/06/11AMOXICILLIN / POTASSIUM

CLAVULANATE

BILIM PHARMACEUTICALS

ISLETMESI 59501 CERKEZKOY TEKIRDAG

200MG/ 28MG POWDER FOR ORAL SUSPENSION

1*70ML GLASS BOTTLE TURKEY SURGIPHARM (U)

LTD

{3C6EA2A9-0551-46FF-AEAE-

DC2619C1F56E}

DAFRA PHARMA LTD DAFRACLAV 7669/06/11AMOXICILLIN / POTASSIUM

CLAVULANATE

BILIM PHARMACEUTICALS

ISLETMESI 59501 CERKEZKOY TEKIRDAG

500MG/ 125MG TABLETS 1*3*5 BLISTERS TURKEY LABOREX (U) LTD{C5DE1CC7-953C-

4FA0-AF27-6D92BFB07E93}

UNIVERSAL CORPORATION

LIMITEDKNAC-75 7670/02/11 DICLOFENAC

UNIVERSAL CORPORATION

LIMITED PLOT NO. 13777 KIKUYU

75MG TABLETS 1*3*10 BLISTERS KENYA MATRIX (U) LTD {00F60FB2-3F34-44A9-B068-2A6C15D1B5B1}

TORRENT PHARMACEUTICALS

LTDTELDAY-40 7671/12/11 TELMISARTAN

TORRENT PHARMACEUTICALS LTD INDRAD 382 721

DIST MEHSANA

40MG TABLETS 1*10*10 BLISTERS INDIA KARURI PHARMACEUTICALS

{B89BC9CB-6037-49249997-157CE59EA9F1}

IPCA LABORATORIES LTD ZERODOL -CR 7672/02/11

ACECLOFENAC COTROLLED

RELEASE

IPCA LABORATORIES LTD

PLOT NO.255/1 ANTHAL SILVASSA

396 230 DADRA AND NAGAR HAVELI

200MG TABLETS 1*3*10 BLISTERS INDIA ABACUS PHARMA (A) LTD

{5530C10E-FD87-4A04-B2AF-F80EA2205802}

CADILA PHARMACEUTICALS

LTDNODON 7673/12/11 NEBIVOLOL

CADILA PHARMACEUTICALS

LTD 1389 TRABAD ROAD DHOLKA DIST

AHMEDABAD GUJARAT

5MG TABLETS 1*3 (1*1*10) BLISTERS INDIAKARURI

PHARMACEUTICALS LTD

{2D676A75-EA9E-4C91-88A2-

B75F214DF4A6}

ASTRA ZENECA UK LTD BETALOC ZOK 7674/12/11 METOPROLOL

ASTRA ZENECA AB GARTUNAVGEN SE

151 58 SODAERTAJJE

100MG TABLETS 1*30 HDPE SWEDEN MACNAUGHTON LTD{B25D2139-7B2A-

4FD8-95C3-23DBBA49B7C5}

Page 148

Page 149: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

ASTRA ZENECA UK LTD BETALOC ZOK 7675/12/11 METOPROLOL

ASTRA ZENECA AB GARTUNAVGEN SE

151 58 SODAERTAJJE

200MG TABLETS 1*30 HDPE SWEDEN MACNAUGHTON LTD{931377C7-1EDA-

4D98-BE9E-3FF8730FEA7D}

ASTRA ZENECA UK LTD BETALOC ZOK 7676/12/11 METOPROLOL

ASTRA ZENECA AB GARTUNAVGEN SE

151 58 SODAERTAJJE

25MG TABLETS 1*1*14 BLISTERS SWEDEN MACNAUGHTON LTD {44EE5E65-11A4-486E-9743-A33207001D5A}

STRIDES ARCOLAB LTD

RIFAMPICIM/ ISONIAZID/

PYRAZINAMIDE/ ETHAMBUTOL

7677/06/11

RIFAMPICIM/ ISONIAZID/

PYRAZINAMIDE/ ETHAMBUTOL

STRIDES ARCOLAB LTD

SURAGAJAKKANAHALI INDLAWADI

CROSS ANEKAL TALUK BANGALORE

562106

150MG/ 75MG/ 400MG/ 275MG TABLETS 1*24*28 BLISTERS INDIA VEERAM

HEALTHCARE (U) LTD{CE0E016D-9368-4B23B2EB-F98A0A6A29AB}

PHARMACARE EPIPROATE CR 7678/05/11 SODIUM VALPROATE

TORRENT PHARMACEUTICALS

LTD AHMEDABAD MEHSANA HIGHWAY TALUKA KADI DIST MEHSANA INDRAD

382 721

300MG TABLETS 1*3*10 BLISTERS INDIA ERIS LTD{99F7D1FA-AB7B-

4D4E-8784-E42C5573245D}

ASTRZENECA UK LIMITED BETALOK ZOK 7679/12/11 METOPROLOL

ASTRA ZENECA AB GARTUNAVAGEN SE

151 58 SODAERTAJJE

50MG TABLETS 1*30 HDPE SWEDEN MACNAUGHTON LTD{5E11D83C-65F8-

43DC-9B54-AA08C6CB3115}

TROIKAA PHARMACEUTICALS

LTDZYLTAN 50 7680/12/11 LORSATAN

TROIKAA PHARMACEUTICALS

LTD THOL DIST MEHSANA PIN 382

728 GUJARAT AHMEDABAD

50MG TABLETS 1*10*10 BLISTERS INDIA ANDYCO PHARMACY{BB986A77-FCE1-

4ADE-B1E7-8B2E33D09BF7}

AGOG PHARMA LTD DIX 7681/12/11 DIGOXIN

AGOG PHARMA LTD PLOT NO. 33

SECTOR II THE VASAI TALUKA

INDUSTRIAL CO-OP ESTATE LTD VASAI

(E) DIST THANE

0.25MG TABLETS 1*10*10 BLISTERS,, 1*1000 HDPE INDIA

GITTOES PHARMACEUTICALS

LTD

{F1CECB41-BAE8-48E8-8F12-

19F7B4BB4984}

UNICHEM LABORATORIES LTD CORVADIL 5 7682/12/11 AMLODIPINE

UNICHEM LABORATORIES LTD

UNIT II VILLAGE BHATAULI KALAN

BADDI DIST SOLAN HIMACHAL PRADESH

173 205

5MG TABLETS 1*3*10 STRIPS INDIA NORVIK ENTERPRISES LTD

{72C09F61-6A80-4F09-9A55-6E28C841162A}

SERUM INSTITUTE OF INDIA MENAFRIVAC 7683/19/11

MENINGOCOCCAL A CONJUGATE

VACCINE

SERUM INSTITUTE OF INDIA 212/ 2

HADARPSAR PUNE -411028

10MCG/ 0.5ML + 10-33MCG/0.5ML

POWDER FOR INJECTION

(LYOPHILISED)

10 DOSE VIAL + 5ML AMPOULE OF

DILUENTINDIA NORVIK

ENTERPRISES LTD

{EA4EE3B3-4AA9-41E4-AA60-

7D1C9B1091CA}

PT SANBE FARMA MEGABAL 7684/27/11 MECOBALAMIN

PT SANBE FARMA JI INDUST/1 NO.9 LEUWIGAJAH

CIMINDI CIMAHI WEST JAVA

500MCG CAPSULES 1*10*10 STRIPS INDONESIA ABACUS PHARMA (A) LTD

{82365604-EA0E-48D9-BE4F-400704A8ED18}

PT SANBE FARMA PELASTIN 7685/06/11 IMIPENEM / CILASTATIN

PT SANBE FARMA JI LEUWIGAJAH I62 CIMINDI CIMAHI

WEST JAVA

500MG/ 500MG POWDER FOR INJECTION 1*1G VIAL INDONESIA ABACUS PHARMA (A)

LTD

{8109EC2C-8EC0-4CF4-BF09-

84E79D45CB2F}

PT SANBE FARMA PLASMINEX 7686/10/11 TRANEXAMIC ACID

PT SANBE FARMA JI NO.8 CIMAREME

PADALARANG WEST JAVA INDONESIA

100MG/ML INJECTION 1*10*5ML INDONESIA ABACUS PHARMA (A) LTD

{1197D883-1AFF-44D5-8D2C-4A4D20A3FB37}

Page 149

Page 150: Human Drugs List - NDA

NATIONAL_DRUG_REGISTER_OF_UGAND

PT SANBE FARMA TERMIRAL 7687/06/11 ACICLOVIR

PT SANBE FARMA JI NO.8 CIMAREME

PADALARANG WEST JAVA INDONESIA

30MG/G EYE OINTMENT 1*3.5G INDONESIA ABACUS PHARMA (A) LTD

{31C3E1C5-D9AA-4016-AD8E-

2BDDF8E775E5}

Page 150