letters for issue on 23.02 - central drugs standard ... · pdf fileletters for issue on...

LETTERS FOR ISSUE ON 23.02.2016 BE NOC FOR EXPORT

S.

NO.

NAME OF THE COMPANY REF.

NO.

TYPE OF

LETTER

1. M/S. AIZANT DRUG RESEARCH

SOLUTIONS PVT. LTD., HYDERABAD-

500100

2635 APPROVAL

LETTER

2. M/S. AJANTA PHARMA LIMITED,

MUMBAI-400 067

2003 CLARIFICATION

LETTER

3. M/S. ALEMBIC PHARMACEUTICALS

LTD., VADODARA-390 003

2259 TEST LICENCE


LTD., VADODARA-390003

2068 APPROVAL

LETTER



50510 APPROVAL

LETTER



2821 APPROVAL

LETTER



2261 APPROVAL

LETTER

8. M/S. ALKEM LABORATORIES LTD.,

TALOJA-410 208, TAL: PANVEL,

DIST: RAIGAD

2660 AMENDMENT

LETTER

9. M/S. ALKEM LABORATORIES LTD.,

TALOJA-410208, TAL: PANVEL, DIST:

RAIGAD

1705 APPROVAL

LETTER

10. M/S. APL RESEARCH CENTRE,

AUROBINDO PHARMA LTD.,

HYDERABAD-500090

2127 APPROVAL

LETTER



HYDERABAD-500090

2129 APPROVAL

LETTER



HYDERABAD-500090

2128 APPROVAL

LETTER



HYDERABAD-500090

40701 APPROVAL

LETTER

14. M/S. AZIDUS LABORATORIES LTD.,

CHENNAI-600 048

40135 APPROVAL

LETTER

15. M/S. CADILA HEALTHCARE LTD.,

AHMEDABAD-380015

3724 APPROVAL

LETTER

16. M/S. CIPLA LIMITED, MUMBAI-400

013

2255 CLARIFICATION

LETTER

17. M/S. CIPLA LIMITED, MUMBAI-

400013

2247 APPROVAL

LETTER


400013

2248 APPROVAL

LETTER


400013

2906 APPROVAL

LETTER

20. M/S. CLIANTHA RESEARCH LIMITED,

AHMEDABAD-380 054

1903 AMENDMENT

LETTER


AHMEDABAD-380054

2147 CLARIFICATION

LETTER


AHMEDABAD-380054

2467 APPROVAL

LETTER


AHMEDABAD-380054

2658 APPROVAL

LETTER


AHMEDABAD-380054

2751 APPROVAL

LETTER


AHMEDABAD-380054

2468 APPROVAL

LETTER


AHMEDABAD-380054

2645 APPROVAL

LETTER


AHMEDABAD-380054

2656 APPROVAL

LETTER


AHMEDABAD-380054

2702 APPROVAL

LETTER

29. M/S. DR. REDDY’S LABORATORIES 4515 AMENDMENT

LTD., HYDERABAD-500 034 LETTER

30. M/S. EMCURE PHARMACEUTICALS

LIMITED, PUNE-411 026

40722 APPROVAL

LETTER

31. M/S. EMCURE PHARMACEUTICALS

LIMITED, PUNE-411 026

2201 TEST LICENCE

32. M/S. HETERO LABS LTD.,

HYDERABAD-500 018

1888 AMENDMENT

LETTER

33. M/S. JUBILANT GENERICS LTD.,

NOIDA-201301, UP

2216 APPROVAL

LETTER

34. M/S. LAMBDA THERAPEUTIC

RESEARCH LTD., AHMEDABAD-380

061

3456 APPROVAL

LETTER



061

35540 REJECTION

LETTER



061

1860 CLARIFICATION

LETTER



061

2758 CLARIFICATION

LETTER



061

2001 CLARIFICATION

LETTER


RESEARCH LTD., AHMEDABAD-

380061

40348 APPROVAL

LETTER


RESEARCH LTD., NAVI MUMBAI-400

614

30594 APPROVAL

LETTER

41. M/S. LOTUS LABS PVT. LTD.,

BANGALORE-560 034

2124 APPROVAL

LETTER

42. M/S. LOTUS LABS PVT. LTD.,

CHENNAI-600 004

2118 APPROVAL

LETTER

43. M/S. LUPIN LIMITED (RESEARCH

PARK), PUNE-411042

2276 CLARIFICATION

LETTER


PARK), PUNE-412115

2105 APPROVAL

LETTER


PARK), PUNE-412115

2895 APPROVAL

LETTER


PARK), PUNE-412115

2355 APPROVAL

LETTER


PARK), PUNE-412115

2896 APPROVAL

LETTER


PARK), PUNE-412115

2106 APPROVAL

LETTER


PARK), PUNE-412115

2910 APPROVAL

LETTER

50. M/S. MACLEODS

PHARMACEUTICALS LTD., ANDHERI

(EAST), MUMBAI-400 059

2526 CLARIFICATION

LETTER

51. M/S. MACLEODS



1671 APPROVAL

LETTER

52. M/S. MACLEODS



2525 APPROVAL

LETTER

53. M/S. MANIPAL ACUNOVA LIMITED,

MANIPAL -576104

2861 TEST LICENCE

54. M/S. MANIPAL ACUNOVA LTD.,

MANGALORE-575001

2484 APPROVAL

LETTER

55. M/S. PAR BIOSCIENCES PRIVATE

LIMITED, CHENNAI-600100

1855 APPROVAL

LETTER

56. M/S. PAR BIOSCIENCES PRIVATE

LIMITED, CHENNAI-600100

1854 APPROVAL

LETTER

57. M/S. QPS BIOSERVE INDIA PVT.

LTD., HYDERABAD – 500 037

33999 APPROVAL

LETTER

58. M/S. RA CHEM PHARMA LTD.,

BALANAGAR, HYDERABAD-500037

51149 APPROVAL

LETTER

59. M/S. SEMLER RESEARCH CENTER

PVT. LTD., BANGALORE-560078

2206 APPROVAL

LETTER



2205 APPROVAL

LETTER



35214 APPROVAL

LETTER



2204 APPROVAL

LETTER



2202 TEST LICENCE

64. M/S. STRIDES ARCOLAB LTD.,

BANGALORE -560076

1840 APPROVAL

LETTER

65. M/S. STRIDES SHASUN LIMITED,

BANGALORE-560076

1841 APPROVAL

LETTER

66. M/S. SUN PHARMACEUTICAL

INDUSTRIES LTD., VADODARA-390

020

2687 APPROVAL

LETTER

67. M/S. SYNCHRON RESEARCH

SERVICES PVT. LTD., AHMEDABAD-

380 059

4394 APPROVAL

LETTER

68. M/S. SYNCHRON RESEARCH

SERVICES PVT. LTD., AHMEDABAD-

380 059

2708 APPROVAL

LETTER

69. M/S. VEEDA CLINICAL RESEARCH

PVT. LTD., AHMEDABAD-380 015

2647 APPROVAL

LETTER


PVT. LTD., AHMEDABAD-380015

2142 AMENDMENT

LETTER



1396 AMENDMENT

LETTER



2144 AMENDMENT

LETTER



2143 AMENDMENT

LETTER



2139 APPROVAL

LETTER



2138 APPROVAL

LETTER



2162 APPROVAL

LETTER



2140 APPROVAL

LETTER

78. M/S. WATSON PHARMA PVT. LTD.,

NAVI MUMBAI-400614

2121 ADDITIONAL

STUDY CENTRE


NAVI MUMBAI-400614

2510 ADDITIONAL

STUDY CENTRE


NAVI MUMBAI-400614

2122 TEST LICENCE


NAVI MUMBAI-400614

2123 TEST LICENCE

82. M/S. WOCKHARDT LIMITED,

AURANGABAD-431 006

1509 TEST LICENCE

BA/BE DIVISION

S. NO. COMPANY NAME FTS NO. /DIARY NO. STATUS

01 M/S. MACLEODS PHARMACEUTICALS,

MUMBAI

33989 QUERY

02 ADVINUS THERAPEUTICS LTD., BENGALURU 6016 QUERY

03 M/S. ACCUTEST BIOLOGICS PVT. LTD.,

MUMBAI

17620 APPROVAL

SUBSEQUENT NEW DRUG

S. NO. NAME OF THE FIRM REFERENCE NO.

FTS NO. TYPE OF LETTER

1. M/S SUN PHARMA 2399 - TEST LICENSE

2. M/S HONOUR LAB 52426 246 DEFICIENCY LETTER

3. M/S NOVARTIS 40629 66097 DEFICIENCY LETTER

4. M/S CLIANTHA RESEARCH LTD.

3107 5452 DEFICIENCY LETTER

5. M/S MICRO LABS 6201 70631 DEFICIENCY LETTER

6. M/S IPCA LABORATORIES 77 341 DEFICIENCY LETTER

7. M/S CIPLA 66269 - AMENDMENT LETTER

8. M/S SOUNDYOTA NUMANDIS - 51556 DEFICIENCY LETTER

9. M/S OPTIMUS DRUG 38400 62423 DEFICIENCY LETTER

10. M/S PANACEA BIOTECH 2668 4983 DEFICIENCY LETTER

11. M/S CADILA HEALTHCARE 51536 69390 DEFICIENCY LETTER

12. M/S ALKEM LABORATORIES 51459 69386 DEFICIENCY LETTER

13. M/S RELIANCE LIFE SCIENCE 31633 51684 DEFICIENCY LETTER

14. M/S TROIKAA PHARMACEUTICALS

1694 3310 DEFICIENCY LETTER

15. M/S ALLERGAN HEALTHCARE 1985 - AMENDMENT LETTER

16. M/S VIRUPAKSHA ORGANICS - 70528 DEFICIENCY LETTER

17. M/S MSN ORGANICS 33134 54096 DEFICIENCY LETTER

18. M/S MYLAN LABORATORIES 52576 871 DEFICIENCY LETTER

VACCINE DIVISION

S.

NO.

COMPANY NAME/ FILE NO DY. NO STATUS

1 M/S LEVIM BIOTECH LLP, 6887 APPROVAL LETTER

2 M/S BHARAT SERUM AND

VACCINES LTD

24982 APPROVAL LETTER

3 M/S BIOMED PVT, LTD 5284 APPROVAL LETTER

4 M/S BOEHRINGER INGELHEIM

INDIA PVT, LTD

395 AMENDMENT LETTER

5 M/S CLIANTHA RESEARCH LTD 248 APPROVAL LETTER

6 M/S AMNEAL

PHARMACEUTICALS COMPANY

I PVT, LTD

114, 113 APPROVAL LETTER

IMPORT

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER

1. Y. CHEM AGENCY 0 APPROVAL LETTER

2. SEVANTIL & SONS 4939 APPROVAL LETTER

3. MEHTA API PVT. LTD. 4966 APPROVAL LETTER

4. MICRO LABS LTD. 4973 APPROVAL LETTER

5. MONARCH PHARMACHEM 5014,5016,5010,5015,5017 APPROVAL LETTER

6. HUFORT HELATHCARE PVT. LTD. 5011,5013 APPROVAL LETTER

7. C.J SHAH & CO. (GODOWN) 5019 APPROVAL LETTER

8. VXL LIFE SCIENCES 5120 APPROVAL LETTER

9. K. SEVANILAL & CO. 4946 APPROVAL LETTER

REGISTRATION

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER

1. SANDOZ PVT LTD. 40463 CLARIFICATION LETTER

2. SYMBIO GENERRICS (I) LTD. 61667 CLARIFICATION LETTER

3. EMCURE PHARMACEUTICALS LTD. 37403 CLARIFICATION LETTER

4. JOHNSON AND JOHNSON LTD. 34684 CLARIFICATION LETTER

5. ASTRAZENECA PHARMA (I) LTD. 38203 CLARIFICATION LETTER

INTERNATIONAL CELL

S. NO FIRM NAME TYPE

01. M/S CADILA PHARMACEUTICALS LTD., GIDC ESTATE, GUJARAT

LETTER

02. M/S OPTIMUS GENERICS LTD., MAHABOOBNAGAR, NOC

03. M/S SYMBIOTEC PHARMALAB LTD., DIST DHAR WC

GLOBAL CLINICAL TRIAL

SR.

NO.

COMPANY NAME REFERENCE STATUS

1 M/S. EXCEL LIFE SCIENCES 311 CLARIFICATION LETTER

2 M/S. BIOCAD 50881 CLARIFICATION LETTER

MEDICAL DEVICE

S.NO. COMPANY NAME DIARY NO STATUS

1. M/S. APOTHECARIES PVT. LTD. 37321 APPROVAL (R-E-RC)

2. M/S. BECTON DICKINSON INDIA PVT. LTD. 39358 APPROVAL (R-IL)

3. M/S. BECTON DICKINSON INDIA PVT. LTD. 39358 APPROVAL (R-RC)

4. M/S. BECTON DICKINSON INDIA PVT. LTD. 50871 APPROVAL (R-E-IL)

5. M/S. BECTON DICKINSON INDIA PVT. LTD. 50871 APPROVAL (R-E-RC)

6. M/S. BECTON DICKINSON INDIA PVT. LTD. 1502 LETTER

7. M/S. BIOMET ORTHOPAEDIC INDIA PVT. LTD. 50352 APPROVAL (R-E-IL)

8. M/S. EMERGO (INDIA) CONSULTING PVT. LTD. 20886 APPROVAL (F-RC)

9. M/S. INNOVATIVE CONCEPTS 3018 APPROVAL (F-IL)

10. M/S. MEDIZONE AESTHETICS 3761 APPROVAL (F-IL)

11. M/S. NATEC MEDICAL PVT. LTD. 36898 APPROVAL (R-IL)

12. M/S. NATEC MEDICAL PVT. LTD. 36898 APPROVAL (R-RC)

13. M/S. NANO THERAPEUTICS PVT. LTD. 63019 APPROVAL (R-IL)

14. M/S. NOBLE BIOCARE INDIA PVT. LTD. 29423 APPROVAL (E-RC)

15. M/S. NOBLE BIOCARE INDIA PVT. LTD. 29423 APPROVAL (E-RC)

16. M/S. NIPRO MEDICAL (INDIA) PVT. LTD. 3041 APPROVAL (R-IL)

17. M/S. NOVO NORDISK INDIA PVT. LTD. 2451 APPROVAL (F-IL)

18. M/S. ORBUS NEICH MEDICAL (INDIA) PVT. LTD. 32751 APPROVAL (R-E-RC)

19. M/S. SMITH & NEPHEW HEALTHCARE PVT. LTD. 37569 APPROVAL (R-E-RC)

20. M/S. SMITH & NEPHEW HEALTHCARE PVT. LTD. 37569 APPROVAL (R-E-RC)

21. M/S. TELEFLEX MEDICAL PVT. LTD. 39310 APPROVAL (R-RC)

22. M/S. TERUMO PENPOL PVT. LTD. 4772 APPROVAL (TEST

LICENSE)

23. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. 33840 LETTER

24. M/S. CERAGEM INDIA PVT. LTD. 40461 LETTER

25. M/S. IDS DENMED PVT. LTD. 40927 LETTER

26. M/S. MAQUET MEDICAL INDIA PVT. LTD. 40034 LETTER

27. M/S. MN SOLUTION 31964 LETTER

28. M/S. MERIL LIFE SCIENCES PVT. LTD. 27497 LETTER

29. M/S. SUTURES INDIA PVT. LTD.

THE DRUGS CONTROLLER, BANGALORE

219 LETTER

30. THE DIRECTOR OF DRUGS CONTROL, CHENNAI

(CLAA)

THE DEPUTY DRUGS CONTROLLER (I), CHENNAI

(CLAA)

(M/S. JAM SURGICAL COMPANY PVT. LTD.,

KANCHIPURAM)

FTS. NO.-

3150

APPROVAL LETTER

31. THE COMMISSIONER, GANDHINAGAR(CLAA)

THE DEPUTY DRUGS CONTROLLER, AHMEDABAD

(CLAA)

(M/S. MERIL HEALTHCARE PVT. LTD.)

FTS. NO. –

70250

LETTER

32. THE DEPUTY DRUGS CONTROLLER, AHMEDABAD

(CLAA)

THE COMMISSIONER, GANDHINAGAR(CLAA)

THE DRUGS CONTROLLER & LICENSING AUTHORITY

(M/S. BOMBAY ORTHO INDUSTRIES, MATODA)

FTS. NO. –

56175

LETTER

33. THE COMMISSIONER, GANDHINAGAR(CLAA)

THE DEPUTY DRUGS CONTROLLER, AHMEDABAD

(CLAA)

(M/S. ORTHOFLEX MEDISYS (I) PVT. LTD.,

VISNAGAR)

FTS. NO. -

8759

LETTER

34. THE STATE DRUGS CONTROLLER, PANCHKULA

(CLAA)

THE DEPUTY DRUGS CONTROLLER, GHAZIABAD

(CLAA)

(M/S. SIORA SURGICALS PVT. LTD., SONEPAT)

FTS. NO. -

69083

APPROVAL LETTER

35. THE DRUGS CONTROLLER, BANGALORE (CLAA)

THE DEPUTY DRUGS CONTROLLER,

BANGALORE(CLAA)

(M/S. S3V VASCULAR TECHNOLOGIES PVT. LTD.,

FTS. NO.-

2097

APPROVAL LETTER

MYSORE)

36. THE DRUGS CONTROLLER & LICENSING

AUTHORITY, JAIPUR (CLAA)


(CLAA)

(M/S. VITROMED HEALTHCARE, JAIPUR)

FTS. NO. -

5957

APPROVAL LETTER

37. THE STATE DRUGS CONTROLLER, PANCHKULA

(CLAA)


(CLAA)

(M/S. LA-MED HEALTHCARE PVT. LTD.,

FARIDABAD)

FTS. NO. -

8750

APPROVAL LETTER

38. THE DRUGS LICENSING AUTHORITY, MOTI DAMAN

(CLAA)

THE DIRECTOR, CHENNAI (CLAA)

FTS. NO.-

60484

LETTER

39. THE DEPUTY DRUGS CONTROLLER (I), MUMBAI

(CLAA)

THE DIRECTOR FOOD & DRUGS ADMINISTRATION,

GOA (CLAA)

(M/S. GOA MEDICARE DEVICES PVT. LTD. GOA)

FTS. NO.-

NIL

LETTER

40. M/S. SAHAJANAND MEDICAL TECHNOLOGIES PVT.

LTD. (CLAA)

THE COMMISSIONER, GANDHINAGAR (CLAA)

56256 LETTER

41. M/S. ANONDITA HEALTHCARE FTS. NO. -

62744

LETTER

42. M/S. TRANSLUMINA THERAPEUTICS, DEHRADUN

(CLAA)

THE DRUGS LICENSING AUTHORITY, DEHRADUN

(CLAA)

FTS. NO.-

581

LETTER

DIAGNOSTICS DIVISION

S.NO. COMPANY NAME DIARY NO STATUS

1. M/S. ACCUREX BIOMEDICAL PVT. LTD. 289 APPROVAL (IL)

2. M/S. ATHENSESE DX PVT. LTD. 51335 APPROVAL (IL)

3. M/S. ABBOTT HEALTHCARE PVT. LTD. 2177 APPROVAL (IL)

4. M/S. BIOGENIUX MEDSYSTEMS PVT. LTD. 1078 APPROVAL (E-IL)

5. M/S. BIOMERIUX INDIA PVT. LTD. 1861 APPROVAL (IL)

6. KNEE DIAGNOSTICS PVT. LTD. 139 APPROVAL (IL)

7. M/S. I-SENS BIOSESORS INDIA PVT. LTD. 645 APPROVAL (IL)

8. M/S. RAPID DIAGNOSTICS PVT. LTD. 1438 APPROVAL (IL)

9. M/S. TRIVITRON HEALTHCARE PVT. LTD. 1168 APPROVAL (E-IL)

10. M/S. URILAB SYSTEMS 106 APPROVAL (IL)

11. M/S. BECKMAN COULTER INDIA PVT. LTD. 2850 APPROVAL (TEST

LICENSE)

12. M/S. ABBOTT HEALTHCARE PVT. LTD. 2567 APPROVAL (TEST

LICENSE)

13. M/S. CHRISTIAN MEDICAL COLLEGE 5823 APPROVAL (TEST

LICENSE)

14. M/S. ALERE MEDICAL PVT. LTD. 3042 APPROVAL (TEST

LICENSE)

15. M/S. ALERE MEDICAL PVT. LTD. 3017 CLARIFICATION LETTER

16. M/S. SOWAR PVT. LTD. 1844 QUERY LETTER

17. M/S. STERANCO HEALTHCARE PVT. LTD. 2094 QUERY LETTER

18. M/S. SD BIOSENSORS HEALTHCARE PVT. LTD. 1686 QUERY LETTER

19. M/S. UNIWORTH LABORATORY

THE JOINT COMMISSIONER, MUMBAI

DR. MAHESH J. MEHTA, MUMBAI

FTS. NO.-

66156

LETTER

20. M/S. ORTHO CLINICAL DIAGNOSTICS INDIA PVT. LTD. 51958 APPROVAL (E-IL)

21. M/S. TRIVITRON HEALTHCARE PVT. LTD. 51788 LETTER

letters for issue on 23.02 - central drugs standard ... · pdf fileletters for issue on...

Documents