government of pakistan ministry of national health services, …. deficiency letter of all... ·...

F.No.10-8/2020-OTC) (M-80)

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Government of Pakistan

Ministry of National Health Services, Regulations & Coordination

Drug Regulatory Authority Of Pakistan

Health & OTC Products Division (Non-Drugs)

*****

Islamabad, the 24th August, 2020

Subject: Submission of deficient information / documents

The applications of following applicants were placed before the Enlistment Evaluation

Committee (EEC) in its 80th meeting held on 26th June, 2020 and the same have been deferred being

deficient of the information / documents as specified in column (3) of the Table below which may be

furnished within 20 days of uploading of this letter on official website of DRAP but not later than 13th

September, 2020. Replies received after due date shall not be entertained:-

S.No Brand name Decision

(1) (2) (3)

Millennium Laboratories, Lahore

128/5, Shaikh Mohammad Raiz Road, Quaid-e-Azam, Industrial Estate Road, Kot Lakhpat, Lahore

1. Wiser Powder

Deferred for following reasons:

Fee challan is not endorsed by concerned division of DRAP.

Food supplement section availability is required.

Monographs of all ingredients are required.

Information regarding source of carbohydrates, fats,

cholesterol and proteins is required.

Testing method of finished product is required.

2. Xporen Syrup





3. M-Cal Tablet




Justification of 3 tablets as serving dose is required.

4. Mega Plus tablets



Monographs of all ingredients including blend are required.

Justification of 2 tablets as serving dose is required.


5. Key Vit Tablets



Stability of omega 3 and omega 6 in tablet is required.


6. Inomalt F Tablets




“SAY NO TO CORRUPTION”

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7. Geomilk Supplement





Justification is required regarding use of zinc oxide in oral

dosage forms.


8. Ferton Tablets Deferred for following reasons:


9. Ferrosip Syrup




Brand name needs to be changed.

10. Vox Tablet




11. Calgrow Tablet



Brand names differ on form 3 and covering letter, needs

clarification.

Monographs of vitamin K2 and red algae calcium are

required.

12. Chemcal Tablet



Monograph of Co enzyme Q10 is required.

13. Ecocal Tablet Deferred for following reasons:


14. Heptolax Tablet



Silymarin comes under common molecules list.

15. Ozcal Flash Tablet Deferred for following reasons:


16. Sureway Powder



Monographs of full cream milk and whey milk are required.

Dextrose comes under common molecules list.

17. Urone K Tablet



Potaasium citrate as single ingredient is registered as urinary

alkalizing agent, added in common molecules list.

18. Calpar Tablet



Monograph of L methyl folate is required.

19. Bioloba Tablet



Monograph of ginkgo biloba is required.

20. Cozam Tablet




21. Lycoz Tablet Deferred for following reasons:

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Monograph of spirulina extract is required.

22. MontarVit Tablet Deferred for following reasons:


23. Geocal Tablet Deferred for following reasons:


24. Spirovin Tablet



Monograph of chiro inositol is required.

N acetyl cysteine comes under common molecules list.

25. Inovit Tablet



Monograph of ginger extract is required.

26. Glumin Tablet




Chondroitin and glucosamine come under common molecules

list.

27. Irofol Tablet




28. Oriseng Tablet



Monograph of red ginseng extract is required

29. Cino Z Tablet



Monographs of zinc, vitamin C are required.

30. Trox Forte Tablet



Monographs of tribulus extrtact, arginine, chlorophytum

borivianum, ginseng extract, saffron and epimedium comp

extract are required.


31. Cino D Drops



Drop filling machine availability is required as firm has

liquid(syrup) section only.

32. Sinum Tablet




33. Permit Tablet



Monographs of vitamin E, iron bisglycinate and zinc is

required.


34. Cartimax Tablet



Chondroitin, glucosamine and hyaluronic acid come under

common molecules list.

35. Oral C Tablet Deferred for following reasons:

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Monograph of vitamin K2 is required.

36. Five C 1000 Tablet



Monographs of zinc, vitamin C, boron, horsetail extract are

required.

37. Colisan Syrup



Aluminium hydroxide and magnesium hydroxide are

registered as drugs, added in common molecules list.

38. Alfanase Drops



Drop filling machine availability is required as firm hold

liquid (syrup) section only.

39. Zecop Syrup


Monograph of L-ornithine L-aspartate is required.


40. Cofmaxl Syrup


Firm applied herbs in crude form while firm possess

nutraceutical facility.


41. Ezine Tablet



Melatonin comes under common molecules list.

Monograph of theanine is required.

42. Bon D Suspension



Monographs of vitamin K2 and red algae calcium are

required.

43. Best Vit Tablet



Monograph of inositol is required.

44. Plus D Syrup



Monograph of ossien mineral complex is required, added in


45. Osical Tablet



Monograph of ossien mineral complex is required, added in


46. Plus D Tablet




47. Cranbest Sachet




48. Minimax Drops



Availability of drop filling machine is required as firm holds


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49. Unimax Supplement Sachet



Monographs of iron bisglycinate, cupric chloride, iodine,

chromium picolinate, molybdenum and codex alimentarious

are required.

Availability of food supplement section is required.


Strength of all ingredients per serving dose is required

according to their RDA values.

50. Minocal D Tablet



Monographs of chiro-inositol, L methyl folate are required.

Melatonin comes under common molecules list.

51. Bh Iron Syrup


Monographs of iron bisglycinate, copper sulphate and folic

acid are required.

52. D Myth Oral Drops Deferred for following reasons:

Availability of drop filling machine is required.

53. Famisafe Powder


Monographs of DHA, vitamin E, vitamin K, vitamin B5,

biotin, sodium, chloride, calcium carbonate, copper sulphate,

iodine and iron bisglycinate are required.


Source of fats, carbs and proteins are required.


54. Macmin Syrup


Monographs of folic acid, pantothenic acid and zinc are

required.


55. Dg Nex Suspension


Sodium bicarbonate comes under common molecules list.

Firm uses ginger herb in crude form while firm possess

nutraceutical facility, needs clarification.

56. Biokof Drops


Drop filling machine availability is required as firm holds


57. Bh Iron Tablet


Monographs of iron bisglycinate and copper chloride is

required.

58. Infert Tablet



Monographs of tribulus, zinc and selenium are required.


dosage form.

59. Eco-X Tablet



Aescin comes under common molecules list.

Monograph of colchicum extract is required.

60. Maxifol Tablet Deferred for following reasons:


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61. Biofax Tablet



Vinpocetine comes under common molecules list.

Monographs of all ingredients in extract form are required.


62. Silebro Syrup



Silymarin comes under common molecules list.

63. Kufset Syrup



Ammonium chloride is registered as drug.

Use of ipecacacuanha extract is required as it also stimulates

emesis.

64. Chemvit Tablet



Trypsin and chymotrypsin are proteolytic enzymes, come

under common molecules list.

65. Sinofeb Tablet



Fenofibrate is registered as anti-hyperlipidemic drug.

66. Ferrofer Sachet



Monograph of lipofer is required.

Salt of iron and its monograph is required

67. Lutex Plus Tablet



Monographs of zeaxanthin and lutein are required.

68. Irobest Tablet



Monographs of iron bisglycinate, L methyl folate and copper

sulphate are required.

69. Urosil D Sachet



Monographs of cranberry and mannose are required.

70. Mv Sip Syrup



Salt of calcium and its monograph are required.


dosage form.

71. Crantec Sachet



Monographs of cranberry extract, calcium phosphate (source

of calcium) and calcium phosphate (source of phosphorus)

are required.

72. Probex Sachet



Monographs of wheat dextrin fiber is required.

Senoside comes under common molecules list.

73. Sb-C Tablet Deferred for following reasons:

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Caffeine is included in common molecules list.

Monograph of guarana seed extract is required.

Testing method of finished of finished product is required.

74. Alfabex Syrup



Monographs of cranberry extract and ginger extract are

required.

75. Tribest Tablet



Monographs of zinc, Co enzyme Q 10, lutein, bacopin,

taurine, green tea extract, tribulus terrestris extract, macuna

extract, withania extract and epimedium saittatum extract are

required.


dosage form.


Oasis Pharma, Lahore

76. Apit Rise Syrup


Monograph of folium extract is required.

Product resembles with Apetar syrup with minor difference of

only one ingredient, needs clarification.

77. Neokol Syrup


Monographs of hederae folium extract and adhatoda vasica

are required.

78. Oci Tablet Deferred for following reasons:

Monographs of red algae (calcium) and iron are required.

79. MN Zinc Syrup Deferred for following reasons:

Monograph of zinc gluconate is required.

80. Ginkar Tablet Deferred for following reasons:

Monograph of ginkgo biloba extract is required

81. Ramz Syrup


Monographs of zingiber officinale extract, menthe piperata

extract, trachspermum ammi and foeniculum vulgare extract

are required.

82. Tresmen Capsule


Monographs of horny goat weed extract, maca root extract,

togkat ali extract, tribulus terrestris extract are required.


83. Sovyis Syrup


Monographs of hedera helix, morus nigra and adhatoda vasica

in extract form are required.

84. Oecin Tablet Deferred for following reasons:


85. Ozym-C Tablet Deferred for following reasons:


86. Othin Tablet Deferred for following reasons:

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Monographs of bacopin, taurin, tribulus terrestris and

withania somnifera are required.


87. Apetar Syrup


Product resembles with apit rise syrup with minor difference

of only one ingredient, needs clarification.

Monograph of folium extract is required.

Fee evidence is required.

88. Osicure Sachet Deferred for further evaluation and clarification.

89. Magnovit Powder Deferred for further evaluation and clarification.

Paragon Herbal Laboratories, Lahore

Plot No. Kht 285, Ktn 570, Allah Hoo Industrial Area, Near Sabzi Mandi, Gujumatta, Ferozepur Road, Lahore

90. Pe-card syrup Deferred for following reasons:


91. PE-Nox capsule


Undertaking of contents of dossiers and brand name are

unsigned and un-stamped.

92. Real cough syrup


Firm has submitted new proposed brand name i.e multikuff

syrup.

Monograph of ivy leaf extract is required.

93. Revisal tablet Deferred for following reason(s):

Differential fee is required.

94. Spermodil-F capsule


Monograph of Eurycoma longofolia extract is required.


95. Stomofil syrup



Monograph of calcium lactate gluconate is required.

96. Vagirena Tablet


Firm has submitted new proposed brand name i.e Fertika

tablet.

Monographs of tribulus is required.

97. V-liver-X syrup



Silymarin is added in common molecules list.

98. V-liver-X tablet


Monograph of milk thistle extract is required.


99. Colic drops


Firm has submitted new proposed brand name i.e ADE care

drops.

Monographs of all ingredients are required according to BP

compendium as mentioned against each ingredient on Form 3.

100. Gynolec capsule


Monographs of iron bisglycinate and L methyl folate are

required.

Firm has submitted new proposed brand name i.e Mediferr

Syrup.

101. Menc on syrup Deferred for following reasons:

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Conversion of strength of vitamin D from micro gram to

International units is required.

102. Mency capsule Deferred for following reasons:

Stability of omega 3 in hard capsule is required.

103. Real-Vit Tablet


Firm has submitted new proposed brand name i.e Medevit

tablet.

Monograph of iron bisglycinate is required.


104. Revive Food supplement


Section availability of food supplement alongwith required

facilities is required.

Monographs of protein, fat, linoleic acid, linolenic acid,

DHA, FOS, taurine,carnitine, inositol and codex

alimentatrious are required.

Halal certification of fat and protein is required.


Unit dose strength is required.

105. Sharbat Foulad


firm has submitted new proposed brand name i.e Preg-Med

tablet.


106. Viron-S Syrup


Firm has submitted new proposed brand name i.e Med-D

Insta drop.

Firm applied said product in syrupform initially and has

changed brand name along with dosage form later, needs

clarification.

107. Cal-Max Sachet Deferred for following reasons:


108. Chew sip Tablet


firm has submitted new proposed brand name i.e Calvita Pro

Syrup.


109. Cor-Vit D tablet


firm has submitted new proposed brand name i.e Med-D

chewable tablet.

Master formula of chewable tablet as dosage form is needed.

110. Lycovit syrup


firm has submitted new proposed brand name i.e Calvita Pro

Syrup.

Monograph of calcium lactate gluconate is required.

111. Mango-C sachet


has submitted new proposed brand name i.e Myo-Med

Sachet.

Monograph of L-methyl folate is required.

112. Choarqa tablet


firm has submitted new proposed brand name i.e Mede-Cal

tablet.


113. Olive oil drop Deferred for further evaluation and clarification.

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114. Arq-e-Badaniya


Firm has submitted new proposed brand name i.e Sea-Med

tablet.

Monographs of red algae calcium and vitamin K2 are

required.

115. Araq-e- gulab Spray


firm has submitted new proposed brand name i.e Medeferr

tablet.

Firm applied said product in oral liquid form initially and has

changed brand name along with dosage form later, needs

clarification.

116. Ginco Plus tablet Deferred for following reasons:


117. Pe-Cal Effervescent Tablet


firm has submitted new proposed brand name i.e M-Cal 1000

effervescent tablet.

Manufacturing process regarding effervescent tablet is

required.

Phytotia Laboratory, Peshawar

27/28-C, Small Industrial Estate, Kohat Road, Peshawar

118. Ortho-A Tablet


Clarification is required either zinc oxide is recommended for

oral use.

Differential fee is not endorsed by concerned division of

DRAP.

Brand name undertaking is required.

119. Dycacia Tablet



DRAP.


Stability of anise oil and cinnamon Bark oil in tablet dosage

form is required.

Monograph of powdered ginger extract is required.


120. V-Plex Tablet


Monographs of iron polymaltose and folic acid are required.


DRAP.


121. Cal-Star Tablet



DRAP.


122. Zuka-M Tablet



DRAP.



123. Ab-One Tablet



DRAP.

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124. Silym Tablet



DRAP.


Silymarin is added in common molecules list.

125. V-Plex Syrup



DRAP.


126. Enerton-S Syrup



DRAP.


127. Dycalia Syrup


Sodium bicarbonate is added in common molecules list.


DRAP.

128. Ab-One Syrup



DRAP.



129. Fenertac Syrup



DRAP.


130. Phytotia Saarbat Toshanda Plus



DRAP.


131. Ener-P Syrup



DRAP.


132. Plex-Plus Syrup



DRAP.


133. Sharbat Podina Syrup



DRAP.



134. Phytocid Syrup



DRAP.


135. Phytotia Colic Syrup Deferred for following reasons:

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DRAP.


Unit dose strength is required as 20ml given by firm is not

rational.

136. Phytotia Sharbart Joshanda Syrup



DRAP.

Monograph of ivy leaf extract is required.


SOIS Life Sciences, Karachi

Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi

137. Zeeova Capsule


Monographs of magnesium sulphate, chromium are required.


138. Fertil-Z Capsule



Monographs of tribulus, alpha Lipoic acid, Taurine, pine bark

extract and selenium are required.


139. Cubex Tablet


Monographs of ginkgo biloba, phosphorus and chloride are

required.


140. Zeecran Sachet




141. Myo-Vit Sachet Deferred for following reasons:


142. Hm-Folvit Tablet




143. Infacure Drops



Monographs of all ingredients in extract form are required.

144. Ironexen Tablet



Monograph of iron chelated is required.

Stiflex Pharmaceuticals Wahcantt

33-B, Small Industrial Estate, Bahtar Road, Wah Cantt

145. Imune Plus Syrup


Monograph of iron polymaltose is required.

Justification of use of zinc oxide in oral dosage form is

required.



146. Fa Plus Syrup Deferred for further evaluation and clarification.

147. Rest Syrup


Product contains melatonin, comes under common molecules

list.

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148. Coral Max Tablet Deferred for following reasons:

Monograph of red algae (calcium) is required.

149. Coral Max Sachet


Conversion of strength of vitamin D from mg/g to

international unit is required.

Wilshire Laboratories Pvt Ltd, Lahore

Plot No.5, Farooq Industrial Estate, 20-KM, Ferozepur Road, Lahore

150. Beano (Brand Name Changed To

Rytil) Tablet


Dossier is devoid of all requirements laid down in form 3 of

SRO 412(I)/2014 except submission of undertaking of

contents of dossier.


151. Geano Tablet






152. Gasrel Tablet






153. B12 1000Mcg Tablet






154. Penemia 1000Mcg Tablet






155. Qubenza 1000Mcg Tablet






156. Benzim Natural Tablet






157. Abdorex Tablet






158. Tummy Care Tablet





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159. Senna-Col Tablet






160. Docsen Tablet






161. C-Rich 500Mg Tablet






162. C-Rise Tablet






163. C-Rose Tablet






164. D-Tab Tablet






165. Bon-Med Tablet






166. D-Lux Tablet






167. E-Plus Tablet






168. Finergy Tablet






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169. D+C Tablet






170. Aktiv-D Tablet






171. G-Lite Tablet






172. G-Lean Tablet






173. G-Trim Tablet






174. Laxante Tablet






175. Nutralax Tablet






176. Ultralax Tablet






177. 2G Plus Tablet






178. Xtrim Tablet






179. Livell Tablet Deferred for following reasons:

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180. Actiliv Tablet






181. Mvg Gold Tablet






182. Revamaxv Tablet






183. Multi-G Tablet






184. New Viogenic Tablet






185. Synergize Tablet






186. Vitina Tablet






187. Cleanze Tablet






188. Senacarb Tablet






189. Vigforce Tablet Deferred for following reasons:

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190. X-Fire Tablet






191. Zamcal D Tablet






192. Dv-Cal Tablet






193. Bonost Tablet






194. Herbatrim Capsule






195. Slender Capsule






196. Craneze Capsule Deferred for further evaluation and clarification.

197. Urisept Capsule






198. Cranuti Capsule






199. D-Cap Capsule






200. Bon-Med Capsule Deferred for following reasons:

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201. D-Lux Capsule






202. Livimax Capsule






203. V.V Plus Capsule






204. Vimax Capsule






205. Colace 100Mg Soft Gel






206. Senna-Col Soft Gel






207. Docsen Soft Gel






208. Enermax Soft Gel






209. E-Plus Soft Gel






210. Finergy Soft Gel Deferred for following reasons:

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211. Evita 1000Iu Soft Gel






212. Elevita Soft Gel






213. Esteem Soft Gel






214. J-Plus Soft Gel






215. Jointace Soft Gel






216. Jointeze Soft Gel






217. Pregnacare Soft Gel






218. Neo-Care Soft Gel






219. Gestat Soft Gel Deferred for further evaluation and clarification.

220. Prizma Soft Gel






221. Domena Soft Gel Deferred for following reasons:

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222. X-Dame Soft Gel






223. Quvert Soft Gel






224. Nutrigenic Soft Gel






225. Vital-B Soft Gel






226. Vit-Hair Soft Gel






227. Nutri Hair Soft Gel






228. Gro-Hair Soft Gel






229. Zamcal Forte Soft Gel






230. Dv-Cal Forte Soft Gel






231. Bonost Forte Soft Gel Deferred for following reasons:

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232. Zomega Soft Gel






233. Xtend Life Soft Gel






234. Vitafish Soft Gel






235. Apperize Syrup






236. Appemax Syrup






237. Eatmax Syrup






238. Abdorex Syrup






239. Tummy Care Syrup






240. Boost Up Syrup






241. Ignize Syrup Deferred for following reasons:

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242. Enzest Syrup






243. Urisept Dry Suspension






244. Cranuti Dry Suspension






245. Urisept Sachet






246. Cranuti Sachet






247. D-Drop






248. Bon-Med Drops






249. D-Lux Drops






250. De-Flu (Name Changed To Pronto

Natural) Syrup






251. Flugo Syrup Deferred for following reasons:

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252. Codral / 4 Flu Syrup






253. De-Tuz Syrup






254. Novacold Syrup






255. Cofnorm Syrup






256. D-Flor Sachet






257. Florestore Sachet






258. Lacoten Sachet






259. Bon-Med Oral Liquid






260. D-Lux Oral Liquid






261. Enermax Sachet Deferred for following reasons:

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262. E-Plus Sachet






263. Finergy Sachet






264. Exen D Dry Suspension






265. D+C Dry Suspension






266. Aktiv-D Dry Suspension






267. Fiore Natural Syrup






268. Ferovina Syrup






269. Iron Up Syrup






270. Hushh For Adults (Sugar Free) Syrup






271. Chestal Syrup Deferred for following reasons:

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272. Qurex Syrup






273. Laxante Syrup






274. Nutralax Syrup






275. Ultra-Lax Syrup






276. Little'S Cold For Children Syrup






277. Vanikuf Syrup






278. Nocold Syrup






279. Liv-Long Syrup






280. Livell Syrup






281. Actiliv Syrup Deferred for following reasons:

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282. Mvg Gold Syrup






283. Revamax Syrup






284. Multi-G Syrup Deferred for further evaluation and clarification.

285. Revamax Syrup






286. Multi-G Syrup






287. Cepacol Syrup






288. Zepacol Syrup






289. Ferogin Syrup






290. Hemowel Syrup






291. Zamcal D Dry Suspension






292. Dv-Cal Dry Suspension Deferred for following reasons:

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293. Bonost Dry Suspension






294. Zegut Sachet






295. Evora Sachet






296. Theralac Sachet






297. Crystal Light Sachet






298. Vit-Light Sachet






299. K-Shot Oral Liquid






300. K-Lux Oral Liquid






301. K-Max Oral Liquid






302. Fastrel Ointment Deferred for following reasons:

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303. Flexel Ointment






304. Proflex Ointment






305. De-Tuz (Sugar Free) Lozenge Tablet Deferred for further evaluation and clarification.

306. Novacold Lozenge Tablet






307. Cofnorm Lozenge Tablet






308. Coldeze Lozenge Tablet






309. Raspeze Lozenge Tablet






310. Smootheze (Sugar Free) Lozenge

Tablet






311. Coldeze Lozenge Tablet






312. Raspeze Lozenge Tablet






313. Actigel (Oral) Gel Deferred for following reasons:

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314. Adora Powder Milk Powder






315. Neo Milk Powder Milk Powder






Apple Laboratories, Islamabad

National Industrial Zone, RCCI Road, 1.5-KM, Rawat, Rawalpindi

316. Aperex Syrup (837)



Form 3 attested and stamped by owner/ CEO is required.

Sodium bicarbonate is added in common molecules list.

317. Hepqure Capsule Deferred for further evaluation and clarification.

318. Api-Up Syrup (839)



Monographs of foeniculum extract, trigonella foenum-gracum

extract and zingiber extract are required.


319. Casigeno Cream (840)




Methyl salicylate is added in common molecules list.

Availability of gas chromography instrument for test/ analysis

of turpentine oil is required as mentioned in dossier.

320. Ava-C Sachet (841)




321. Apsure Adult Milk (842)




Dextrose is added in common molecules list.

Food supplement availability is required.

Monograph of skimmed milk powder is required.

Etihad Herbal Industries, Lahore

9.5-KM, Sheikhupura Road, Lahore-Pakistan

322. Sharbat Faulad Syrup (843)



Monograph of iron compound (folad patri) is required and

clarification of its use in health products.

323. Fresh Bloom Syrup (844)


fee evidence is required.

Salt of iron and its monograph are required.

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324. GinkoBext Syrup Deferred for further evaluation and clarification.

325. Arq-E-Mehzal Arq (846)


Breakup of fee is required.

Monograph of menthe slyvestris is required.

Safety undertaking of product is required.

Stability of all ingredients in water (only) as an inactive

ingredient is required.

326. Gluta-D Capsule (847) Deferred for following reasons:


327. D-Call Supplement (848)



Monographs of magnesium oxide is required.

Unit dose per serving is required.

Stability of formulation in powder/ granules is required.

Jar filling machine availability is required.

328. D-Chiro Plus Capsule Deferred for following reasons:


329. Myomelat Sachet (850)



Melatonin is added in common molecules list.

Stability of formulation in powder/ granules is required.

330. Ginbest Syrup (851)



Citicholine is added in common molecules list.

Monograph of gingko extract is required.

331. Link-D (1000IU) Deferred for further evaluation and clarification.

332. Elliko Syrup



Monographs of ginseng and ginkgo biloba extract are

required.

333. Elli-D Softgel



Stability confirmation of vitamin K2 in softgel preparation is

required.


334. Orthorid Super Tablet



Glucosamine, chondroitin and hyaluronic acid are added in


Monograph of collagen is required and also provide type of

collagen which is to be used in formulation.

Justification of use of methylene chloride as inactive


335. QoloniTaryaq-e-Badan Capsule Deferred for further evaluation and clarification.

336. Mactose Syrup



Firm uses herbs in crude form.

337. Maca Capsule Deferred for following reasons:


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Monograph of lepidium meyenii is required.

338. Milk Pro Capsule



Firm uses herbs in crude form.

339. Amino-Health Capsule



Monographs of L-arginine and L-ornithine are required.


340. Colic Drop



Beta galactosidase (lactase) is added in common molecules

list.

Drop filling machine availability is required.

341. Eryon Softgel Deferred for following reasons:


342. Zippy-D (10000IU) Softgel



Brand name undertaking is unsramped and un-signed.

343. Bi-Digas Syrup



Clarification is required either said formulation covers under

Arq (herbal) or Syrup (nutraceutical) section as firm uses

herbs in crude form.

344. Bone Fol Syrup Deferred for following reasons:


345. Brodil Syrup



Monographs of ivy leaf extract and licorice extract are

required.

346. E-Coline Syrup Deferred for following reasons:


347. Zie-Cid Syrup






348. Etihad Ghutti Syrup






349. Heparax Syrup







350. Ibofen Syrup Deferred for following reasons:


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351. Colic Syrup






352. Dyromax Syrup






353. Fefivit Tablet



Justification of use of methylene chloride as an inactive


354. E-Flu Tablet



Firm uses herbs in crude form, needs clarification.

355. Spongel mouth gel 25gm Gel



The product is claimed to be pain relieving.

Oral (gel) section availability is required.

356. Capsiloc 30gm Gel



Justification of use of capsicum oleoresin is required.

357. Fitness Super Tonic Syrup






358. G-Lec Capsule




359. Phaki




360. Dreamset Tablet



Safety profile of valerian extract is required.

Justification of use of methylene chloride as an inactive


361. Power Max Capsule



Firm uses tribulus in crude form, needs clarification.

362. Protect Capsule Deferred for further evaluation and clarification.

363. Glucose-D Plus sachet Deferred for following reasons:

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Glucose is added in common molecules list.

Form 3 is un-stamped and un-signed.

Stability of vitamin D in powder/granules form is required.

364. Miti Chore Suspension



Monograph of copper and its salt is required.


365. Fix Balm



Winter green is added in common molecules list.

Monographs of turpentine oil and menthol are required.

Phytocon International Private Limited, Lahore

339-A, Sundar Industrial Estate, Raiwind Road, Lahore

366. Arbucon Cream Deferred for further evaluation and clarification.

367. Emolin Cream


Paraffin is added in schedule D of LRA rules, 1976, needs

clarification of its use in health products.


SOIS Life Sciences, Karachi


368. Evanol Softgel



Stability of formulation in softgel dosage form is required.

369. Caltramag-D Tablet



Prescribed form 3 to be changed w.r.t addition of salts against

each vitamins and minerals.

Opal Laboratories, Karachi

Plot LC 42, Lite Landhi, Karachi

370. Hb-Booster Syrup


Firm has changed brand name i.e femalt syrup.

Monographs of iron bisglycinate and malt extract are

required.

371. Caripill Syrup


Prescribed form 3 is required.

Carica papaya leaf extract monograph is required.


372. Caripill Tablet



Carica papaya leaf extract monograph is required.




373. Ceramon Lotion


The product is claimed to be cosmetic.


Hyaluronic acid is added in common molecules list.

Scotmann Pharmaceutical, Islamabad

5-D, I-10/3 Industrial Area, Islamabad

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374. Profemme Tablet



Monographs of genistein and teavigo are required.

Justification of use of both beta carotene and vitamin in same

formulation is required.

2 tablet per serving dose justification is required.

375. Probono Tablet



Monographs of genistein and magnesium are required.

2 tablets per serving dose is required.

376. Obino Tablet


Monographs of vitamin B1, vitamin B2, vitamin B3, vitamin

B6, zinc and teavigo are required.

2 tablets per serving dose justification is required.



377. Behold Tablet




B6, teavigo, hydroxyl tyrosol are required.


Beta carotene exceeds RDA, needs clarification.

378. Curcuma Softgel



Stability of turmeric in softgel dosage form is required.

379. Hitrax Tablet



Monographs of vitamin B1, vitamin B2, vitamin B3 are

required.


380. Brainy Tablet


Monographs of vitamin B1, vitamin B6 are required.


Caffeine is added in common molecules list.


381. Hartiest Tablet



Monographs of vitamin B2, vitamin B6 teavigo are required.

Clarification of use of teavigo is required.




382. Imuna Tablet



Monographs of vitamin B1, vitamin B6, vitamin D,zinc,

teavigo are required.


383. Ocupro Tablet



Monograph of genistein is required.

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384. Nutrion Tablet




B6, iodine are required.

Clarification is required which type/ kind of vitamin K is used

in formulation.

2 tablets per serving dose is required.

Sois Life Sciences, Karachi


385. Ocupure Softgel



Monographs of lutein and zeaxanthin are required.



386. Tufcuf Softgel



Monographs of Echinacea, elderberry and white willow are

required.





387. Emkay Plus Softgel



Monograph of red algae calcium is required.

Alpha Nutraceutical, Lahore

21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore

388. Kufpro Syrup



Monographs of banafsha extract, cinamom extract, glychhriza

extract and lasoodi extract are required.

testing method of finished product is required.

389. Glosil Plus Syrup



Monograph of foeniculum vulgare is required.

390. Prochel Tablet Deferred for further evaluation and clarification.

391. Propol-G Syrup Deferred for further evaluation and clarification.

392. Axio Syrup



Monographs of ginger extract and fennel extract are required.

393. Myderm Lotion



Sulphur is added in common molecules list.


394. Propol-G Tablet



Stability of omega 3 fatty acids in tablet dosage form is

required.

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Justification of stability and use of zinc oxide in oral dosage

form is required.


395. Moringa Capsule Deferred for further evaluation and clarification.

M/s Phytocon International Private Limited


396. Hi-Vit Tablet


Monographs of vitamin D3, ferrous gluconate, manganese

sulphate are required.


dosage form.

Viegen Pharma, Lahore

Plot No. 74-G, Sundar Industrial Estate, Sundar Raiwind Road, Lahore

397. Pholx Tablet Deferred for further evaluation and clarification.

398. Jufex Syrup



Monograph of hedera folium extract is required.

399. LCT Tablet



Justification of use of zinc oxide in oral dosage form is

required.



400. Go-Stress Capsule Deferred for following reasons:

Monograph of withania somnifera extract is required.

401. Unipep Tablet Deferred for following reasons:

Serratiopeptidase is included in common molecules list.

402. P-Glyce Capsule



Justification is required regarding use of licorice liquid

extract in hard shell capsule.



403. Kiddy-D Softgel Deferred for further evaluation and clarification.

Nutritional Food Works and Chemicals, BWP

Plot No.66-67-A, Small Industrial Estate, Bahawalpur

404. Calvit-C Sachet


Dextrose is added in common molecules list.

Clarification of “ each tube contains” in calvit-C sachet is

required, needs correction.

Justification of role of anhydrous citric acid as an active


Huzaifa International, Sargodha

Commerical Area, Aziz Bhatti Town Sargodha

M/s SUPER’S DIANA, S.L., ubicada a Ctra. C-17, KM 17, del municipi de Parets del Valles, (Barcelona)

405. Eli-Plus Liquid (veterinary)


Form 5 is un-stamped.

Photocopy of Free sale certificate is attached. Original FSC

notarized by law representative and countersigned by

Pakistan embassy/ consulate in country of origin, is required.

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According to real time and accelerated stability data of

required batches, range of assay results of vitamin E is from

95.45g/L to 93.24g/L at 18 months’ time point to 36 months’

time points, clarification/ justification is required either assay

of vitamin E at above mentioned time points falls within

specified limit or otherwise.

CoA of finished product is required.

Contents undertaking is required.

Manufacturing license is required.

Last inspection report is required.

M/s. Agro Poul Vet International,

1/12-A, Sheet No. 24, Model Colony, Karachi

Agent of M/s Inner Mongolia Huatian Pharmaceutical Co., Ltd. Economic Development zone, Yuanhbaoshan District,

ChiFeng city, Inner Mongolia, P.R. CHINA

406. Vitamino Plus Feed Supplement

Liquid Solution Deferred for further evaluation and clarification.

Nutrimed Laboratories, Karachi

Plot No. B-42, S.I.T.E. Super Highway, Karachi

407. Geri Phos Syrup Deferred for further evaluation and clarification.

Calgan Phyto Pharma Pvt Ltd,

Plot No. 2, Green Park Road, Near Band Road Grid Station, Lahore

408. Algium Tablet Deferred for further evaluation and clarification.

409. Vitamix Liquid Deferred for following reasons:


410. Gyne-5 Tablet



Strength of ingredients is required.

411. Marticid Liquid Deferred for further evaluation and clarification.

412. Calpan-D Tablet



Monograph of algae mineral complex is required.

413. Oscal Insta Sachet


Stability of vitamin D3 in powder/ granules dosage form is

required.

414. Fosgink Liquid



Form 3 to be revised w.r.t omission of sorbitol as it is an

inactive ingredient.

Nutrimed Laboratories, Karachi

Plot No. B-42, S.I.T.E. Super Highway, Karachi

Evaluator: (Zain Ul Abidin, AD-V)

415. Refort-M Syrup



Monograph of fish oil is required.


416. Renobex-M Syrup Deferred for following reasons:




417. Enzilact Drops Deferred for following reasons:

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Lactase is added in common molecules list.

PolyfineNutra-Sciences

Plot No. 39-40 D, Industrial Estate, Hayatabad, Peshawar

418. Calrex-D Liquid



Formulation contains large amount of calcium carbonate i.e

12gm in 120ml, needs justification.

419. Vitora-D Liquid



Strength of ingredients are required.

420. Cytaplex Liquid Deferred for following reasons:


421. Incomin Syrup Deferred for following reasons:


422. Vitazee Liquid




423. Iron-F Liquid Deferred for following reasons:


424. Zybex-L Liquid Deferred for following reasons:


(Muhammad Abdul Ghaffar)

Secretary, EEC

government of pakistan ministry of national health services, …. deficiency letter of all... ·...

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