LETTERS FOR ISSUE ON 16.03.2015
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 4468 / Test Licence
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 5233 / Test Licence
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 5234 / Test Licence
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 46527 / Approval Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 4728 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 5071 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 5070 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 5089 / Test Licence
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 4807 / Test Licence
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 5100 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 4651 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 4819 / Test Licence
M/s. Bio Scientific Research Laboratories (India) Pvt. Ltd., Dist. Thane-401 104 / 2374 / Test Licence
M/s. Cadila Healthcare Ltd.,, Ahmedabad-380 015 / 5341 / Test Licence
M/s. Cipla Limited, Mumbai-400 013 / 5000 / Test Licence
M/s. Cipla Limited, Mumbai-400 013 / 5001 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 5430 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 4771 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 4809 / Test Licence
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 3632 / Amendment Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 4288 / Test Licence
M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 4966 / Test Licence
M/s. Hetero Labs Ltd., Hyderabad-500 018 / 5175 / Approval Letter
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 5336 / Approval Letter
M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 1338 / Amendment Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 3795 / Test Licence
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 5225 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 5859 / Amendment Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 5859 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 6603 / Additional Study Centre
M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 5252 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 5373 / Test Licence
M/s. Lupin Limited (Research Park), Pune-412 115 / 4674 / Approval Letter
M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 3604 / Amendment Letter
M/s. Manipal Acunova Limited, Manipal -576104 / 490 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 7095 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 7292 / Amendment Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 4948 / Test Licence
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 6629 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 5126 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 6500 / Approval Letter
M/s. Vimta Labs Ltd., Hyderabad-500051 / 4947 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 4857 / Test Licence
M/s. Wockhardt Limited, Aurangabad-431 006 / 5289 / Approval Letter
M/s. Wockhardt Limited, Aurangabad-431 006 / 5290 / Approval Letter
COSMETIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Satguru Ram Singh Khadi Gram Udyog Eekai, Punjab / 2733 / Deficiency Letter
M/s. S.H.A.M.K. International pvt. Ltd, Mumbai / 216 / Deficiency Letter
M/s. Makeover Trading, New Delhi / 619 / Deficiency Letter
M/s. Baccarose Perfumes & Beauty Products Pvt. Ltd, Mumbai / 1116 / Deficiency Letter
M/s. Beverly Hills Marketing Pvt. Ltd, New Delhi / 2960 / Approval Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Boston Scientific India Pvt. Ltd. / 49218 / Approval (F-RC)
M/s. Boston Scientific India Pvt. Ltd. / 49218 / Approval (F-IL)
M/s. St. Jude Medical India Pvt. Ltd. / 50074 / Approval (F-RC)
M/s. St. Jude Medical India Pvt. Ltd. / 50074 / Approval (F-IL)
M/s. Becton Dickinson India Pvt. Ltd. / 44480 / Approval (R-RC)
M/s. Becton Dickinson India Pvt. Ltd. / 44480 / Approval (R-IL)
M/s. Becton Dickinson India Pvt. Ltd. / 1451 / Approval (R-E-RC)
M/s. Becton Dickinson India Pvt. Ltd. / 1451 / Approval (R-E-IL)
M/s. Oncocare Scientifics Pvt. Ltd. / 48562 / Approval (R- RC)
M/s. B. Braun Medical (India) Pvt. Ltd. / 47275 / Approval (R-E-RC)
M/s. Baxter India Pvt. Ltd. / 3044 / Approval (R-IL)
M/s. Galderma India Pvt. Ltd.
The Commissioner, Mumbai.
The DDC (I), Mumbai. / 1173 / Approval Letter
M/s. B. L. Lifesciences. / 40624 / Query Letter
M/s. Emergo (India) Consulting Pvt. Ltd. / 48369 / Query Letter
M/s. Oncocare Scientifics Pvt. Ltd. / 48562 / Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Siemens Limited. / 496 / Approval (IL)
M/s. Siemens Limited. / 524 / Query Letter
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Pharmazell (Vizag) Private Limited, Visakhapatnam, A.P. / WC Certificate
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Intas Pharmaceuticals Ltd., / 37470 / - / CT NOC Letter
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERSarvear Pharmaceuticals U.A / 4924 / Approval Letter
Gangwal Chemicals Pvt. Ltd. / 4946 / Approval Letter
Eisai Pharmaceuticals India Pvt. Ltd. / 4982 / Approval Letter
Eskag Pharma Pvt Ltd. / 5114 / Approval Letter
Troikaa Pharmaceuticals Ltd. / 5047 / Approval Letter
Shell Lifesciences Pvt. Ltd. / 5196 / Approval Letter
Prime Pharmachem / 5198 / Approval Letter
Prime Pharmachem / 5200 / Approval Letter
Hufort Healthcare Pvt. Ltd. / 5197 / Approval Letter
Merck Limited / 5048 / Approval Letter
C.J. Shah & Co. (Godown) / 5199 / Approval Letter
Harshada Corporation / 5195 / Approval Letter
Harshada Corporation / 5194 / Approval Letter
ANM Pharma Pvt. Ltd. / 5176 / Approval Letter
Cadila Healthcare Ltd. / 5201 / Approval Letter
Inspira Bio Pharm Pvt. Ltd. / 5203 / Approval Letter
Inspira Bio Pharm Pvt. Ltd. / 5202 / Approval Letter
Wockhardt Limited / 4497 / Approval Letter
Abbott Healthcare Pvt. Ltd. / 4450 / Approval Letter
Aaditya Pharmachem / 4603 / Approval Letter
Intas Pharmaceuticals / 4772 / Approval Letter
Abil chemipharma pvt. ltd. / 4703 / Approval Letter
Boehringer Ingelheim India Pvt. Ltd. / 4739 / Approval Letter
Astrazeneca Pharma India Limited / 4780/4779 / Approval Letter
Astrazeneca Pharma India Limited / 4781 / Approval Letter
Johnson & Johnson Ltd., / 5104 / Approval Letter
Johnson & Johnson Limited / 5105 / Approval Letter
Johnson & Johnson Ltd., / 5102 / Approval Letter
Johnson & Johnson Limited / 5106 / Approval Letter
Johnson & Johnson Limited / 5103 / Approval Letter
Johnson & Johnson Ltd. / 6112 / Approval Letter
Glaxo Smith Kline Pharmaceuticals Ltd. / 5578 / Approval Letter
Glaxo Smith Kline Pharmaceuticals Ltd. / 5577 / Approval Letter
Glaxo Smith Kline Pharmaceuticals Ltd. / 5576 / Approval Letter
Astellas Pharma India pvt. Ltd. / 49232 / Approval Letter
Serdia Pharmaceuticals (India) Pvt. Ltd. / 4792 / Approval Letter
LETTER PERTAINING TO REGISTRATION
S.no. / Name of applicant / Diary no. / Type of letterSun pharma lab / 49865 / Approval letter
Anantco enterprises pvt. Ltd. / 3273 / Approval letter
Esschem pvt. Ltd. / 39914 / Approval letter
Shah tc / 2010,6850 / 02 approval letter
Astellas pharma india pvt. Ltd. / 44656 / Approval letter
Bayer pharmaceuticals pvt. Ltd. / 4904 / Approval letter
Win medicare pvt. Ltd. / 6904 / Amended letter
Bristrol myers squibb india pvt ltd. / 1406 / Clarification letter
Apothecaries pvt. Ltd. / 38358 / Clarification letter
Anantco enterprises pvt. Ltd. / Nil / Letter
Alliance pharma/shah tc / Nil / Letter
Chandra bhagat / Nil / Letter
LETTER PERTAINING TO SHELF LIFE/RULE-37
S.no. / Name of applicant / Diary no. / Type of letterDalas biotech ltd. / 47378 / Clarification letter
Maxheal pharmaceuticals india ltd. / 49106 / Clarification letter
Bayer pharmaceutical pvt. Ltd / 1895 / Approval letter
(GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. INC Research / 2121/2122 / New Sites Approval letter
2. / M/s. Boehringer / 6098 / Clarification Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Biological E. Ltd / 237 / Approval letter
2 / M/s Reliance life sciences Pvt, Limited / 97 / Clarification letter
3 / M/s Serum Institute of India Ltd / 1633, 8543, 9579, 9581 (fts no) / Approval letter
4 / M/s Shantha Biotechnics Limited / Clarification letter
5 / M/s Novartis Healthcare Ltd / 51373 / Acknowledge letter
6 / M/s Wockhardt Research centre / 15473, 3751915473 / Approval letter
7 / M/s Novo Nordisk India pvt, ltd / 4523 / Approval letter
8 / M/s Roche product India Pvt, ltd / 47727 / Approval letter
9 / M/s Sanofi Pasteur India Pvt, ltd / 50902 / Approval letter
10 / M/s Bharat Biotech International ltd / 5797 / Approval letter
11 / M/s MSD Pharmaceutical pvt, ltd / 44416 / Clarification letter
12 / M/s Lambda Therapeutic Research ltd / 4643, 4763, 5640 / Approval letter
13 / M/s Cliantha Reseach ltd / 5124, 4768, 5123 / Approval letter
14 / M/s Merck Specialities Pvt, ltd / 42746 / Approval letter
15 / M/s Bharat Serum and vaccine ltd / 2154 / Amendment letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. GopaldasVisram& Co. Ltd., / 50761 / Clarification Leter
M/s. GopaldasVisram& Co. Ltd., / 656 / Clarification Leter
M/s. GopaldasVisram& Co. Ltd., / 658 / Clarification Leter
M/s. Symbiotic Drugs & Diabetic Care / 60964 / Clarification Leter
LETTERS FOR ISSUE ON 13.03.2015
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 4469 / Test Licence
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 4012 / Test Licence
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 4604 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 4650 / Approval Letter
M/s. Bio Scientific Research Laboratories (India) Pvt. Ltd., Dist. Thane-401 104 / 2375 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 4432 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 4766 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 7190 / Test Licence
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 4459 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 4576 / Approval Letter
M/s. Hetero Labs Ltd., Hyderabad-500 018 / 4236 / Approval Letter
M/s. Indoco Remedies Ltd., Navi Mumbai-400 701 / 4439 / Test Licence
M/s. Lupin Limited (Research Park), Pune-412 115 / 4679 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 4680 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 4672 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 4555 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 3264 / Approval Letter
M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 4871 / Approval Letter
M/s. Mylan Laboratories Limited, Hyderabad-500 062 / 4697 / Test Licence
M/s. Strides Arcolab Ltd., Bangalore -560076 / 51215 / Test Licence
M/s. Unichem Laboratories Ltd., Mumbai-400 102 / 6383 / Amendment Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 4765 / Clarification Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 4764 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 6042 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 2602 / Additional Study Centre
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 4730 / Test Licence
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Maquet India Pvt. Ltd. / FTS-14251 / Letter
M/s. India Medtronic Pvt. Ltd. / 47757 / Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Sandor Medicadis Pvt, Ltd / 732 / Clarification letter
2 / M/s Reliance life sciences Pvt, Limited / 2747 / Clarification letter
3 / M/s Sanofi Sythelabo India Ltd / clarification letter
4 / M/s Cadila Healthcare Limited / Clarification letter
5 / M/s Ceva I Pvt, Ltd / Clarification letter
6 / M/s Cadila Healthcare Ltd / 43696 / Approval & office Memorandum
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. AstraZeneca / - / Clarification Letter
2. / M/s. Pfizer / - / Minutes of SEC
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Megafine Pharma / - / 1829 / IPC NOC
M/s Cadila Healthcare / - / 2137 / Deficiency Letter
M/s Synokem Pharmaceutical / 4613, 4177 / 7942, 7079 / Deficiency Letter (2)
M/s Eisai Pharm technology / 1169 / 2015 / Deficiency Letter
M/s Athena Drug / 44310 / 65965 / Deficiency Letter
M/s ICPA Health Products / 51440 / 46 / Deficiency Letter
M/s Ajanta Pharma LTd. / 1742 / 3009 / Deficiency Letter