Letters for Issue on 23.02.2015

LETTERS FOR ISSUE ON 23.02.2015

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad-380 015 / 64676 / Reminder Query
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 50350 / Test Licence
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 4731 / Clarification Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 4735 / Clarification Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 2369 / Test Licence
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 2927 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 21785 / Reminder Query
M/s. Athena Drug Delivery Solutions Pvt. Ltd., Dist. Thane, Maharashtra-421 501 / 3184 / Clarification Letter
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 46710 / Reminder Query
M/s. Cipla Limited, Mumbai-400 013 / 2170 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 3087 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 3084 / Approval Letter
M/s. Intas Pharmaceuticals Ltd., Ahmedabad-380 009 / 59905 / Reminder Query
M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 2784 / Clarification Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 2713 / Test Licence
M/s. Lupin Limited (Research Park), Pune-412 115 / 3257 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 3264` / Clarification Letter
M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 2843 / Approval Letter
M/s. Manipal Acunova Limited, Manipal -576104 / 3162 / Approval Letter
M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 2698 / Clarification Letter
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 3170 / Test Licence
M/s. Strides Arcolab Ltd., Bangalore -560076 / 3025 / Approval Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 21341 / Reminder Query
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 3164 / Approval Letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Bayer Pharmaceuticals Pvt. Ltd / - / Query Letter
M/s. Ajanta Pharma Limited. / - / Query Letter (2)
M/s. MSN Labs Ltd / - / Query /CT-BE/BE NOC Letter (5)
M/s. Johnson & Johnson / - / CT/BE /IPC Letter (2)
M/s. Cipla Ltd / - / BE-NOC/ IPC/CT-BE/ Query Letter (4)
M/s. Bharat Serums and Vaccines Ltd / - / Query Letter
M/s Glaxo Smith Kline Pharmaceuticals Limited / - / Query Letter
M/s Lupin Limited / - / Query Letter (2)
M/s Novartis Healthcare Private Limited / - / Letter
M/s. Gennova Biopharmaceuticals Limited / - / Query Letter
Dr. Nithya R. / - / Query Letter
M/s Virbac Animal Health India Pvt. Ltd / - / Query Letter
M/s. Emcure Pharmaceuticals Ltd / - / Query Letter
M/s MSD Pharmaceuticals Pvt. Ltd / - / Query Letter
M/s Eisai Pharmaceuticals India Pvt. Ltd / - / Query Letter
M/s Huvepharma SEA (Pune) Pvt. Ltd / - / Query Letter (2)
M/s Cadila Healthcare Ltd. / - / Query Letter
M/s Olive Healthcare / - / Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Reckitt Benckiser India Ltd., / 48507 / Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Reckitt Benckiser (India) Pvt. Ltd. / 49074 / Approval (F-RC)
M/s. Reckitt Benckiser (India) Pvt. Ltd. / 49074 / Approval (F-IL)
M/s. Becton Dickinson India Pvt. Ltd. / 44479 / Approval (R-RC)
M/s. Becton Dickinson India Pvt. Ltd. / 44479 / Approval (R-IL)
M/s. Boston Scientific India Pvt. Ltd. / 50699 / Approval (R-E-RC)
M/s. Boston Scientific India Pvt. Ltd. / 50699 / Approval (R-E-IL)
M/s. Covidien Healthcare India Pvt. Ltd. / 42112 / Approval (R-E-RC)
M/s. Covidien Healthcare India Pvt. Ltd. / 42112 / Approval (R-E-IL)
M/s. Covidien Healthcare India Pvt. Ltd. / 37764 / Approval (R-E-RC)
M/s. Covidien Healthcare India Pvt. Ltd. / 38546 / Approval (R-E-IL)
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 885 / Approval (R-E-RC)
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 885 / Approval (R-E-IL)
M/s. Merit Medical Systems India Pvt. Ltd. / 38192 / Approval (E-IL)
M/s. Veiva Scientific India Pvt. Ltd. / 1018 / Approval (E-IL)
M/s. Stryker India Pvt. Ltd. / 12073 / Approval (F-IL)
M/s. Boston Scientific India Pvt. Ltd. / 50683 / Letter
M/s. Johnson & Johnson Ltd. / 47937 / Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Biomedica. / 50676 / Approval (IL)
M/s. Jeev Diagnostics Pvt. Ltd. / 50463 / Approval (IL)
M/s. Roche Diagnostics India Pvt. Ltd. / 50214 / Approval (IL)
M/s. Roche Diagnostics India Pvt. Ltd. / 50403 / Approval (IL)
M/s. Qiagen India (P) Ltd. / FTS-7009 / Approval Letter
M/s. Molbio Diagnostics Pvt. Ltd.
The Director, Goa. / Nil / Letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Bayer Pharmaceuticals Pvt. Ltd., / 50518 / - / ApprovalsLetter
M/s Novartis Healthcare Pvt. Ltd., / 43271 / - / Approvals Letter
M/s GSK Pharmaceuticals Ltd., / 25603 / - / Approvals Letter
M/s Athena Drug Delivery Solutions Pvt. Ltd., / 45401 / - / Approvals Letter
M/s Serdia Pharmaceuticals (I) Pvt. Ltd., / 48926 / 73800 / Amendment Letter
M/s Ipca Laboratories Ltd., / 1484 / 2243 / Additional site letter
M/s Cadila Pharmaceuticals Limited., / 51191 / 77270 / Deficiency Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy. No. / STATUS
1 / M/s QPS Bioserve Ltd / Clarification letter
2 / M/s Intas Pharmaceutical ltd / Clarification letter
3 / M/s Novartis Healthcare Pvt, ltd / 46552 / Clarification letter
4 / M/s Pfizer ltd / 44294, 321 / Clarification letter
7 / M/s Roche Product India Pvt, ltd / 2214, 3709 / Approval letter
8 / M/s M.J. Biiopharma Pvt, ltd / 1138 / Clarification letter
9 / M/s Bharat serum and vaccine ltd / Approval letter
10 / M/s Baxter India Pvt, ltd / Approval letter
11 / M/s Claris Lifesciences ltd / 2418 / Approval letter
12 / M/s Merck Speciaalities pvt, ltd / 42746 / Approval letter
13 / M/s Panav Biotech / 36408 / Approval letter
14 / M/s Venkateshwara Hatcheries Pvt. Ltd / 43039, 43034,43044 / Approval letter
15 / M/s Eli Lilly and Company (India) Pvt. Ltd / 43782 / Clarification letter
16 / M/s Sandor medicaids Pvt. Ltd / 2444 / Approval letter
17 / M/s Reliance Life Sciences Pvt Ltd / 3290 / Approval letter
18 / M/s GlaxoSmithKline Pharmaceuticals Ltd / 49181 / Clarification letter
19 / M/s MSD Phamaceuticals Pvt Ltd / Clarification letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. PPD / 2186 / Additional sites Approval
2. / M/s. Pfizer / 1982 / Additional Site Approval
3. / M/s. Novartis / 3812 / Export NOC Approval
4. / M/s. B. J Medical College / 35450 / CT NOC Approval Letter
5. / M/s. Sanofi / 1090/3043 / Additional sites Approval

WRITTEN CONFIRMATION

S. No / Firm Name / Type of Letter
1. / Alchem International Ltd., Alwar, Rajasthan / Letter