LETTERS FOR ISSUE ON 09.02.2015
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Lincoln Pharmaceuticals Ltd., C/o. M/s. Shree KrishnaKeshav, Gujarat / 509 / Approval
02 / M/s. Claris Injectables Ltd., Gujarat / 784 / Approval
03 / M/s. Biomatrix Healthcare Pvt. Ltd., C/o. M/s. Shree KrishnaKeshav, Gujarat / 1700 / Approval
04 / M/s. Bal Pharma Ltd., Pune / 77274 / Approval
05 / M/s. Stallion Laboratories Pvt. Ltd., C/o. M/s. Shree Krishna Keshav, Gujarat / 76657 / Approval
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 / 1011 / Approval Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 888 / Approval Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 1008 / Approval Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 996 / Approval Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 988 / Test Licence
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 1219 / Clarification Letter
M/s. Alkem Laboratories Ltd., Dist: Raigad / 119 / Clarification Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 616 / Test Licence
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 429 / Approval Letter
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 865 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 685 / Clarification Letter
M/s. Cipla Limited, Mumbai-400 013 / 689 / Test Licence
M/s. Cipla Limited, Mumbai-400 013 / 688 / Test Licence
M/s. Cipla Limited, Mumbai-400 013 / 1105 / Test Licence
M/s. Cipla Ltd., Mumbai-400 008 / 53 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 470 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 552 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 234 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 926 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 977 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 973 / Test Licence
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 755 / Test Licence
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 758 / Test Licence
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 563 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 625 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 1109 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 76 / Clarification Letter
M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 43649 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 726 / Clarification Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 887 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 1227 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 710 / Test Licence
M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 1248 / Approval Letter
M/s. Macleods Pharmaceuticals Ltd., Mumbai-400 059 / 1064 / Clarification Letter
M/s. Manipal Acunova Ltd., Mangalore-575 001 / 488 / Test Licence
M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 50351 / Additional Study Centre
M/s. Semler Research Center, Bangalore-560078 / 471 / Approval Letter
M/s. Semler Research Center, Bangalore-560078 / 661 / Approval Letter
M/s. Semler Research Center, Bangalore-560078 / 2018 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 800 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 968 / Test Licence
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. B. J. Medical College / 1779 / TL Approval Letter
2. / M/s. MSD / 46732 / Change in PI Approval Letter
3. / M/s. Govt. Medical College / 20970 / CT NOC Approval Letter
4. / M/s. Boehringer / 49459 / PA Approval Letter
5. / M/s. Parexel / 1743 / Change in PI Approval Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Merit Medical Systems India Pvt. ltd., / 45010 / Form 10 Query Letter
M/s. Becton Dickinson India Pvt. ltd., / 45777 / Query Letter
M/s. Cure Surgicals. / 43735 / Query letter
M/s. Boston Scientific India Pvt., Ltd., / 43208 / Query letter
M/s. Max Neeman Medial International ltd., / 46625 / Query Letter
M/s. B.Braun Medical (India) Pvt ltd., / 44216 / Query Letter
M/s. Biomet Orthopaedic India Private Limited / 46436 / Query Letter
M/s. India Medtronic Private Limited / 33466 / End F-10 Letter
M/s. Clairvoyance Consulting., / 43718 / End F-10 Letter
M/s. Biotronik Medical Devices India Pvt ltd. / 51339 / Query Letter
M/s. Abbott Healthcare Pvt. Ltd. / 51441 / Amendment
M/s. Joint Commissioner (KD), Thane. / 75367 / CLLA
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Medispec India Limited / 46639 / Query Letter
2. / M/s. Greentime Healthcare Pvt Ltd., / 49184 / T/L
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Lupin Ltd. / 45400, 49563 / 67704, 74650 / Deficiency Letter (2)
M/s Ranbaxy Lab. Ltd. / 48715 / 73104 / Deficiency Letter
M/s Hetero Labs / 44970 / 66733 / Deficiency Letter
M/s Apothecaries Ltd. / 40184 / 59220 / Deficiency Letter
M/s Intas pharmaceuticals / 43655 / 64924 / Deficiency Letter
M/s Troikaa Pharmaceuticals / 46640 / 69640 / Deficiency Letter
M/s Sun Pharmaceutical / 51439 / - / Deficiency letter
M/s Micro Labs Ltd. / 48097 / 72063 / Deficiency Letter
M/s Enaltec Labs Pvt. Ltd / 44355 / 65953 / Deficiency Letter
REGISRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERTEVA PHARMACEUTICAL / 44808 / CLARIFICATION LETTER
BAXTER INDIA PVT. LTD. / 38555 / CLARIFICATION LETTER
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Novartis Healthcare Pvt, Ltd / 11483, 48477 / Approval & Acknowledge Letter
2 / M/s Eli Lilly and Company India Pvt, ltd / 285 / Amendment Letter
3 / M/s Cadila Healthcare ltd / 41541 / Clarification letter
4 / M/s Agila Specialities Pvt, ltd / 49063 / Approval Letter
5 / M/s Reliance Life Sciences pvt, ltd / 49220, 48939, 48757, 48756 / Approval Letter
6 / M/s Pan Era Biotech Pvt, ltd / 44390, 44392, 44391 / Approval Letter
7 / M/s Wyeth ltd / 47161 / Clarification letter
8 / M/s Panav Bio-Tech / 215, / Approval & Amendment Letter
9 / M/s GSK Pharmaceuticals ltd / 34469, 37473 / Approval & Amendment Letter
10 / M/s Intas Biopharmaceutical ltd / 47750, 587 / Clarification letter
11 / M/s Roche Product India Pvt, ltd / 46628 / Clarification letter
12 / M/s Cadila Healthcare ltd / 49773 / Clarification letter
13 / M/s Human Biological Institute / 37540 / Approval Letter
14 / M/s Kedrion Biopharma India Pvt, ltd / 51037 / Approval & Continuation letter
15 / M/s Bharat Biotech International ltd / 45950 / Approval letter
16 / M/s Veeda Clinical Research Pvt, ltd / 925 / Approval letter
17 / M/s Norwich Clinical Services Pvt, ltd / 1317 / Approval letter
18 / M/s Bharat Serum and vaccine ltd / 43283 / Approval letter
19 / M/s Merck Specialities Pvt, ltd / 43172 / Clarification letter
SEC MEETING
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Sanofi Pasteur India Pvt, ltd / Invitation letter
2 / M/s Bharat Biotech International ltd / Invitation letter
3 / M/s Cadila Pharmaceutical ltd / Invitation letter
4 / M/s Sinopharma India Pvt, ltd / Invitation letter
5 / M/s Human Biological Institute / Invitation letter
6 / M/s Novartis Healthcare Pvt, ltd / Invitation letter
7 / M/s Synergy Diagnostics / Invitation letter
8 / M/s Dr. Reddy Laboratories Ltd / Invitation letter
9 / M/s FDC ltd / Invitation letter
10 / M/s GSK Pharmaceutical ltd / Invitation letter