LETTERS FOR ISSUE ON 19.02.2015
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 2734 / Approval Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 3877 / Test Licence
M/s. APL Research Center, Hyderabad-500 038 / 3404 / Reminder Query
M/s. APL Research Center, Hyderabad-500 038 / 4680 / Reminder Query
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 4676 / Reminder Query
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 3917 / Reminder Query
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 2289 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 2288 / Approval Letter
M/s. Cipla Limited, Mumbai-400 013 / 53 / Approval Letter
M/s. Cipla Limited, Mumbai-400 013 / 1936 / Test Licence
M/s. Cipla Ltd., Mumbai-400 008 / 983 / Reminder Query
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 2363 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 2424 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 4124 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 2621 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 2622 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 2732 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 2731 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 2631 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 2620 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 2620 / Amendment Letter
M/s. Ranbaxy Laboratories Ltd., New Delhi / 2682 / Approval Letter
M/s. Semler Research Center, Bangalore-560078 / 2672 / Approval Letter
M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 059 / 4382 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 2433 / Test Licence
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 2585 / Approval Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Maya Clinicals / - / NDAC Meeting Letter
2. / M/s. Novartis / - / NDAC Meeting Letter
3. / M/s. Kendle / - / NDAC Meeting Letter
4. / M/s. Boehringer / - / NDAC Meeting Letter
WRITTEN CONFIRMATION/NOC
S. No / Firm Name / Type of Letter1. / M/s Ranbaxy Laboratories Ltd. Gurgaon,Haryana / Approval letter
2. / M/s IPCA Laboratories Ltd. Indore ,Madhya Pradesh / Approval letter
3. / M/s. Cyro Healthcare Pvt. Ltd.Manesar ,Haryana / Approval letter
4 / M/s Ranbaxy Laboratories Ltd. Gurgaon,Haryana / Approval letter
5 / M/s S Kant Healthcare Ltd. Valsad, Gujarat / Approval letter
6 / M/s IPCA Laboratories Ltd. Indore ,Madhya Pradesh / Approval letter
7 / M/s Centurion Laboratories Gorwa,Vadodara / letter
8 / M/s D.K. Pharma Chem Pvt. Ltd. Thane,Maharashtra / Approval letter
9 / M/s. Vital Healthcare Vapi,Gujarat / Approval
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Fresenius Medical Care India / 47964 / Approval Letter
M/s. Dr. Reddy;s Laboratories / 47604 / Amendment Letter
M/s. Troikaa Pharmaceuticaals Ltd., / 48344 / Amendment Letter
M/s. HLL Lifecare Limited / 58582 / Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Reckitt Benckiser (India) Pvt. Ltd. / 49080 / Approval (F-RC)
M/s. Reckitt Benckiser (India) Pvt. Ltd. / 49080 / Approval (F-IL)
M/s. Osstem Implant India Pvt. Ltd. / 4997 / Approval (R-RC)
M/s. Biotranik Medical Devices India Pvt. Ltd. / 50949 / Approval (R-E-RC)
M/s. Axon Medical Solutions Pvt. Ltd. / 1654 / Approval (F-IL)
M/s. Innvolution Healthcare Pvt. Ltd. / 1020 / Approval (F-IL)
The Drugs Licensing Authority, Uttarakhand (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Bio-Med Health Care Product Pvt. Ltd.) / FTS-3640 / Approval Letter
The Drugs Licensing Authority, Uttarakhand (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Global Medikit Ltd.) / FTS-2702 / Approval Letter
M/s. Piramal Enterprises Ltd. / Nil / Clarification Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. KHC Healthcare India Pvt. Ltd. / 49735 / Approval (IL)
M/s. Siemens Ltd. / 51258 / Approval (IL)
M/s. Thyrocare Technologies Ltd. / FTS-76410 / Approval (IL)
M/s. Roche Diagnostics India Pvt. Ltd. / 49878 / Approval (E-IL)
M/s. Beckman Coulter India Pvt. Ltd. / 48307 / Approval (TL)
M/s. Accurex Biomedical Pvt. Ltd. / 49554 / Approval Letter
M/s. KHC Healthcare India Pvt. Ltd. / 49735 / Query Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Sanofi Synthelabo Indai Ltd / 41845 / Clarification letter
2 / M/s Vesper Pharmaceuticals / 77080 (fts no) / Clarification letter
3 / M/s GSK Asia Pvt, ltd / 43699, 25527 / Clarification letter
4 / M/s Sanofi Pasteur India Pvt, ltd / 2155, 50145, / Approval Letter
5 / M/s Intas Pharmaceuticals ltd / Clarification letter
6 / M/s Boehringer Ingelheim India ltd / 47534 / Approval letter
7 / M/s Zoetis india ltd / 3242 / Approval letter
8 / M/s Cadila Healthcare , ltd / 47346 / Clarification letter
9 / M/s Reliance life sciences Pvt, ltd / 47606 / Clarification letter
10 / M/s Synergy Diagnostics Pvt, ltd / 46261 / Clarification letter
11 / M/s Novartis Healthcare Pvt, ltd / 51075 / Clarification letter
12 / M/s LG Lifesciences India pvt, ltd / 41979 / Clarification letter
13 / M/s Hetero Drugs ltd / Clarification letter
14 / M/s Shantha Biotechnics ltd / 1100 / Clarification letter
15 / M/s Biocon ltd / 46502 / Clarification letter
16 / M/s Eli Lilly and company India pvt, ltd / 48066 / Clarification letter
17 / M/s Virbac Animal Health India Pvt, ltd / 1725, 1701, 1700 / Continuation letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Synokem / - / - / SECLetter
M/s Pfizer / - / - / SEC Letter
Themis Medicare / - / - / Query Letter
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Akums Drugs & Pharmaceuticals Ltd., Uttarakhand / 6036 / Approval
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Boehringer / 1347 / TL Approval Letters
2. / M/s. Quintiles / 2108/2917 / Clarification Letters
3. / M/s. Pfizer / 360 / TL Approval
4. / M/s. Novartis / 1512/1930 / TL & Export NOC Approval
5. / M/s. Roche / 50873 / PA Approval letter