LETTERS FOR ISSUE ON26.12.2014
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Biocon Ltd., / Nil / SEC Letter
M/s. Torrent Pharmaceuticals Pvt. Ltd., / 46928 / Letter
M/s. Sun Pharmaceuticals Industries Ltd., / 42215 / Letter
M/s. Dagon Pharmaceuticlas Pvt. Ltd., / 49889 / Letter
M/s. Shreya Life Sciences Pvt. Ltd., / 44562 / Letter
M/s. Shreya Life Sciences Pvt. Ltd., / 50793 / Letter
M/s. Unibiotech Formulations / 43441 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 35196 / Clarification Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 42790 / Letter
M/s. Elder Pharmaceuticals / 10251 / Letter
M/s. SunGlow Pharmaceuticals, / 42448 / Clarification Letter
M/s. Sain Medicaments Pvt. Ltd., / 49772 / Letter
M/s. Dr. Sain’s Laboratories, / 50681 / Letter
M/s. Next Wave (India) / 41569 / Letter
M/s. Gelnova Laboratories (I) Pvt. Ltd., / 43287 / Letter
M/s. Gelnova Laboratories (I) Pvt. Ltd., / 43250 / Letter
M/s. Cartel Laboratories / 13696 / Letter
M/s. Abaris Healthcare / 49706 / Letter
M/s. Goodman Pharmaceuticals Pvt. Ltd., / 56798 / Clarification Letter
M/s. Aeon Formulations Pvt. Ltd., / 48401 / Clarification Letter
M/s. Bayer Pharmaceuticals Pvt. Ltd., / 30020 / Letter
M/s. Bayer Pharmaceuticals Pvt. Ltd., / 29268 / Letter
Vaccine Division
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Biovet Pvt, ltd / 45933 / Approval Letter
2 / M/s Apac Biotech Pvt, ltd / Clarification Letter
3 / M/s Intas Pharmaceuticals ltd / 17601 / Clarification Letter
4 / M/s Reliance Life Sciences Pvt, ltd / 45834, 48326 / Approval & Clarification Letter
5 / M/s Novo Nordisk India ltd / 39300 / Approval Letter
6 / M/s Novartis Healthcare Pvt, ltd / 12296 / Approval Letter
7 / M/s Pfizer Product India Pvt, ltd / 46246 / Approval Letter
8 / M/s Ferring Pvt, ltd / 47384 / Approval Letter
9 / M/s Zoetis India Pvt, ltd / 48129, 44153, 45908 / Continuation & Clarification Letter
10 / M/s Hipra Ltd / 45089 / Clarification Letter
11 / M/s Sanofi Synthelabo India ltd / Clarification Letter
12 / M/s Trigensis Life Sciences Pvt, ltd / Clarification Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/sCipla Limited / 46901 / 70043 / Query Letter
M/s Novartis India Ltd., / 45372 / 67713 / Query Letter
M/s Troikaa Pharmaceuticals Ltd., / 42090 / 62312 / Amendment Letter
M/s ManipalAcunova Ltd., / 47010 / 70228 / Additional site letter
M/s Serdia Pharmaceuticals (I) Pvt. Ltd., / 43279 / 63906 / Amendment Letter
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 / 49130 / Clarification Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 42088 / Amendment Letter
M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003, Andhra Pradesh / 49706 / Clarification Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 48547 / Clarification Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 48158 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 48157 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 49238 / Test Licence
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 48394 / Clarification Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 48510 / Clarification Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 48512 / Test Licence
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 48574 / Approval Letter
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 49985 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 48492 / Clarification Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 6636 / Rejection Letter
M/s. Lambda Therapeutic Research Ltd., Navi Mumbai-400 614 / 48701 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 49566 / Test Licence
M/s. Panacea Biotec Ltd., New Delhi-110 044 / 48804 / Test Licence
M/s. Panexcell Clinical Lab Pvt. Ltd., Navi Mumbai-400 701 / 49588 / Approval Letter
M/s. Sipra Labs Limited, Hyderabad-500 018 / 48163 / Approval Letter
M/s. Synapse Labs Pvt. Ltd., Kharadi, Pune-411 014 / 49011 / Test Licence
M/s. Themis Medicare Ltd., Mumbai-400 104 / 64709 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 47911 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 48428 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 45752 / Approval Letter
M/s. Wockhardt Limited, Aurangabad-431 006 / 48545 / Approval Letter
Medical Device
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Hester Diagnostics Pvt. Ltd. / 41345 / Letter
M/s. Hester Diagnostics Pvt. Ltd. / 41344 / Letter
M/s. Stryker India Pvt. Ltd. / 38783 / Query Letter
Diagnostic Division
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Abbott Healthcare Pvt. Ltd. / 42060 / Query Letter
M/s. Agappe Diagnostics Ltd. / 44249 / Query Letter
M/s. Beckman Coulter India Pvt. Ltd. / 44717 / Query Letter
M/s. Biocell Medicare. / 42522 / Query Letter
M/s. Biomerieux India Pvt. Ltd. / 47644 / Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Biocon Ltd., / Nil / SEC Letter
M/s. Torrent Pharmaceuticals Pvt. Ltd., / 46928 / Letter
M/s. Sun Pharmaceuticals Industries Ltd., / 42215 / Letter
M/s. Dagon Pharmaceuticlas Pvt. Ltd., / 49889 / Letter
M/s. Shreya Life Sciences Pvt. Ltd., / 44562 / Letter
M/s. Shreya Life Sciences Pvt. Ltd., / 50793 / Letter
M/s. Unibiotech Formulations / 43441 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 35196 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 42790 / Letter
M/s. Elder Pharmaceuticals / 10251 / Letter
M/s. SunGlow Pharmaceuticals, / 42448 / Letter
M/s. Sain Medicaments Pvt. Ltd., / 49772 / Letter
M/s. Dr. Sain’s Laboratories, / 50681 / Letter
M/s. Next Wave (India) / 41569 / Letter
M/s. Gelnova Laboratories (I) Pvt. Ltd., / 43287 / Letter
M/s. Gelnova Laboratories (I) Pvt. Ltd., / 43250 / Letter
M/s. Cartel Laboratories / 13696 / Letter
M/s. Abaris Healthcare / 49706 / Letter
M/s. Goodman Pharmaceuticals Pvt. Ltd., / 56798 / Letter
M/s. Aeon Formulations Pvt. Ltd., / 48401 / Letter
M/s. Bayer Pharmaceuticals Pvt. Ltd., / 30020 / Letter
M/s. Bayer Pharmaceuticals Pvt. Ltd., / 29268 / Letter
Global Clinical Trial
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Max Neeman / 48287 / TL Approval Letter
2. / M/s. BIOCAD / 48005 / Clarification Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/sCipla Limited / 46901 / 70043 / Query Letter
M/s Novartis India Ltd., / 45372 / 67713 / Query Letter
M/s Troikaa Pharmaceuticals Ltd., / 42090 / 62312 / Amendment Letter
M/s Manipal Acunova Ltd., / 47010 / 70228 / Additional site letter
M/s Serdia Pharmaceuticals (I) Pvt. Ltd., / 43279 / 63906 / Amendment Letter
M/s Intas / - / - / SEC Letter
M/s GSK / - / - / SEC Letter
M/s Eisai / - / - / SEC Letter
M/s Troikaa / - / - / SEC Letter
M/s Hetero / - / - / SEC Letter