LETTERS FOR ISSUE ON17.12.2014
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 / 43966 / Clarification Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 47097 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 47410 / Approval Letter
M/s. Axis Clinicals Ltd., Hyderabad-500 049 / 47407 / Clarification Letter
M/s. Axis Clinicals Ltd., Hyderabad-500 049 / 47406 / Clarification Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 47409 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 47408 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 47280 / Test Licence
M/s. Clinigene International Ltd., Bangalore-560 100 / 47075 / Test Licence
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 47006 / Clarification Letter
M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 47079 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 47082 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 47110 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46755 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46754 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 47484 / Approval Letter
M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 46852 / Approval Letter
M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 46712 / Approval Letter
M/s. Synapse Labs Pvt. Ltd., Kharadi, Pune-411 014 / 48172 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 47339 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 46845 / Approval Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Ipca Laboratories Ltd., / 43726,43729 / 64938,64936 / Query Letter(2)
M/s Cadila Healthcare Ltd., / 64844 / - / Query Letter
M/s Cadila Pharmaceuticals Limited / 42103 / 62310 / Query Letter
M/s Themis Medicare Ltd., / 46388 / 69182 / Query Letter
M/s Zim Laboratories Ltd. / 28990 / - / Approval Letter
M/s MSN Laboratories Ltd., / 22198,37579 / - / Approval Letter(1)/ Query Letter(1)
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. B. Braun Medical (India) Pvt. Ltd. / 42107 / Approval (F-RC)
M/s. B. Braun Medical (India) Pvt. Ltd. / 42107 / Approval (F-IL)
M/s. Globe Bio Medicals. / 43724 / Approval (F-RC)
M/s. Globe Bio Medicals. / 43724 / Approval (F-IL)
M/s. Terumo India Pvt. Ltd. / 40579 / Approval (F-RC)
M/s. Terumo India Pvt. Ltd. / 40579 / Approval (F-IL)
M/s. St. Jude Medical India Pvt. Ltd. / 38898 / Approval (R-RC)
M/s. St. Jude Medical India Pvt. Ltd. / 38898 / Approval (R-IL)
M/s. Teleflex Medical Pvt. Ltd. / 43405 / Approval (R-RC)
M/s. Teleflex Medical Pvt. Ltd. / 43405 / Approval (R-IL)
M/s. Abbott Healthcare Pvt. Ltd. / 28440 / Approval (E-RC)
M/s. Abbott Healthcare Pvt. Ltd. / 28440 / Approval (E-IL)
M/s. Boston Scientific India Pvt. Ltd. / 35477 / Approval (R-E-RC)
M/s. Boston Scientific India Pvt. Ltd. / 35477 / Approval (R-E-IL)
M/s. Boston Scientific India Pvt. Ltd. / 37761 / Approval (R-E-RC)
M/s. Boston Scientific India Pvt. Ltd. / 37761 / Approval (R-E-IL)
M/s. Totipotent SC Scientific Product Pvt. Ltd. / 43091 / Approval (R-E-RC)
M/s. Bioaide Technologies Pvt. Ltd. / 43994 / Approval (F-IL)
M/s. Venus Remedies Ltd. / FTS-52753 / Approval (F-IL)
The State Drugs Controller Haryana (CLAA)
The Deputy Drugs Controller (I) Ghaziabad (CLAA)
(M/s. Mais India Medical Devices Pvt. Ltd.) / FTS-55041 / Approval Letter
M/s. Johnson & Johnson Ltd. / 38044 / Letter
M/s. Johnson & Johnson Ltd. / 43214 / Letter
M/s. Meril Life Sciences Pvt. Ltd. / 40231 / Approval Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Abbott Healthcare Pvt. Ltd.
All port offices of CDSCO. / 38148 / Approval (IL)
M/s. AgappeDiagnostics Ltd.
All port offices of CDSCO. / 40650 / Approval (IL)
M/s. Aspen Diagnostics Pvt. Ltd.
All port offices of CDSCO. / 40491 / Approval (IL)
M/s. Beckman Coulter India Pvt. Ltd.
All port offices of CDSCO. / 40724 / Approval (IL)
M/s. M M Trading Company.
All port offices of CDSCO. / 43200 / Approval (IL)
M/s. SD Biosensor Healthcare Pvt. Ltd.
All port offices of CDSCO. / 38901 / Approval (IL)
M/s. Roche Diagnostics India Pvt. Ltd.
All port offices of CDSCO. / 40816 / Approval (E-IL)
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERDr. Ramesh Kumar / - / Query Letter
Dr. Gadipudi Avanthi / - / Query Letter
Dr. Neena Khanna / - / Meeting Notice 22-12-2014 (Dermatology)
M/s. Boehringer / - / Meeting Notice 24-12-2014 (Metabolism)
M/s. Lupin / - / Meeting Notice 24-12-2014 (Metabolism)
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Novartis / 43560 / Change in PI Approval
2. / M/s. Cliantha / 44364 / Change in PI Approval
3. / M/s. Pfizer / 47035 / Clarification Letter
4. / M/s. Boehringer / 46609 / Clarification Letter
5. / M/s. Klinera / 45412 / Clarification Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS4 / M/s Shantha Biotechnics ltd / 27781 / Clarification Letter
6 / M/s Novo Nordisk India Pvt, ltd / 45996 / Clarification Letter
7 / M/s Biocon ltd / 42945 / Clarification Letter
8 / M/s Symbio Generrics India Pvt, ltd / 34010 / Clarification Letter
9 / M/s Merck Specialities Pvt, Ltd / 30109 / Clarification Letter
10 / M/s Sanofi Synthelabo (India) Ltd. / 27484 / Approval letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Akums Drugs / 45794 / Approval Letter
M/s. Sun Pharmaceuticals / 49370 / Letter
M/s. USV Limited / 43331 / Letter
M/s. Adcock Ingram Healthcare / 34858 / Letter
M/s. Shield Healthcare / 50224 / Letter
M/s. Universal Twin Labs / 62138 / Letter
M/s. Sigma-Tau India Pvt. Ltd., / 44417 / Amendment Letter
M/s. Inventia Healthcare / 46990 / Letter
M/s. East West Pharma / 49247 / Letter
M/s. Glenwell Pharma / 49041 / Letter
M/s. Yash Medicare / 50301 / Letter
M/s. Cris Pharma / 42418 / Letter
M/s. Healthy Life Pharma / 42244 / Letter
M/s. Vivimed Labs / 42468 / Approval Letter
M/s. Darwin Formulations / 48042 / Letter
M/s. Takeda Pharmaceuticals / 36800 / Clarification Letter
M/s. Takeda Pharmaceuticals / 38653 / Clarification Letter