LETTERS FOR ISSUE ON02.12.2014
New drug
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERM/s. Sun Pharmaceuticals Industries Ltd. / - / Query Letter
Vaccine Division
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Dr. Reddy’s Laboratories Ltd / 39495 / Approval Letter
2 / M/s Novo Nordisk India Pvt, Ltd / 43191 / Approval Letter
3 / M/s Biological E. ltd / 43760 / Approval Letter
4 / M/s USV ltd / 30214, 34391 / Approval Letter
5 / M/s Zoetis India Pvt, Ltd / 38332 / Amendment Letter
6 / M/s Hetero Drugs , ltd / 41499 / Approval Letter
7 / M/s Wockhardt Research Centre / 37138 / Clarification letter
8 / M/s Sun Pharmaceutical Industries Ltd. / 35223 / Clarification letter
9 / M/s Biocon Limited / 43427 / Clarification letter
10 / M/s Reliance Life Science Pvt. Ltd / Clarification letter
11 / M/s L.V Prasad Eye Institute / Clarification letter
12 / M/s Trigenesis Life Science Pvt, ltd / Approval Letter
13 / M/s Kemwell Biopharma Pvt, ltd / 22008 / Approval Letter
14 / M/s Seasons Biologicals Pvt, ltd / 14799 / Approval Letter
Medical Device
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Abbott Healthcare Pvt. Ltd. / 31911 / Letter
M/s. Boston Scientific India Pvt. Ltd. / 31991 / Query Letter
M/s. Becton Dickinson India Pvt. Ltd. / 34569 / Query Letter
M/s. Biomet Orthopaedic India Pvt. Ltd. / 39030 / Query Letter
M/s. Becton Dickinson India Pvt. Ltd. / 44247 / Query Letter
M/s. Bard India Healthcare Pvt. Ltd. / 30183 / Query Letter
M/s. Coloplast (India) Pvt. Ltd. / 40281 / Query Letter
M/s. Depuy Medical Pvt. Ltd. / 33238 / Query Letter
M/s. Johnson & Johnson Ltd. / 27562 / Query Letter
M/s. Nipro India Corporation Pvt. Ltd. / 30224 / Query Letter
M/s. Teleflex Medical Pvt. Ltd. / 43511 / Query Letter
Diagnostic Division
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Alere Medical Pvt. Ltd. / 40933 / Query Letter
M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 32456 / Query Letter
M/s. Biomerieux India Pvt. Ltd. / 40107 / Letter
M/s. Biomerieux India Pvt. Ltd. / 40108 / Query Letter
M/s. Dynamic Tracom Pvt. Ltd. / 38404 / Query Letter
M/s. DSS Imagetech Pvt. Ltd. / 23354 / Query Letter
M/s. Mindray Medical India Pvt. Ltd. / 40484 / Query Letter
M/s. Roche Diagnostics India Pvt. Ltd. / 34141 / Query Letter
M/s. Roche Diagnostics India Pvt. Ltd. / 38285 / Letter
M/s. R-BiopharmaNeugen Pvt. Ltd. / FTS-63298 / Query Letter
M/s. Randox Laboratories (India) Pvt. Ltd. / 37711 / Query Letter
Written Confirmation
International Cell
S. No / Firm Name / Type of Letter1. / M/s. Cipla Limited, Pune / WC Certificate
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 / 43964 / Amendment Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 46359 / Amendment Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 44912 / Test Licence
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 45602 / Amendment Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 45610 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 44962 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 45681 / Approval Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 45603 / Clarification Letter
M/s. Cadila Pharmaceutical Ltd., Dholka-387 810, Ahmedabad / 39960 / Test Licence
M/s. Cipla Limited, Mumbai-400 008 / 45648 / Test Licence
M/s. Cipla Limited, Mumbai-400 008 / 45645 / Test Licence
M/s. Cipla Limited, Mumbai-400 008 / 45646 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 45002 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 44999 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 45487 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 45488 / Approval Letter
M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 44197 / Amendment Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 45544 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 42459 / Test Licence
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 42398 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-411 042 / 45780 / Approval Letter
M/s. Om Sai Clinical Research Pvt. Ltd., Sangli-416 416, Maharsahtra / 45562 / Clarification Letter
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 45179 / Clarification Letter
M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 44370 / Test Licence
M/s. Synapse Labs Pvt. Ltd., Kharadi, Pune-411 014 / 43665 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 46245 / Test Licence
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Abaris Healthcare Pvt. Ltd., Gujarat / 65268, 65265, 66898 / Approval
02 / M/s. Goa Formulation Ltd., C/o. M/s. Parenterals Drugs (I) Ltd., M.P. / 56879 / Approval
03 / M/s. HLL Lifecare Ltd., M/s. Innvol Medical India Ltd., T.N. / 69184 / Approval
Registration
S. No. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1 / APC Pharmaceuticals & Chemicals / 45117 / Approval
2 / Shah TC / 30299 / Approval
3 / DPB Antibiotics (P) Ltd / 41619 / Approval
4 / Novartis India Ltd / 45332 / Approval
5 / BASF India Ltd / 36295 / Approval
6 / Apple Lifecare India Pvt Ltd / 46374 / Approval
7 / Uni-Chemie International / 43321 / Clarification
8 / Allied Pharma Solutions / 36535 / Clarification
Global Clinical Trial
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Quintiles / 44652 / TL Approval Letter
2. / M/s. PPD / 46167 / TL & Export NOC Approval
3. / M/s. Novo Nordisk / 40084 / Additional sites approval
4 / M/s. Novartis / 38573 / Additional Sites Approval
5 / M/s. ICON / 44117 / Change in Pi Approval
6 / M/s. Max Neeman / 44301 / Amendment in TL Approval
7 / M/s. Boehringer / 42665 / Additional Sites Approval
8 / M/s. BMS / 43073 / Change in site address Approval
9 / M/s. Pharmanet / 36481 / Change in Pi Approval
10 / M/s. Excel Life Sciences / 39407 / Clarification Letter
11 / M/s. Accutest / - / Clarification Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 39245 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 45680 / Approval Letter
M/s. APL Research Centre, Hyderabad-500 072 / 44968 / Amendment Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 45448 / Clarification Letter
M/s. Cipla Limited, Mumbai-400 008 / 45647 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 46497 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 46197 / Test Licence
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 45508 / Approval Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 45027 / Approval Letter
M/s. Hetero Labs Ltd., Hyderabad-500 018 / 44699 / Clarification Letter
M/s. Hetero Labs Ltd., Hyderabad-500 018 / 45644 / Test Licence
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 45500 / Test Licence
M/s. Lupin Limited (Research Park), Pune-411 042 / 45608 / Clarification Letter
M/s. Lupin Limited (Research Park), Pune-411 042 / 45779 / Approval Letter
M/s. Om Sai Clinical Research Pvt. Ltd., Sangli-416 416, Maharsahtra / 47152 / Clarification Letter
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 46263 / Test Licence
M/s. Synapse Labs Pvt. Ltd., Kharadi, Pune-411 014 / 47517 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 43961 / Test Licence