LETTERS FOR ISSUE ON17.07.2014
INTERNATIONAL CELL (MISC.)
S. No / Firm Name / Type of Letter1. / M/s. Micro Labs Ltd. / Letter
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Global Pharma Healthcare Ltd., Thiruporur / 16149, 33947 / Query
02 / M/s. Choksi Imaging Ltd., C/o M/s. Unijules Lifesciences Ltd., Nagpur / 40384 / Query
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Mainpal Acunova Ltd., Bangalore / 41322 / Approval
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 25325 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 25324 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 25359 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 25322 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 24800 / Approval Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 25201 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 25464 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 26181 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 26178 / Approval Letter
M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 15076 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 25626 / Clarification Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 25627 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Navi Mumbai-400614 / 23980 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 25836 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 25837 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 25972 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 25690 / Approval Letter
M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 25424 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 044 / 23810 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 25450 / Approval Letter
M/s. Watson Pharma Pvt Ltd ., Navi Mumbai-400614 / 24319 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Azidus Laboratories Ltd., Chennai-600 048 / 26353 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 23707 / Test Licence
M/s. Hetero Labs Ltd., Hyderabad-500 018 / 25916 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 25734 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 064 / 23797 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 064 / 23798 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 064 / 23799 / Test Licence
M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 27741 / Test Licence
M/s. Wockhardt Ltd CPB, Clinical Pharmacokinetics and Biopharmaceuties Dept., Aurangabad-431 210 / 25467 / Test Licence
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERM/s. Glenmark Pharmaceuticals / - / Letter
Dr. YC Janardhan Reddy / - / Letter
M/s Emcure Pharmaceuticals / - / Letter
M/s Cadila Healthcare / - / Letter (2)
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. BL Lifesciences Pvt. Ltd. / 18878 / Approval (F-RC)
M/s. Advanced Life Sciences Pvt. Ltd. / 15886 / Approval (R-RC)
M/s. Maquet Medical India Pvt. Ltd. / 22517 / Approval (R-RC)
M/s. Maquet Medical India Pvt. Ltd. / 22517 / Approval (R-IL)
M/s. Surgimed. / 59300 / Approval (R-RC)
M/s. Synthes Medical Pvt. Ltd. / 24462 / Approval (F-IL)
M/s. Becton Dickinson India Pvt. Ltd. / 18578 / Approval (R-E-IL)
M/s. B. Braun Medical (India) Pvt. Ltd. / 20500 / Approval Letter
The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Ahmedabad (CLAA)
(M/s. Meril Life Sciences Pvt. Ltd.) / FTS-32900 / Approval Letter
The Director of Drugs controller, Chennai (CLAA)
The Deputy Drugs Controller (I), Chennai (CLAA)
(M/s. SIDD Life Sciences Pvt. Ltd.) / FTS-33944 / Approval Letter
The Deputy Drugs Controller (I), Mumbai / 21514 / Letter
All port offices of CDSCO. / 21514 / Letter
All port offices of CDSCO. / 18118 / Letter
All port offices of CDSCO. / 17542 / Letter
M/s. Covidien Healthcare India Pvt. Ltd. / 17542 / Query Letter
M/s. Covidien Healthcare India Pvt. Ltd. / 18118 / Query Letter
M/s. Johnson & Johnson. / 21514 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Siemens Limited. / 20159 / Approval (IL)
M/s. Reliance Life Sciences Pvt. Ltd. / 21740 / Approval (TL)
M/s. Johnson & Johnson Ltd. / 20534 / Approval Letter
M/s. Alere Medical Pvt. Ltd. / 7091 / Query Letter
M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 18817 / Query Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Arion Healthcare / 14716 / Letter
M/s. Glenmark Pharmaceuticals Ltd., / 27427 / Approval Letter
M/s. Boehringer Ingelheim / 20138 / Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s VHB Life sciences Ltd / 16431 / Clarification letter
2 / M/s Manipal Acunova Ltd / 21870 / Clarification letter
3 / M/s PanEra Biotech Pvt, Ltd / 14506 / Clarification letter
4 / M/s GSK Pharmaceuticals ltd / 23412, 11478 / Clarification letter
5 / M/s Intas Pharmaceutical Ltd / 18362 / Clarification letter
6 / M/s Reliance Life Sciences Pvt, ltd / Clarification letter
7 / M/s Hipra (I) pvt, ltd / Clarification letter
8 / M/s Life Cell International Pvt, ltd / Clarification letter
BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Wokhardt Ltd / 30509 (fts no) / Approval letter
2 / M/s Serum Institute of India Ltd / 37937 (fts no) / Approval letter
COSMETICS DIVISTION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Lure Nails and Spa solution Pvt. Ltd., New Delhi / 22378 / Deficiency Letter
M/s. Major Brands India Pvt. Ltd, Mumbai / 22187 / Deficiency Letter
M/s. Makoha General Trading Company Pvt. Ltd, Coimbatore / 23256 / Deficiency Letter
M/s. Beverly Hills Marketing Pvt. Ltd, New Delhi / 21831 / Deficiency Letter
M/s. Jaron Cosmetique Pvt. Ltd, Mumbai / 23282 / Deficiency Letter
M/s. L’Oreal India Pvt. Ltd, Mumbai / 14639, 15483, 15909, / Deficiency Letter
M/s. SMI Traders and Distributors Pvt. Ltd, Tamilnadu / 20144 / Approval Letter
M/s. M.S. Distributors, Pvt. Ltd, New Delhi / 19905 / Approval Letter
M/s. M.S. Distributors, Pvt. Ltd, New Delhi / 19906 / Approval Letter
M/s. Alcon Laboratories (I) Pvt. Ltd, Bangalore / 17416 / Approval Letter
M/s. Classic International, Delhi / 2564, 22415 / Approval Letter
M/s. Nivea India Pvt. Ltd, Mumbai / 18580 / Approval Letter
M/s. Wella India Haircosmetics Pvt. Limited, Mumbai / 17141 / Approval Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. BMS / 43781 / Clarification Letter
2. / M/s. Sristek / 17857/12557 / Clarification Letter
3. / M/s. Pfizer / 16122/4673 / Clarification Letter
4. / M/s. Biogen Idec / 7521 / TL Approval Letter
5. / M/s. Novartis / 21867/19645/20802/
21871/5908/1139 / PA Approval/Change in PI Approval/TL Approval/Clarification Letter
6. / M/s. Quintiles / 17637 / PA Approval letter
7. / M/s. Novo Nordisk / 23644 / TL Approval Letter
8. / M/s. Boehringer / 2450 / PA Approval Letter
9. / M/s. Kendle / 2201 / Change in site Approval