LETTERS FOR ISSUE ON 30.03.2015
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 / 6897 / Approval Letter
M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 3481 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 6764 / Approval Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 6170 / Approval Letter
M/s. Famy Care Ltd., Navi Mumbai-400 709 / 6898 / Test Licence
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 6743 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 5251 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 5250 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 6808 / Clarification Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 6809 / Clarification Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 6807 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 6835 / Approval Letter
M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 6306 / Clarification Letter
M/s. Ranbaxy Laboratories Ltd., New Delhi / 3405 / Approval Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 6749 / Approval Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 6750 / Approval Letter
M/s. Sun Pharma Advanced Research Company Ltd.
Tandalja, Vadodara-390 020 / 27090 (reply 4850) / Rejection Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 6832 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 6801 / Approval Letter
M/s. Vimta Labs Ltd., Hyderabad-500051 / 6347 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 6814 / Approval Letter
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Beryl Drugs Pvt. Ltd., M.P. / 7787 / Query
02 / M/s. Dr. Reddy’s Laboratories Ltd., C/o. M/s. Amanta Healthcare, Gujarat / 8608 / Approval
03 / M/s. Glenmark Pharmaceuticals Ltd., C/o. M/s. Amanta Healthcare, Gujarat / 6704 / Approval
04 / M/s. Wexford Laboratories Pvt. Ltd., C/o. M/s. Amanta Healthcare, Gujarat / 7779 / Approval
05 / M/s. Axa Parenterals Ltd., Uttarakhand / 9294 / Approval
06 / M/s. Claris Life Sciences C/o. M/s. Claris Otsuka Pvt. Ltd., Gujarat / 12090 / Approval
07 / M/s. Unique Pharmaceuticals Laboratory C/o. M/s. J. B. Chemicals & Pharmaceuticals Ltd., Gujarat / 11377 / Approval
08 / M/s. Sun Pharmaceuticals Ltd., Gujarat / 10496 / Approval
09 / M/s. Fresenius Kabi Oncology Ltd., C/o. M/s. Cipla Ltd., Goa / 8733 / Approval
10 / M/s. Avision Pharmaceuticals Pvt. Ltd., M/s. Abaris Healthcare Pvt. Ltd., Gujarat / 7782 / Query
11 / M/s. Alembic Pharmaceuticals Ltd., C/o. M/s. Amanta Healthcare, Gujarat / 4065 / Approval
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s MSD Pharmaceutical Pvt. Ltd., / 50451 / - / Amendment Letter
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Deccan Nutraceuticals Pvt. Ltd., Pune Maharashtra. / WC Certificate
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Biosensors Interventional Technologies (India) Pvt. Ltd., / 5454 / Approval (F-RC)
M/s. Biosensors Interventional Technologies (India) Pvt. Ltd., / 5454 / Approval (F-IL)
M/s. Gland Pharma Ltd., / 5708 / Approval (F-IL)
M/s. Somani Agencies. / 4738 / Approval (F-IL)
M/s. Fresenius Medical Care India Pvt. Ltd.
The DDC, Chennai.
The Drugs Controller, Chennai.
The ADC(I), Chennai.
The ADC(I), Chennai. / 48221 / Approval Letter
The State Drugs Controller, Haryana (CLAA)
The DDC (I), Ghaziabad (CLAA)
(M/s. Lars Medicare Pvt. Ltd.,) / FTS-5289 / Approval Letter
M/s. Dentsply India Pvt. Ltd. / 48495 / Approval Letter
M/s. SiroClinpharm Pvt. Ltd. / 5455 / Letter
M/s. Covidien Healthcare Pvt. Ltd. / 2723 / Letter
M/s. Johnson & Johnson Ltd. / 49491 / Query Letter
M/s. Johnson & Johnson Ltd. / 50750 / Query Letter
M/s. Shreyaas Healthcare. / 4431 / Query Letter
M/s. SandorMedicaids Pvt. Ltd. / FTS-9490 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Beckman Coulter India Pvt. Ltd. / 50781 / Approval (IL)
M/s. Beckman Coulter India Pvt. Ltd. / 2360 / Approval (IL)
M/s. Bio Rad Laboratories (India) Pvt. Ltd. / 3166 / Approval (IL)
M/s. Omega Dx (Asia) Pvt. Ltd. / 2517 / Approval (IL)
M/s. Syndicate Diagnostics Pvt. Ltd. / 2997 / Approval (IL)
M/s. Beckman Coulter India Pvt. Ltd. / 3117 / Query Letter
M/s. Biogeny Diagnostic Pvt. Ltd. / 146 / Approval (IL)
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Amgen / 7427 / Clarification Letter
2. / M/s. Sanofi / 3675 / Clarification Letter
3. / M/s. Roche / 2284 / TL Approval letter
4. / M/s. Maya Clinicals / 5590 / Additional sites Approval
5. / M/s. Novartis / 1925 / TL Approval Letter
6. / M/s. Maya Clinicals / - / Clarification letter
7. / M/s. Axis Clinicals / - / Clarification Letter