LETTERS FOR ISSUE ON24.12.2014

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 48277 / Approval Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 48278 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 48397 / Clarification Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 48396 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 48181 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 48453 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 48444 / Approval Letter
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 49417 / Clarification Letter
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 49789 / Clarification Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 48395 / Clarification Letter
M/s. Indoco Remedies Ltd., Mumbai-400 098 / 48558 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46663 / Amendment Letter
M/s. Lupin Limited (Research Park), Pune-411 042 / 48369 / Approval Letter
M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 49377 / Approval Letter
M/s. Ranbaxy Laboratories Ltd., New Delhi / 48384 / Approval Letter
M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 49902 / Approval Letter (Duplicate Copy)
M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 48490 / Approval Letter
M/s. Sipra Labs Limited, Hyderabad-500 018 / 48411 / Approval Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Biotronik Medical Devices India Pvt. Ltd. / 45456 / Approval (F-RC)
M/s. Emergo (India) Consulting Pvt. Ltd. / 45050 / Approval (F-RC)
M/s. Stryker India Pvt. Ltd. / 40859 / Approval (F-RC)
M/s. Dentacare. / 45086 / Approval (F-IL)
M/s. D B Lifescience. / 43358 / Approval (F-IL)
M/s. OptoEurocor Healthcare Limited. / 46323 / Approval (F-IL)
M/s. Clarivoyance Consulting. / 45061 / Approval Letter
M/s. Biomet Orthopaedics (I) Pvt. Ltd. / 44890 / Letter
M/s. Bard India Healthcare Pvt. Ltd. / 42664 / Letter
M/s. Johnson & Johnson Ltd. / 45351 / Letter
M/s. Johnson & Johnson Ltd. / 42549 / Letter
M/s. Johnson & Johnson Ltd. / 41904 / Letter
M/s. DattMediproducts Ltd. / 48021 / Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Abbott Healthcare Pvt. Ltd.
All port offices of CDSCO. / 42966 / Approval (IL)
M/s. Iris Healthcare Technologies Pvt. Ltd.
All port offices of CDSCO. / 38353 / Approval (IL)
M/s. Randox Laboratories (India) Pvt. Ltd.
All port offices of CDSCO. / 37711 / Approval (IL)
M/s. BiogeniuxMedsystems Pvt. Ltd.
All port offices of CDSCO. / 42959 / Approval (E-IL)
M/s. Maurya Sales Corporation.
All port offices of CDSCO. / 43454 / Approval (TL)

LVP DIVISION

S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS
01 / M/s. Unique Pharmaceuticals Laboratories, Gujarat / 73327 / Approval
02 / M/s. Akums Drugs & Pharmaceuticals, Haridwar / 71441 / Approval

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Novartis / 46695/48843/43135/47405 / Additional sites Approval/Clarification Letter
2. / M/s. Boehringer / 47830 / Additional sites Approval
3. / M/s. Pfizer / 43917 / CT NOC Approval Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy. No. / STATUS
1 / M/s Indian Immunological ltd / Clarification Letter
2 / M/s Sun Pharmaceuticals Industries ltd / 44102 / Clarification Letter
3 / M/s Ceva India Pvt, ltd / Clarification Letter
5 / M/s Stempeutics Research PVt, ltd / Clarification Letter
6 / M/s Sanofi Synethelabo India ltd / Clarification Letter
7 / M/s Roche Product India Pvt, ltd / 23436 / Clarification Letter
8 / M/s Bharat Biotech International Ltd / 36558 / Clarification Letter
9 / M/s Serum Institute of India ltd / 44083 / Approval Letter
10 / M/s EliLilly and company india Pvt, ltd / 18176 / Approval Letter

SEC MEETING

S. No. / COMPANY NAME / Dy. No. / STATUS
1 / M/s Cadila Healthcare ltd / Invitation Letter
2 / M/s Roche Product India Pvt, ltd / Invitation Letter
3 / M/s Reliance Life Sciences / Invitation Letter
4 / M/s Bharat Serum and vaccine Ltd / Invitation Letter
5 / M/s Biocon pvt, ltd / Invitation Letter
6 / Dr. Reddy Laboratories / Invitation Letter
7 / M/s QPS Bioserve India Pvt, ltd / Invitation Letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Bayer Zydus / - / Meeting Notice 13-01-2015 (Oncology)
M/s. Eisai Pharma / - / Meeting Notice 13-01-2015 (Oncology)
M/s. Hetero Labs / - / Meeting Notice 13-01-2015 (Oncology)
Dr. Anurag Srivastava / - / Meeting Notice 13-01-2015 (Oncology)
M/s. Novartis / - / Meeting Notice 13-01-2015 (Oncology)
M/s Bayer Pharma / - / Meeting Notice 13-01-2015 (Oncology)

REGISTRATION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
GSK PHARMACEUTICALS LTD. / 32743 / CLARIFICATION LETTER
SANOFI-SYNTHELABO INDIA LTD. / 35561 / CLARIFICATION LETTER
BAYER PHARMACEUTICALS PVT. LTD. / 33144 / CLARIFICATION LETTER
SHAH TC OVERSEAS / 43227 / CLARIFICATION LETTER

COSMETIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Zeus Wonder Trading, Mumbai / 42815 / Deficiency Letter
M/s. Avon Beauty Products Pvt. Ltd, Gurgaon / 44696 / Deficiency Letter
M/s. Ocea Marine Cosmetic Pvt. Ltd, Mumbai / 42707 / Approval Letter
M/s. Pigeon India Pvt. Ltd, Mumbai / 42539 / Approval Letter
M/s. J.K. International, Rohini Delhi, / 44316 / Approval Letter
M/s. Global Hospitality Brands, New Delhi / 44267 / Approval Letter
M/s. VLCC Healthcare Ltd, Haryana / 44446 / Approval Letter
M/s. Total Exports, Mumbai / 44707 / Approval Letter
M/s. Baccarose Perfumes & Beauty Product Pvt. Ltd, Mumbai / 30784 / Approval Letter
M/s. Baccarose Perfumes & Beauty Product Pvt. Ltd, Mumbai / 44684 / Approval Letter
M/s. Sesderma India Pvt. Ltd, New Delhi / 44296 / Approval Letter