LETTERS FOR ISSUE ON 11.02.2014
BE NOC FOR EXPORT
2nd List
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. BA Research India Ltd., Ahmedabad-380 054 / 7777 / Clarification Letter
M/s. BA Research India Ltd., Ahmedabad-380 054 / 9102 / Clarification Letter
M/s. BA Research India Ltd., Ahmedabad-380 054 / 50980 / Clarification Letter
M/s. BA Research India Ltd., Ahmedabad-380 054 / 31274 / Clarification Letter
M/s. BA Research India Ltd., Ahmedabad-380 054 / 27478 / Clarification Letter
M/s. Cadila Healthcare Ltd., Ahmedabad-380 015 / 18779 / Clarification Letter
M/s. Cadila Healthcare Ltd., Ahmedabad-380 015 / 43720 / Clarification Letter
M/s. Cipla Ltd., Mumbai-400 008 / 54556 / Clarification Letter
M/s. Cipla Ltd., Mumbai-400 008 / 53739 / Clarification Letter
M/s. Cipla Ltd., Mumbai-400 008 / 59596 / Clarification Letter
M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 14913 / Clarification Letter
M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 56199 / Clarification Letter
M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 41655 / Clarification Letter
M/s. Clinigene International Ltd., Bangalore-560 100 / 4705 / Clarification Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 34198 / Clarification Letter
M/s. Glenmark Generics Ltd., Mumbai-400 026 / 30117 / Clarification Letter
M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 26382 / Clarification Letter
M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 25543 / Clarification Letter
M/s. Inventia Healthcare Pvt. Ltd., Thane (West)-400 604 / 44915 / Clarification Letter
M/s. Ipca Laboratories Ltd., Mumbai-400 067 / 38321 / Clarification Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 56232 / Clarification Letter
M/s. Orchid Healthcare, Tamil Nadu / 26640 / Clarification Letter
M/s. Orchid Healthcare, Tamil Nadu / 22928 / Clarification Letter
M/s. QPS Bioserve India (P) Ltd., Hyderabad – 500 037 / 15092 / Clarification Letter
M/s. QPS Bioserve India (P) Ltd., Hyderabad – 500 037 / 24471 / Clarification Letter
M/s. QPS Bioserve India (P) Ltd., Hyderabad – 500 037 / 24149 / Clarification Letter
M/s. QPS Bioserve India (P) Ltd., Hyderabad – 500 037 / 31312 / Clarification Letter
M/s. QPS Bioserve India (P) Ltd., Hyderabad – 500 037 / 36932 / Clarification Letter
M/s. RA Chem Pharma Ltd., Hyderabad-500 037 / 49229 / Clarification Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 16156 / Clarification Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 47863 / Clarification Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 40474 / Clarification Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 37498 / Clarification Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 45010 / Clarification Letter
M/s. Vimta Labs Ltd., Hyderabad-500 051 / 20991 / Clarification Letter
M/s. Vimta Labs Ltd., Hyderabad-500 051 / 717 / Clarification Letter
M/s. Watson Pharma Private Ltd., Navi Mumbai-400 614 / 46647 / Clarification Letter
M/s. Watson Pharma Private Ltd., Navi Mumbai-400 614 / 48423 / Clarification Letter
VACCINE DIVISION
Sr. No. / Company Name / Dy. No. / STATUS1 / M/s Reliance Life Science Pvt, Limited / 230 / Approval letter
2 / M/s Biocon Limited / 57300 / Approval letter
3 / M/s Sandor Medicaids Pvt Ltd / Clarification letter
4 / M/s Sanofi Pasteur India Pvt, Ltd / 1738 / Clarification letter
6 / M/s Lupin Ltd / Clarification letter
7 / M/s GlaxoSmithKline Asia Pvt Ltd / 28986,37975 / Clarification letter
8 / M/s Intas Biopharmaceutical Ltd / 56542 / Clarification letter
9 / M/s Sanofi Synthelabo (India)Ltd / 2456 / Clarification letter
BIOLOGICAL DIVISION
Sr. No. / Company Name / Dy. No. / STATUS1 / M/s Intas Pharmaceuticals Limited / 64738 / Approval letter
2 / M/s Sun Phamaceuticals Industries Ltd / 77063 (fts no) / Clarification Letter
3 / M/s Johnson & Johnson Ltd / 58072 / Approval letter
4 / M/s Serum Instiute of India Ltd / Clarification Letter
5 / M/s Bharat Biotech International Lrd / Clarification Letter
6 / M/s Zydus Cadila Healthcare Ltd / Clarification Letter
7 / M/s Green Signal Biopharma Pvt, Ltd / Clarification Letter
8 / M/s Chiron Behring Vaccine Pvt, ltd / Clarification Letter
9 / M/s Sanofi Pasteur India Ltd / Clarification Letter
10 / M/s Virchow Biotech Pvt, Ltd / Approval letter
11 / M/s Biomed Pvt, Ltd / 2361, 1474, 1473 / Approval letter
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERKantilal Manilal & Co. Pvt. Ltd., / 1455 / Approval Letter
Kantilal Manilal & Co. Pvt. Ltd., / 1456 / Approval Letter
Nandlal Bankatlal Pvt. Ltd. / 1596 / Approval Letter
Haresh Oveta / 1618 / Approval Letter
Haresh Oveta / 1619 / Approval Letter
Glaxo SmithKline Pharmaceuticals Ltd. / 1550 / Approval Letter
Ace Pharma / 1597 / Approval Letter
ADD Biotech / 1613 / Approval Letter
Add-Biotec / 1612 / Approval Letter
Sharon Biomedicine Ltd. / 1609 / Approval Letter
Johnson & Johnson Ltd., / 1638 / Approval Letter
Puja Enterprises / 1594 / Approval Letter
Puja Enterprises / 1594 / Approval Letter
Micro Labs Ltd. / 1532 / Approval Letter
Micro Labs Ltd. / 1533 / Approval Letter
Ipca Laboratories Ltd. / 1525 / Approval Letter
Ipca Laboratories Ltd. / 1523 / Approval Letter
Ipca Laboratories Ltd. / 1524 / Approval Letter
Laborate Pharmarceuticals India Limited, Unit-II / 1765 / Approval Letter
Aquatic Remedies Pvt. Ltd. / 1805 / Approval Letter
Akums Drugs & Pharmaceuticals Ltd., / 1823 / Approval Letter
Micro Orgo-Chem / 1803 / Approval Letter
Sagar Rubber Products Pvt. Ltd. / 1804 / Approval Letter
S.Kesarimal, / 1889 / Approval Letter
Zuventus Healthcare Ltd. / 1685 / Approval Letter
Nectar Lifesciences Ltd. / 1944 / Approval Letter
Samarth Pharma Pvt. Ltd. / 1703 / Approval Letter
Glenmark Pharmaceuticals Ltd. / 1780 / Approval Letter
Glenmark Pharmaceuticals Ltd. / 1781 / Approval Letter
Glenmark Pharmaceuticals Ltd. / 1788 / Approval Letter
Glenmark Pharmaceuticals Ltd. / 1789 / Approval Letter
Shree Pharma / 1937 / Approval Letter
Shree Pharma / 1939 / Approval Letter
Shree Pharma / 1938 / Approval Letter
Shree Pharma / 1936 / Approval Letter
Shree Pharma / 1934 / Approval Letter
Shree Pharma / 1935 / Approval Letter
Pradipkumar Pharma Pvt. Ltd. / 1705 / Approval Letter
Piramal Enterprises Ltd. / 1814 / Approval Letter
Piramal Enterprises Ltd. / 1813 / Approval Letter
RPG Life Sciences Ltd. / 1942 / Approval Letter
DPB Antibiotics / 1806 / Approval Letter
Merck Limited / 1917 / Approval Letter
Mahima Life Sciences Pvt Ltd. / 1162 / Approval Letter
Pradipkumar & Co. / 2542 / Approval Letter
MSD Pharmaceuticals Pvt. Ltd. / 2746 / Approval Letter
Biotavia Labs Pvt. Ltd. / 1961 / Approval Letter
Biotavia Labs Pvt. Ltd. / 1962 / Approval Letter
Harshada Corporation, / 1957 / Approval Letter
Kalgov Labs Ltd., / 2003 / Approval Letter
Concept Pharmaceuticals Ltd., / 1966 / Approval Letter
Ketan Pharma, / 2067 / Approval Letter
Ruskin Chemipharm / 2026 / Approval Letter
Harish Enterprises, / 1956 / Approval Letter
Harish Enterprises, / 1955 / Approval Letter
Rumit Lifecare / 2068 / Approval Letter
Wockhardt Limited(C/o. M/s. Yeluri Formulations Pvt. Ltd.) / 2002 / Approval Letter
Central Drug House / 2002 / Approval Letter
Central Drug House / 2208 / Approval Letter
G.C. Chemie Pharmie Ltd., / 2206 / Approval Letter
Astra Pharmaceuticals / 2168 / Approval Letter
Venus Remedies Ltd. / 2158 / Approval Letter
Glenmark Pharmaceuticals Ltd. / 2234 / Approval Letter
Glenmark Pharmaceuticals Ltd. / 2239 / Approval Letter
Glenmark Pharmaceuticals Ltd. / 2235 / Approval Letter
Glenmark Pharmaceuticals Ltd. / 2238 / Approval Letter
Novartis Healthcare Pvt. Ltd. / 2339 / Approval Letter
Dilipkumar and Company / 2223 / Approval Letter
Dilipkumar and Company / 2225 / Approval Letter
Dilipkumar and Company / 2226 / Approval Letter
Sun Pharma Laboratories Ltd. / 2300 / Approval Letter
Sun Pharma Laboratories Ltd. / 2301 / Approval Letter
Sun Pharma Laboratories Ltd. / 2299 / Approval Letter
Akorn India Pvt. Ltd. / 2259 / Approval Letter
Rajasthan Antibioti cs Ltd. / 735 / Amended Letter
Imagine products india pvt. Ltd. / 1125 / Amended Letter
Lupin Ltd. / 63861 / Clarification Letter
Micro Labs Ltd. / 65252 / Clarification Letter
Bharat Serums and Vaccines Ltd.l / 414,413,412,415, / 3 Clarification Letter
Gorang International / 65145 / Clarification Letter
USV Ltd. / 03 / Clarification Letter
Pragati Raw Pharma Pvt. Ltd. / 65104 / Clarification Letter
Tablets India Ltd. / 253 / Clarification Letter
Healkraft Pharma India Pvt. Ltd. / 252 / Clarification Letter
MSD Pharmaceuticals Pvt. Ltd. / 51355 / Clarification Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Vapi Care Pharma / Nil / Letter
M/s. Themis Medicare Ltd., / 33320 / Letter
M/s. Hetero Labs Ltd., / 33320 / Clarification Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 42799 / Clarification Letter
M/s. Inject Care Parenterals Pvt. Ltd., / 42303 / Clarification Letter
M/s. Fresenius Medical Care India Pvt. Ltd., / 37818 / 2 Approval Letters
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Quintiles / - / Clarification Letters
2. / M/s. MSD / - / Clarification Letter
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/sMicro Labs C/o M/s AhlconParenteras (I) Ltd, Bhiwadi (Raj.) / 5432 / Query Letter
02 / M/s. Agio Pharmaceuticals Ltd., C/o M/s AhlconParenteras (I) Ltd, Bhiwadi (Raj.) / 5427 / Query Letter
03 / M/s. Cadila Healthcare Ltd., C/o M/s AhlconParenteras (I) Ltd, Bhiwadi (Raj.) / 5437 / Query Letter
04 / M/s. Orchid Healthcare Ltd., C/o M/s AhlconParenteras (I) Ltd, Bhiwadi (Raj.) / 5440 / Query Letter
05 / M/s. B/Braun Medical (India) Pvt. Ltd., C/o M/s AhlconParenteras (I) Ltd, Bhiwadi (Raj.) / 5444 / Query Letter
06 / M/s Scan biotech Ltd., C/o M/s AhlconParenteras (I) Ltd, Bhiwadi (Raj.) / 5434 / Query Letter
07 / M/s Ranbaxy Laboratories ltd., C/o M/s AhlconParenteras (I) Ltd, Bhiwadi (Raj.) / 5430 / Query Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERM/s. IBA Molecular Imaging India / - / Clarification Letter
M/s. Ajanta Pharma / - / Clarification Letter
WRITTEN CONFIRMATION
S. No / Firm Name / Type of LetterM/s. Mac-Chem Products (India) Pvt. Ltd., / Letter
M/s. Herbal Creations (A unit of Kumaon Exports Pvt. Ltd.) / Letter