LETTERS FOR ISSUE ON 09.01.2015
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERM/s. Cipla Ltd. / - / Query Letter (2)
Akums / - / Meeting Notice 12-01-2015 (Gastroenterology & Hepatology)
M/s Cipla / - / Meeting Notice 12-01-2015 (Gastroenterology & Hepatology)
M/s Bharat Serums and Vaccine Ltd. / - / Meeting Notice 12-01-2015 (Vaccine)
Dr. Malabika Roy / - / Meeting Notice 12-01-2015 (Vaccine)
Dr. Ramesh R. / - / Meeting Notice 12-01-2015 (Vaccine)
Global Clinical Trial
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. GSK / 43078 / TL Approval letter
2. / M/s. Novartis / 47577/49058 / PA/Change in PI Approval
3. / M/s. Quintiles / 49315 / Change in PI Approval
4. / M/s. Eli Lilly / 40440 / Clarification Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Therdose Pharma Pvt. Ltd., / 4511 / 66963 / Query Letter
M/s Dr. Reddy’s Laboratories Limited., / 46869 / 70017 / Query Letter
M/s InnovaCaptabPvt. Ltd., / - / 70353 / Query Letter
M/s Intas Pharmaceuticals Limited., / 30382 / - / Amendment Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 49148 / Clarification Letter
M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 50662 / Approval Letter
M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 51219 / Test Licence
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 49424 / Clarification Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 49614 / Approval Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 49800 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 49862 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 49860 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 35835 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 49484 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 35826 / Approval Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 49479 / Test Licence
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 49639 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 49634 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 49798 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 48395 / Test Licence
M/s. Lupin Limited (Research Park), Pune-411 042 / 48373 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-411 042 / 48665 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 51157 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 49799 / Approval Letter
M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 50143 / Approval Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 49426 / Approval Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 37836 / Amendment Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 49790 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 49486 / Test Licence
M/s. Vimta Labs Ltd., Hyderabad-500 051 / 49797 / Clarification Letter
Written Confirmation
International Cell
S. No / Firm Name / Type of Letter1. / M/s. Alembic Pharmaceutical Limited, Gujarat / WC Certificate
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERCentury Pharmaceuticals Limited / 46583 / Approval Letter
Aquatic Remedies Pvt. Ltd. / 49812 / Approval Letter
Skies / 50013 / Approval Letter
Skies / 50003 / Approval Letter
Skies / 50004 / Approval Letter
Skies / 50005 / Approval Letter
Skies / 50007 / Approval Letter
Skies / 50007 / Approval Letter
Skies / 50012 / Approval Letter
Skies / 50014 / Approval Letter
Skies / 50015 / Approval Letter
Skies / 50016 / Approval Letter
Skies / 50017 / Approval Letter
Skies / 50018 / Approval Letter
Skies / 50019 / Approval Letter
Reckitt Benckiser Healthcare India Limited / 50053 / Approval Letter
G.C. Chemie Pharmie Ltd., / 49980 / Approval Letter
C.J. Shah & Co. (Godown) / 49853 / Approval Letter
Knowell Pharma Solutions / 49989 / Approval Letter
Medi Pharma Drug House / 49981 / Approval Letter
Sandoz Private Ltd. / 49981 / Approval Letter
S.M. Marketing Agency, / 50095 / Approval Letter
Gorang International / 50100 / Approval Letter
Imex Overseas / 50225 / Approval Letter
C.J. Shah & Co. (Godown) / 50207 / Approval Letter
Nandlal Bankatlal Pvt. Ltd. / 50101 / Approval Letter
J.B.Chemicals & Pharmaceuticals Ltd., / 50068 / Approval Letter
General Import Company (India) Pvt. Ltd. / 50208 / Approval Letter
Shell-Life Sciences Pvt. Ltd. / 50187 / Approval Letter
DPB Antibiotics / 50097 / Approval Letter
DPB Antibiotics / 50096 / Approval Letter
DPB Antibiotics / 50098 / Approval Letter
Claris Otsuka Pvt Ltd. / 50248,50250,50249 / 03 Approval Letter
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERSHAH TC / 49863 / APPROVAL LETTER
APC PHARMACETUICALS & CHEMICALS / 50060 / AMENDED LETTER
MSD PHARMCETUICALS PVT. LTD / 29695 / LETTER
MYLAN PHARMACEUTICALS PVT. LTD. / 42403 / CLARIFICATION LETTER
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Gland Pharma Ltd., Hyderabad / 75375 / Approval
Vaccine Division
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Dr. Reddy Laboratories Ltd / Clarification Letter
2 / M/s Sanofi Synthelabo India ltd / Clarification Letter
3 / M/s Hipra India Pvt, Ltd / Clarification Letter
4 / M/s Lupin ltd / 43209 / Clarification Letter
5 / M/s GSK Asia Pvt, Ltd / 43289, 43293, 43295, 43296, 43292, 43294, 26914, 26915 / Clarification Letter
6 / M/s Reliance Life Sciences PVt, ltd / Clarification Letter
7 / M/s Wyeth ltd / 47162 / Clarification Letter
8 / M/s Sandor Medicaids Pvt, ltd / 43009 / Clarification Letter
9 / M/s Boehringer Ingelheim India Pvt, Ltd / 46708 / Clarification Letter
10 / M/s Roche Product India PVt, Ltd / 41906 / Clarification Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Sun Pharmaceuticals / Nil / SEC Letter
M/s. Troikaa Pharma / Nil / SEC Letter
M/s. Pharma Synth Formulations / 49554 / Letter
M/s. Psychotropics India Ltd., / 43474 / Letter
M/s. Anphar Organics / 58348 / Letter
M/s. Laborate Pharmaceuticals / 38535 / Approval Letter