LETTERS FOR ISSUE ON 06.05.2015
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /DIARY NO. / STATUS01 / M/S. NIRMA LTD., GUJARAT / 14375, 14374, 14376 / APPROVAL
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /DIARY NO. / STATUS01 / M/S. GLENMARK GENERICS LTD., MUMBAI / 20570 / AMENDMENT
02 / M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., GUJARAT / 11840 / QUERY
03 / M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., GUJARAT / 11869 / QUERY
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /DIARY NO. / STATUS01 / M/S. SHRI KRISHNA KESHAV, GUJARAT / 20636 / APPROVAL
02 / M/S. KEYUR PHARMACHEM INDIA PVT. LTD., BHIWANDI / 11135 / QUERY
03 / M/S. CLARIS INJECTABLES LTD., GUJARAT / 17574 / APPROVAL
04 / M/S. CLARIS LIFESCIENCES LTD., C/O. M/S. CLARIS INJECTABLE LTD., GUJARAT / 19493 / APPROVAL
05 / M/S. GLAND PHARMA LTD., A.P. / 20831 / APPROVAL
06 / M/S. UNIQUE PHARMACEUTICALS LABORATORIES, GUJARAT / 21086 / APPROVAL
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /DIARY NO. / STATUS01 / M/S. RANBAXY LABORATORIES LTD., NEW DELHI / 12690 / AMENDMENT
02 / M/S. AIZANT DRUG RESEARCH SOLUTIONS PVT. LTD., HYDERABAD / 11649 / APPROVAL
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. NO / FIRM NAME / TYPE OF LETTER1. / M/S. IPCA LABORATORIES LTD., SEJAVTA, RATLAM, M.P. / LETTER
COSMETIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/S. BACCAROSE PERFUMES & BEAUTY PRODUCTS PVT. LTD, MUMBAI / 7291 / APPROVAL LETTER
M/S. L’OREAL INDIA PRIVATE LIMITED, MUMBAI / 7378 / APPROVAL LETTER
M/S. SEPHORA COSMETICS PRIVATE LIMITED, NEW DELHI / 7461 / APPROVAL LETTER
M/S. STREAMLINE SERVICES INDIA, WEST BENGAL / 7664 / APPROVAL LETTER
M/S. FACES COSMETICS INDIA PVT. LTD, MUMBAI / 7801 / APPROVAL LETTER
M/S. NATIONAL TRADERS, MAHARASHTRA / 7908 / APPROVAL LETTER
M/S. NUGA MEDICAL INDIA PVT. LTD, NOIDA / 8935 / APPROVAL LETTER
M/S. INCORP MARKETING PVT. LTD, KARNATAKA / 9155 / APPROVAL LETTER
M/S. ETHICARE REMEDIES, RAJKOT GUJARAT / 9330 / APPROVAL LETTER
M/S. MYRAH SPA & PRODUCTS PVT. LTD, MUMBAI / 9702 / APPROVAL LETTER
M/S. CAMEX WELLNESS LIMITED, GUJARAT / 9999 / APPROVAL LETTER
M/S. L’OCCITANE INDIA PVT. LTD, NEW DELH / FTS-5089 / APPROVAL LETTER
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/S. GLENMARK PHARMACEUTICALS LTD., / 10957 / AMENDMENT LETTER
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/S THEMIS MEDICARELTD., / 8217,2430 / 13825,4215 / DEFICIENCYLETTER (2)
M/S INTAS PHARMACEUTICALS LTD., / 1129,7612 / 2151,12971 / DEFICIENCY LETTER (2)
M/S RANBAXY / 4902 / 8292 / DEFICIENCY LETTER
M/S KUSUM HEALTHCARE PVT. LTD., / 8357 / 14262 / DEFICIENCY LETTER
M/S INVENTIA HEALTHCARE PVT. LTD., / 7389 / 12172 / DEFICIENCY LETTER
VACCINE DIVISION
S. NO. / COMPANY NAME / DY. NO. / STATUS1 / M/S SANOFI SYNTHELABO INDIA LTD / 2317 / CLARIFICATION LETTER
2 / M/S LAMBDA THERAPEUTIC RESEARCH LTD / 12991 / APPROVAL LETTER
3 / M/S CLIANTHA RESEARCH LTD / 28745, 37791 / APPROVAL LETTER
4 / M/S INTAS PHARMACEUTICALS LTD / 20302 (FTS NO) / APPROVAL LETTER
5 / M/S NOVARTIS INDIA LTD / 12519 / CLARIFICATION LETTER
6 / M/S AMNEAL PHARMACEUTICALS CO. (I) PVT, LTD / 12966 / APPROVAL LETTER
7 / M/S PROSPER CHANNEL LIFE SCIENCE INDIA PVT. LTD / CLARIFICATION LETTER
8 / M/S APAC BIOTECH LTD / CLARIFICATION LETTER
M/S AMNEAL PHARMACEUTICALS CO. (I) PVT, LTD / 12966 / APPROVAL LETTER
GLOBAL CLINICAL TRIAL
SR. NO. / NAME OF FIRM / REFERENCE NO. / TYPE OF LETTER1. / M/S. MANIPAL ACUNOVA / 6700 / TEST LICENSE APPROVAL LETTER
2. / M/S PFIZER / 50058 / CLARIFICATION LETTER
3. / M/S INC RESARCH / 6689 / CLARIFICATION LETTER