LETTERS FOR ISSUE ON29.10.2014
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/sAlcon Laboratories India Pvt. Ltd., / 30263 / 44434 / Test licence
M/s Novartis India Ltd., / 32270 / - / Approval Letter
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Parenteral Drugs (I) Ltd., M.P. / 56875 / Query
02 / M/s. Akums Drugs & Pharmaceuticals, Haridwar / 61825 / Approval
03 / M/s. Vetoquinol Animal Health, C/o. M/s. Ahlcon Parenterals, Alwar / 61798 / Approval
04 / M/s. Unijules life Sciences, Nagpur / 62032 / Approval
05 / M/s. Denis Chem, Gujarat / 62784 / Approval
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Wockhardt CPB, Aurangabad / 15083 / Approval
COSMETICS DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Siroya Wellness, Karnataka / 36980 / Approval Letter
M/s. Sephora Cosmetics Private Limited, New Delhi / 36788 / Approval Letter
M/s. Baccarose Perfume & Beauty Products Pvt. Ltd, Mumbai / 33368 / Approval Letter
M/s. Belleza Enterprises Private Limited, Mumbai / 35817 / Approval Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. B. Braun Medical India Pvt. Ltd. / 38387 / Approval Letter
M/s. Ossur Asia-The Swedish Trade & Invest Council / 39930 / Approval Letter
M/s. S B Medicare Pvt. Ltd. / 38287 / Approval Letter
M/s. Max Neeman Medical International Ltd. / 39078 / Query Letter
M/s. Shah Distributors. / 38687 / Query Letter
M/s. Care Well Medical Systems. / 36029 / Approval (R-RC)
M/s. Care Well Medical Systems. / 39427 / Approval (R-IL)
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Meril Diagnostics Pvt. Ltd.
All port offices of CDSCO. / 36812 / Approval (IL)
M/s. KKHC Healthcare India Pvt. Ltd.
All port offices of CDSCO. / 34978 / Approval (E-IL)
M/s. Qiagen India Pvt. Ltd. / 37276 / Approval Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/sJohnson & Johnson Limited, / 33559 / 49381 / Amendment Letter
M/s Bharat Serum and Vaccines Ltd., / - / 49067 / Query Letter
M/s Reddy’s Laboratories Limited., / 32453 / 47876 / Query Letter
M/s Emcure Pharmaceuticals Limited., / 31714 / 46575 / BE NOC / Query Letter (2)
M/s Lupin Limited., / 23931 / 35205 / Query Letter (2)
M/s Sun Pharmaceutical Industries Ltd., / 7450 / 11410 / Query Letter
M/s Cipla Ltd., / 7450 / 11410 / Query Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERM/s. Astra Zeneca Pharma / - / Query Letter (3)
M/s. Emcure Pharmaceuticals Ltd / - / Query Letter
LETTER PERTAINING TO RULE-37/SHELF LIFE
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERDR. REDDY’S LABORATORIES LTD. / 29681 / CLARIFICATION LETTER
MSD PHARMACEUTICAL PVT. LTD. / 41300 / CLARIFICATION LETTER
CENTAUR PHARMACETUICAL PVT. LTD. / 38356 / CLARIFICATION LETTER
DSM SINOCHEM PHARMACEUTICAL INDIA PVT. LTD. / 32102 / Approval Letter
CENTURION LABORATOREIS / 40813 / Approval Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Biocon Ltd / 34799 / Clarification Letter
2 / M/s Roche Product India Pvt, ltd / Clarification Letter
3 / M/s GSK Pharmaceuticals ltd / 40900 / Clarification Letter
4 / M/s Reliance Life Sciences / 18376 / Clarification Letter
5 / M/s Serum Institue of India Ltd / 43449 / Approval Letter
6 / M/s Cadila Healthcare ltd / 31044 / Approval Letter
7 / M/s Unimed Technologies Ltd / 38054, 11030 / Approval Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Novartis / 39965 / Change in PI Approval
2. / M/s. GSK / 24198/33644 / Change in PI Approval
3. / M/s. BIOCAD / 30678/30808/39406 / Change in PI & New Sites Approval
4. / M/s. BMS / 40141 / Change in PI Approval