Letters for Issue on 06.02.2014

LETTERS FOR ISSUE ON 06.02.2014

REGISTRIAON

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
DIVINNE SBR INTERNATIONAL PVT. LTD. / 38865 / APPROVAL LETTER
ELDER PHARMACEUTICALS LTD. / 56490 / APPROVAL LETTER

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
The Commissioner, Thane (CLAA)
The Deputy Drugs Controller (I), Mumbai (CLAA)
(M/s. Adler Mediequip Pvt. Ltd., Maharashtra) / FTS-1773 / Approval Letter
The Commissioner, Thane (CLAA)
The Deputy Drugs Controller (I), Mumbai (CLAA)
(M/s. Adler Mediequip Pvt. Ltd., Maharashtra) / FTS-1773 / Approval Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference no. / Type of Letter
1. / M/s. Quintiles / 47616/62238,43274 / Clarification Letter, TL Approval Letter
2. / M/s. St. John’s national Academy / - / Clarification Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Gnosis Pharmaceuticals Pvt. Ltd., / 64626 / Clarification Letter
M/s. Bonn Schetering Biosciences / 48072 / Letter
M/s. Sun Pharmaceuticals Industries Ltd., / 54776 / 3 Approval Letter
M/s. Fresenius Kabi India Pvt. Ltd., / 52411 / Letter
M/s. Hetero Labs / 26668 / Approval Letter
M/s. Torrent Pharmaceuticals Pvt. Ltd., / 63541 / Amendment Letter
M/s. Vindas Chemical Industries / 65541 / Letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Bharat Serum / - / Clarification Letter
M/s. Sanofi / - / Clarification Letter
M/s. MSN / - / Clarification Letter
M/s. Cadila Healthcare / - / Clarification Letter
M/s. Hetero / - / Clarification Letter
M/s. Council of Scientific & Industrial Research, CSIR / - / Approval Letter

LVP DIVISION

S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS
01 / M/s Akums Drugs, Uttarakhand / 4270 / Approval
02 / M/s. Axa Parenterals., Uttarakhand / 5006 / Approval
03 / M/s. Unique Pharmaceutical Laboratories, Gujarat / 4297 / Approval
04 / M/s. Shree Krishna Keshav, Gujarat / 1061 / Approval
05 / M/s. Parenteral Drugs (I) Ltd., Indore / 1760 / Approval

COSMETIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Raj Dhanvantary Pharmacy, Jamnagar / 61771 / Approval Letter
M/s. Diversey India Private Limited, Mumbai / 62247 / Approval Letter
M/s. Seema Enterprises , Delhi / 62798 / Approval Letter
M/s. Baccarose Perfumes & Beauty Products Pvt. Ltd, / 63113 / Approval Letter

SUBSEQUENT DRUGS DIVISION

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
1. / M/s Sunglow Pharma / 63658 / - / Approval Letter
2. / M/s Troikaa Pharma / 47230 / 65125 / Deficiency Letter
3. / M/s J.B. Chemicals / 62177 / 85347 / Approval Letter(2)
4. / M/s Torrent Pharma / 34480 / 4855 / Letter
5. / M/s Intas Pharma / 32617 / 45722 / Letter

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad-380 015 / 61702 / Clarification Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad-380 015 / 64676 / Clarification Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 63546 / Approval Letter
M/s. APL Research Center, Hyderabad-500 038 / 60131 / Clarification Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 23511 / Clarification Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 24889 / Clarification Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 28562 / Clarification Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 56794 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 30821 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 60751 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 60750 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 60072 / Approval Letter
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 64565 / Approval Letter
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 60345 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 1010 / Approval Letter
M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 60992 / Approval Letter
M/s. Manipal Acunova Ltd., Mangalore-575 001 / 61704 / Approval Letter
M/s. Mylan Laboratories Ltd., Medak District -502 325, AP / 47152 / Clarification Letter
M/s. RA Chem Pharma Ltd., Hyderabad-500 037 / 59524/59689 / Clarification Letter
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 61630 / Clarification Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 53834 / Clarification Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 57969/65383 / Rejection Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 60748 / Clarification Letter
M/s. Vimta Labs Ltd., Hyderabad-500 051 / 61661 / Approval Letter
M/s. Axis Clinicals Ltd., Hyderabad-500 049 / 63644 / Rejection Letter

ONLY TEST LICENCE FOR BE

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 61627 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 61808 / Test Licence
M/s. Bio Scientific Research Laboratories (India) Pvt. Ltd., Dist. Thane-401 104 / 1309 / Test Licence
M/s. Cipla Limited, Mumbai-400 008 / 60116 / Test Licence
M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 62293 / Test Licence
M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 62292 / Test Licence
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 60990 / Test Licence
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 61904 / Test Licence