LETTERS FOR ISSUE ON 10.03.2014
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Bochem Healthcare / 6535 / Clarification Letter
M/s. IPCA Laboratories Ltd. / 64282 / Clarification Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Reliance Life Sciences Pvt, Ltd / 6073, 230,2075,,2407 / Approval & Clarification Letter
2 / M/s Biological E. Ltd / 4716 / Approval Letter
3 / M/s HLL Biotech Ltd / 85553 (fts no) / Approval Letter
4 / M/s Intas Pharmaceuticals Ltd / 2426, 4842 / Approval Letter
5 / M/s GSK Pharmaceuticals Ltd / 2100 / Approval Letter
6 / M/s Shantha Biotechnics Ltd / 59835, FTS 5600 / Approval Letter
7 / M/s Biomed Pvt, Ltd / 3632, 3631 / Approval Letter
BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Chirong Behring Vaccine Pvt, Ltd / 6381 (fts no) / Approval Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 5068 / Approval Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 63455 / Approval Letter
3. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 4223 / Approval Letter
4. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 4351 / Approval Letter
5. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 1606 / Approval Letter
6. / M/s. APL Research Centre, Hyderabad-500 090 / 1438 / Approval Letter
7. / M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 2577 / Approval Letter
8. / M/s. Wockhardt CPB, Clinical Pharmacokinetics and Biopharmaceuties Dept., Aurangabad-431 210 / 2152 / Approval Letter
9. / M/s.Ra Chem Pharma Ltd, Balanagar, Hyderabad -500037 Andhra Pradesh / 1212 / Rejection Letter
10. / M/s.Sun Pharmaceutical Industries Ltd Tandalja, Vadodara -390020 Gujarat, India. / 64473 / Rejection Letter
11. / M/s.Accutest research Laboratoaries (I) Pvt. Ltd. TTC Industrial Area, Khairne Navi Mumbai -400709 / 698 / Rejection Letter
12. / M/s.Lotus Labs Pvt Ltd No. 07 Jasma Bhavan Road, Millers Tannk Bed Area, Opp. Gurunanak Bhavan, Vasanthnagar Bangalore-560052 / 23353 / Rejection Letter
13 / M/s.Alembic Ltd Alembic Road Vadodra -390003 / 10804 / Clarification Letter
14 / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 33554 / Clarification Letter
15 / M/s.Veeda Clin ical Reseach Pvt Ltd shivalik Plaza -A Near I.I.M. Ambawadi, Ahmedabad-380015 / 1600 / Clarification Letter
16 / M/s.Alembic Ltd Alembic Road Vadodra -390003 / 64377 / Clarification Letter
17 / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 724 / Clarification Letter
18 / M/s.Wockhardt Ltd Wockhardt Tower Bandra-Kurla Complex Bandra (E) Mumbai-400051 / 611 / Clarification Letter
19 / M/s.Veeda Clin ical Reseach Pvt Ltd shivalik Plaza -A Near I.I.M. Ambawadi, Ahmedabad-380015 / 33731 / Clarification Letter
20 / M/s. Famy Care Ltd., A-539 TTC Industrial Area Thane, Belapur Road, MIDC Mahape Navi Mumbai -400709 / 65124 / Clarification Letter
21 / M/sCliantha Research Ltd Oppostie Pushparaj Towers, Nr. Judges Bungalows, Bodakdev,Ahmedabad-380054 / 12949 / Clarification Letter
22 / M/s. GVK Biosciences Pvt. Ltd 7th floor, Swarna Jayanthi Commerical Complex, Ameerpet Hyderabad-500038 / 40429 / Clarification Letter
23 / M/s. Lambda Therapetuic Research Ltd Near Gujarat High Court, S.G. Highway, Gota,Ahmedabad-380061 / 11173 / Clarification Letter
24 / Cliantha Research Ltd / 1491 / Approval Letter
25 / M/s. Lotus Labs Pvt. Ltd. / 1266 / Approval Letter
26 / M/s. Veeda Clinical Research Pvt. Ltd. / 4987 / Approval Letter
27 / M/s. Torrent Pharmaceuticals Ltd. (Research Centre) / 726 / Approval Letter
28 / M/s. Synapse Labs Pvt. Ltd. / 8675 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Drug Monitoring Research Institute (P) Ltd., Navi Mumbai-400 701 / 1526 / Test Licence
M/s. Manipal Acunova Ltd., Mangalore-575 001 / 2651 / Test Licence
M/s. Drug Monitoring Research Institute (P) Ltd., Navi Mumbai-400 701 / 51343 / Test Licence
RA Chem Pharma Ltd / 35740 / Test Licence
WRITTEN CONFIRMATION
S. No / Firm Name / Type of LetterM/s. Divi’s Laboratories Pvt. Ltd., / WC Letter
EXPORT NOC
S. No / Firm Name / Diary No. / Type of LetterM/s. Fresenius Kabi Oncology Ltd., / 6076 / Approval Letter
M/s. Sequent Scientific Ltd., / 6199 / Approval Letter
M/s. Bharat Parenterals Ltd., / 6987 / Approval Letter
M/s. Hospira Healthcare India Pvt. Ltd., / 6610 / Approval Letter