LETTERS FOR ISSUE ON 01.04.2014
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Exactech India (P) Ltd. / 6978 / Query Letter
2. / M/s. Medionics India Pvt. Ltd. / 55420 / Query Letter
3. / M/s. Vygon India Pvt. Ltd. / 664 / Query Letter
4. / M/s. Vygon India Pvt. Ltd. / 664 / Clarification Letter
5. / M/s. Vygon India Pvt. Ltd. / 664 / Clarification Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. BioMerieux India Pvt. Ltd. / 7500 / Query Letter
2. / M/s. MHS Pharmaceuticals Pvt. Ltd. / 7791 / Query Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s GlaxoSmithKline Pharmaceuticals Limited / 7845 / Clarification letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Laborate Pharmaceuticals India Ltd., / 43198 / Clarification Letter
2. / M/s. Mylan Laboratories Ltd., / 60753 / Letter
3. / M/s. Apshsri Pharmaceuticals / 50607 / Clarification Letter
4. / M/s. Akums Drugs & Pharmaceuticals Ltd., / 7436 / Clarification Letter
5. / M/s. Bochem Health Care Pvt. Ltd., / 6535 / Letter
6. / M/s. Famy Care Ltd., / 29269 / Approval Letter
7. / M/s. Cyano Pharma (P) Ltd., / 6534 / Approval Letter
8. / M/s. Salute Bestochem, / 48624 / Clarification Letter
9. / M/s. Hetero Labs Ltd., / 10078 / Clarification Letter
10. / M/s. Kivi Labs Ltd., / 1999 / Clarification Letter
11. / M/s. Alcon Laboratories India Pvt. Ltd., / 62770 / Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Kendle / 55507/69 / PA Approval Letter/Clarification Letter
2. / M/s. Excel Life Sciences / - / Clarification Letter
3. / M/s. Novartis / 31293/15807 / CT NOC Approval letter/Clarification Letter
4. / M/s. Sanofi / 6782 / Additional Sites Approval
5. / M/s. Max Neeman / 11763 / Additional Sites Approval
6. / M/s. Klinera / 5233 / Amendment in CT NOC Approval
7. / M/s. BIOCAD / 5939 / CT NOC Approval Letter
8. / M/s. Eli Lilly / 2011 / TL Approval letter
9. / M/s. B. J. Medical College / 4720 / TL Approval Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s UrsaPharm Ltd. / 56271 / 77684 / Deficiency Letter
2. / M/s Zim Lab / 52835 / 72269 / Deficiency Letter
3. / M/s Watson Parma / 57130 / 78934 / Deficiency Letter
4. / M/s Serdia Pharma / 13118 / - / Approval Letter
5. / M/s Micro Labs / 23603 / 32813 / Deficiency Letter
6. / M/s Intas Pharmaceuticals / 54365 / - / Approval Letter
7. / M/s Novartis Healthcare / 43108 / - / Approval Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. Sun Pharmaceuticals Ltd. / - / Letter
2. / M/s. Bayer Pharma Pvt. / - / Letter
3. / M/s. Mylan Laboratories Ltd. / - / Letter(2)
WRITTEN CONFIRMATION
S. No / Firm Name / Type of LetterM/s. Resonance Laboratories Pvt. Ltd., / Clarification Letter
1. / M/s. Elixir Pharma / Clarification Lette
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 3442 / Approval Letter
2. / M/s. APL Research Centre, Hyderabad-500 038 / 1672 / Clarification Letter
3. / M/s. APL Research Centre, Hyderabad-500 072 / 639 / Amendment Letter
4. / M/s. Axis Clinicals Ltd., Hyderabad-500 049 / 3411 / Clarification Letter
5. / M/s. Biocon Ltd., Bangalore-560 100 / 64415 / Clarification Letter
6. / M/s. Clinigene International Ltd., Bangalore-560 100 / 9062 / Approval Letter
7. / M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 7966 / Amendment Letter
8. / M/s. Glenmark Generics Ltd., Mumbai-400 026 / 4669 / Clarification Letter
9. / M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 341 / Amendment Letter
10. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 1441 / Clarification Letter
11. / M/s. Lupin Bioresearch Center, Pune-411 021 / 3349 / Approval Letter
12. / M/s. Lupin Bioresearch Center, Pune-411 021 / 4143 / Approval Letter
13. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 7782 / Approval Letter
14. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 36230 / Approval Letter
15. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 3537 / Clarification Letter
16. / M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 47063 / Approval Letter
17. / M/s. Unichem Laboratories Ltd., Mumbai-400102 / 2303 / Approval Letter
18. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 4222 / Clarification Letter
19. / M/s. Vimta Labs Ltd., Hyderabad-500 051 / 3423 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 3642 / Test Licence
2. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 4341 / Test Licence
3. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 3495 / Test Licence
4. / M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 4296 / Test Licence
5. / M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 4293 / Test Licence