LETTERS FOR ISSUE ON 16.05.2014
BA/BE DIVISION
S. NO. / COMPANY NAME / Diary No. /FTS / STATUS01 / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai / 47653 / Approval
02 / M/s. Taab Bio Study Services, Kolkata / 17295 / Approval
03 / M/s. Enem Nostrum Remedies Pvt. Ltd., Mumbai / Query
04 / M/s. Drug Monitoring Research Institute, Mumbai / 33503& 53023 / Approval
05 / M/s. Bio-Equivalence Study Centre, Jadhavpur University, Kolkata / 64046 / Approval
06 / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Gujarat / 40003 / Approval
07 / M/s Accutest Research Laboratories (I) Pvt. Ltd., Unit-II, Gujarat. / 47173 / Approval
08 / M/s. Lupin Bio Research Centre, Pune. / 58098 / Approval
09 / M/s. Semler Research Centre pvt. Ltd., Bangalore / Query
10. / M/s. Axis Clinical Ltd., Hyderabad / Query
11. / M/s. Axis Clinical Ltd., Hyderabad / Query
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Mitrra Industries Pvt. Ltd., Haryana / 25654 / Query
02 / M/s. Akums Drugs, Uttarakhand / 19690 / Query
03 / M/s. Euro life Health Care, Uttarakhand / 19397 / Query
04 / M/s. Alembic C/o M/s. Denis Chem, Gujarat / 14755 / Query
05 / M/s. Axa Parental, Uttarakhand / 18527 / Query
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Torrent Pharamceuticals Ltd. / 18384 / Approval Letter
2. / Vyali International / 16197 / Approval Letter
3. / Vyali International / 16196 / Approval Letter
4. / Vyali International / 16085 / Approval Letter
5. / Cipla Ltd. / 16059 / Approval Letter
6. / Cipla Ltd. / 16060 / Approval Letter
7. / Cipla Ltd. / 16058 / Approval Letter
8. / Cipla Ltd. / 16061 / Approval Letter
9. / Maxcure Nutravedics Limited / 16194 / Approval Letter
10. / Maxcure Nutravedics Limited / 16195 / Approval Letter
11. / Mylan Laboratories Ltd. / 15890 / Approval Letter
12. / Mylan Laboratories Ltd. / 15889 / Approval Letter
13. / Mylan Laboratories Ltd. / 15888 / Approval Letter
14. / Alves Healthcare Pvt.Ltd. / 16080 / Approval Letter
15. / Alves Healthcare Pvt.Ltd. / 16082 / Approval Letter
16. / Micro Labs Ltd. / 16001 / Approval Letter
17. / Micro Labs Ltd. / 16002 / Approval Letter
18. / Cadila Healthcare Ltd. / 16198 / Approval Letter
19. / Cadila Healthcare Ltd. / 16199 / Approval Letter
20. / Ciron Drugs & Pharmaceuticals(P) Ltd. / 16190 / Approval Letter
21. / Lyka Labs Ltd. / 15843 / Approval Letter
22. / Minerva Biogenix Pvt. Ltd. / 15936 / Approval Letter
23. / Next Gen Pharma India Pvt. Ltd. / 16212 / Approval Letter
24. / Uttaranchal Biotech Limited / 16213 / Approval Letter
25. / Vital Therapeutics Pvt.Ltd. / 16211 / Approval Letter
26. / Astra Pharmaceuticals / 16081 / Approval Letter
27. / Mona Pharmachem / 16083 / Approval Letter
28. / Sun Pharma Laboratories Ltd. / 16021 / Approval Letter
29. / CBC Corporation (India) Pvt. Ltd. / 15937 / Approval Letter
30. / Nitin Lifesceinces Ltd. Unit-III / 16175 / Approval Letter
31. / Alembic Pharmaceuticals Ltd.,(API Division Panelav) / 16005 / Approval Letter
32. / Baader Schulz Laboratories / 16084 / Approval Letter
33. / Ketan Pharma, / 16086 / Approval Letter
34. / Wockhardt Limited / 16705 / Approval Letter
35. / Wockhardt Limited / 8707 / Approval Letter
36. / Novartis Healthcare Pvt. Ltd. / 15797 / Clarification Letter
37. / Sparsha Pharma International Pvt. Ltd. / 15441 / Clarification Letter
38. / Macleods Pharmaceuticals Ltd. / 15158 / Clarification Letter
39. / Aeon Formulations Pvt. Ltd. / 15090 / Clarification Letter
40. / Bayer Zydus Pvt . Ltd. / 12260 / Clarification Letter
41. / Wyeth Ltd. / 17208 / Clarification Letter
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / UNI-CHEMIE INTERNATIONAL / 14802 / APPROVAL LETTER
2. / BIOCAD INDIA PVT. LTD. / 6452 / CLARIFICATION LETTER
3. / NOVARTIS HEALTHCARE PVT. LTD. / 10689 / CLARIFICATION LETTER
4. / JOHNSON & JOHNSON LTD. / 10045,11551 / 2 CLARIFICATION LETTER
5. / ANANTCO ENTERPRISES PVT. LTD. / 17837 / CLARIFICATION LETTER
RULE-37/SHELF LIFE
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / SANOFI-SYNTHELABO INDIA LTD. / 16586 / APPROVAL LETTER
2. / SANOFI-SYNTHELABO INDIA LTD. / 14130 / AMENDED LETTER
3. / PFIZER LTD. / 16751 / CLARIFICATIO LETTER
4. / KOPRAN LTD. / 15862 / CLARIFICATIO LETTER
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. India Medtronic Pvt. Ltd. / 9329 / Approval (F-RC)
2. / M/s. Sandor Medicaids Pvt. Ltd. / 11512 / Approval (F-RC)
3. / M/s. Johnson & Johnson Ltd. / 65370 / Approval (E-RC)
4. / M/s. Boston Scientific India Pvt. Ltd. / 44610 / Approval (R-E-RC)
5. / M/s. MN Solutions. / 10770 / Approval (R-E-RC)
6. / M/s. India Medtronic Pvt. Ltd. / 9329 / Approval (F-IL)
7. / M/s. Meril Life Sciences Pvt. Ltd. / 9982 / Approval (F-IL)
8. / M/s. Boston Scientific India Pvt. Ltd. / 44610 / Approval (R-E-IL)
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 14795 / Approval (IL)
2. / M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 14028 / Approval (IL)
3. / M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 9253 / Approval (IL)
4. / M/s. Compact Diagnostics India (P) Ltd. / 11857 / Approval (IL)
5. / M/s. Immunoshop India Pvt. Ltd. / 12153 / Approval (IL)
6. / M/s. Roche Diagnostics India Pvt. Ltd. / 111879 / Approval (TL)
7. / M/s. Compact Diagnostics India (P) Ltd. / 11857 / Query Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Eli Lilly / 18114 / Amendment in TL Approval
2. / M/s. Wyeth / 10744 / Clarification Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Bristol Myers Sqibb / 52492 / - / Approval Letter