Letters for Issue on 07.05.2015

LETTERS FOR ISSUE ON 07.05.2015

SUBSEQUENT NEW DRUG

S. NAME OF THE FIRM REFERENCE FTS NO. TYPE OF LETTER NO. NO.

1. M/S MICRO LABS 48097 72063 IPC NOCLETTER

2. M/S RPG 15641 - PERMISSION LIFESCIENCES LTD., LETTER 3. M/S GLENMARK 12091 20077 AMENDMENT PHARMACEUTICALS LETTER LTD.,

NEW DRUG

S.NO. NAME OF APPLICANT DIARY TYPE OF LETTER NO. 1. M/S. AKUMS DRUGS & - QUERY LETTER PHARMACEUTICALS LTD 2. M/S. PRECISE CHEMIPHARMA PVT - QUERY LETTER LTD 3. DR. GANAPATHI SURYANARAYANA - LETTER 4. M/S. CADILA HEALTHCARE LIMITED - LETTER 5. M/S HETERO LABS LIMITED - MEETING NOTICE 12/05/2015 (NEUROLOGY & PSYCHIATRY) 6. M/S MSN LABORATORIES PVT LTD - MEETING NOTICE 12/05/2015 (NEUROLOGY & PSYCHIATRY) 7. M/S LUPIN LIMITED - MEETING NOTICE 12/05/2015 (NEUROLOGY & PSYCHIATRY)

GLOBAL CLINICAL TRIAL

SR. NO. NAME OF FIRM REFERENCE NO. TYPE OF LETTER 1. M/S. QUINTILES 8287 PA APPROVAL LETTER

2. M/S. ASTRAZENECA 9403/10074 TL APPROVAL LETTERS

3. M/S. PHARMACEUTICAL 9495 AMENDMENT IN EXPORT RESEARCH ASSOCIATES NOC APPROVAL

4. M/S. BMS 12714 TL APPROVAL LETTER

5. M/S. REGIONAL CANCER 4071 TL & ADDITIONAL CENTRE PATIENTS APPROVAL LETTERS

IMPORT

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. UNICHEM LABORATORIES 11040 APPROVAL LETTER LTD., 2. SANZYME LTD.(C/O. M/S. 11039 APPROVAL LETTER KALINDI MEDICARE PVT. LTD.) 3. SUN PHARMA LABORATORIES 11139 APPROVAL LETTER LTD. 4. DILIPKUMAR AND COMPANY 11122 APPROVAL LETTER 5. MERCK LIMITED 11097 APPROVAL LETTER 6. FARMACHEM LIFE PVT. LTD. 11265 APPROVAL LETTER 7. AQUATIC REMEDIES PVT. LTD. 11266 APPROVAL LETTER 8. CIPLA LTD. 11387 APPROVAL LETTER 9. CIPLA LTD. 11388 APPROVAL LETTER 10. ANM PHARMA PVT. LTD. 11278 APPROVAL LETTER 11. IMEX OVERSEAS 11302 APPROVAL LETTER 12. C.J. SHAH & CO. (GODOWN) 11390 APPROVAL LETTER 13. GALDERMA INDIA PVT. LTD. 11407 APPROVAL LETTER 14. NANDLAL BANKATLAL PVT. 11438 APPROVAL LETTER LTD. 15. M.S.HEALTHCARE PVT. LTD 11432 APPROVAL LETTER 16. SUN RISE ENTERPRISES 11561 APPROVAL LETTER 17. ALKEM LABORATORIES LTD. 11631 APPROVAL LETTER (UNIT-III) 18. ALKEM LABORATORIES LTD. 11632 APPROVAL LETTER (UNIT-II), 19. SUN RISE ENTERPRISES 11560 APPROVAL LETTER 20. BIOTAVIA LABS PVT. LTD. 11436 APPROVAL LETTER 21. BIOTAVIA LABS PVT. LTD. 11434 APPROVAL LETTER 22. BIOTAVIA LABS PVT. LTD. 11435 APPROVAL LETTER 23. K.SEVANTILAL & CO. 11576 APPROVAL LETTER 24. M.S.HEALTHCARE PVT. LTD 11446 APPROVAL LETTER 25. UNIMED TECHNOLOGIES LTD. 11578 APPROVAL LETTER 26. JOHNSON & JOHNSON LTD. 11584 APPROVAL LETTER 27. ZIL PHARMA 11643 APPROVAL LETTER 28. MEDREICH LTD. 4981 APPROVAL LETTER

REGISTRATION

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. EVONIK DEGUSSA INDIA PVT. 10648 AMENDED LETTER LTD. 2. SANLAR IMEX SERVICES 7222 AMENDED LETTER PVT.LTD. 3. LUPIN LTD. NIL LETTER 4. CHEMET OF SPAN CENTRE 3560 CLARIFICATION LETTER 5. SHAH TC OVERSEAS PVT. LTD. 6856,5304 02 CLARIFICATION LETTER

LETTER PERTAINING TO RULE-37

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. SANOFI SYNTHELABO INDIA 8819 APPROVAL LETTER LTD.

MEDICAL DEVICE

S.NO. COMPANY NAME DIARY NO STATUS

1. M/S. BAUSCH AND LOMB (INDIA) PVT. LTD. 9817 APPROVAL (F-RC)

2. M/S. KALYX INDIA HEALTHCARE PVT. LTD. 3272 APPROVAL (F-RC)

3. M/S. KALYX INDIA HEALTHCARE PVT. LTD. 3272 APPROVAL (F-IL)

4. M/S. MED-EL INDIA PVT. LTD. 10247 APPROVAL (R-RC) 5. M/S. NIDHI SURGICAL PVT. LTD. 12713 APPROVAL (R-RC)

6. M/S. BIOMET ORTHOAPEDIC INDIA PVT. LTD. 4998 APPROVAL (E-RC)

7. M/S. BIOMET ORTHOAPEDIC INDIA PVT. LTD. 4998 APPROVAL (E-IL)

8. M/S. SUTURES INDIA PVT. LTD. 8194 APPROVAL (F-IL)

9. M/S. MYLAN LABORATORIES LTD. 10344 APPROVAL (TL)

10. THE DRUGS LICENSING AUTHORITY, FTS-15658 APPROVAL UTTARAKHAND (CLAA) LETTER

THE DDC (I) GHAZIABAD (CLAA)

(M/S. POLY MEDICURE LTD.)

11. M/S. BECTON DICKINSON INDIA PVT. LTD. 11232 APPROVAL LETTER

12. M/S. COLOPLAST INDIA PVT. LTD. 11152 APPROVAL LETTER

13. M/S. EMERGO (INDIA) CONSULTING PVT. LTD. 1551 LETTER

14. M/S. DATTMEDIPRODUCTS LTD. FTS-14367 LETTER

15. M/S. JOHNSON & JOHNSON LTD. 3022 LETTER

16. M/S. ACCREDITED CONSULTANTS PVT. LTD. 2359 QUERY LETTER

17. M/S. EMERGO (INDIA) CONSULTING PVT. LTD. 10608 QUERY LETTER

18. M/S. ELEVEN2SIX STORE. 12724 QUERY LETTER

DIAGNOSTIC DIVISION

S.NO. COMPANY NAME DIARY NO STATUS

1. M/S. MICROGENE DIAGNOSTIC SYSTEM PVT. 7164 APPROVAL (IL) LTD.

2. M/S. ROCHE DIAGNOSTICS INDIA PVT. LTD. 7343 APPROVAL (IL)

3. M/S. SIEMENS LTD. 6980 APPROVAL (IL)

4. M/S. TRIVITRON HEALTHCARE PVT. LTD. 51442 APPROVAL (IL) 5. M/S. TRIVITRON HEALTHCARE PVT. LTD. 3928 APPROVAL (IL)

6. M/S. ABBOTT HEALTHCARE PVT. LTD. 6859 APPROVAL (E-IL)

7. M/S. ABBOTT HEALTHCARE PVT. LTD. 8504 APPROVAL (E-IL)

8. M/S. AVANTOR PERFORMANCE MATERIALS 6675 APPROVAL (E-IL) INDIA LTD.

9. M/S. BECTON DICKINSON INDIA PVT. LTD. 6910 APPROVAL (E-IL)

10. M/S. ROCHE DIAGNOSTICS INDIA PVT. LTD. 7408 APPROVAL (E-IL)

11. M/S. ROCHE DIAGNOSTICS INDIA PVT. LTD. 9942 APPROVAL (E-IL)

12. M/S. SAS ENTERPRISES. 7223 APPROVAL (E-IL)

13. M/S. MERIL DIAGNOSTICS PVT. LTD. 8331 APPROVAL (TL)

14. M/S. ROCHE DIAGNOSTICS INDIA PVT. LTD. 9499 APPROVAL (TL)

15. M/S. GREINER BIO-ONE (INDIA) PVT. LTD. 304 LETTER

16. M/S. ALLIANCE TRANSFUSION PVT. LTD. 3401 QUERY LETTER

17. M/S. ALERE MEDICAL PVT. LTD. 5253 QUERY LETTER