LETTERS FOR ISSUE ON

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1 S FOR ISSUE ON BIOLOGICAL DIVISION S. NO. NAME OF COMPANY DY. NO STATUS 1 M/S LV PRASAD EYE INSTITUTE ACKNOWLEDGE 2 M/S PFIZER LTD APPROVAL 3 M/S GSK ASIA PVT, LTD APPROVAL 4 M/S BHARAT SERUM AND VACCINE LTD CLARIFICATION 5 M/S MYLAN LABORATORIES LTD 17318, APPROVAL & CLARIFICATION 6 M/S CADILA PHARMACEUTICALS LTD CONTINUATION MEDICAL DEVICE S.NO. COMPANY NAME DIARY NO STATUS

2 1. THE COMMISSIONER, GANDHINAGAR (CLAA) THE DEPUTY DRUGS CONTROLLER, AHMEDABAD (CLAA) (M/S. HYGEIA ORTHO PVT. LTD., AHMEDABAD) FTS. NO APPROVAL SUBSEQUENT NEW DRUG S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF 1. M/S CIPLA - - SEC 2. M/S SUN - - SEC 3. M/S LYKA LABS LTD., - - SEC 4. M/S EMCURE PHARMACEUTICALS - - SEC LTD 5. M/S PANACEA BIOTEC LTD., - - SEC 6. M/S UNITED BIOTECH (P) LTD., - - SEC 7. M/S ALKEM - - SEC 8. M/S ABBOTT INDIA LTD., - - SEC 9. M/S BHARAT SERUM AND VACCINES LTD., - - SEC 10. M/S UNIMED TECHNOLOGY LTD., - - SEC 11. M/S RUSAN - - SEC 12. M/S NOVARTIS - - SEC 13. M/S SUN - - SEC 14. M/S MANKIND PHARMA LIMITED., DEFICIENCY 15. M/S CELON LABORATORIES LTD., DEFICIENCY 16. M/S PAVIOUR PHARMACEUTICALS PRIVATE LIMITED., DEFICIENCY 17. M/A ABBOTT INDIA LTD., DEFICIENCY SHELF LIFE S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. MILAN LABORATRIES INDIA PVT. LTD. NIL GLOBAL CLINICAL TRIAL

3 SR. NO. COMPANY NAME REFERENCE NO. STATUS 1 M/S. MANIPAL ACUNOVA 2 M/S. MAYA CLINICALS EXPORT NOC APPROVAL NEW SITES APPROVAL `3 M/S. NOVO NORDISK - MINUTES OF MEETING LVP DIVISION S. NO. COMPANY NAME FTS NO. /DIARY NO. STATUS 01 M/S. AMANTA HEALTHCARE LTD., GUJARAT QUERY 02 M/S. WINTAC LTD., BANGALORE QUERY 03 M/S. BERYL DRUGS LTD., M. P. QUERY 04 M/S. ULTRA LABORATORIES PVT. LTD.., KERALA QUERY BE NOC FOR EXPORT S. NO. NAME OF THE COMPANY REF. NO. TYPE OF 1. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., NAVI MUMBAI M/S. AG RESEARCH PRIVATE LIMITED, HYDERABAD M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA APPROVAL APPROVAL APPROVAL

4 4. M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA M/S. ALKEM LABORATORIES LTD., TALOJA , TAL: PANVEL, DIST: RAIGAD APPROVAL APPROVAL APPROVAL 7. M/S. APOTEX RESEARCH PVT. LTD., BANGALORE CLARIFICATION 8. M/S. ATHENA DRUG DELIVERY SOLUTIONS PVT. LTD., DIST. THANE, MAHARASHTRA M/S. CADILA PHARMACEUTICAL LTD., DHOLKA , AHMEDABAD APPROVAL APPROVAL 10. M/S. CIPLA LIMITED, MUMBAI APPROVAL 11. M/S. CIPLA LIMITED, MUMBAI APPROVAL 12. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD M/S. EMCURE PHARMACEUTICALS LIMITED, PUNE M/S. GLENMARK PHARMACEUTICALS LTD., NAVI MUMBAI APPROVAL APPROVAL APPROVAL APPROVAL APPROVAL 17. M/S. HETERO LABS LTD., HYDERABAD CLARIFICATION 18. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD CLARIFICATION APPROVAL 20. M/S. LIFESAN CLINICAL RESEARCH, MUMBAI REJECTION

5 21. M/S. LOTUS LABS PVT. LTD., BANGALORE TEST LICENCE 22. M/S. LOTUS LABS PVT. LTD., BANGALORE CLARIFICATION 23. M/S. LOTUS LABS PVT. LTD., CHENNAI APPROVAL 24. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE APPROVAL 25. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE APPROVAL 26. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE APPROVAL 27. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE APPROVAL 28. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE APPROVAL 29. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI (EAST), MUMBAI M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI (EAST), MUMBAI APPROVAL APPROVAL 31. M/S. MANIPAL ACUNOVA LTD., MANGALORE TEST LICENCE 32. M/S. MANIPAL ACUNOVA LTD., MANGALORE TEST LICENCE 33. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., HARYANA 34. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., HARYANA 35. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. SYNGENE INTERNATIONAL LTD., BANGALORE M/S. TORRENT PHARMACEUTICALS LTD. (RESEARCH CENTRE), GUJARAT APPROVAL APPROVAL APPROVAL APPROVAL 2699 APPROVAL APPROVAL

6 39. M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD APPROVAL APPROVAL 41. M/S. VIMTA LABS LTD., HYDERABAD CLARIFICATION

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