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Transcription:

S FOR ISSUE ON 21.06.2016 LVP DIVISION S. NO. COMPANY NAME FTS NO. /DIARY NO. STATUS 01 M/S. GLOBAL PHARMA HEALTHCARE PVT. LTD., THIRUPORUR 27509 APPROVAL BIOLOGICAL DIVISION NAME OF COMPANY DY.NO. STATUS M/S PANACEA BIOTECH LTD 3299, APPROVAL M/S HIPRA INDIA PVT, LTD 15692 APPROVAL M/S LUPIN LIMITED 17931 APPROVAL M/S BHARAT SERUM AND VACCINE LTD 7218 AMENDMENT SHELF LIFE S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. NOSCH LABS PVT. LTD NIL 2. SUN PHARMACEUTICAL INDUSTRIAL LTD. 13062 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-400709 2. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., NAVI MUMBAI-400709 15649 APPROVAL 16539 APPROVAL

3. M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA- 390003 4. M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA- 390003 5. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD-500090 6. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD-500090 7. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD-500090 15746 APPROVAL 11277 APPROVAL 16124 APPROVAL 16143 APPROVAL 16145 APPROVAL 8. M/S. CIPLA LIMITED, MUMBAI-400013 15489 APPROVAL 9. M/S. CIPLA LIMITED, MUMBAI-400013 17307 APPROVAL 10. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD- 11. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD- 12. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD- 13. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD- 14. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD- 15. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD- 16. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD- 17. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD- 18. M/S. GLENMARK PHARMACEUTICALS LTD., NAVI MUMBAI-400705 19. M/S. GLENMARK PHARMACEUTICALS LTD., NAVI MUMBAI-400705 20. M/S. GLENMARK PHARMACEUTICALS LTD., NAVI MUMBAI-400705 15560 APPROVAL 10581 APPROVAL 15728 APPROVAL 15861 APPROVAL 16024 APPROVAL 11589 APPROVAL 11314 APPROVAL 11460 APPROVAL 16052 APPROVAL 16022 APPROVAL 16051 APPROVAL

21. M/S. HETERO LABS LTD., HYDERABAD-500018 15568 APPROVAL 22. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD-380061 23. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD-380061 24. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD-382481 25. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD-382481 26. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., NAVI MUMBAI-400614 27. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., NAVI MUMBAI-400614 11222 APPROVAL 10388 APPROVAL 17755 APPROVAL 17200 APPROVAL 15720 APPROVAL 16209 APPROVAL 28. M/S. LOTUS LABS PVT. LTD., BANGALORE-560034 15955 APPROVAL 29. M/S. LOTUS LABS PVT. LTD., BANGALORE-560034 15956 APPROVAL 30. M/S. LOTUS LABS PVT. LTD., BANGALORE-560034 16019 APPROVAL 31. M/S. LOTUS LABS PVT. LTD., BANGALORE-560034 16010 APPROVAL 32. M/S. LOTUS LABS PVT. LTD., BANGALORE-560034 16020 APPROVAL 33. M/S. LOTUS LABS PVT. LTD., BANGALORE-560064 16009 APPROVAL 34. M/S. LOTUS LABS PVT. LTD., CHENNAI-600004 16121 APPROVAL 35. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 15477 APPROVAL 36. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 10928 APPROVAL 37. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI 38. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI 39. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI 40. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI 41. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI 15713 APPROVAL 2526 APPROVAL 1668 APPROVAL 1667 APPROVAL 15712 APPROVAL

42. M/S. MANIPAL ACUNOVA LTD., MANGALORE-575001 15754 APPROVAL 43. M/S. MICRO THERAPEUTIC RESEARCH LABS PVT. LTD., COIMBATORE-641029 44. M/S. NORWICH CLINICAL SERVICES PVT. LTD., BANGALORE-560034 10103 APPROVAL 16177 APPROVAL 45. M/S. PANACEA BIOTEC LTD., PUNJAB FTS NO. 27921 TEST LICENCE 46. M/S. PANEXCELL CLINICAL LAB PVT. LTD., NAVI MUMBAI-400701 47. M/S. RA CHEM PHARMA LTD., BALANAGAR, HYDERABAD-500037 48. M/S. SEMLER RESEARCH CENTER PVT. LTD., BANGALORE-560078 49. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., HARYANA 50. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., HARYANA 51. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA-390020 52. M/S. VEEDA CLINICAL RESEARCH PVT. LTD., 53. M/S. VEEDA CLINICAL RESEARCH PVT. LTD., 54. M/S. VEEDA CLINICAL RESEARCH PVT. LTD., 55. M/S. VEEDA CLINICAL RESEARCH PVT. LTD., 16734 APPROVAL 10204 APPROVAL 5106 APPROVAL 15668 APPROVAL 15966 APPROVAL 15710 APPROVAL 15564 APPROVAL 15566 APPROVAL 16163 APPROVAL 15866 APPROVAL FDC DIVISION S.NO. NAME OF COMPANY DIARY NO DOCUMENT 1. M/S. SYNOKEM PHARMACEUTICALS, 19083 2. M/S. AKUMS DRUGS & PHARMACEUTICALS 7681 COSMETICS DIVISION

S.NO. NAME OF THE FIRM DIARY NO. STATUS 1. M/S. VOV INTERNATIONAL, MAHARASHTRA 2. M/S. MICHAEL TRADERS, TAMILNADU 3. M/S. AURORA TRADING, NEWDELHI 17442 DEFICIENCY 14488 DEFICIENCY 16505 DEFICIENCY SUBSEQUENT NEW DRUG S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF 1. M/S THINQ PHARMA CRO LTD., 16728 - TEST LICENSE/ CT NOC (2) GLOBAL CLINICAL TRIAL SR. NO. COMPANY NAME REFERENCE NO. STATUS 1 M/S. NOVARTIS 50889/37347 CT NOC & TL APPROVAL 2 M/S. JSS 152191 TL APPROVAL MEDICAL DEVICE S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. STRYKER INDIA PVT. LTD 13667 APPROVAL (E-RC) 2. M/S. GOLDWIN MEDICARE LTD. FTS. NO.-31078 CLARIFICATION 3. M/S. TOSHBRO MEDICALS PVT. LTD. FTS. NO.-28913 CLARIFICATION 4. M/S. TTK PROTECTIVE DEVICE LIMITED FTS. NO.- QUERY

5. DR. INDERJEET SINGH HURA, ADC(I) M/S SHANKHESHWAR IMPEX PRIVATE LIMITED 6. THE STATE DRUGS CONTROLLER, PANCHKULA (CLAA) GHAZIABAD (CLAA) (M/S. LARS MEDICARE PVT. LTD., SONEPAT) 7. THE STATE DRUGS CONTROLLER, PANCHKULA (CLAA) GHAZIABAD (CLAA) (M/S. HARSORIA HEALTHCARE PVT. LTD., GURGAON) 8. THE STATE DRUGS CONTROLLER, PANCHKULA (CLAA) GHAZIABAD (CLAA) (M/S. MEDI PLUS INDIA LTD., BAHADURGARH) 9. THE COMMISSIONER, GANDHINAGAR (CLAA) AHMEDABAD (CLAA) THE DRUGS CONTROLLER & LICENSING AUTHORITY, JAIPUR (CLAA) 10. THE COMMISSIONER, GANDHINAGAR (CLAA) GANDHINAGAR (CLAA) THE DRUGS CONTROLLER & LICENSING AUTHORITY, AHMEDABAD 24468 NIL FTS. NO. - 32183 FTS. NO. - 32184 FTS. NO. - 32183 NIL FTS NO.31929 APPROVAL APPROVAL APPROVAL

(CLAA) DIAGNOSTICS DIVISION S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. ABBOTT HEALTHCARE PVT. LTD. 10104 APPROVAL (RENEWAL-RC) 2. M/S. CADILA HEALTHCARE LTD. 11576 3. M/S VISHAT DIAGNOSTIC PVT LTD., 14069 QUERY 4. M/S VISHAT DIAGNOSTIC PVT. LTD., 7486 QUERY 5. M/S VISHAT DIAGNOSTIC PVT LTD., 12016 QUERY 6. M/S VISHAT DIAGNOSTIC PVT LTD 7801 QUERY 7. M/S GEUINE BIOSYSTEM FTS NO.21139 8. SH. N.C BAKSHI FTS NO. 19983 QUERY NEW DRUG S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. M/S. CADILA HEALTHCARE LTD. - (3) 2. M/S. ALKEM LABORATORIES LTD. - QUERY 3. M/S. IND-SWIFT LTD. - QUERY 4. M/S. MICRO LABS LTD. - QUERY 5. M/S. AJANTA PHARMA LIMITED - QUERY 6. M/S. HETERO LABS LTD - QUERY 7. M/S BOEHRINGER INGELHEIM INDIA PVT LTD -