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1 S FOR ISSUE ON NEW DRUG S.NO. NAME OF APPLICANT DIARY TYPE OF NO. 1. M/S. CIREX PHARMACEUTICALS LTD - QUERY 2. M/S. LUPIN LIMITED - ADDITIONAL SITES REGISTRATION S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. INTAS PHARMACEUTICAL 6613 APPROVAL /CLARIFICATION 2. DIVINNE SBR ITERNATIONAL PVT CLARIFICATION IMPORT S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. MEHTA PHARMACEUTICAL CLARIFICATION INDUSTRIES 2. AQUATIC REMEDIES PVT CLARIFICATION 3. NOVARTIS HEATLHCARE PVT CLARIFICATION 4. SKIES 20116, CLARIFICATION 5. RIOTH HEALTHCARE PVT CLARIFICATION 6. MICRO LABS CLARIFICATION 7. PIRAMAL ENTERPRISES CLARIFICATION 8. BRENNTAG INGREDEINTS CLARIFICATION
2 9. UNIMAX CHEMICALS CLARIFICATION 10. MEHTA PHARMACEUTICAL INDUSTRIES CLARIFICATION COSMETIC DIVISION S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. DESIGN, ADARSH NAGAR, DELHI APPROVAL 2. M/S. ARCHIES LIMITED, NEW DELHI APPROVAL 3. M/S. SHISEIDO INDIA PVT. LTD, MUMBAI APPROVAL 4. M/S. WIPRO ENTERPRISES LIMITED, BANGALORE APPROVAL 5. M/S. GILLETTE INDIA LIMITED, MUMBAI APPROVAL 6. M/S. DIVINE CARE, CHENNAI DEFICIENCY SUBSEQUENT NEW DRUG S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF 1. M/SINTAS CT NOC PHARMACEUTICALS 2. M/S SUN PHARMA AMENDMENT 3. M/S TROIKAA PHARMA DEFICIENCY 4. M/S BAYER DEFICIENCY PHARMACEUTICALS 5. M/S ABOTT DEFICIENCY HEALTHCARE 6. M/S ALLERGAN INDIA DEFICIENCY 7. M/S ALCON LABORATORIES TEST LICENSE
3 BA/BE DIVISION S. NO. COMPANY NAME FTS NO. /DIARY NO. 01 M/S. QPS BIOSERVE INDIA PVT., HYDERABAD 02 M/S. BIOANALYTICAL LABORATORY, GRAND CENTRE, PANACEA BIOTECH, MUMBAI STATUS APPROVAL QUERY 03 M/S. LAMBDA THERAPEUTIC RESEARCH, MUMBAI QUERY LVP DIVISION S. NO. COMPANY NAME FTS NO. /DIARY NO. STATUS 01 M/S. SUN PHARMACEUTICALS, GUJARAT 02 M/S. SHREE KRISHNA KESHAV, GUJARAT APPROVAL APPROVAL VACCINE DIVISION S. NO. COMPANY NAME DY. NO. STATUS 1 M/S SERUM INSTITUTE OF INDIA 2 M/S RELIANCE LIFE SCIENCES PVT,,LTD (FTS NO) APPROVAL (FTS NO) APPROVAL 3 M/S CADILA HEALTHCARE LIMITED 32738, 32741, 33938, (FTS NO) APPROVAL 4 M/S NOVO MEDI SCIENCES CLARIFICATION
4 PVT, LTD 5 M/S INTERVET INDIA PVT, LTD 21431, 9003 CLARIFICATION 6 M/S FRONTIER LIFELINE CLARIFICATION 7 M/S REGENERATIVE MEDICAL SERVICES PVT. LTD 8 M/S INTAS PHARMACEUTICALS 9 M/S NOVO NORDISK INDIA PVT, LTD CLARIFICATION CLARIFICATION APPROVAL 10 M/S GLOBION INDIA PVT, LTD CLARIFICATION 11 M/S WOCKHARDT LTD CLARIFICATION 12 M/S BIOLOGICAL E. LTD (FTS NO) APPROVAL 13 M/S L.V. PRASAD EYE INSTITUTE 14 M/S BHARAT SERUM AND VACCINE LTD APPROVAL CLARIFICATION MEDICAL DEVICE S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. ARTHOPLASTY APPROVAL (F-IL) 2. M/S. BARD INDIA HEALTHCARE PVT APPROVAL (F-RC) 3. M/S. BARD INDIA HEALTHCARE PVT APPROVAL (F-IL) 4. M/S. BECTON DICKINSON INDIA PVT APPROVAL (F-RC) 5. M/S. BECTON DICKINSON INDIA PVT APPROVAL (F-IL) 6. M/S. BIOMET ORTHOPAEDIC INDIA PVT APPROVAL (E-IL) 7. M/S. BOSTON SCIENTIFIC INDIA PVT APPROVAL (F-RC)
5 8. M/S. BOSTON SCIENTIFIC INDIA PVT APPROVAL (F-IL) 9. M/S. BOSTON SCIENTIFIC INDIA PVT M/S. CARDIO MEDICAL DEVICES PVT APPROVAL (F-IL) 11. M/S. CARL ZEISS INDIA (BANGALORE ) PVT. 12. M/S. CARL ZEISS INDIA (BANGALORE ) PVT APPROVAL (E-RC) 9926 APPROVAL (E-IL) 13. M/S. CLINICARE (INDIA) PVT APPROVAL (F-IL) 14. M/S. COOK INDIA MEDICAL DEVICES PVT APPROVAL (CT) 15. M/S. DEEP MEDICAL DEVICES PVT APPROVAL (F-IL) 16. M/S. EURO MEDI TOOLS PVT APPROVAL (F-IL) 17. M/S. GLOBAL SURGICALS PVT APPROVAL (F-IL) 18. M/S. HESTER DIAGNOSTIC PVT APPROVAL (F-IL) 19. M/S. INNVOLUTION HEALTHCARE PVT APPROVAL (F-IL) 20. M/S. INNVOLUTION HEALTHCARE PVT APPROVAL (F-IL) 21. M/S. INDIA MEDTRONIC PVT APPROVAL (R-RC) 22. M/S. INDIA MEDTRONIC PVT APPROVAL (R-IL) 23. M/S. JOHNSON & JOHNSON PVT M/S. KOX MED & LAB PVT APPROVAL (F-IL) 25. M/S. LIFELONG MEDITECH M/S. MERIT MEDICAL SYSTEMS INDIA PVT APPROVAL (F-IL) 27. M/S. NOBEL BIOCARE INDIA PVT APPROVAL (TL) 28. M/S. NOBEL BIOCARE INDIA PVT APPROVAL (TL) 29. M/S. NOBEL BIOCARE INDIA PVT APPROVAL (TL) 30. M/S. PAREKH INTEGRATED SERVICES PVT APPROVAL (F-IL)
6 31. M/S. SHAH DISTRIBUTORS APPROVAL (R-IL) 32. M/S. SHUBHAN ENTERPRISES APPROVAL (F-IL) 33. M/S. SPINEMED SYSTEMS PVT APPROVAL (R-IL) 34. M/S. TOTIPOTENT SC SCIENTIFIC PRODUCTS PVT. 35. M/S. VASCULAR THERAPEUTICS INDIA PVT APPROVAL (E-IL) APPROVAL (F-IL) 36. M/S. WEALTH TAXI TECHNOLOGY PVT CLARIFICATION 37. M/S. BECTON DICKINSON INDIA PVT QUERY 38. M/S. AMARANTE WELLNESS ZONE CLARIFICATION 39. M/S. HEALTHY OPTION PVT CLARIFICATION 40. M/S. STERICATGUTSRINGS PVT M/S. B BRAUN MEDICAL (INDIA0 PVT QUERY 42. M/S. TROIKAA PHARMACEUTICAL M/S. JOHNSON & JOHNSON PVT M/S. JOHNSON & JOHNSON PVT THE JOINT COMMISSIONER (KD), THANE (CLAA) QUERY DDC, CDSCO, MUMBAI (CLAA) M/S. GEORGE PHILIPS MEDICAL ENGINEERING PVT. 46. THE COMMISSIONER, GANDHINAGAR (CLAA) DDC, CDSCO, AHMEDABAD (GUJ.) (CLAA) APPROVAL M/S. BIOTECH VISION CARE PVT. 47. THE COMMISSIONER, GANDHINAGAR (CLAA) DDC, CDSCO, AHMEDABAD (GUJ.) (CLAA) APPROVAL
7 M/S. SAHAJANAND MEDICAL TECHNOLOGIES PVT. 48. M/S. S3V VASCULAR TECHNOLOGIES PVT. 49. M/S. S3V VASCULAR TECHNOLOGIES PVT APPROVAL (F-RC) 4778 APPROVAL (F-IL) DIAGNOSTICS DIVISION S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. AIMS APPROVAL (IL) 2. M/S. ALERE MEDICAL PVT APPROVAL (E-IL) 3. M/S. ALLIED BIOTECHNOLOGY INDIA PVT APPROVAL (IL) 4. M/S. ARKRAY HEALTHCARE PVT APPROVAL (IL) 5. M/S. BECKMAN COULTER INDIA PVT APPROVAL (IL) 6. M/S. BECKMAN COULTER INDIA PVT APPROVAL (IL) 7. M/S. BECKMAN COULTER INDIA PVT M/S. BIOMERIEUX INDIA PVT M/S. BIOMERIEUX INDIA PVT APPROVAL (IL) 10. M/S. BIO-RAD LABORATORIES (INDIA) PVT APPROVAL (IL) 11. M/S. DHR HOLDING INDIA PVT APPROVAL (IL) 12. M/S. EURO DIAGNOSTIC SYSTEMS PVT APPROVAL (E-IL) 13. M/S. HALYARD HEALTH INDIA PVT APPROVAL (IL)
8 14. M/S. IMMUCOR INDIA PVT APPROVAL (IL) 15. M/S. JOHNSON & JOHNSON PVT M/S. KRYPTON BIOMEDICAL PVT APPROVAL (IL) 17. M/S. LILAC MEDICARE PVT APPROVAL (IL) 18. M/S. LILAC MEDICARE PVT M/S. LILAC MEDICARE PVT M/S. LILAC MEDICARE PVT APPROVAL (E-IL) 21. M/S. LILAC MEDICARE PVT APPROVAL (E-IL) 22. M/S. PAMMVI EXPORTS PVT APPROVAL (IL) 23. M/S. PINKI SCIENTIFIC APPROVAL (IL) 24. M/S. ROCHE DIAGNOSTICS INDIA PVT APPROVAL (E-IL) 25. M/S. ROCHE DIAGNOSTICS INDIA PVT APPROVAL (E-IL) 26. M/S. SANDOR MEDICAIDSPVT APPROVAL (IL) 27. M/S. SIEMENS LIMITED APPROVAL (IL) 28. M/S. SIEMENS LIMITED APPROVAL (IL) 29. M/S. SIEMENS LIMITED APPROVAL (IL) 30. M/S. SIEMENS LIMITED APPROVAL (E-IL) 31. M/S. SIEMENS LIMITED APPROVAL (IL) 32. M/S. SIEMENS LIMITED APPROVAL (E-IL) 33. M/S. SYSMEX INDIA PVT APPROVAL (IL) 34. M/S. TRANSASIA BIO-MEDICALS LIMITED APPROVAL (IL) 35. M/S. TRANSASIA BIO-MEDICALS LIMITED APPROVAL (IL) 36. M/S. TRANSASIA BIO MEDICALS LIMITED APPROVAL (E-IL) 37. M/S. TRIVITRON HEALTHCARE PVT APPROVAL (IL) 38. M/S. TRIVITRON HEALTHCARE PVT APPROVAL (IL) 39. M/S. UNIQUE DIAGNOSTICS & SCIENTIFIC APPROVAL (IL)
9 40. M/S. WERFEN MEDICAL INDIA PVT APPROVAL (IL) 41. M/S. ATHENESEDX PVT BE NOC FOR EXPORT S. NO. NAME OF THE COMPANY REF. NO. TYPE OF 1. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT., NAVI MUMBAI M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT., NAVI MUMBAI M/S. ALEMBIC PHARMACEUTICALS, VADODARA M/S. APOTEX RESEARCH PVT., BANGALORE M/S. AZIDUS LABORATORIES, CHENNAI M/S. CADILA HEALTHCARE,, AHMEDABAD AMENDMENT TEST LICENCE AMENDMENT TEST LICENCE TEST LICENCE TEST LICENCE 7. M/S. CIPLA LIMITED, MUMBAI APPROVAL 8. M/S. CIPLA LIMITED, MUMBAI TEST LICENCE 9. M/S. CIPLA LIMITED, MUMBAI TEST LICENCE 10. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD M/S. HIGLANCE LABORATORIES PVT., GREATER NOIDA , U.P. 12. M/S. LOTUS LABS PVT., BANGALORE M/S. LUPIN LIMITED (RESEARCH PARK), PUNE AMENDMENT APPROVAL TEST LICENCE AMENDMENT
10 14. M/S. MANIPAL ACUNOVA, MANGALORE M/S. QUEST LIFE SCIENCES (P), CHENNAI M/S. SEMLER RESEARCH CENTER, BANGALORE M/S. SYNGENE INTERNATIONAL, BANGALORE M/S. WATSON PHARMA PVT., NAVI MUMBAI M/S. WATSON PHARMA PVT., NAVI MUMBAI M/S. WATSON PHARMA PVT., NAVI MUMBAI APPROVAL APPROVAL AMENDMENT CLARIFICATION APPROVAL APPROVAL APPROVAL
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