LETTERS FOR ISSUE ON

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1 S FOR ISSUE ON NEW DRUG S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. M/S. VIRCHOW BIOTECH PVT LTD - QUERY 2. M/S. MSN LABORATORIES PVT - CT-NOC & BE NOC LTD (3) 3. M/S. NATCO PHARMA LTD. - BE-NOC 4. M/S. CADILA HEALTHCARE - CT-NOC LIMITED 5. M/S INTAS PHARMACEUTICALS - QUERY LIMITED 6. M/S. BDR LIFESCIENCES - PHARMACEUTICALS PVT LTD 7. M/S AJANTA PHARMA LTD - QUERY (2) MEDICAL DEVICE S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. TELEFLEX MEDICAL PVT. LTD M/S. TELEFLEX MEDICAL PVT. LTD M/S. FAITH BIOTECH PVT. LTD SEC 4. M/S. VARDHAMAN REMEDIES PVT. LTD SEC 5. M/S. KENTRON BIOTECHNOLOGY PVT. LTD SEC 6. M/S. EMERGO INDIA CONSULTING PVT. LTD SEC VACCINE DIVISION S. NO. COMPANY NAME DY. NO STATUS 1 M/SGSK ASIA PVT, LTD CLARIFICATION 2 M/S SANOFI PASTEUR INDIA PVT, LTD 37587, CLARIFICATION & CDL

2 3 M/S ALCON LABORATORIES INDIA PVT, LTD APPROVAL 4 M/S SYNAPSE LABS PVT, LTD APPROVAL 5 M/S BHARAT BIOTECH INTERNATIONAL LTD CLARIFICATION SUBSEQUENT NEW DRUG S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF 1. M/S BHARAT SERUMS AND VACCINES LIMITED., DEFICIENCY GLOBAL CLINICAL TRIAL SR. NO. FILE NO. REFERENCE NO. STATUS 1 M/S. NOVARTIS TL APPROVAL 2 M/S. ASTRAZENECA 50448/50450 CT NOC& TL APPROVAL S 3 M/S. QUINTILES CHANGE IN CRO APPROVAL 4 M/S. MAYA CLINICALS 5 M/S. NOVO NORDISK SITE APPROVAL - MINUTES OF SEC COSMETIC DIVISION S. NO. COMPANY NAME DIARY NO. STATUS 1. M/S. SAKURA EBIZ PRIVATE LIMITED, NEW APPROVAL

3 DELHI 2. M/S. S.H.A.M.K. INTERNATIONAL PVT. LTD, MUMBAI APPROVAL 3. M/S. GEOSMATIC COSMECUTICALS & COSMOCARE PVT. LTD, MAHARASTRA APPROVAL 4. M/S. LIBERTY PERFUMES, MUMBAI APPROVAL 5. M/S. RONAK HEALTHCARE PVT. LTD, VADODARA, APPROVAL 6. M/S. ORIFLAME INDIA PVT. LTD, NEW DELHI APPROVAL 7. M/S KUNDAN CUTLERY PVT LTD., MUMBAI APPROVAL 8. M/S. SHREE HARDEV ENTERPRISES, MUMBAI APPROVAL 9. M/S. L'OREAL INDIA PVT. LTD, LOWER PAREL, MUMBAI 27772, 25373, 25559, 27133, 25583, 25558, 27132, 29178, 29843, 31948, APPROVAL

4 M/S. MARKS AND SPENCER RELIANCE INDIA PVT LTD., MUMBAI , 30787, 32659, APPROVAL IMPORT S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. DOLPHIN INTERNATIONAL ,39482 CLARIFICATION 2. SUN PHARMACEUTICAL INDUSTRIES LTD ,39544 CLARIFICATION REGISTRATION S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. CENTAUR CHEM APPROVAL 2. KIMIA BIOSCIENCES PVT. LTD APPROVAL 3. NOVARTIS HEALTHCARE PVT. LTD APPROVAL 4. UNI-CHEMIE INTERNATIONAL, APPROVAL 5. GANGWAL CHEMICALS PVT. LTD APPROVAL 6. SHAH TC APPROVAL 7. CHEMO AG, CLARIFICATION 8. THE MANISH GLOBAL CLARIFICATION 9. DIVINNE SBR INTERNATIONAL CLARIFICATION PVT.LTD. 10. SANOFI SYNTHELABO PVT.LTD AMENDMENT 11. EASTERN CHEMICAL PVT.LTD AMENDMENT 12. MAN MILL CHEMICALS PVT.LTD AMENDMENT RULE-37/MISC./SHELF LIFE S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. MERCK LTD CLARIFICATION BE NOC FOR EXPORT

5 S. NO. NAME OF THE COMPANY REF. NO. TYPE OF 1. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., NAVI MUMBAI M/S. AIZANT DRUG RESEARCH SOLUTIONS PVT. LTD., HYDERABAD M/S. AIZANT DRUG RESEARCH SOLUTIONS PVT. LTD., HYDERABAD M/S. ANACIPHER CLINICAL RESEARCH ORGANISATION (A DIVISION OF INDOCO REMEDIES LTD.), HYDERABAD M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD M/S. AZIDUS LABORATORIES LTD., CHENNAI M/S. AZIDUS LABORATORIES LTD., CHENNAI M/S. CLIANTHA RESEARCH LIMITED, APPROVAL CLARIFICATION CLARIFICATION CLARIFICATION CLARIFICATION CLARIFICATION CLARIFICATION APPROVAL AMENDMENT

6 AHMEDABAD M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD M/S. DR. REDDY S LABORATORIES LTD., HYDERABAD M/S. DR. REDDY S LABORATORIES LTD., HYDERABAD M/S. EMCURE PHARMACEUTICALS LTD., PUNE M/S. GLENMARK PHARMACEUTICALS LTD., NAVI MUMBAI M/S. INVENTIA HEALTHCARE PVT. LTD., THANE (WEST) M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD M/S. LOTUS LABS PVT. LTD., BANGALORE M/S. LOTUS LABS PVT. LTD., BANGALORE M/S. LUPIN LIMITED APPROVAL APPROVAL CLARIFICATION APPROVAL CLARIFICATION CLARIFICATION CLARIFICATION CLARIFICATION APPROVAL APPROVAL CLARIFICATION

7 21. M/S. LUPIN LIMITED 22. M/S. LUPIN LIMITED 23. M/S. LUPIN LIMITED 24. M/S. LUPIN LIMITED 25. M/S. LUPIN LIMITED 26. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI (EAST), MUMBAI M/S. MANIPAL ACUNOVA LIMITED, MANIPAL M/S. MSN LABORATORIES PVT. LTD., MEDAK M/S. RA CHEM PHARMA LTD., BALANAGAR, HYDERABAD M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA APPROVAL APPROVAL APPROVAL APPROVAL APPROVAL APPROVAL APPROVAL APPROVAL APPROVAL CLARIFICATION CLARIFICATION

8 32. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD M/S. VERGO CLINICALS, GOA M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI APPROVAL CLARIFICATION APPROVAL CLARIFICATION ADDITIONAL STUDY CENTRE APPROVAL

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