LETTERS FOR ISSUE ON 10.04.2015
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. NO / FIRM NAME / TYPE OF LETTER1. / M/S. GLOBAL CALCIUM PRIVATE LIMITED, HOSUR, TAMILNADU. / WC CERTIFICATE
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / TYPE OF LETTER1. / M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., NAVI MUMBAI-400 709 / 8978 / TEST LICENCE
2. / M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD-500 090 / 7507 / ADDITIONAL STUDY CENTRE
3. / M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD-500 090 / 7508 / AMENDMENT LETTER
4. / M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD-500 090 / 7781 / CLARIFICATION LETTER
5. / M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD-500 090 / 2257 / APPROVAL LETTER
6. / M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD-500 090 / 3491 / APPROVAL LETTER
7. / M/S. CIPLA LIMITED, MUMBAI-400 013 / 2705 / APPROVAL LETTER
8. / M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-380 054 / 6103 / CLARIFICATION LETTER
9. / M/S. DR. REDDY’S LABORATORIES LTD., HYDERABAD-500 034 / 7083 / TEST LICENCE
10. / M/S. GLENMARK GENERICS LTD., NAVI MUMBAI-400 705 / 5796 / TEST LICENCE
11. / M/S. INVENTIA HEALTHCARE PVT. LTD., DIST. THANE-421 506 / 5540 / APPROVAL LETTER
12. / M/S. LOTUS LABS PVT. LTD., BANGALORE-560 052 / 7247 / CLARIFICATION LETTER
13. / M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412 115 / 7472 / CLARIFICATION LETTER
14. / M/S. PIRAMAL CLINICAL RESEARCH, HYDEARBAD-500 013 / 4549 / APPROVAL LETTER
15. / M/S. RANBAXY LABORATORIES LTD., GURGAON-122 015 / 6478 / CLARIFICATION LETTER
16. / M/S. SITEC LABS PVT LTD, NAVI MUMBAI-400701 / 7492 / APPROVAL LETTER
17. / M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA-390 020 / 7476 / APPROVAL LETTER
18. / M/S. TORRENT PHARMACEUTICALS LTD. (RESEARCH CENTRE), GUJARAT / 6800 / APPROVAL LETTER
19. / M/S. TORRENT PHARMACEUTICALS LTD. (RESEARCH CENTRE), GUJARAT / 7442 / APPROVAL LETTER
20. / M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD-380 015 / 50936 / REJECTION LETTER
VACCINE DIVISION
S. NO. / COMPANY NAME / DY. NO. / STATUS1 / M/S RELIANCE LIFE SCIENCES PVT, LTD / 34392 / APPROVAL LETTER
2 / M/S MSD WELCOME TRUST HILLMAN LAB PVT, LTD / 3995 / CLARIFICATION LETTER
3 / M/S DR. REDDY LABORATORIES LTD / 3010 / APPROVAL LETTER
4 / M/S ELI LILLY AND COMPANY INDIA PVT ,LTD / CLARIFICATION LETTER
5 / M/S NOVARTIS HEALTHCARE PVT, LTD / 5701 / PERMISSION LETTER
6 / M/S ROCHE PRODUCT INDIA PVT, LTD / 6180 / CLARIFICATION LETTER
7 / M/S PANAV BIOTECH / 6747 / AMENDMENT LETTER
8 / M/S HIPRA INDIA PVT, LTD / APPROVAL LETTER
9 / M/S BHARAT SERUM AND VACCINE LTD / 14318 (FTS NO) / APPROVAL LETTER
10 / M/S NOVO NORDISK PVT, LTD / CLARIFICATION LETTER
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/S INTAS PHARMACEUTICALS / 2457 / 4376 / DEFICIENCY LETTER
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/S TORRENT PHARMACEUTICALS LTD / - / QUERY LETTER
2. / M/S. VENUS REMEDIES LTD. / - / QUERY LETTER
3. / M/S. AJANTA PHARMA LIMITED / - / QUERY LETTER
4. / M/S. SIRO CLINPHARM PVT LTD. / - / QUERY LETTER
5. / M/S. SANOFI-SYNTHELABO (INDIA) LIMITED / - / QUERY LETTER
COSMETIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/S. PROCTER & GAMBLE HOME PRODUCTS LIMITED, MUMBAI / 1898 / APPROVAL LETTER
2. / M/S. ORIFLAME INDIA PRIVATE LIMITED, JASOLA, NEW DELHI / 2382 / APPROVAL LETTER
3. / M/S. ITC LIMITED, KOLKATA / 3104 / APPROVAL LETTER
4. / M/S. VLCC PERSONAL CARE LTD, NEW DELHI / 4082 / DEFICIENCY LETTER
5. / M/S. USV LIMITED, MUMBAI / 4178 / APPROVAL LETTER
6. / M/S. ABBOTT HEALTHCARE PVT. LTD, MUMBAI / 4449, 4618 / DEFICIENCY LETTER
7. / M/S. A K MARKETING CHENNAI / 4886 / DEFICIENCY LETTER
8. / M/S. ADOR MULTI PRODUCTS LIMITED, MUMBAI / 4910 / DEFICIENCY LETTER
9. / M/S. ARCHIES LIMITED, NEW DELHI / 5008 / DEFICIENCY LETTER
10. / M/S. SESDERMA PVT. LTD, NEW DELHI / 5431 / APPROVAL LETTER
11. / M/S. BAJORIA FOODS PVT. LTD, MUMBAI / 5642 / APPROVAL LETTER
12. / M/S. WIPRO ENTERPRISES LIMITED, BANGALORE / 5643 / DEFICIENCY LETTER
13. / M/S. ANT INTERNATIONAL, EXPORTS PVT. LTD, MUMBAI / 6064 / APPROVAL LETTER
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / SHAH TC / 7333 / AMENDMENT LETTER
2. / RUSKIN CHEMIPHARM / 4049 / CLARIFICATION LETTER
3. / UNI-CHEMIE INERNATIONAL / 49144 / CLARIFICATION LETTER
4. / ROCHE PRODUCTS INDIA PV.T LTD. / 46958 / CLARIFICATION LETTER
5. / GUTHY RENKER MARKETING PVT. LTD. / 30460 / CLARIFICATION LETTER
6. / BAYER PHARMACEUTICALS PVT. LTD. / 8429 / CLARIFICATION LETTER
7. / JOHNSON & JOHNSON LTD. / 6257 / CLARIFICATION LETTER
8. / ALLIANCE PHARMA AGENCIES / 47424 / CLARIFICATION LETTER
9. / SANDOZ PVT,.LTD. / 4390 / CLARIFICATION LETTER
10. / THE WATSON PHARMA PVT. LTD. / NIL / LETTER
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / BIOCON LTD./ANANTCO ENTERPRISES PVT. LTD. / 8856 / CLARIFICATION LETTER
2. / MICRO LABS LTD. / 9235 / CLARIFICATION LETTER
3. / BAXTER INDIA PV.T LTD. / 8636 / CLARIFICATION LETTER
4. / TORRENT PHARMACEUTICALS LTD. / 8461 / CLARIFICATION LETTER
GLOBAL CLINICAL TRIAL
SR. NO. / NAME OF FIRM / REFERENCE NO. / TYPE OF LETTER1. / M/S. CLIANTHA / - / CLARIFICATION LETTER