Letters for Issue on 16.04.2015
LETTERS FOR ISSUE ON 16.04.2015
COSMETIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/S. BACCAROSE PERFUMES & BEAUTY PRODUCTS PVT. LTD, MUMBAI / 3119 / DEFICIENCY LETTER
M/S. FULLIFE HEALTHCARE PVT. LTD, MUMBAI / 3238 / DEFICIENCY LETTER
M/S. LOTUS HERBALS PVT. LTD, NEW DELHI / 3356 / APPROVAL LETTER
M/S. AELIUS PHARMA PVT. LTD, MUMBAI / 3486 / APPROVAL LETTER
M/S. NEW INDIA AGENCIES, MUMBAI / 3587 / DEFICIENCY LETTER
M/S. ISHWARI PRASAD & SONS PVT. LTD, MUMBAI / 3998 / APPROVAL LETTER
M/S. JUMEIRAH LIFESTYLE INDIA PRIVATE LIMITED, NEW DELHI / 4887 / APPROVAL LETTER
M/S. INVOGUE COSMETICS, NEW DELHI / 5076 / DEFICIENCY LETTER
M/S. SIBERIAN HEALTH INTERNATIONAL PRIVATE LIMITED, NEW DELHI / 5829 / APPROVAL LETTER
M/S. NATIONAL TRADERS, MUMBAI / 5938 / APPROVAL LETTER
M/S. SSIZ INTERNATIONAL, MUMBAI / 6296 / DEFICIENCY LETTER
M/S. RECKITT BENCKISER (INDIA) LIMITED, NEW DELHI / 6468 / DEFICIENCY LETTER
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / TYPE OF LETTERM/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., NAVI MUMBAI-400 709 / 3830 / APPROVAL LETTER
M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., NAVI MUMBAI-400 709 / 2442 / APPROVAL LETTER
M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., NAVI MUMBAI-400 709 / 7558 / APPROVAL LETTER
M/S. ACTIMUS BIOSCIENCES PVT. LTD., VISAKHAPATNAM-530 003 / 11025 / APPROVAL LETTER
M/S. ACTIMUS BIOSCIENCES PVT. LTD., VISAKHAPATNAM-530 003 / 10635 / APPROVAL LETTER
M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA-390 003 / 1219 / APPROVAL LETTER
M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-380 054 / 11223 / APPROVAL LETTER
M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-380 054 / 7933 / APPROVAL LETTER
M/S. INVENTIA HEALTHCARE PVT. LTD., THANE (WEST)-400 604 / 4032 / APPROVAL LETTER
M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD-380 061 / 8924 / APPROVAL LETTER
M/S. MICRO THERAPEUTIC RESEARCH LABS PVT. LTD., CHENNAI-600 059 / 7487 / APPROVAL LETTER
M/S. NORWICH CLINICAL SERVICES PVT. LTD., BANGALORE-560 034 / 10124 / AMENDMENT LETTER
M/S. RANBAXY LABORATORIES LTD., NEW DELHI / 33576 / APPROVAL LETTER
M/S. SUN PHARMA ADVANCED RESEARCH COMPANY LTD., VADODARA-390 020 / 10324 / APPROVAL LETTER
M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA-390 020 / 3342 / REJECTION LETTER
M/S. UNICHEM LABORATORIES LTD., MUMBAI-400 102 / 8174 / AMENDMENT LETTER
M/S. UNICHEM LABORATORIES LTD., MUMBAI-400 102 / 7730 / APPROVAL LETTER
M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD-380 015 / 11216 / APPROVAL LETTER
M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI-400614 / 5571 / APPROVAL LETTER
VACCINE DIVISION
S. NO. / COMPANY NAME / DY. NO. / STATUS1 / M/S RELIANCE LIFE SCIENCES PVT, LTD / 13287 (FTS NO) / APPROVAL LETTER
2 / M/S GSK ASIA PVT, LTD / 8093 (FTS NO) / APPROVAL LETTER
3 / M/S LOTUS LABS PVT, LTD / 7639, 7638 / APPROVAL LETTER
4 / M/S CHIRON BEHRING VACCINE PVT, LTD / 7604, / CLARIFICATION LETTER
5 / M/S LG LIFE SCIENCES INDIA PVT, LTD / 41978 / CLARIFICATION LETTER
6 / M/S ELI LILLY AND COMPANY INDIA PVT, LTD / 5022, 6989, 7936, 7935 / CLARIFICATION LETTER
7 / M/S ORGANON INDIA PVT, LTD / 7520 / CLARIFICATION LETTER
8 / M/S ALCON LABORATORIES INDIA PVT, LTD / 5024 / CLARIFICATION LETTER
9 / M/S ESSCHEM PVT, LTD / 6012 / CLARIFICATION LETTER
10 / M/S BIOVIZ TECHNOLOGIES PVT, LTD / 3058 / CLARIFICATION LETTER
11 / M/S HLL LIFECARE LTD / 4782 / CLARIFICATION LETTER
12 / M/S NOVARTIS HEALTHCARE PVT, LTD / 5207 / CLARIFICATION LETTER
13 / M/S HUMAN BIOLOGICALS INSTITUTE / 7197 / ACKNOWLEDGE LETTER
14 / M/S NOVO NORDISK INDIA PVT, LTD / 47581 / APPROVAL LETTER
15 / M/S ROCHE PRODUCT INDIA PVT, LTD / 9231 / CLARIFICATION LETTER
16 / M/S LEVIM BIOTECH LLP, / 4932 / CLARIFICATION LETTER
17 / M/S CLIARIS LIFE SCIENCES PVT, LTD / 7538 / CLARIFICATION LETTER
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/S. SUN PHARMA LABORATORIES LTD., / 71 / LETTER
M/S. ELANPHARMA (INDIA) PVT. LTD., / 14079 / LETTER
M/S. KEMWELLBIOPHARMAPVT. LTD., / 1180 / LETTER
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/S. B. BRAUN MEDICAL (INDIA) PVT. LTD. / 4489 / QUERY LETTER
M/S. DECCAN DENTAL DEPOT PVT. LTD. / 30395 / LETTER
M/S. FRESENIUS MEDICAL CARE INDIA PVT. LTD. / 4500 / QUERY LETTER
M/S. JOHNSON & JOHNSON LTD. / 782 / QUERY LETTER
M/S. MORULAA HEALTH TECH PVT. LTD. / 2728 / QUERY LETTER
M/S. 3M INDIA LTD. / 2707 / QUERY LETTER
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/S. QIAGEN INDIA (P) LTD. / 2296 / APPROVAL (IL)
M/S. ALLIANCE TRANSFUSION PVT. LTD. / 3401 / QUERY LETTER
M/S.AVANTOR PERFORMANCE MATERIALS INDIA LTD. / 6345 / QUERY LETTER
M/S. BIO-RAD LABORATORIES (I). / 712 / QUERY LETTER
M/S. KRYPTON BIOMEDICAL PVT. LTD. / 5046 / QUERY LETTER
M/S. KIMBERLY-CLARK HYGIENE PRODUCTS PVT. LTD. / 49476 / QUERY LETTER
M/S. R-BIOPHARMNEUGEN PVT. LTD. / 1940 / QUERY LETTER
M/S. RANDOX LABORATORIES (INDIA) PVT. LTD. / 4300 / QUERY LETTER
M/S. SECURE BIOTECH. / 48795 / QUERY LETTER
M/S. SECURE BIOTECH. / 48796 / QUERY LETTER
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /DIARY NO. / STATUS01 / M/S. CENTRE FOR ADVANCED DRUG RESEARCH AND TESTING(CADRAT) / 12751 / RENEWAL OF APPROVAL
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /DIARY NO. / STATUS01 / M/S. THEMIS MEDICARE LTD., C/O M/S. AKUMS DRUGS & PHARMACEUTICAL LTD. HARIDWAR / 11380 / GRANT
02 / M/S. ABARIS HEALTHCARE PVT. LTD., MEHSANA, GUJARAT / 11920,11124,9526 / APPROVAL
GLOBAL CLINICAL TRIAL
SR. NO. / NAME OF FIRM / REFERENCE NO. / TYPE OF LETTER1. / M/S. ST. JOHN’S / 49107 / CT NOC APPROVAL
2. / M/S. TATA MEMORIAL HOSPITAL / 47169 / CT NOC APPROVAL
3. / M/S. ICON / 10241 / CHANGE IN PI APPROVAL LETTER
4. / M/S. BOEHRINGER / 43636 / CT NOC APPROVAL
5. / M/S. MAX NEEMAN / 41871 / CT NOC APPROVAL
6. / M/S. PFIZER / 34282 / CT NOC APPROVAL
7. / M/S. INC RESEARCH / 3715 / CLARIFICATION LETTER
8. / M/S. PPD / 30131/3111 / CLARIFICATION LETTER
9. / M/S. NOVARTIS / - / MINUTES OF SEC
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERDR. NEENA KHANNA / - / MEETING NOTICE 30-04/2015 (DERMATOLOGY & ALLERGY)
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERV.TRIBHOVANDAS, / 8408 / APPROVAL LETTER
KALGOV LABS LTD., / 9167 / APPROVAL LETTER
C.J. SHAH & CO. (GODOWN) / 9018 / APPROVAL LETTER
GENERAL IMPORT COMPANY (INDIA) PVT. LTD. / 9019 / APPROVAL LETTER
NANDLAL BANKATLAL PVT. LTD. / 8594 / APPROVAL LETTER
MEDI PHARMA DRUG HOUSE / 8691 / APPROVAL LETTER
G.C. CHEMIE PHARMIE LTD., / 8223 / APPROVAL LETTER
PRATISTHA PHARMA / 7799 / APPROVAL LETTER
UCB INDIA PRIVATE LTD. / 6294 / APPROVAL LETTER
NAPROD LIFESCIENCES PVT. LTD. / 9114 / APPROVAL LETTER
NORTHERN MEDICAL SERVICES / 9616 / APPROVAL LETTER
MICRO LABS LTD. / 10252 / APPROVAL LETTER
MICRO LABS LTD. / 10253 / APPROVAL LETTER
KEMWELL BIOPHARMA PVT. LTD. / 9026 / APPROVAL LETTER
KANTILAL MANILAL & CO. PVT. LTD., / 9329 / APPROVAL LETTER
MEHTA API PVT. LTD. / 9339 / APPROVAL LETTER
BHARAT SERUMS AND VACCINES LTD. / 9329 / APPROVAL LETTER
UNNATI PHARMACEUTICALS PVT. LTD. / 9336 / APPROVAL LETTER
TROIKAA PHARMACEUTICALS LTD., / 9435 / APPROVAL LETTER
SUN PHARMACEUTICAL INDUSTRIES LTD., / 9550 / APPROVAL LETTER
ANM PHARMA PVT. LTD. / 9425 / APPROVAL LETTER
ANM PHARMA PVT. LTD. / 9428 / APPROVAL LETTER
ANM PHARMA PVT. LTD. / 9426 / APPROVAL LETTER
K.SEVANTILAL & CO. / 9562 / APPROVAL LETTER
CORONA REMEDIES PVT. LTD. / 9559 / APPROVAL LETTER
CORONA REMEDIES PVT. LTD. / 9560 / APPROVAL LETTER
SEVANTILAL & SONS / 9561 / APPROVAL LETTER
C.J. SHAH & CO. (GODOWN) / 9458 / APPROVAL LETTER
C.J. SHAH & CO. (GODOWN) / 9459 / APPROVAL LETTER
C.J. SHAH & CO. (GODOWN) / 9460 / APPROVAL LETTER
KIMIA BIOSCIENCE PVT. LTD. / 10680 / AMENDED LETTER
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERETHACHEM / 49079,47446 / 02 APPROVAL LETTER
DAIWAT CHEMICALS / 3801 / APPROVAL LETTER
ZOETIS INDIA LTD. / 40609 / APPROVAL LETTER
NOVARTIS INDIA LTD. / 47454 / APPROVAL LETTER
BRISTOL MYERS SQUIBB INDIA PVT. LTD. / 4475 / APPROVAL LETTER
CHANDRA BHAGAT / NIL / CANCELLED LETTER
ANANTCO ENTERPIRSES PV.T LTD. / NIL / CANCELLED LETTER
ESSCHEM PVT. LTD. / 2924 / AMENDED LETTER
TRIGENESIS LIFE SCIENCES PVT. LTD. / 3943 / CLARIFICATION LETTER