LETTERS FOR ISSUE ON29.12.2014
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 / 42628 / Test Licence
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 48618 / Test Licence
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 48713 / Approval Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 48459 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 48509 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 48438 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 49803 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 48443 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 48596 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 48454 / Query Letter
M/s. Hetero Labs Ltd., Hyderabad-500 018 / 49247 / Query Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 38698 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 47659 / Amendment Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 064 / 43207 / Amendment Letter
M/s. Manipal Acunova Limited, Manipal -576104 / 48430 / Test Licence
M/s. Manipal Acunova Limited, Manipal -576104 / 48617 / Test Licence
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 49575 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 50204 / Approval Letter
M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 059 / 49481 / Query Letter
M/s. VerGo Pharma Research Pvt. Ltd. (Div- VerGo Clinicals), Goa-403 110 / 37428 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 48249 / Test Licence
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Bharat Biotech International Ltd. / 36557 / Clarification letter
2 / M/s Biogenomics Ltd / 47749 / Clarification letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. IPCA Laboratories Ltd., / 26231 / Approval Letter
M/s. Pfizer Ltd., / 34212 / Amendment Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERM/s. Cadila Healthcare Ltd / - / IND Recommendation
M/s. Akums Drugs and Pharmaceuticals Limited / - / Meeting notice on 12.01.2015 (Gastroenterology and Hepatology)
M/s. Cipla / - / Meeting notice on 12.01.2015 (Gastroenterology and Hepatology)
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Intas / - / - / SEC Letter (2)
M/s GSK / - / - / SEC Letter
M/s Eisai / - / - / SEC Letter
M/s Troikaa / - / - / SEC Letter
M/s Hetero / - / - / SEC Letter
M/s Cliantha / - / - / SEC Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Clairvoyance Consulting. / 30462 / Approval (F-RC)
M/s. Smith Medical India Pvt. Ltd. / 48789 / Approval (F-RC)
M/s. Smith Medical India Pvt. Ltd. / 48789 / Approval (F-IL)
M/s. Abbott Healthcare Pvt. Ltd. / 31460 / Approval (E-RC)
M/s. Abbott Healthcare Pvt. Ltd. / 31460 / Approval (E-IL)
M/s. Boston Scientific India Pvt. Ltd. / 31990 / Approval (E-RC)
M/s. Boston Scientific India Pvt. Ltd. / 31990 / Approval (E-IL)
M/s. Boston Scientific India Pvt. Ltd. / 38235 / Approval (E-IL)
M/s. Meril Life Sciences Pvt. Ltd. / 41218 / Approval (F-TL)
The Joint Commissioner (K.D)., Thane (CLAA)
The Deputy Drugs Controller (I), Mumbai (CLAA)
M/s. Eagle Optics Pvt. Ltd. Mumbai (CLAA) / FTS-54940 / Letter
M/s. Johnson & Johnson Ltd. / Nil / Approval Letter
M/s. Ivoclar Vivadent. / 32947 / Clarification Letter
M/s. Johnson & Johnson Ltd. / 44241 / Letter
M/s. Emergo (I) Consulting Pvt. Ltd. / 37008 / Query Letter
The Deputy Drugs Controller (I), Ghaziabad
The State Licensing Authority, Delhi. / Nil / Letter
M/s. Accredited Consultants Pvt. Ltd. / 36844 / Letter
M/s. Accredited Consultants Pvt. Ltd. / 36145 / Letter
M/s. B. Braun Medical (India) Pvt. Ltd. / 25879 / Query Letter
M/s. Bard India Healthcare Pvt. Ltd. / 29551 / Query Letter
M/s. Biomet Orthopaedics India Pvt. Ltd. / 43496 / Query Letter
M/s. Johnson & Johnson Ltd. / 38042 / Query Letter
M/s. Manik Medicaids. / 47379 / Letter
M/s. Paul Hartmann Medical Pvt. Ltd. / 41891 / Letter
M/s. SMB Corporation of India. / FTS-95944 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. NK Healthcare Pvt. Ltd. / 42118 / Approval (R-RC)
M/s. Biocell Medicare.
All port offices of CDSCO. / 47009 / Approval (IL)
M/s. Golden Harvest Industries.
All port offices of CDSCO. / 43174 / Approval (IL)
M/s. OSB Agencies Pvt. Ltd.
All port offices of CDSCO. / 43429 / Approval (IL)
M/s. Beckman Coulter India Pvt. Ltd.
All port offices of CDSCO. / 43779 / Approval (E-IL)
M/s. Abbott Healthcare Pvt. Ltd.
All port offices of CDSCO. / 44603 / Approval (TL)
M/s. Werfen Medical India Pvt. Ltd.
All port offices of CDSCO. / 44259 / Approval (TL)
M/s. KDH Biomedicals Pvt. Ltd.
All port offices of CDSCO. / 46718 / Approval Letter
M/s. Becton Dickinson India Pvt. Ltd.
All port offices of CDSCO. / 39852 / Letter
M/s. Diasorin Trivitron Healthcare Pvt. Ltd. / 41776 / Query Letter
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERCalcutta Chemsales Corporation, / 45922
N.J. Pharma / 41951
Unimed Technologies Ltd. / 48513
Intervet India Pvt.Ltd / 48613
Trokiaa Pharmaceuticals Ltd. / 49038
Sterile India (Pvt.) Ltd. / 49094
Medopharm Private Limited / 19052
Alembic Ltd., / 49199
Biotavia Labs Pvt. Ltd. / 49125
K.Sevantilal & Co. / 49245
Maxcure Nutravedics Limited / 49252
Sagar Rubber Products Pvt. Ltd. / 49152
Aquatic Remedies Pvt. Ltd. / 49151
Glaxo Smith Kline Pharmaceuticals Ltd. / 49336
Wockhardt Limited / 49194
Wockhardt Limited / 49187
Intas Pharmaceuticals Ltd. / 49422
Alkem Laboratories Ltd. / 49041
Alkem Laboratories Ltd. / 49042
Bayer Pharmaceuticals Pvt. Ltd. / 49170
Bayer Pharmaceuticals Pvt. Ltd. / 49171
Piramal Enterprises Ltd. / 49738
Johnson & Johnson Ltd., / 49627
Zydus Healthcare / 46260
MSD Pharmaceuticals Pvt. Ltd. / 48800
C.J. Shah & Co. (Godown) / 49179
C.J. Shah & Co. (Godown) / 48179
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERESSCHEM PVT. LTD. / 47070 / APPROVAL LETTER
ANANTCO ENTERPRISES PVT. LTD. / 47502 / APPROVAL LETTER
GSK PHARMACEUTICAL LTD. / 39928,49692 / APPROVAL LETTER
ZAMBON INDIA PVT. LTD / 44767 / APPROVAL LETTER
NEHA PHARMA PV. LTD / 48918 / APPROVAL LETTER
VITA PHARMA AGENCIES / 40799 / APPROVAL LETTER
ABBOTT INDIA LTD. / 41425 / APPROVAL LETTER
SHAH TC / 47924,43223,43225,43221 / APPROVAL LETTER/03 AMENDED LETTTER
MSD PHARMACEUTICAL PVT. LTD. / 46934 / AMENDED LETTTER
UNICHEMIE INTERNATIONAL / 45855 / AMENDED LETTTER
FRESENIUS KABI INDIA PVT. LTD. / 42725 / AMENDED LETTTER
UNICHEMIE INTERNATIONAL / 43982 / CLARIFICATION LETTER
DSM SINOCHEM / 35575 / CLARIFICATION LETTER
P.K PHARMATECH PVT. LTD. / 33539 / CLARIFICATION LETTER
ARCHERCHEM / 34216 / CLARIFICATION LETTER
ABIL CHEMPHARMA PVT. LTD. / 35557 / CLARIFICATION LETTER
CHOKSI CHEMICALS CORPORATION / NIL / LETTER