LETTERS FOR ISSUE ON 16.02.2015

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Sun Pharma / Nil / SEC Meeting Letter
M/s. Sun Pharma / Nil / SEC Meeting Letter
M/s. Emcure Pharmaceuticals / Nil / SEC Meeting Letter
M/s. Crescent Labs / 34324 / Approval Letter
M/s. Crescent Labs / 34325 / Approval Letter
M/s. Crescent Labs / 28801 / Approval Letter
M/s. Curetech Skincare / 2658 / Approval Letter
M/s. GMH Organics / 46215 / Approval Letter

WRITTEN CONFIRMATION

INTERNATIONAL CELL

S. No / Firm Name / Type of Letter
1. / M/s Hospira Healthcare India Pvt. Ltd. Tamil Nadu / Approval letter
2. / M/s Sandoz Pvt. Ltd. Navi Mumbai / Approval letter
3. / M/s Nabros Pharma Pvt. Ltd. Khera / letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy. No. / STATUS
1 / M/s Bharat Biotech International Ltd / Clarification letter
2 / M/s Global Hospitals / Clarification letter
3 / M/s Intervet India Pvt, Ltd / Clarification letter
4 / M/s GlaxoSmithKline Asia Pvt. Ltd / 41151, 40902, 40904, 41150, 40901, 40903 / Approval letter
5 / M/s Hipra (I) Ltd / Clarification letter
7 / M/s Reliance life sciences Pvt, ltd / 42081 / Clarification letter
8 / M/s Syngene International ltd / 48537 / Clarification letter
9 / M/s Dr Reddy Laboratories ltd / Clarification letter
10 / M/s Prosper Channel Life Science India Pvt, ltd / Clarification letter
11 / M/s Lupin Limited / 1327 / Approval letter
12 / M/s Plasmagen Biosciences Pvt, ltd / 14139 / Approval letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Sun Pharma / Nil / SEC Meeting Letter
M/s. Sun Pharma / Nil / SEC Meeting Letter
M/s. Emcure Pharmaceuticals / Nil / SEC Meeting Letter
M/s. Crescent Labs / 34324 / Approval Letter
M/s. Crescent Labs / 34325 / Approval Letter
M/s. Crescent Labs / 28801 / Approval Letter
M/s. Curetech Skincare / 2658 / Approval Letter
M/s. GMH Organics / 46215 / Approval Letter

MEDICAL DEVICE DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Johnson & Johnson ltd., Vapi / 47124 / E-RC & E-F-10
M/s. Ranbaxy Laboratories Ltd., New Delhi / 46945 / Test License
M/s. India Medtronic Pvt. Ltd., Thane / 48048 / RC & F-10
M/s. St. Jude Medical India Pvt. Ltd., Hyderabad / 42531 / RC & F-10
M/s. Mediplus (India) Ltd., Bahadurgarh / SLA Panchkula / FTS no. 3651 / letter
M/s. Polymedicure ltd., Faridabad / SLA Panchkula / FTS no. 2093 / Letter

DIAGNOSTICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. ARK Diagnostics Pvt. Ltd., Bangalore / 39978 / Form 10
M/s. Roche Diagnotics India Pvt. Ltd., Mumbai / 50213 / E-F-10
M/s. Siemens Ltd., Vadodara / 51194 / F-10

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Novartis Healthcae Private Limited / - / Query Letter
Dr. Ashok Kumar / - / Letter
Dr. Yujwal Raj / - / Letter
M/s. MSN Laboratories Ltd / - / Query Letter
M/s. Eisai Pharmaceuticals India Pvt .Ltd / - / Query Letter (2)
M/s. Cadila Healthcare Limited / - / Approval Letter
M/s. Johnson & Johnson / - / Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Novartis / 50802/50801/1255/47577 / Change in site address,Change in PIs & PA Approval Letters
2. / M/s. Eli Lilly / 511 / PA Approval Letter
3. / M/s. Sanofi / 49060 / TL Approval