Letters for Issue On30.12.2014
LETTERS FOR ISSUE ON30.12.2014
Cosmetics Division
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Utsav Exim Limited, New Delhi / 43210 / Approval Letter
M/s. Iris Impex & Distribution, Maharashtra / 43405 / Approval Letter
M/s. Visage Beauty & Health Care Pvt. Ltd, Noida UP India / 43404 / Approval Letter
M/s. Kryolan Cosmetics India P. Ltd, Tamil Nadu / 44295 / Approval Letter
M/s. Sephora Cosmetics Private Limited, New Delhi / 42762 / Approval Letter
M/s. G.S. Pharmbutor Pvt. Ltd, Uttarkhand / 44713 / Approval Letter
M/s. Geosmatic Cosmeceuticals & Cosmocare Pvt. Ltd, Pune / 44636 / Deficiency Letter
M/s. Artlife Products Pvt. Ltd, New Delhi / 44607 / Deficiency Letter
M/s. JCKRC Spa Destination Ltd., Navi Mumbai / 44314 / Deficiency Letter
M/s. JCKRC Spa Destination Pvt. Ltd, Navi Mumbai / 43437 / Deficiency Letter
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. GVK Bio Sciences, Gujarat / 6827 / Approval
02 / M/s. QPS Bioserve India Pvt. Ltd., Hyderabad / Query
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Aiswarya Lifesciences, H.P. / 73933 / Approval
02 / M/s. Pentagon Labs Ltd., M.P. / 73343, 62825 / Approval
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Biomet Orthopedic India Pvt. Ltd. / 43123 / Approval (F-RC)
M/s. Biomet Orthopedic India Pvt. Ltd. / 43123 / Approval (F-IL)
M/s. Hester Diagnostics Pvt. Ltd. / 30616 / Approval (R-RC)
M/s. Hester Diagnostics Pvt. Ltd. / 30616 / Approval (R-IL)
M/s. India Medtronic Pvt. Ltd. / 24859 / Approval (R-E-RC)
M/s. India Medtronic Pvt. Ltd. / 24859 / Approval (R-E-IL)
M/s. Cook India Medical Devices Pvt. Ltd. / 369 / Approval Letter
M/s. Clairvoyance Consulting. / 45060 / Approval Letter
M/s. Innvolution Healthcare Pvt. Ltd. / 45060 / Approval Letter
M/s. Boston Scientific India Pvt. Ltd. / 43580 / Letter
Dr. Praveen Malik, New Delhi / FTS-65642 / Letter
All zonal/sub-zonal offices of CDSCO. / FTS-71653 / Letter
Mr. B. Kumar, Chennai. / FTS-75722 / Letter
M/s. Endoline Proscope Systems. / 42412 / Letter
M/s. MN Solutions. / 35235 / Query Letter
M/s. St. Jude Medical India Pvt. Ltd. / 33829 / Query Letter
M/s. Vascular Concepts Ltd. / 33542 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Arkray Healthcare Pvt. Ltd.
All port offices of CDSCO. / 42546 / Approval (IL)
M/s. Alere Medical Pvt. Ltd.
All port offices of CDSCO. / 42798 / Approval (IL)
M/s. Imperial Biotek.
All port offices of CDSCO. / 37958 / Approval (IL)
M/s. Matrix Labs.
All port offices of CDSCO. / 43583 / Approval (E-IL)
M/s. U R Biomedical Pvt. Ltd.
All port offices of CDSCO. / 43582 / Approval (TL)
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Maya Clinicals / 47698/32796/47092 / Additional sites / PA Approval
2. / M/s. Boehringer / 46886/46464 / Additional sites approval
3. / M/s. B J Medical College / 39581 / CT NOC Approval
4. / M/s.Novartis / 48462 / Change in PI Approval letter
5. / M/s. Dr. Reddy / - / NDAC Meeting Letter
6. / M/s. Klinera / - / NDAC Meeting Letter
7. / M/s. MSD / - / NDAC Meeting letter
8. / M/s. Pfizer / - / NDAC Meeting Letter
9. / M/s. Maya Clinical / - / NDAC Meeting Letter
10. / M/s. GSK / - / NDAC Meeting Letter
11. / M/s. Manipal Acunova / - / NDAC Meeting Letter
12. / M/s. Max neeman / - / NDAC Meeting Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Intas Pharmaceuticals Ltd / 69362 (fts no) / Approval letter
2 / M/s Roche Products India pvt, Ltd / 35634 / Approval letter
3 / M/s Panacea Biotech ltd / 42772 / Clarification Letter
4 / M/s Dr. Reddy’s Laboratories / 40465 / Acknowledge letter
5 / M/s GSK Pharmaceuticals ltd / 34470, 23245 / Approval & Amendment Letter
6 / M/s Bharat Serum and vaccine ltd / Approval letter