LETTERS FOR ISSUE ON17.04.2014

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Meril Life Sciences Pvt. Ltd. / 53711 / Query Letter
M/s. St. Jude Medical India Pvt. Ltd. / 41831 / Query Letter
M/s. Span Healthcare Pvt. Ltd. / 59953 / Query Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Becton Dickinson India Pvt. Ltd; / 5513 / Query Letter
M/s. Becton Dickinson India Pvt. Ltd. / 8728 / Query Letter
M/s. Paviour Pharmaceuticals Pvt. Ltd. / 9018 / Query Letter

IMPORT

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
FDC Limited / 10642 / Withdrawal letter
Pratistha pharma / 6084,6085,6086, 6087,6088 / 5 Withdrawal letter
Indi Pharma Pvt. Ltd. / 5685 / Withdrawal letter
Nischem international / nil / Withdrawal letter
Baxter India Pvt. Ltd. / 5588 / Withdrawal letter
Piramal Healthcare Ltd. / 5406 / Withdrawal letter
Venus Remedies Ltd / Nil / Withdrawal letter
Ind-Swift Laboratories Ltd. / 6027,6026 / 2 Withdrawal letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s GlaxoSmithKline Asia Pvt Ltd / Clarification letter
2 / M/s Cadila Pharmaceuticals Ltd / 13846 / Clarification letter
3 / M/s Ceva (I) Pvt Ltd / 7850 / Clarification letter
4 / M/s Roche products (India) Pvt Ltd / Clarification letter
5 / M/s Lupin limited (biotech Division) / 7003 / Clarification letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Lupin Ltd. / 6883 / - / Approval Letter
M/s MSD Pharmaceutical / 22376 / 35182 / Deficiency Letter
M/s Athena Drug / 65246 / - / Deficiency Letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
Dr. Arvind Saili. / - / Approval Letter
M/s. Intervet Ltd. / - / Clarification Letter
M/s Dr. S Aneja. / - / Clarification Letter

WRITTEN CONFIRMATION

S. No / Firm Name / Type of Letter
M/s. Vasudha Pharm Chem Ltd., / Clarification Letter
M/s. Sionc Pharmaceuticals Pvt. Ltd. / WC Approval
M/s. Parabolic Drugs Ltd. / Clarification Letter
4-5 / M/s. Alembic Pharmaceuticals Ltd. / Clarification Letter

IMPORT

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
FDC Limited / 10642 / Withdrawal letter
Pratistha pharma / 6084,6085,6086, 6087,6088 / 5 Withdrawal letter
Indi Pharma Pvt. Ltd. / 5685 / Withdrawal letter
Nischem international / nil / Withdrawal letter
Baxter India Pvt. Ltd. / 5588 / Withdrawal letter
Piramal Healthcare Ltd. / 5406 / Withdrawal letter
Venus Remedies Ltd / Nil / Withdrawal letter
Ind-Swift Laboratories Ltd. / 6027,6026 / 2 Withdrawal letter
Cipla Ltd. / 10271 / Clarification Letter
Torrent Pharmaceuticals Ltd. / 11459 / Clarification Letter
Dr. Reddy’s Labs Ltd. / 9695 / Clarification Letter
Famy Care Ltd. / 11475 / Clarification Letter

REGISTRATION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
ANANTCO ETNERPRISES PVT. LTD. / 51917 / Clarification Letter
BIOCON LTD / 14591 / Clarification Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Sanofi / 833 / Clarification Letter
2. / M/s. Clinigene / 11938 / Clarification Letter
3. / M/s. Boehringer / 3181 / Clarification Letter