Letters for Issue on 09.03.2015

LETTERS FOR ISSUE ON 09.03.2015

LVP DIVISION

S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS
01 / M/s. Shri Krishna Keshav Laboratories Ltd., Gujarat / 4962, 54433, 23838 / Approval
02 / M/s. Unique Pharmaceuticals Ltd., Gujarat / 8564 / Approval
03 / M/s. Bal Pharma Ltd., Maharashtra / 8588 / Approval
04 / M/s. Eurolife Healthcare (P) Ltd., Haridwar / 7280 / Approval
05 / M/s. Aishwarya Healthcare, H.P. / 6886 / Approval
06 / M/s. Aurobindo Pharma Ltd., A.P. / 8102, 8109 / Approval
07 / M/s. Abaris Healthcare Pvt. Ltd., Gujarat / 6014, 6708 / Approval
08 / M/s. Claris Injectable C/o. M/s. Claris Otsuka, Gujarat / 9148 / Approval

NEW DRUG

WRITTEN CONFIRMATION

INTERNATIONAL CELL

S. No / Firm Name / Type of Letter
1. / M/s. Granules India Limited, Visakhapatnam A.P. / Approval letter
2. / M/s. Sai Life sciences Limited, Hyderabad / Query Letter
3. / M/s. Sai Life sciences Limited, Karnataka / Query Letter
4. / M/s. Sequent scientific Ltd., New Mangalore / Query Letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s IPCA / - / - / SEC Letter
M/s Intas / - / - / SEC Letter
M/s Boehringer / - / - / SEC Letter
M/s MSD / - / - / SEC Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Sun Pharma / Nil / SEC Letter
M/s. Boehringer Ingelheim (India) / 50460 / Clarification Letter
M/s. Boehringer Ingelheim (India) / 3268 / Clarification Letter
M/s. Boehringer Ingelheim (India) / 3497 / Amendment Letter
M/s. Takeda Pharmaceuticals / 36800 / Letter
M/s. Fresenius Kabi India Pvt. Ltd., / 4256 / Amendment Letter
M/s. Tirupati Medicare Ltd., / 27665 / Clarification Letter
M/s. FDC Ltd., / 42401 / Approval Letter
M/s. IPCA Laboratories Ltd., / 3413 / Amendment Letter
M/s. IPCA Laboratories Ltd., / 47980 / Approval Letter
M/s. Olive Healthcare / 1891 / Clarification Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Accredited Consultants Pvt. Ltd. / 50404 / Approval (F-RC)
M/s. Becton Dickinson India Pvt. Ltd. / 35666 / Approval (R-RC)
M/s. Becton Dickinson India Pvt. Ltd. / 35666 / Approval (R-IL)
M/s. Exactech India (P) Ltd. / 47979 / Approval (R-RC)
M/s. Exactech India (P) Ltd. / 47979 / Approval (R-IL)
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 33194 / Approval (R-RC)
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 33194 / Approval (R-IL)
M/s. Molnlycke Health Care India Pvt. Ltd. / 33866 / Approval (E-RC)
M/s. Molnlycke Health Care India Pvt. Ltd. / 33866 / Approval (E-IL)
M/s. Covidien Healthcare India Pvt. Ltd. / 41943 / Approval (R-E-RC)
M/s. Covidien Healthcare India Pvt. Ltd. / 41943 / Approval (R-E-IL)
M/s. OrbusNeich Medical (India) Pvt. Ltd. / 47268 / Approval (R-E-RC)
M/s. Coloplast India Pvt. Ltd. / 3112 / Approval (F-IL)
M/s. India Medtronic Pvt. Ltd. / 348 / Approval (F-IL)
M/s. Lifecare Devices Pvt. Ltd. / 1672 / Approval (F-IL)
M/s. Novomed Incorporation Pvt. Ltd. / 1853 / Approval (F-IL)
M/s. Novomed Incorporation Pvt. Ltd. / 2697 / Approval (F-IL)
M/s. Covidien Healthcare India Pvt. Ltd. / 49102 / Approval Letter
M/s. Covidien Healthcare India Pvt. Ltd. / 49101 / Approval Letter
M/s. Mtex India Pvt. Ltd. / 48576 / Clarification Letter
M/s. South India Surgical Co. Ltd. / 4136 / Clarification Letter
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 50477 / Approval (E-RC)
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 50477 / Approval (E-IL)
M/s. Access Devices. / 2910 / Approval (R-IL)
The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Gujarat (CLAA)
(M/s. Matrix Meditec Pvt. Ltd.., Ahmedabad) / FTS-59873 / Approval Letter
The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Gujarat (CLAA)
(M/s. Spectra Vision., Bhavnagar) / FTS-7305 / Approval Letter
M/s. Abbott Healthcare Pvt. Ltd. / 50496 / Query Letter
M/s. Encarta Pharma Pvt. Ltd. / 45486 / Query Letter
M/s. B L Lifesciences Pvt. Ltd. / 36294 / Approval (R-RC)

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. DSS Imagetech Pvt. Ltd. / 50247 / Approval (E-RC)
M/s. Lilac Medicare Pvt. Ltd. / 5107 / Approval (IL)
M/s. Meril Diagnostics Pvt. Ltd. / 51419 / Approval (IL)
M/s. SM Biotech. / 50179 / Approval (IL)
M/s. Bio-Rad Laboratories (India) Pvt. Ltd.
M/s. Bio-Rad Laboratories., France
All port offices of CDSCO. / 9564 / Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Dilip B. Kadam / 4530 / Export NOC Approval Letter
2. / M/s. Scan Biotech / - / Letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Centaur Pharmaceuticals Pvt. Ltd. / - / Query Letter
M/s. Novartis / - / Meeting Notice 17.03.2015 (Oncology)
M/s. Pfizer Products India Pvt. Ltd / - / Meeting Notice 17.03.2015 (Oncology)
M/s. Ranbaxy Laboratories Limited, / - / Query Letter
Dr. Ramesh Kumar R, / - / CT NOC Letter
Dr. Gadipudi Avanthi / - / CT NOC Letter
M/s. Hetero Labs Limited / - / Query letter