LETTERS FOR ISSUE ON 28.02.2014

WRITTEN CONFIRMATION

S.No. / Firm Name / Status
1. / M/s. Cipla Ltd., / Clarification Letter
2. / M/s. Rusan Pharma Ltd., / Clarification Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. BSN Medical Pvt. Ltd. / 52812 / Approval (F-RC)
M/s. BSN Medical Pvt. Ltd. / 52812 / Clarification Letter
M/s. Johnson & Johnson Ltd.
M/s. Ethicon Endo-Surgery LLC, USA
M/s. Ethicon Endo-Surgery Mexico
All Port offices of CDSCO. / 55176 / Clarification Letter
M/s. Regenix Drugs Ltd. / 47735 / Clarification Letter
The Dy. Drugs Controller (I), Chennai (CLAA)
The Director of Drugs Control, Chennai (CLAA)
M/s. SIDD Life Science Pvt. Ltd., Chennai. / FTS-77438 / Clarification Letter
The Commissioner, Gujarat (CLAA)
M/s. Meril Life Sciences Pvt. Ltd., Gujarat (CLAA)
The Deputy Drugs Controller (I), Gujarat (CLAA) / 2943 / Clarification Letter
The Deputy Drugs Controller (I), Hyderabad / FTS-724 / Clarification Letter
M/s. J. Mitra and Bros. / 1683 / Clarification Letter
M/s. Johnson & Johnson Ltd. / 55609 / Clarification Letter
M/s. Kimberley Clark Hygiene Products Pvt. Ltd. / 5537 / Clarification Letter
M/s. Macquet Medical India Pvt. Ltd. / 55614 / Clarification Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Johnson & Johnson Ltd. / 64933 / Approval (RC)
M/s. Alere Medical Pvt. Ltd. / 60709 / Approval (IL)
M/s. Kee Pharma Ltd. / 2931 / Approval (IL)
M/s. KHC Healthcare India Pvt. Ltd. / 2567 / Approval (IL)
M/s. Medsource Ozone Biomedicals (P) Ltd. / 4482 / Approval (IL)
M/s. Nectar Lifesciences Ltd. / 1633 / Approval (IL)
M/s. U. R. Biomedical Pvt. Ltd. / 1124 / Approval (IL)
M/s. Weldon Biotech (India) Pvt. Ltd. / 1611 / Approval (IL)
M/s. Alere Medical Pvt. Ltd. / 4943 / Approval (E-IL)
M/s. Becton Dickinson India Pvt. Ltd. / 3328 / Approval (E-IL)
M/s. Diasorin Triviron Healthcare Pvt. Ltd. / 5055 / Approval (TL)
M/s. Immucor India Pvt. Ltd. / 5294 / Approval (TL)
M/s. Meshayu Consultants Pvt. Ltd. / 1128 / Clarification Letter
M/s. Nectar Lifesciences Ltd. / 1633 / Clarification Letter
M/s. U.R. Biomedical Pvt. Ltd, / 1124 / Clarification Letter
M/s. Weldon Biotech (India) Pvt. Ltd. / 1611 / Clarification Letter

COSMETIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Suraj Inn Private Limited, Karnataka / FTS NO. 720 / Deficiency Letter
M/s. GLF Lifestyle Brands Private Limited, New Delhi / 950 / Approval Letter
M/s. G.S. Pharmabutor Pvt. Ltd, Uttarakhand / 2236 / Approval Letter
M/s. JCKRC SPA Destination Private Limited, Mumbai / 3324 / Approval Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Reliance / 5590 / Change in site Approval
2. / M/s. Novartis / 54844,39335/26839/45614 / Change in PI Approval, sites approbval

REGISTRATION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
PFIZER LTD. / 1311 / CLARIFICATION LETTER
AKRON PVT. LTD. / NIL / CLARIFICATION LETTER
ORGANON INDIA LTD. / 30260 / CLARIFICATION LETTER
BIOCON LTD. / 127 / CLARIFICATION LETTER
KOPRAN LTD. / 388 / CLARIFICATION LETTER
SPARSH BIOTECH PVT. LTD. / 4871 / CLARIFICATION LETTER

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Reddy’s Lab / - / - / Letter
M/s Novartis / - / - / Letter
M/s Johnson & Johnson / - / - / Letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. GSK / - / Letter
M/s. Bayer / - / Letter
M/s. Hetero Labs / - / Letter
M/s. Novartis Helathcare / - / Letter
M/s. Maya Clinicals / - / Letter
M/s. Dr. Reddy’s Laboratories / - / Letter
M/s. Johnson & Johnson / - / Letter
M/s. Max Neeman / - / Letter
M/s. Wyeth / - / Letter
M/s. Biocon / - / Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s GlaxoSmithKline Pharmaceuticals Ltd / 25960 / Clarification letter
2 / M/s Sanofi Pasteur India Pvt Ltd / 64944 / Clarification letter
3 / M/s Novo Nordisk India Pvt Ltd / 2462 / Clarification letter
4 / M/s Chiron Behring vaccines Pvt Ltd / Clarification letter
5 / M/s Bio-Med (P) Ltd / 63361 / Clarification letter
7 / M/s MSD Pharmaceuticals Pvt Ltd / 58884 / Approval letter
8 / M/s Reliance Life Sciences Pvt Ltd / 1154,2408 / Approval letter
9 / M/s Sandor Medicaids Pvt Ltd / 1 5166 / Approval letter
10 / M/s Eli Lilly and Company (India) Pvt Ltd / 3751,5645 / Approval letter