LETTERS FOR ISSUE ON25.04.2014

WRITTEN CONFIRMATION

S. No / Firm Name / Type of Letter
1. / M/s. Biochemicals and Synthetic Products Ltd. / WC Letter
2. / M/s. Ray Chemicals. Pvt. Ltd., / Clarification Letter
3. / M/s. R. L. Fine Chemicals Pvt. Ltd., / Clarification Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Adcock Ingram Healthcare Pvt. Ltd., / 42980 / Clarification Letter
M/s. Akums Drugs & Pharamceuticals Ltd., / 37014 / Clarification Letter
M/s. Akums Drugs & Pharamceuticals Ltd., / 42795 / Clarification Letter
Dr. Reddy’s Laboratories Ltd., / 37231 / Approval Letter
Cosmos Pharmacals Ltd., / Nil / Clarification Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Bard India Healthcare Pvt. Ltd. / 9583 / Approval (F-RC)
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 12387 / Approval (R-RC)
M/s. Bausch & Lomb Eye Care (I) Pvt. Ltd. / 12615 / Approval (R-E-RC)
M/s. Depuy Medical / 67431 / Approval (F-IL)
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 12387 / Approval (R-IL)
M/s. Bausch & Lomb Eye Care (I) Pvt. Ltd. / 12615 / Approval (R-E-IL)
M/s. Johnson & Johnson Ltd. / 6391 / Query Letter
M/s. Becton Dickinson India Pvt. Ltd. / 59466 / Query Letter
M/s. Biomet Orthopaedic India Pvt. Ltd. / 7099 / Query Letter
M/s. Emergo (India) Consulting Pvt. Ltd. / 7085 / Query Letter
M/s. Hester Diagnostics Pvt. Ltd. / 8710 / Query Letter
M/s. India Medtronic Pvt. Ltd. / 63982 / Query Letter
M/s. Johnson & Johnson Ltd. / 56856 / Query Letter
M/s. Meril Healthcare Pvt. Ltd. / 40775 / Query Letter
M/s. St. Jude Medical India Pvt. Ltd. / 58429 / Query Letter
M/s. Surya Surgical Industries. / 7873 / Query Letter
M/s. Surya Surgical Industries. / 63409 / Query Letter
The State Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
M/s. Medi Plus India Ltd., Haryana (CLAA) / FTS -12697 / Approval Letter
The State Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
M/s. Siora Surgicals Pvt. Ltd., Haryana (CLAA) / FTS 14044 / Approval Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Vertech Health Solutions India Pvt. Ltd. / 6850 / Approval (IL)
M/s. Labx / 9450 / Approval (IL)
M/s. Roche Diagnostics India Pvt. Ltd. / 6483 / Approval (IL)
M/s. SkyQuest Technology Consulting Pvt. Ltd. / 8468 / Approval (IL)
M/s. Abbott Healthcare Pvt. Ltd. / 7489 / Approval (IL)
M/s. SkyQuest Technology Consulting Pvt. Ltd. / 8468 / Query Letter
M/s. SD Biostandard Diagnostics Pvt. Ltd. / 9256 / Query Letter

REGISTRATION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
DIVINNE SBR INTERNATIONAL PVT. LTD. / 8687 / APPROVAL LETTER
WIPRO GE HEATLHCARE PVT. LTD. / 7321 / CLARIFICATION LETTER

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Zim Laboratories Ltd., / 40055 / - / Approval Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Roche Product (India) Pvt Ltd / 1466 / Clarification letter
2 / M/s Pfizer Limited / 6533 / Clarification letter

BIOLOGICAL DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Biological E. Limited / 10195 / Approval letter
2 / M/s Panacea Biotech Ltd / 8091 / Approval letter

WRITTEN CONFIRMATION

S. No / Firm Name / Type of Letter
1. / M/s. Arora Aromatics Pvt. Ltd. / Letter
2. / M/s. Orchid Chemicals and Pharmaceuticals Ltd., / Amendment Letter
3. / M/s. Mylan Laboratories Ltd. / WC Letter Amended
4. / M/s. Neuland Laboratoris LTD. / WC Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Novo Nordisk / 11650/11649 / Change in Lab Approval letter
2. / M/s. St. John’s National Academy / 8270 / Clarification Letter
3. / M/s. Amgen / 31269 / Clarification Letter
4. / M/s. Max Neeman / 2430 / Clarification Letter
5. / M/s. Pfizer / 2120/4659 / Clarification Letter
6. / M/s. Eli Lilly / 63397 / Clarification Letter