LETTERS FOR ISSUE ON 26.05.2014

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
1.  / M/s. BMS / - / Letter (2)
2.  / M/s. Eli Lilly / - / Clarification Letter
3.  / M/s. Biocon / - / Letter
4.  / M/s. Cadila Healthcare / - / Letter
5.  / M/s. Cadila Pharmaceuticals / - / Letter
6.  / M/s. Sun Pharma / Letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
1.  / M/s GKM New Pharma / 5615 / 8915 / Deficiency Letter
2.  / M/s Megafine Pharma / 14756 / - / Deficiency Letter
3.  / M/s Lasco International / 9897 / 15291 / Deficiency Letter
4.  / M/s Ranbaxy Lab Ltd. / 7744 / 11762 / Deficiency Letter
5.  / M/s Sparsha Pharma / 9049 / 13724 / Deficiency Letter
6.  / M/s Zim Lab Ltd. / 18413 / - / Deficiency Letter
7.  / M/s Inventia Healthcare / 17401 / 25844 / Deficiency Letter
8.  / M/s Allergan India Pvt Ltd. / 55539 / 76464 / Deficiency Letter
9.  / M/s Torrent Pharma / 58920 / 81616 / Deficiency Letter
10.  / M/s Hetero Labs Ltd. / 43078 / 59202 / Deficiency Letter
11.  / M/s Shilpa Medicare / 7024 / 10941 / Deficiency Letter

Written Confirmation

S. No / Firm Name / Type of Letter
1. / M/s. Unilab Chemicals & Pharmaceuticals Pvt. Ltd. / Written Confirmation Letter

Medical Device

S.NO. / COMPANY NAME / DIARY NO / STATUS
1.  / M/s. Accredited Consultants Pvt. Ltd. / 2711 / Query Letter
2.  / M/s. Biomet Orthopaedic India Pvt. Ltd. / 4335 / Query Letter
3.  / M/s. India Medtronic Pvt. Ltd. / 2338 / Query Letter
4.  / M/s. Johnson & Johnson Ltd. / 13897 / Query Letter
5.  / M/s. Kimberly-Clark Hygiene Products Pvt. Ltd. / 287 / Query Letter
6.  / M/s. Lepu Medica Technology (Beijing) Co. Ltd. / 11809 / Query Letter
7.  / M/s. MN Solutions. / 398 / Query Letter
8.  / M/s. Smith & Nephew Healthcare Pvt. Ltd. / 11914 / Query Letter
9.  / M/s. Sahajanand Medical Technology Pvt. Ltd. / 17713 / Query Letter
10. / M/s. Vygon India Pvt. Ltd. / 633 / Query Letter
11. / The Deputy Drugs Controller (I), Chennai (CLAA)
The Drugs Controller & Licensing Authority, Kerala (CLAA)
M/s. Jayon Implants Pvt. Ltd. / FTS-12737 / Query Letter

Diagnostic Division

S.NO. / COMPANY NAME / DIARY NO / STATUS
1.  / M/s. Accurex Biomedical Pvt. Ltd. / 15036 / Query Letter
2.  / M/s. BioSystems Diagnostics Pvt. Ltd. / 16468 / Query Letter
3.  / M/s. L B Diagnostics / 13975 / Query Letter

Vaccine Division

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Bharat Biotech International Ltd / 15894, 18327, 13009 / Approval & Clarification letter
2 / M/s Biological E. Ltd / 19278 / Approval Letter
3 / M/s Globion India Pvt, ltd / 8469 / Approval Letter
4 / M/s Roche Product (India) Pvt, Ltd / 14281 / Approval Letter
5 / M/s Lupin Ltd / 14720 / Approval Letter
6 / M/s Syngene International Ltd / Approval Letter