LETTERS FOR ISSUE ON 20.01.2015
REGISTRATION
S.no. / Name of applicant / Diary no. / Type of letter1. / G.lucatos & co. / 49155 / Letter
2. / Bharat serums and vaccines ltd. / 40443 / Clarification letter
3. / Sanofi-synthelabo india ltd. / 36682 / Clarification letter
4. / Kenko corporation / 39454, / 02 clarification letter
5. / Lundbeck india pvt. Ltd. / 27483 / Clarification letter
6. / Akzo nobel india ltd. / 40523 / Clarification letter
7. / Tattva pharma exim services / 42818 / Clarification letter
8. / Divinne sbr international pv.t ltd. / 34736,42458,48437 / 03 clarification letter
9. / Rifa pharma / 50503 / Clarification letter
10. / P.k. pharmatech pvt. Ltd. / 39778 / Clarification letter
11. / Trichem / 40541 / Clarification letter
12. / Dpb antibiotics pvt. Ltd. / 38720 / Clarification letter
13. / Forum products ltd. / 37710 / Clarification letter
14. / Msc chemicals / 49890 / Clarification letter
15. / Kawarlal cdef / 47090 / Clarification letter
16. / Shah tc / 46681 / Clarification letter
17. / Unichemie international / 43313 / Clarification letter
18. / Ychem agency / 47532 / Clarification letter
19. / Abbott india ltd. / 46303 / Clarification letter
20. / Boehringer ingelheim india pv.t ltd. / 48136 / Clarification letter
21. / Dr. Willmar schwabe india pvt. Ltd. / 49418 / Clarification letter
22. / Novartis helathcare pvt. Ltd. / 45685 / Clarification letter
23. / Bayer pharmaceuticals pvt. Ltd. / 46528 / Clarification letter
24. / Bohra sales & service ltd,. / 47861 / Clarification letter
25. / Msd pharmaceuticals pv.t ltd. / 45091 / Clarification letter
26. / Takeda pharmaceuticals india pv.t ltd. / 50034 / Clarification letter
27. / Senaru formulations pvt. Ltd. / 46302 / Clarification letter
28. / Imagine products india pvt. Ltd. / 45810 / Clarification letter
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / INSPIRA BIO-PHARMA PVT. LTD. / 50951 / CLRIFICATION LETTER
2. / ROCHE PROUDCT INDIA PVT. LTD. / 50529,50619 / 02 CLRIFICATION LETTER
3. / BIOCON LTD. / 50872 / CLRIFICATION LETTER
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Sun Pharma Laboratories Ltd., / - / - / SEC Letter
2. / M/s Athena / - / - / SEC Letter (2)
3. / M/s Zim / - / - / SEC Letter (2)
4. / M/s IPCA / - / - / SEC Letter (2)
5. / M/s Modi Mundi / - / - / SEC Letter
6. / Johnson & Johnson / - / - / SEC Letter
7. / M/s Novartis / - / - / SEC Letter
8. / M/s Inventia / - / - / SEC Letter
9. / M/s Serdia / - / - / SEC Letter
10. / M/s Samarth / - / - / SEC Letter
11. / M/s Ranbaxy / - / - / SEC Letter
12. / M/s Pfizer / - / - / SEC Letter
13. / M/s Lincoln / - / - / SEC Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 50627 / Approval Letter
2. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 50697 / Approval Letter
3. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 33615 / Reminder Query
4. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 50688 / Approval Letter
5. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 50689 / Test Licence
6. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 9355 / Reminder Query
7. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 25219 / Reminder Query
8. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 61561 / Reminder Query
9. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 50639 / Approval Letter
10. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 50638 / Approval Letter
11. / M/s. Drug Monitoring Research Institute (P) Ltd., Navi Mumbai-400 701 / 44915 / Approval Letter
12. / M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 44774 / Approval Letter
13. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 50664 / Test Licence
14. / M/s. Lambda Therapeutic Research Ltd., Navi Mumbai-400 614 / 50890 / Approval Letter
15. / M/s. Lupin Bioresearch Center, Pune-411 021 / 49034 / Clarification Letter
16. / M/s. Panexcell Clinical Labs Pvt. Ltd., Navi Mumbai-400 701 / 51331 / Rejection Letter
17. / M/s. Shasun Pharmaceuticals Limited, Puducherry-605014 / 50466 / Clarification Letter
18. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 50698 / Test Licence
19. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 48237 / Test Licence
COSMETIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. S.V. Impex, Chennai / 44900 / Deficiency Letter
2. / M/s. Ambience Hotels & Resorts Pvt. Ltd, New Delhi / 45112 / Deficiency Letter
3. / M/s. Aero Pharma (Silvassa), Silvassa / 45065 / Deficiency Letter
4. / M/s. Dormir India Private Limited, Delhi / 45826 / Deficiency Letter
5. / M/s. Streamline Services India, West Bengal / 45763 / Deficiency Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Novartis Healthcare India Ltd / 40112, 47972, 45665 / Approval & Amendment Letter
2 / M/s Bharat Biotech International Ltd / 41913 / Acknowledge letter
3 / M/s GSK Pharmaceuticals Ltd / 44821, 40770 / Approval Letter
4 / M/s Gennova Biopharmaceuticals ltd / Clarification letter
5 / M/s Reliance Life sciences Pvt, Ltd / 50653,4522649894 / Clarification & letter
6 / M/s EliLilly and company India Pvt, Ltd / 48065 / Approval letters
7 / M/s Serum Institute of India Ltd / 47155 / Approval letters
8 / M/s Shantha Biotechnics Limited / 46566 / Approval letter
9 / M/s Venkateshwara Hatcheries pvt, ltd / 50303 / Amendment letter
10 / M/s APAC Biotech Pvt, ltd / Continuation letter
11 / M/s Ranbaxy Laboratories Ltd / 49279 / Amendment letter
12 / M/s Hester Biosciences Ltd / 50928 / Continuation letter
13 / M/s Sandor Medicaids Pvt, ltd / 37255, 46541 / Clarification letter
14 / M/s Esschem Pvt ltd / 39441 / Clarification letter
15 / M/s Intas Pharmaceutical ltd / Clarification letter
16 / M/s Baxter India Pvt, ltd / 58015 / Approval letter
17 / M/s Roche Product India Pvt, ltd / Acknowledge letter
18 / M/s Pavior pharmaceuticals Pvt ,ltd / Approval letter
EXPORT OF BIOLOGICAL SAMPLES
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Cliantha Research Ltd / 50665, 51012 / Approval Letter
2 / M/s Lamdha Therapeutics Research Pvt, ltd / 50473 / Approval Letter
MEDICAL DEVICE DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Piramal Healthcare Limited., Mumbai / 44741 / MDAC-Letter
2. / M/s. Zimmer India pvt. Ltd., Gurgaon / 27312 / MDAC-Letter
3. / M/s. Biomet Orthopaedics India pvt. Ltd., Ahmedabad / 49553 / MDAC-Letter
4. / M/s. Heraeus Technologies India Pvt. Ltd., Gurgaon / 48166 / MDAC-Letter
5. / M/s. Heraeus Technologies India Pvt. Ltd., Gurgaon / 48165 / MDAC-Letter
6. / M/s. Surya Surgicals Industries., Chennai / 42392 / MDAC-Letter
7. / M/s. Endoline Proscope Systems, New Delhi / 42412 / Query Letter
8. / M/s. Meril Life Sciences Pvt. Ltd., Vapi / 46906 / Query Letter
9. / M/s. Meril Life Sciences Pvt. Ltd., Vapi / 46907 / Query Letter
10. / M/s. Meril Life Sciences Pvt. Ltd., Vapi / 46905 / Query Letter
11. / M/s. Totipotent SC Scientific Product Pvt. Ltd., Gurgaon / 37486 / Query Letter
12. / M/s. Allergan Healthcare India Pvt. Ltd., Maharashtra / 35094 / Query Letter
13. / M/s. Anand Mediproducts Pvt. Ltd., New Delhi / 38568 / Query Letter
14. / M/s. Glenmark Generics Ltd., New Delhi / 50202 / Query Letter
15. / M/s. Zimmer India Pvt. Ltd., Gurgaon / 38911 / Query Letter
16. / SLA Solan, Himachal Pradesh/ M/s. Basic Healthcare Products Pvt. Ltd., Solan / FTS no. 73493 / Letter
17. / M/s. Amplitude India Pvt. Ltd., Pune / 37977 / Query Letter
18. / M/s. Johnson & Johnson Ltd., Valsad / 37088 / Query Letter
19. / M/s. Boston Scientific India Pvt. Ltd., New Delhi / 50701 / Query Letter
20. / M/s. Biosensors Interventional Technologies (India) Pvt. Ltd., Umbergaon / 47146 / Query Letter
21. / M/s. Boston Scientific India Pvt. Ltd., New Delhi / 46384 / Query Letter
DIAGNOSTICS DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Bio-Rad Laboratories (I), Gurgaon / 36579 / Query Letter
2. / M/s. Transasia Bio-Medicals Ltd., Daman / 46824 / Query Letter
3. / M/s. Unilab Biosciences Pvt. Ltd., Pune / 44788 / Query Letter