Letters for Issue on 27.01.2015

LETTERS FOR ISSUE ON 27.01.2015 NEW DRUG

S.NO NAME OF APPLICANT DIARY TYPE OF . NO. LETTER 1. M/s. Fulford (I) Ltd - Query Letter

2. M/s. Johnson & Johnson Limited - Query Letter 3. Dr. R.S. Paranjape - TL Letter (2) 4. M/s. MSD Pharmaceuticals Pvt Ltd - Letter 5. M/s. Emcure Pharmaceuticals Ltd - Query Letter 6. M/s. BMS India Pvt. Ltd - CT-NOC Letter

IMPORT

S.no. Name of applicant Diary no. Type of letter 1. Haresh oveta 50743 Approval letter 2. Micro labs ltd. 50632 Approval letter 3. Micro labs ltd.unit-iii 50631 Approval letter 4. Micro labs ltd. 50633 Approval letter 5. Alkem laboratories ltd. 50647 Approval letter 6. Vxl life sciences 50706 Approval letter 7. Vxl life sciences 50707 Approval letter 8. Merck limited 50618 Approval letter 9. Claris otsuka private limited 50646 Approval letter 10. Dove pharmaceuticals 50630 Approval letter 11. Ranbaxy laboratories ltd. 50926 Approval letter 12. Ranbaxy laboratories ltd. 50925 Approval letter 13. Hufort healthcare pvt. Ltd. 50871 Approval letter 14. Dpb antibiotics 50870 Approval letter 15. Pravin pharma 50868 Approval letter 16. Prachem laboratories 50869 Approval letter 17. Granules india ltd. 50882 Approval letter 18. Shell-life sciences pvt. Ltd. 51049 Approval letter 19. Indoco remedies ltd. 51145 Approval letter 20. Shell-life sciences pvt. Ltd. 51052 Approval letter 21. Shell-life sciences pvt. Ltd. 51051 Approval letter 22. Shell-life sciences pvt. Ltd. 51050 Approval letter 23. Scott edil pharmacia ltd. 51010 Approval letter 24. Sevantilal & sons 51108 Approval letter 25. Sevantilal & sons 51109 Approval letter 26. Scott edil pharmacia ltd. 51007 Approval letter 27. Sagar rubber products pvt. Ltd. 51047 Approval letter 28. Scott edil pharmacia ltd. 51011 Approval letter 29. Shamshree lifesciences ltd. 51172 Approval letter 30. Shell-life sciences pvt. Ltd. 51048 Approval letter 31. Ruskin chemipharm 51132 Approval letter 32. Ruskin chemipharm 51130 Approval letter 33. Ruskin chemipharm 51131 Approval letter 34. Micro labs ltd. 46636 Approval letter 35. Inspira bio pharm pvt. Ltd. 51041 Approval letter 36. Lupin ltd. 44356 Approval letter 37. Symbio generrics india pvt. 47316 Approval letter Ltd. 38. Aquatic remedies pvt. Ltd. 50645 Approval letter 39. Pfizer products india pvt.ltd. 50185 Approval letter 40. Roche products (india) pvt. 50289 Approval letter Ltd. 41. General import company 290 Approval letter (india) pvt. Ltd. 42. General import company 291 Approval letter (india) pvt. Ltd. 43. General import company 292 Approval letter (india) pvt. Ltd. 44. General import company 293 Approval letter (india) pvt. Ltd. 45. General import company 294 Approval letter (india) pvt. Ltd. 46. Skies 201 Approval letter 47. Skies 203 Approval letter 48. Skies 204 Approval letter 49. Biotavia labs pvt. Ltd. 220 Approval letter 50. Biotavia labs pvt. Ltd. 219 Approval letter 51. Biotavia labs pvt. Ltd. 217 Approval letter 52. Biotavia labs pvt. Ltd. 218 Approval letter 53. C.j. shah & co. (godown) 295 Approval letter 54. Gorang international 240 Approval letter 55. Prime pharmachem 239 Approval letter 56. Emcure pharmaceuticals ltd. 235 Approval letter 57. Troikaa pharmaceuticals ltd. 288 Approval letter 58. Ruskin chemipharm 275 Approval letter 59. Unique pharmaceutical 303 Approval letter laboratories(a div. Of j.b. chemicals & pharmaceuticals ltd.), 60. Dr. Reddy's laboratories 210 Approval letter limited 61. Bdh industries ltd 253 Approval letter 62. Otsuka chemical (india) pvt. 173 Approval letter Ltd., 63. Boerhringer ingelheim india 47594 Amended letter pvt. Ltd. 64. Bayer pharmaceuticals pvt. 158 Amended letter Ltd. 65. Claris otsuka pvt. Ltd. 208,209, 04 amended letter 51368,51366 66. General import company india 51389 Amended letter pv.t ltd. 67. Innova captab 238 Amended letter

REGISTRATION

S.no. Name of applicant Diary no. Type of letter 1. Msd pharmaceutical pvt. 45120,46934 02 approval letter Ltd. 2. Abbott healthcare pvt. Ltd. 33650 Approval letter 3. Mylan pharmaceuticals pvt. 1527 Approval letter Ltd. 4. Archerchem 48078 Approval letter 5. Teva pharmaceutical and 51232,33662,51231 03 approval letter chemical industreis pvt. Ltd. 6. Umicore india pv.t ltd. 42477 Approval letter 7. Basf india ltd. 49596 Approval letter 8. Blue cross laboratories ltd. 50978 Approval letter 9. Dsm sinochem 44460 Approval letter 10. Next gen 48696 Approval letter 11. Fulford india ltd. 49796 Approval letter 12. B.m.chemie 48770 Approval letter 13. Dispo surgicals 41124 Approval letter 14. Eastern chemicals pvt. Ltd. 44344 Approval letter 15. Esschem pvt. Ltd. 33393,38214 02 approval letter 16. Glaxo smith kline asia pvt. 47454 Approval letter Ltd. 17. Dr. Reddys 51166 Amended letter 18. Neha pharma pvt. Ltd. 81 Amended letter 19. Novartis helathcare pvt. 43616 Amended letter Ltd. 20. Boehringer ingelheim 47594 Amended letter 21. Bristol myers squibb india 325 Amended letter pvt. Ltd. 22. Bayer pharmaceutical pv.t 47982 Amended letter ltd. 23. Baxter india pvt. Ltd. 29850 Amended letter 24. Shah tc 47003 Amended letter 25. Msd pharmaceuticals pvt. Nil Cancelled letter Ltd. 26. Ferring pharmaceuticals 26859,26860 02 clarification pvt. Ltd. letter 27. Brenntag ingredinets 48385 Clarification letter 28. Sow pharma 33563 Clarification letter

LETTER PERTAINING TO RULE -37

S.no. Name of applicant Diary no. Type of letter 1. Pureeera india pv.t ltd. 50385 Clarification letter

SUBSEQUENT NEW DRUG

S. NAME OF THE REFERENCE FTS NO. TYPE OF NO. FIRM NO. LETTER 1. M/s Micro Labs Ltd., 51274 77493 Query Letter

FDC DIVISION

S.NO NAME OF COMPANY DIARY NO DOCUMENT . 1. M/s. Swiss Garnier 63919 Letter 2. M/s. Akums Drugs & 27161 Letter Pharmaceuticals 3. M/s. Sanzyme Ltd., 45459 Letter 4. M/s. Pfizer Ltd., 28189 Letter 5. M/s. Gopaldas Vishram 50040 Clarification Letter 6. M/s. USV Ltd., 42197 Letter