LETTERS FOR ISSUE ON 12.07 - Central Drugs Standard ... Letter 12-07-2016.pdf · letters for issue on 12.07.2016 ... m/s. zydus takeda healthcare pvt. ltd., ... m/s. cadila healthcare

LETTERS FOR ISSUE ON 12.07.2016

BIOLOGICAL DIVISION

S. NO NAME OF COMPANY DY. NO STATUS

1 M/S SANOFI INDIA LTD

39573 APPROVAL LETTER

2 M/S LUPIN LTD 14350 APPROVAL LETTER

3 M/S NOVARTIS HEALTHCARE PVT, LTD


4 M/S DR. REDDY’S LABORATORIES LTD


5 M/S LG LIFE SCIENCES INDIA PVT, LTD

17530 AMENDMENT LETTER

6 M/S GSK ASIA PVT, LTD

36862, 12532, 12929

AMENDMENT LETTER

7 M/S CADILA HEALTHCARE LTD

18637, 20504

APPROVAL & INVITATION LETTER

8 M/S HETERO DRUGS LTD

18077, APPROVAL LETTER

9 M/S RELIANCE LIFE SCIENCES PVT, LTD


10 M/S NOVO NORDISK PVT, LTD `

INVITATION LETTER

11 M/S SANZYME LTD INVITATION LETTER

12 M/S ROCHE PRODUCTS INDIA PVT, LTD

INVITATION LETTER

13 M/S RELIANCE LIFE SCIENCES PVT, LTD

INVITATION LETTER

14 M/S GENNOVA BIOPHARMACEUTICAL LTD

INVITATION LETTER

15 M/S JOHNON & JOHNSON

INVITATION LETTER

INTERNATIONAL CELL

S. NO FIRM NAME TYPE

1. M/S. CADILLA HEALTHCARE, GUJARAT WC

2. M/S. CADILLA PHARMACEUTICALS, GUJARAT WC

3. M/S. SUN PHARMA, TAMIL NADU WC

4. M/S. RICHTER THEMIS MEDICARE PVT LTD., WC

5. M/S. MEHTA API PVT. LTD., MAHARASHTRA WC

6. M/S. EMBIO LTD., MAHARASHTRA WC

7. M/S. SHARON BIOMEDICINE LTD., MAHARSHTRA WC

8. M/S. RA CHEM PHAMACEUTICALS, KRISHNA DIST WC

9. M/S. INOGENT LABORATORIES, HYDERABAD WC

10. M/S. ZYDUS TAKEDA HEALTHCARE PVT. LTD., MUMBAI WC

11. M/S. LAKE CHEMICALS, LAKSHMINARAYAN COMPLEX,

BANGALORE

WC

12. M/S. UNIQUE CHEMICALS, GUJARAT WC

13. M/S. AMI LIFE SCIENCES PVT. LTD., VADODARA,

GUJARAT

WC

14. M/S. BELOOR BAYIR CHEMICALS, BANGALORE WC

15. M/S. HETERO DRUGS LTD., VISHAKHAPATAM WC

16. M/S. MACLEODS PHARMACEUTICALS LTD., GUJARAT WC

17. M/S. SWATI SPENTOSE PVT. LTD. GUJARAT WC

18. M/S. SUN PHARMACEUTICALS INDUSTRIES LTD. WC

19. M/S. MYLAN LABORATORIES LTD., UNIT-VII,

TELANGANA

WC

20. M/S. SANOFI INDIA LIMITED, GUJARAT WC

21. M/S. MELODY HEALTHCARE PVT LTD., MAHARASHTRA WC

22. M/S. ATUL LTD., GUJARAT WC

23. M/S. ANEK PRAYOG, RAIGAD WC

24. M/S. GRANULES INDIA LTD., UNIT-II, AP. WC

25. M/S. KORES (INDIA) LTD., RAIGAD, MAHARASHTRA LETTER

26. M/S. BIOCON LTD., BOMASANDRA, BANGALORE LETTER

27. M/S. BIOCON LTD., SITE-I, ELECTRONIC CITY,

BANGALORE

LETTER

28. M/S. CADILA HEALTHCARE LIMITED, ANKLESHWAR,

GUJARAT

LETTER

29. M/S. PROVENTUS LIFE SCIENCES, CHENNAI LETTER

30. M/S. SYMBIOTECH PHARMALAB, MP LETTER

31. M/S. SHRI KRISHNA PHARMACEUTICALS LIMITED,

UNIT-1, A.P

LETTER

32. M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA,

GUJARAT

LETTER

GLOBAL CLINICAL TRIAL

SR.

NO.

COMPANY

NAME

REFERENCE

NO.

STATUS

1 M/S. SANOFI 18100 CLARIFICATION

LETTER

2 M/S. ROCHE 19198 TL APPROVAL

LETTER

3 M/S. CADILA 19416 SITE APPROVAL

LETTER

4 M/S. NOVARTIS 18322 EXPORT NOC

APPROVAL LETTER

NEW DRUG

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER

1. M/S. ROCHE PRODUCTS (INDIA) PVT LTD

- MEETING NOTICE LETTER 19.07.2016 (ONCOLOGY)

2. M/S. BOEHRINGER INGELHEIM INDIA PVT LTD.

- MEETING NOTICE LETTER 19.07.2016 (ONCOLOGY)

3. M/S. AJANTA PHARMA - MEETING NOTICE LETTER 25.07.2016 (PULMONARY)

4. M/S. BOEHRINGER INGELHEIM INDIA PVT LTD.

- MEETING NOTICE LETTER 25.07.2016 (PULMONARY)

5. M/S. ELI-LILLY - MEETING NOTICE LETTER 28.07.2016 (REPRODUCTIVE & UROLOGY)

6. M/S. NOVARTIS PHARMACUTICALS

- MEETING NOTICE LETTER 29.07.2016 (ANTIMICROBIAL)

7. M/S. MICRO LABS - MEETING NOTICE LETTER 29.07.2016 (ANTIMICROBIAL)

COSMETICS DIVISION


1. M/S. ITC LIMITED, KOLKATA 19474 APPROVAL LETTER

2. M/S. N K HEALTHCARE PVT. LTD, NEW DELHI 17588 APPROVAL LETTER

3. M/S. FASHION IDENTITY PVT. LTD, MUMBAI 18217 APPROVAL LETTER

BE NOC FOR EXPORT

S. NO. NAME OF THE COMPANY REF. NO. TYPE OF LETTER

1. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD.,

NAVI MUMBAI-400709



NAVI MUMBAI-400709



NAVI MUMBAI-400709



NAVI MUMBAI-400709



NAVI MUMBAI-400709



NAVI MUMBAI-400709


7. M/S. ACTIMUS BIOSCIENCES PVT. LTD.,

VISAKHAPATNAM-530003











11. M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA-

390003


12. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA

LTD., HYDERABAD-500090

















18. M/S. APOTEX RESEARCH PVT. LTD., BANGALORE-

560099


19. M/S. AZIDUS LABORATORIES LTD., CHENNAI-600048 20388 CLARIFICATION LETTER

20. M/S. AZIDUS LABORATORIES LTD., CHENNAI-600048 18388 APPROVAL LETTER

21. M/S. CADILA PHARMACEUTICAL LTD., DHOLKA-387810,

AHMEDABAD


22. M/S. CIPLA LIMITED, MUMBAI-400013 18980 AMENDMENT LETTER

23. M/S. CIPLA LIMITED, MUMBAI-400013 20364 APPROVAL LETTER

24. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-

380054



380054



380054



380054



380054



380054


30. M/S. DR. REDDY’S LABORATORIES LTD., HYDERABAD-

500034


31. M/S. DR. REDDY’S LABORATORIES LTD., HYDERABAD-

500034


32. M/S. EMCURE PHARMACEUTICALS LIMITED, PUNE-

411026


33. M/S. EMCURE PHARMACEUTICALS LIMITED, PUNE-

411026


34. M/S. GLENMARK PHARMACEUTICALS LTD., NAVI

MUMBAI-400705


35. M/S. HETERO LABS LTD., HYDERABAD-500018 13013 APPROVAL LETTER



38. M/S. INVENTIA HEALTHCARE PVT. LTD., DIST. THANE- 19335 APPROVAL LETTER

421506

39. M/S. INVENTIA HEALTHCARE PVT. LTD., DIST. THANE-

421506


40. M/S. JUBILANT GENERICS LTD., NOIDA-201301, UP 17549 APPROVAL LETTER

41. M/S. LAMBDA THERAPEUTIC RESEARCH LTD.,

AHMEDABAD-382481



AHMEDABAD-382481



AHMEDABAD-382481



AHMEDABAD-382481



AHMEDABAD-382481



AHMEDABAD-382481


47. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., NAVI

MUMBAI-400 614


48. M/S. LOTUS LABS PVT. LTD., BANGALORE-560034 17718 APPROVAL LETTER





53. M/S. LOTUS LABS PVT. LTD., CHENNAI- 600 004 18711 APPROVAL LETTER

54. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 20602 CLARIFICATION LETTER

55. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 20603 CLARIFICATION LETTER

56. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 12856 APPROVAL LETTER









65. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI

(EAST), MUMBAI-400059


66. M/S. MANIPAL ACUNOVA LIMITED, MANGALORE-

575001


67. M/S. MANIPAL ACUNOVA LIMITED, MANIPAL -576104 19723 APPROVAL LETTER

68. M/S. MANIPAL ACUNOVA LTD., MANGALORE-575001 20149 APPROVAL LETTER

69. M/S. MICRO THERAPEUTIC RESEARCH LABS PVT. LTD.,

CHENNAI-600059

20791 AMENDMENT LETTER

70. M/S. MICRO THERAPEUTIC RESEARCH LABS PVT. LTD.,

CHENNAI-600059

19833 CLARIFICATION LETTER

71. M/S. RA CHEM PHARMA LTD., BALANAGAR,

HYDERABAD-500037


72. M/S. STRIDES SHASUN LIMITED, BANGALORE-560076 16653 APPROVAL LETTER

73. M/S. SUN PHARMA ADVANCED RESEARCH COMPANY

LTD., VADODARA-390 020

20264 TEST LICENCE

74. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,

HARYANA



HARYANA



HARYANA



HARYANA



HARYANA



VADODARA-390 020



VADODARA-390 020



VADODARA-390020



VADODARA-390020


83. M/S. VEEDA CLINICAL RESEARCH PVT. LTD.,

AHMEDABAD-380015


84. M/S. VEEDA CLINICAL RESEARCH PVT. LTD.,

AHMEDABAD-380015


85. M/S. VERGO PHARMA RESEARCH PVT. LTD. (DIV-

VERGO CLINICALS), GOA-403110


86. M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI-

400614


87. M/S. WOCKHARDT LIMITED, AURANGABAD-431006 16901 APPROVAL LETTER

SUBSEQUENT NEW DRUG

S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF LETTER

1. M/S TROIKAA PHARMACEUTICAL LTD.,

- 34667 LETTER

MISC.


1. MYLAN LABORATORIES LTD. NIL LETTER

MEDICAL DEVICE

S.NO. COMPANY NAME DIARY NO STATUS

1. M/S. ST. JUDE MEDICAL INDIA PVT. LTD. 15604 QUERY LETTER

2. M/S. JSS MEDICAL RESEARCH INDIA LIMITED 2358 LETTER

3. M/S. SAHAJANAND MEDICAL TECHNOLOGIES PVT. LTD. FTS. NO.-

33328

LETTER

4. THE DEPUTY DRUGS CONTROLLER, GHAZIABA (CLAA)

THE STATE DRUGS CONTROLLER & LICENSING AUTHORITY,

PANCHKULA ( CLAA)

M/S. R.N.S. SURGICAL PVT. LTD., BAHADURGARH

FTS. NO.-

34464

QUERY LETTER

5. THE DRUGS LICENSING & CONTROLLING AUTHORITY,

LUCKNOW (CLAA)

THE DEPUTY DRUGS CONTROLLER, GHAZIABAD (CLAA)

(M/S. NARANG MEDICAL LTD., GHAZIABAD)

FTS. NO. -

34649

APPROVAL LETTER

6. M/S. CADILA HEALTHCARE LIMITED

(ONLINE APPROVAL)

807 APPROVAL (IL)

7. M/S. DR. REDDYS LABORATORIES LTD.

(ONLINE APPROVAL)

929 APPROVAL (IL)

8. M/S. DR. REDDYS LABORATORIES LTD.

(ONLINE APPROVAL)

1186 APPROVAL (IL)

9. M/S. GLAND PHARMA LIMITED

(ONLINE APPROVAL)

1160 APPROVAL (IL)

10. M/S. G.C. CEHMIE PHARMIE LTD.

(ONLINE APPROVAL)

1306 APPROVAL (IL)

11. M/S. INDICAL MEDSURG PVT. LTD.

(ONLINE APPROVAL)

2727 APPROVAL (IL)

12. M/S. GLAND PHARMA LIMITED

(ONLINE APPROVAL)

2022 APPROVAL (IL)

13. M/S. EDWARDS LIFESCIENCES INDIA PVT. LTD.

(ONLINE APPROVAL)

3048 APPROVAL (E-IL)

14. M/S. ARIHANT ENTERPRISES

(ONLINE APPROVAL)

2519 APPROVAL (IL)

15. M/S. INTAS PHARMACEUTICAL LTD.

(ONLINE APPROVAL)

2155 APPROVAL (IL)

16. M/S. MORULAA HEALTHTECH PVT. LTD.

(ONLINE APPROVAL)

690 APPROVAL (IL)

17. M/S. OSSTEM IMPLANT INDIA PVT. LTD.

(ONLINE APPROVAL)

1917 APPROVAL (IL)

18. M/S. SUN PHARMACEUTICAL INDUSTRIES LIMITED

(ONLINE APPROVAL)

3108 APPROVAL (IL)

19. M/S. WIN SURGICAL

(ONLINE APPROVAL)

2480 APPROVAL (IL)

20. M/S. VYGON INDIA PVT. LTD. 17842 CLARIFICATION LETTER

21. M/S. CARL ZEISS INDIA (BANGALORE) PVT. LTD. 12797 APPROVAL (R-RC)

22. M/S. KLB INSTRUMENTS CO. PVT. LTD. 15090 APPROVAL (E-RC)

DIAGNOSTICS DIVISION

S.NO. COMPANY NAME DIARY NO STATUS

1. M/S. BECKMAN COULTER INDIA PVT. LTD.

(ONLINE APPROVAL)

2138 APPROVAL (IL)

2. M/S. KINEDEX BIOMEDICALS PVT. LTD.

(ONLINE APPROVAL)

1902 APPROVAL (IL)

3. M/S. VANUGUARD DIAGNOSTICS PVT. LTD.,

(ONLINE APPROVAL)

2413 APPROVAL (IL)

4. M/S. ASPEN LABORATORIES PVT. LTD.

(ONLINE APPROVAL)

1748 APPROVAL (IL)

5. M/S. SD BIOSENSOR HEALTHCARE PVT. LTD.

(ONLINE APPROVAL)

1033 APPROVAL (IL)

6. M/S. BIO-RAD LABORATORIES (INDIA) PVT. LTD.

(ONLINE APPROVAL)

1923 APPROVAL (IL)

7. M/S. ACCUREX BIOMEDICAL PVT. LTD.,

(ONLINE APPROVAL)

1405 APPROVAL (IL)

8. M/S. ASTRAA BIOMEDICALS

(ONLINE APPROVAL)

2729 APPROVAL (IL)

9. M/S. BECKTON DICKINSON INDIA PVT. LTD.

(ONLINE APPROVAL)

1362 APPROVAL (IL)

10. M/S. VIJYOTI MANAGEMENT & COMMUNICATIONS

LEARNING INSTITUTE PVT. LTD.

(ONLINE APPROVAL)

1721 APPROVAL (IL)

11. M/S. POCT SERVICES PVT. LTD.

(ONLINE APPROVAL)

1709 APPROVAL (IL)


(ONLINE APPROVAL)

2906 APPROVAL (IL)


(ONLINE APPROVAL)

2942 APPROVAL (IL)

14. M/S. BIOSYSTEMS DIAGNOSTICS PVT. LTD.

(ONLINE APPROVAL)

2941 APPROVAL (IL)

15. M/S. DIASORIN TRIVITRON HEALTHCARE PVT. LTD.

(ONLINE APPROVAL)

2891 APPROVAL (IL)

16. M/S. IMMUCOR INDIA PVT. LTD.

(ONLINE APPROVAL)

2741 APPROVAL (IL)

17. M/S. MATRIX LABS

(ONLINE APPROVAL)

1778 APPROVAL (IL)

Documents

LETTERS FOR ISSUE ON 12.07 - Central Drugs Standard ... Letter 12-07-2016.pdf · letters for issue on 12.07.2016 ... m/s. zydus takeda healthcare pvt. ltd., ... m/s. cadila healthcare