LETTERS FOR ISSUE ON 19.01 - Central Drugs Standard · PDF fileletters for issue on 19.01.2016 ba/be division s. no. company name fts no. /diary no. status 01 m/s. alembic research

LETTERS FOR ISSUE ON 19.01.2016

BA/BE DIVISION

S. NO. COMPANY NAME FTS NO. /DIARY

NO.

STATUS

01 M/S. ALEMBIC RESEARCH

CENTRE,VADODARA

432 QUERY

02 M/S. MANIPAL ACUNOVA, BANGLORE 722 QUERY

03 M/S. SYNCHRON RESEARCH SERVICES,

AHMEDABAD

52424 QUERY

04 M/S. TAAB BIOSTUDY SERVICES,

KOLKATA

25666 APPROVAL

05 M/S. LAMBDA THERAPEUTICS

RESEARCH, GUJARAT

37142 QUERY

06 M/S. GLENMARK PHARMACEUTICALS,

MUMBAI

26611 APPROVAL

IMPORT

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

1. AQUATIC REMEDIES PVT. LTD. 50650 APPROVAL LETTER

2. ANM PHARMA PVT. LTD. 50758 APPROVAL LETTER

3. VARDHMAN HEALTHCARE ( A DIVISION OF VARDHMAN STAMPINGS PVT. LTD.)

50756 APPROVAL LETTER

4. ANANTCO ENTERPRISES PVT. LTD. 50761 APPROVAL LETTER

5. PRIME PHARMACHEM 50717 APPROVAL LETTER

6. PRIME PHARMACHEM 50716 APPROVAL LETTER

7. GENERAL IMPORT COMPANY (INDIA) PVT. LTD.


8. KIMIA BIOSCIENCE PVT. LTD. 50797 APPROVAL LETTER

9. PRADIPKUMAR & CO. 50724 APPROVAL LETTER

10. SYMBIO GENERRICS INDIA PVT. LTD.


11. SYMBIO GENERRICS INDIA PVT. 50653 APPROVAL LETTER

LTD.





14. UNIMED TECHNOLOGIES LTD. 51067 APPROVAL LETTER

15. MEDI PHARMA DRUG HOUSE 51011 APPROVAL LETTER

16. DPB ANTIBIOTICS 51013 APPROVAL LETTER

17. NANDLAL BANKATLAL PVT. LTD. 51012 APPROVAL LETTER

18. DEL TRADE INTERNATIONAL PVT. LTD.






21. SOLREX PHARMACEUTICALS COMPANY


22. KAWARLAL & CO. (GODOWN) 51189 APPROVAL LETTER

23. PRATISTHA PHARMA 51159 APPROVAL LETTER

24. SAGAR RUBBER PRODUCTS PVT. LTD.


25. SAGAR RUBBER PRODUCTS PVT. LTD.


26. RIOTH HEALTHCARE PRIVATE LIMITED


27. AUROBINDO PHARMA LIMITED (UNIT-VI)



29. RUSKIN CHEMIPHARM 51340 APPROVAL LETTER

30. HARESH OVETA 51165 APPROVAL LETTER

31. BIOTAVIA LABS PVT. LTD. 38457 APPROVAL LETTER


33. FARMACHEM LIFE PRIVATE LIMITED


34. FARMACHEM LIFE PRIVATE LIMITED



36. VITAL THERAPEUTICS PVT. LTD. 51449 APPROVAL LETTER

37. DOLPHIN INTERNATIONAL, 51440 APPROVAL LETTER


39. GLAXOSMITHKLINE PHARMACEUTICALS LTD.



41. G.C. CHEMIE PHARMIE LIMITED 51676 APPROVAL LETTER

42. PFIZER LIMITED 51719 APPROVAL LETTER


44. TORRENT PHARMACEUTICALS LTD. 51549 APPROVAL LETTER


46. G.C. CHEMIE PHARMIE LIMITED 51675 APPROVAL LETTER

47. NECTAR LIFESCIENCES LTD. (UNIT NO. II)


48. CHANDRA BHAGAT PHARMA PRIVATELIMITED


49. CONCEPT PHARMACEUTICALS LIMITED.,




51. TRENDS PHARMA, 52130 APPROVAL LETTER

52. VITAL THERAPEUTICS PVT. LTD. 52016 APPROVAL LETTER



55. SUN PHARMACEUTICAL INDUSTRIES LTD.,


56. REXCIN PHARMACEUTICALS PVT. LTD.


57. MYLAN LABORATORIES LIMITED (STERILE PRODUCT DIVISION)






60. CENTRAL DRUG HOUSE 52014 APPROVAL LETTER

61. MEHTA API PVT. LTD., 52131 APPROVAL LETTER

62. GORANG INTERNATIONAL 52015 APPROVAL LETTER

63. SEVANTILAL & SONS 51768 APPROVAL LETTER

64. SUN PHARMA LABORATORIES LTD. 52084 APPROVAL LETTER

65. SUN PHARMACEUTICAL INDUSTRIES LTD. C/O M/S. ANKUR DRUGS & PHARMA PVT. LTD.


66. SUN PHARMACEUTICAL INDUSTRIES LIMITED


67. K.SEVANTILAL & CO. 51769 APPROVAL LETTER


69. ANUH PHARMA LTD. 50979 APPROVAL LETTER

70. IMAGING PRODUCTS(INDIA) PVT. LTD.


71. PASSIM MEDICHEM AGENCIES 51448 APPROVAL LETTER

72. MYLAN LABORATORIES LIMITED 51784 APPROVAL LETTER

(HSF)

73. HUFORT HEALTHCARE PVT. LTD. 51904 APPROVAL LETTER

74. RUMIT LIFECARE 51898 APPROVAL LETTER

75. AJANTA PHARMA LTD. 52227 APPROVAL LETTER

76. AJANTA PHARMA LTD. 52226 APPROVAL LETTER

77. AJANTA PHARMA LTD. (C/O. M/S. HEALTHCARE FORMULATIONS PVT. LTD. )


78. AJANTA PHARMA LTD. (C/O. M/S. RATNAMANI HEALTHCARE PVT. LTD. )



80. MICRON PHARMACEUTICALS 52199 APPROVAL LETTER

81. RUMIT LIFECARE 51899 APPROVAL LETTER


83. PARAM PHARMA 51902 APPROVAL LETTER

84. PIONEER BIO-PHARMA PVT. LTD., 51903 APPROVAL LETTER

85. CIPLA LTD. 52379 APPROVAL LETTER

86. ESPEE PHARMACHEM PVT. LTD. 52401 APPROVAL LETTER

87. MICRON PHARMACEUTICALS 52201 APPROVAL LETTER

88. ASSOCIATED BIOTECH 52400 APPROVAL LETTER


90. KETAN PHARMA, 52299 APPROVAL LETTER

91. LALCHAND BHIMRAJ, 52297 APPROVAL LETTER

92. AJANTA PHARMA LTD. (C/O. M/S. ACULIFE HEALTHCARE PRIVATE LIMITED )


93. MEHTA API PVT. LTD., 52295 APPROVAL LETTER

94. GUFIC LIFESCIENCES PVT. LTD. 52295 APPROVAL LETTER

95. SUN RISE ENTERPRISES 52364 APPROVAL LETTER

96. INTAS LIFESCIENCES PVT. LTD. 52403 APPROVAL LETTER

97. AUROBINDO PHARMA LIMITED (UNIT-XV)




99. IMPETUS HEALTHCARE 51900 APPROVAL LETTER

100. WOCKHARDT LTD., 50851 APPROVAL LETTER

101. GLAXO SMITH KLINE PHARMACEUICAL LTD. C/O M/S. PANACEA BIOTEC LTD.

56 APPROVAL LETTER

102. GANGWAL CHEMICALS PVT. LTD. 18 APPROVAL LETTER


104. SUN PHARMACEUTICAL 100 APPROVAL LETTER

INDUSTRIES LTD.


106. BHARAT PARENTERALS LIMITED 141 APPROVAL LETTER

107. CADILA HEALTHCARE LTD. 189 APPROVAL LETTER





112. ZUVENTUS HEALTHCARE LTD. 339 APPROVAL LETTER

113. ALEMBIC PHARMACEUTICALS LIMITED

297 APPROVAL LETTER

114. HINDUSTAN ANTIBIOTICS LTD. 199 APPROVAL LETTER

115. KAWARLAL & CO. 224 APPROVAL LETTER


117. KOPRAN LIMITED 305 APPROVAL LETTER

118. MACLEODS PHARMACEUTICALS LIMITED

200 APPROVAL LETTER

119. MSN LABORATORIES PRIVATE LIMITED

400 APPROVAL LETTER

120. JAI PHARMA LTD. 393 APPROVAL LETTER

121. SHAMSHREE LIFESCIENCES LTD. 442 APPROVAL LETTER

122. SUN PHARMACEUTICAL INDUSTRIES LTD.,

98 APPROVAL LETTER


124. SUN PHARMACEUTICAL INDUSTRIES LIMITED,

510 APPROVAL LETTER

125. CIPLA LTD.(GODOWN) 483 APPROVAL LETTER

126. C.J. SHAH & CO. (GODOWN) 629 APPROVAL LETTER

127. C.J. SHAH & CO. (GODOWN) 628 APPROVAL LETTER



130. DILIPKUMAR AND COMPANY 484 APPROVAL LETTER

131. DILIPKUMAR AND COMPANY 476 APPROVAL LETTER

132. ACULIFE HEALTHCARE PVT. LTD. 569 APPROVAL LETTER

133. TROIKAA PHARMACEUTICALS LTD., 567 APPROVAL LETTER

134. USV LIMITED 598 APPROVAL LETTER

135. ANANTCO ENTERPRISES PVT. LTD. 641 APPROVAL LETTER

136. R.N. LABORATORIES PVT LTD. 773 APPROVAL LETTER


786 APPROVAL LETTER

138. K.SEVANTILAL & CO. 766 APPROVAL LETTER

139. KETAN PHARMA, 740 APPROVAL LETTER

140. SERDIA PHARMACEUTICALS(INDIA) PVT. LTD.

772 APPROVAL LETTER

141. MSC CHEMICALS 987 APPROVAL LETTER

142. PIRAMAL ENTERPRISES LTD. 861 APPROVAL LETTER

143. PIRAMAL ENTERPRISES LTD. 860 APPROVAL LETTER

144. PMV LIFESCIENCE PVT. LTD. 994 APPROVAL LETTER

145. SUN PHARMACEUTICAL INDUSTRIES LIMITED

877 APPROVAL LETTER

146. J.B. KHOKHANI & CO. 945 APPROVAL LETTER


988 APPROVAL LETTER

148. PRADIPKUMAR PHARMA PVT. LTD. 959 APPROVAL LETTER



151. SIRMAXO CHEMICALS PVT. LTD. 40406 APPROVAL LETTER

152. SIRMAXO CHEMICALS PVT. LTD. 40405 APPROVAL LETTER



155. GLENMARK PHARMACEUTICALS LIMITED




158. LALCHAND BHIMRAJ, 1115 APPROVAL LETTER

159. BIOTAVIA LABS PVT. LTD. 1119 APPROVAL LETTER


161. ACEPHARMA, 1040 APPROVAL LETTER


163. DOVE PHARMACEUTICALS 1031 APPROVAL LETTER

164. ANTHEM BIO SCIENCES PVT. LTD. 1056 APPROVAL LETTER

REGISTRATION


1. RIFA PHARMA NIL APPROVAL LETTER

2. UNICHEMIE INTERNATIONAL 25504 APPROVAL LETTER

3. KENKO CORPORATION 39026 AMENDED LETTER

4. LASCO INTERNATIOANL 37689 AMENDED LETTER

5. GSK ASIA PVT. LTD. NIL LETTER

6. JOHNSON & JOHNSON PVT. LTD. 38224 LETTER

SHELF LIFE


1. KOPRAN LTD. 37145 APPROVAL LETTER

VACCINE DIVISION

S.

NO.

COMPANY NAME/ FILE NO DY. NO STATUS

1 M/S BIOCON LTD 40091 CLARIFICATION LETTER

2 M/S KEMWELL BIOPHARMA

PVT, LTD

40091 CLARIFICATION LETTER

3 M/S BIOGEN IDEC BIOTECH

INDIA PVT, LTD

35870, 36120 APPROVAL LETTER

4 M/S NOVO NORDISK INDIA

PVT, LTD


5 M/S ROCHE PRODUCTS

INDIA PVT, LTD


6 M/S JOHNSON & JOHNSON

PVT, LTD

51093 ACKNOWLEDGE LETTER

7 M/S BAYER

PHARMACEUTICALS PVT, LTD

40940 AMENDMENT LETTER

8 M/S SANOFI INDIA LTD 39532 APPROVAL LETTER

9 M/S ELIL LILLY AND

COMPANY INDIA PVT ,LTD

39832 ACKNOWLEDGE LETTER

10 M/S WOCKHARDT

HOSPTIALS LTD


11 M/S NOVARTIS HEALTHCARE

PVT, LTD

52193 AMENDMENT LETTER

12 M/S VIRCHOW BIOTECH PVT,

LTD


13 M/S BAXTER INDIA PVT, LTD 49525 APPROVAL LETTER

14 M/S DR. REDDY

LABORATORIES LTD


15 M/S PANACEA BIOTECH LTD 37006 APPROVAL LETTER

16 M/S BIOVIZ TECHNOLOGIES

PVT, LTD


17 M/S RELIANCE LIFE SCIENCES

PVT, LTD

58623, 62103, 62102,

67167, 66644, 63517,

58659, 59607

APPROVAL LETTER

MEDICAL DEVICE

S.NO. COMPANY NAME DIARY NO STATUS

1. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. 28787 APPROVAL (E-RC)

2. M/S. CARL ZEISS INDIA (BANGALORE) PVT. LTD. 36141 APPROVAL (E-IL)

3. M/S. COOK INDIA MEDICAL DEVICES PVT. LTD. 40401 APPROVAL (R-E-IL)

4. M/S. DISPOSAFE HEALTH AND LIFE CARE LTD. FTS. NO.-

55679

SPECIAL CODE

LETTER

5. M/S. EMERGO (INDIA) CONSULTING PVT. LTD. 34964 APPROVAL (F-RC)

6. M/S. HERAEUS TECHNOLOGIES INDIA PVT. LTD. 293 APPROVAL (R-E-

RC)

7. M/S. HERAEUS TECHNOLOGIES INDIA PVT. LTD. 293 APPROVAL (R-E-IL)


RC)


RC)

10. M/S. JOHNSON & JOHNSON PVT. LTD. 11416 APPROVAL (R-E-

RC)

11. M/S. JOHNSON & JOHNSON PVT. LTD. 11416 APPROVAL (R-E-IL)

12. M/S. KATARA DENTAL PVT. LTD. 36749 APPROVAL (R-RC)

13. M/S. KATARA DENTAL PVT. LTD. 36749 APPROVAL (R-IL)

14. M/S. MEDIZONE AESTHETICS 38155 APPROVAL (F-RC)

15. M/S. MEDI TECH DEVICES PVT. LTD. 51341 APPROVAL (F-IL)

16. M/S. SUN PHARMACEUTICAL INDUSTRIES

LIMITED

51504 APPROVAL (F-IL)

17. M/S. SURYA SURGICAL INDUSTRIES 42392 APPROVAL (F-RC)

18. M/S. BIORADMEDISYS PVT. LTD. 52049 APPROVAL (F-IL)

19. M/S. MM SURGICALS 51388 APPROVAL (TL)

20. M/S. ABBOTT HEALTHCARE PVT. LTD. 28940 QUERY LETTER

21. M/S. BECTON DICKINSON INDIA PVT. LTD. 36550 LETTER

22. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. 28442 QUERY LETTER

23. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. 39521 LETTER

24. M/S. BIOMET ORTHOPAEDIC INDIA PVT. LTD. 26299 QUERY LETTER

25. M/S. COOK INDIA MEDICAL DEVICES PVT. LTD. 50820 LETTER

26. M/S. DEENA ENTERPRISE 26840 QUERY LETTER

27. M/S. RITHWIK PHARMA PVT. LTD. 51555 LETTER

28. THE STATE DRUGS CONTROLLER, PANCHKULA

(CLAA)

THE DEPUTY DRUGS CONTROLLER, GHAZIABAD

(CLAA)

(M/S. POLY MEDICURE LTD., BALLABGARH)

FTS. NO.-

683

APPROVAL LETTER


(CLAA)


(CLAA)

(M/S. MEDI PLUS INDIA LTD., BAHADURGARH)

FTS. NO.-

685

APPROVAL LETTER


(CLAA)

FTS. NO.-

69604

APPROVAL LETTER


(CLAA)

(M/S. HARSORIA HEALTHCARE PVT. LTD.,

GURGAON)

31. THE COMMISSIONER, GANDHINAGAR (CLAA)

THE ASSISTANT DRUGS CONTROLLER,

AHMEDABAD (CLAA)

(M/S. MERIL HEALTHCARE PVT. LTD., CHALA

VAPI)

FTS. NO. -

68626

APPROVAL LETTER



AHMEDABAD (CLAA)

(M/S. BIOTECH VISION CARE PVT. LTD., GANDHI

NAGAR)

FTS. NO. -

65953

APPROVAL LETTER


THE DEPUTY DRUGS CONTROLLER, AHMEDABAD

(CLAA)

(M/S. MIV THERAPAUTICS (I) PVT. LTD., SURAT)

FTS. NO. -

1073

APPROVAL LETTER



AHMEDABAD (CLAA)

{M/S. POLYMER

TECHNOLOGIESINTERNATIONAL(EOU),

VADODARA}

FTS. NO. -

64927

APPROVAL LETTER

35. THE DRUGS LICENSING & CONTROLLING

AUTHORITY, LUCKNOW (CLAA

THE DEPUTY DRUGS CONTROLLER,

GHAZIABAD(CLAA)

M/S. JAI DURGAPRECISON STEEL

FTS. NO.-

58632

QUERY LETTER

36. THE DEPUTY DRUGS CONTROLLER, AHMEDABAD

(CLAA)

FTS. NO. -

63675

QUERY LETTER

THE COMMISSIONER, GANDHINAGAR (CLAA)

M/S. BONETECHMEDISYS PVT. LTD.,

AHMEDABAD

37. THE JOINT DIRECTOR & LICENSING AUTHORITY,

CDSCO, HYDERABAD

(M/S. RELISYS MEDICAL DEVICE LIMITED,

TELANGANA)

FTS. NO.-

816

LETTER

38. SHRI S K BHANDARI (BRIG. DDCDS (E&S)

DTE. GEN. OF DENTAL SERVICES

NIL CLARIFICATION

LETTER

SUBSEQUENT NEW DRUG

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

1. M/S NU THERAPEUTICS PVT. LTD.,

50071 67002 DEFICIENCY/ IPC NOC LETTER

2. M/S INTAS 50243 67136 ADDITIONAL SITES LETTER

3. M/S AMIT ENTERPRISES. 40798 66394 LETTER

4. M/S MSN 38796 63158 DEFICIENCY LETTER ,

5. M/S GLENMARK 38551 62555 DEFICIENCY LETTER

6. M/S EMCURE 37402 61130 LETTER

7. M/S AKUMS DRUGS & PHARMACEUTICALS LTD.

36970 60198 DEFICIENCY LETTER

8. M/S BHARAT SERUMS AND VACCINES LIMITED.,

36709 59968 DEFICIENCY LETTER

9. M/S CLIANTHA 39467 64296 DEFICIENCY LETTER

10. M/S TORRENT 33454 54355 DEFICIENCY LETTER

11. DR. REDDY’S 34806 56440 DEFICIENCY LETTER

DIAGNOSTICS DIVISION

S.NO. COMPANY NAME DIARY NO STATUS

1. M/S. BECKMAN COULTER INDIA PVT. LTD. 39282 APPROVAL (IL)

2. M/S. BECKMAN COULTER INDIA PVT. LTD. 36668 APPROVAL (E-IL)

3. M/S. MEDSOURCE OZONE BIOMEDICALS PVT. LTD. 39708 APPROVAL (IL)

4. M/S. OPERON BIOTECH AND HEALTHCARE 51339 APPROVAL (IL)

5. M/S. QIAGEN INDIA PVT. LTD. 32934 APPROVAL (IL)

6. M/S. ARMEDIQ HEALTHCARE INDIA 51615 APPROVAL (TL)

7. M/S. BIOMERIUX INDIA PVT. 40301 APPROVAL (TL)

8. M/S. CAN-INDIA HEALTHCARE PRODUCTS 50046 APPROVAL (TL)

9. M/S. DIASORIN TRIVITRON HEALTHCARE PVT. LTD. 51789 APPROVAL (TL)

10. M/S. MORULAAHEALTHTECH PVT. LTD. 29950 APPROVAL (TL)

11. M/S. MORULAAHEALTHTECH PVT. LTD. 29950 APPROVAL (TL)

12. M/S. ROCHE DIAGNOSTICS INDIA PVT. LTD. 50566 APPROVAL (TL)



Documents

LETTERS FOR ISSUE ON 19.01 - Central Drugs Standard · PDF fileletters for issue on 19.01.2016 ba/be division s. no. company name fts no. /diary no. status 01 m/s. alembic research