翻译:JULIA 来源:Julia法规翻译 


目前缬沙坦CEP持有情况


共有28份CEP,分别由22家公司持有,28份中有2只被搁置,3份被持有人撤回,其中华海CEP被搁置日期为2018年7月9日。


Substance

Certificate Holder

Certificate Number

Issue Date

Status

End date

Valsartan Process II

ALEMBIC PHARMACEUTICALS  LIMITED IN 390 003  Vadodara

  R0-CEP  2014-075-Rev 00

13/04/2016

VALID


Valsartan

ALEMBIC  PHARMACEUTICALS LIMITED IN 390 003  Vadodara

  R1-CEP  2010-065-Rev 03

27/07/2018

VALID


Valsartan Process II

AUROBINDO PHARMA  LIMITED IN 500 038  Hyderabad

  R1-CEP  2011-174-Rev 00

03/08/2017

VALID


Valsartan Process II,  o-Xylene route

AUROBINDO PHARMA  LIMITED IN 500 038 Hyderabad

  R0-CEP  2016-101-Rev 00

19/08/2016

VALID


Valsartan

DIVI’S LABORATORIES  LIMITED IN 500 032  Hyderabad

  R0-CEP  2012-338-Rev 02

12/08/2016

VALID


Valsartan

DR. REDDY’S  LABORATORIES LIMITED IN 500 034  Hyderabad

  R1-CEP  2009-405-Rev 00

04/08/2016

VALID


Valsartan

GRANULES INDIA LIMITED  IN 500 081 Hyderabad

  R0-CEP  2013-012-Rev 00

05/03/2015

WITHDRAWN BY HOLDER

03/01/2018

Valsartan

HARMAN FINOCHEM  LIMITED IN 400 098 Mumbai

  R0-CEP  2016-026-Rev 00

10/11/2017

VALID


Valsartan Process III

HETERO LABS LIMITED IN  500 018 Hyderabad

  R0-CEP  2016-069-Rev 01

04/05/2018

VALID


Valsartan Process-II

HETERO LABS LIMITED IN  500 018 Hyderabad

  R0-CEP  2012-296-Rev 02

10/08/2017

WITHDRAWN BY HOLDER

25/05/2018

Valsartan

HETERO LABS LIMITED IN  500 018 Hyderabad

  R0-CEP  2011-246-Rev 01

29/09/2015

WITHDRAWN BY HOLDER

08/09/2017

Valsartan

IPCA Laboratories  Limited IN 400 067 Mumbai

  R1-CEP  2010-100-Rev 01

18/05/2018

VALID


Valsartan

JUBILANT GENERICS  LIMITED IN 571 302  Nanjangud

  R1-CEP  2011-110-Rev 01

27/06/2018

VALID


Valsartan

KRKA d.d. SI 8501 Novo  Mesto

  R1-CEP  2011-148-Rev 00

08/03/2018

VALID


Valsartan

LUPIN LIMITED IN 400  055 Mumbai

  R0-CEP  2012-274-Rev 02

23/01/2017

VALID


Valsartan

MACLEODS  PHARMACEUTICALS LIMITED IN 400 059  Mumbai

  R1-CEP  2011-180-Rev 01

11/06/2018

VALID


Valsartan

MYLAN LABORATORIES  LIMITED IN 500 096  Hyderabad

  R1-CEP  2009-396-Rev 02

11/01/2018

VALID


Valsartan

NOVARTIS PHARMA AG CH  4002 Basel

  R0-CEP  2016-290-Rev 00

06/12/2017

VALID


Valsartan

SECOND PHARMA CO.,  LTD. CN 312 369 Shangyu  City

  R0-CEP  2014-008-Rev 00

03/02/2015

VALID


Valsartan

SIGNA S.A. DE C.V. MX  50071 Toluca

  R0-CEP  2011-231-Rev 00

24/06/2014

VALID


Valsartan Process 3  and Process 5

SUN PHARMACEUTICAL  INDUSTRIES LIMITED IN 400 063 Mumbai

  R0-CEP  2013-335-Rev 03

29/10/2015

VALID


Valsartan

SUN PHARMACEUTICAL  INDUSTRIES LIMITED IN 400  063 Mumbai

  R1-CEP  2010-196-Rev 00

29/03/2017

VALID


Valsartan ID: 7611

Teva Pharmaceutical  Industries Ltd. IL 49131  Petach Tikva

  R0-CEP  2011-121-Rev 00

28/06/2013

VALID


Valsartan

TEVA PHARMACEUTICAL  INDUSTRIES LTD. IL  4951033 Petach Tikva

  R1-CEP  2010-207-Rev 00

29/09/2017

VALID


Valsartan

ZHEJIANG CHANGMING  PHARMACEUTICAL CO., LTD.  CN 317 200 Tiantai

  R0-CEP  2014-162-Rev 00

03/11/2016

VALID


Valsartan

Zhejiang Hisun  Pharmaceutical Co., Ltd. CN  318 000 Taizhou City

  R0-CEP  2013-095-Rev 00

04/09/2014

SUSPENDED

28/10/2016

Valsartan

ZHEJIANG HUAHAI  PHARMACEUTICAL CO., LTD. CN  317 024 Linhai

  R1-CEP  2010-072-Rev 00

09/06/2016

SUSPENDED

09/07/2018

Valsartan

ZHEJIANG TIANYU  PHARMACEUTICAL CO., LTD. CN  318 020 Taizhou

  R0-CEP  2013-159-Rev 01

17/01/2018

VALID


目前缬沙坦CEP持有情况


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