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Carbidopa

CAS number: 38821-49-7

Molecular formula: C10H16N2O5

molecular weight: 244.24

Chemical structure:

Producers shown on SFDA

(Record date:06/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Wild Wind Pharmaceutical Co., Ltd.GMP, DMF
Valid till July 2022
Zhejiang Chiral Medicine Chemicals Co., Ltd.
GMPValid till September 2021

Guilin Auspicious Pharmaceutical Co., Ltd.

GMP
Valid till January 2018


Producers shown on EP

(Quoted from EP website;record date:06/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Carbidopa
Kraemer & Martin Pharma Handels GmbH DE 47804 Krefeld
  R0-CEP 2006-066-Rev 00
21/06/2007
WITHDRAWN BY HOLDER
28/02/2008
Chemistry
Carbidopa
Smruthi Organics Limited IN 413 255 Solapur
  R0-CEP 2006-138-Rev 01
26/11/2009
WITHDRAWN BY EDQM
13/12/2013
Chemistry
Carbidopa
EGIS Pharmaceuticals PLC HU 1106 Budapest
  R1-CEP 1998-032-Rev 01
02/04/2009
WITHDRAWN BY HOLDER
07/01/2019
Chemistry
Carbidopa
SHANDONG XINHUA PHARMACEUTICAL CO., LTD. CN 255 086 Zibo
  R0-CEP 2016-052-Rev 01
12/09/2018
VALID
/Chemistry
Carbidopa
ZHEJIANG WILD WIND PHARMACEUTICAL CO., LTD. CN 322 105 Geshan Town
  R1-CEP 2009-073-Rev 01
19/04/2018
VALID
/
Chemistry
Carbidopa
MAITHRI DRUGS PRIVATE LIMITED IN 502 313 Bonthapally Village
  R0-CEP 2020-143-Rev 00
11/06/2021
VALID
/
Chemistry
Carbidopa Process-II
BACHEM S.A. CH 1895 Vionnaz
  R0-CEP 2020-364-Rev 00
22/06/2021
VALID
/
Chemistry
Carbidopa
BACHEM S.A. CH 1895 Vionnaz
  R1-CEP 2000-012-Rev 08
16/12/2019
VALID
/
Chemistry
Carbidopa
Glochem Industries Limited IN 500 018 Hyderabad
  R0-CEP 2010-338-Rev 02
06/05/2015
EXPIRED
09/03/2017
Chemistry
Carbidopa Process B, micronised, non-micronised
Zhejiang Chiral Medicine Chemicals Co., Ltd. CN 311 227 Hangzhou
  R1-CEP 2014-126-Rev 00
22/07/2019
VALID
/
Chemistry
Carbidopa
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2002-052-Rev 06
10/03/2021
VALID
/
Chemistry
Carbidopa Micronised, non-micronised
Zhejiang Chiral Medicine Chemicals Co., Ltd. CN 311 227 Hangzhou
  R1-CEP 2007-067-Rev 03
17/10/2017
VALID
/
Chemistry
Carbidopa
FERMION OY FI 02200 Espoo
  R1-CEP 2011-275-Rev 01
10/04/2017
VALID
/
Chemistry
Carbidopa
DIVI'S LABORATORIES LIMITED IN 500 032 Hyderabad
  R1-CEP 2005-057-Rev 04
11/01/2018
VALID
/
Chemistry
Carbidopa
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2001-352-Rev 05
19/02/2021
VALID
/
Chemistry


Producer:Zhejiang Wild Wind Pharmaceutical Co., Ltd., established in 1993, is subordinate to Wildwind  group. The production area of the company covers an area of more than 200 mu. At present, the main products include methyldopa, carbidopa, 1-hydroxybenzotriazole, etc. The company passed ISO9001 and ISO14001 system certification in 2004 and OHSAS18001 system certification in 2014. At present, three products have passed domestic GMP certification and obtained 2 cos certificates and 1 FDA certificate.

Staff size:300-399 persons

Registered capital:RMB 75 million 


Producer:Zhejiang Chiral Medicine Chemicals Co., Ltd.was established in 1998 and acquired by Zhejiang Yongtai Technology Co., Ltd. in 2016, becoming a wholly-owned subsidiary of Yongtai technology.

The company is located in Xiaoshan Nanyang Development Zone, covering an area of 15000 m2. It is a high-tech drug production enterprise approved and supported by the state, specializing in the research, development, production, operation and sales of biological API. At present, the company has more than 300 employees, of which middle and senior professional technicians and managers account for 25%. The company has unique advantages and capabilities in the development of new products and the transformation of scientific research achievements into industrial production. At the same time, it has high-quality and high-level market sales personnel, and has established a one-stop system of research and development, production, market research and product sales. At the same time, the company has two U.S. patents and seven invention patents. The APIs (gabapentin, carbidopa and etodolic acid) produced by the company have passed the certification of FDA of the United States, Australian officials and KFDA of South Korea, and have EU CEP certificate and Chinese GMP certificate. The API (gabapentin) produced by the company has become one of the main suppliers in the global market.

Staff size:200-299 persons

Registered capital:RMB 20.348152 million


Producer:Guilin Auspicious Pharmaceutical Co., Ltd., established in 2002, is a joint venture between Hong Kong Bandung Technology Co., Ltd. and Guilin Pharmaceutical Co., Ltd,.

The plant covers an area of about 4500 square meters and a construction area of 3533.82 square meters, which is suitable for the production scale. The building area of oral solid preparation workshop is 980 square meters, and the warehouse area of oral solid preparation workshop is 150 square meters. The building area of sterile API workshop is 840 square meters, the building area of powder injection workshop is 840 square meters, the quality inspection center is 323.82 square meters, and the warehouse area is 400 square meters.

The company passed the national GMP certification for tablets and capsules in 2004, API (cephalosporin) passed the national GMP certification in 2006 and powder injection passed the national GMP certification in 2007. The annual production capacity of existing drugs is: 100 million tablets, 30 million capsules, 30 million bottles of powder injection and 5 tons of sterile API.

Staff size:100-199 persons

Registered capital:RMB 6 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978