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. | GMP | Valid 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Carbidopa | Kraemer & Martin Pharma Handels GmbH DE 47804 Krefeld | R0-CEP 2006-066-Rev 00 | 21/06/2007 | WITHDRAWN BY HOLDER | 28/02/2008 | Chemistry |
Carbidopa | Smruthi Organics Limited IN 413 255 Solapur | R0-CEP 2006-138-Rev 01 | 26/11/2009 | WITHDRAWN BY EDQM | 13/12/2013 | Chemistry |
Carbidopa | EGIS Pharmaceuticals PLC HU 1106 Budapest | R1-CEP 1998-032-Rev 01 | 02/04/2009 | WITHDRAWN BY HOLDER | 07/01/2019 | Chemistry |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.
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