Captopril
CAS number： 62571-86-2
Molecular formula： C9H15NO3S
molecular weight： 217.28500
Chemical structure：
Producers shown on SFDA
(Record date:01/09/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Zhejiang Huahai Pharmaceutical Co., Ltd. | GMP, DMF | Valid till September 2024 |
Zhejiang Changming Pharmaceutical Co., Ltd. | GMP | Valid till December 2018 |
Chongqing Southwest No.2 Pharmaceutical Factory Co., Ltd. | GMP | Valid till February 2020 |
Changzhou Pharmaceutical Factory Co., Ltd. | GMP | Valid till November 2023 |
Zhongfu Pharmaceutical Co., Ltd. | GMP | Valid till March 2024 |
Taicang Pharmaceutical Factory | GMP | Valid till June 2019 |
Huazhong Pharmaceutical Co., Ltd. | GMP | Valid till February 2021 |
Producers shown on EP
(Quoted from EP website；record date:01/09/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Captopril | Farmhispania, S.A. ES 08160 Montmeló | R1-CEP 1997-018-Rev 06 | 01/03/2011 | VALID | / | Chemistry |
| Captopril | EGIS Pharmaceuticals PLC HU 1106 Budapest | R1-CEP 1997-101-Rev 04 | 19/12/2011 | WITHDRAWN BY HOLDER | 16/01/2019 | Chemistry |
| Captopril | ZHONGFU PHARMACEUTICAL CO., LTD. CN 261 100 Weifang City | R1-CEP 2003-113-Rev 02 | 07/10/2016 | VALID | / | Chemistry |
| Captopril | Wockhardt Limited IN 400 051 Mumbai | R1-CEP 1998-052-Rev 04 | 24/06/2014 | VALID | / | Chemistry |
| Captopril | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R1-CEP 1997-023-Rev 10 | 19/10/2020 | VALID | / | Chemistry |
Producer:Zhejiang Huahai Pharmaceutical Co., Ltd.was founded in 1989 and headquartered in Zhejiang, China. The company has nearly 7000 employees and more than 40 subsidiaries around the world (including China, the United States, Japan, Germany, etc.As a leading enterprise in the internationalization of Chinese medicine, Huahai pharmaceutical is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the Anda document number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States. It has established China's pharmaceutical quality image in the world's high-end pharmaceutical market.
Staff size:About 7000 persons
Registered capital:RMB 1 billion 492 million
Producer:Chongqing Southwest No.2 Pharmaceutical Factory Co., Ltd.has a registered capital of 50 million yuan, covers an area of more than 90 Mu and employs more than 250 people,
It has a modern workshop in line with GMP standards, and has passed the new domestic GMP certification, FDA review, EU official review, ISO9001 quality management system certification, ISO14001 environmental management system certification and OHSAS18000 occupational health and safety management system certification.
Producer:Chongqing Southwest NO.2 Pharmaceutical Factory Co., Ltd., formerly known as Chongqing Southwest Pharmaceutical second factory, is a modern comprehensive pharmaceutical enterprise integrating the production of chemical APIs, pharmaceutical and chemical intermediates and solid preparations. Founded in 1958, it has more than 50 years of experience in the development and production of APIs, preparations and pharmaceutical and chemical intermediates. In 2005, the enterprise successfully completed the construction of the "Three Gorges Reservoir area environmental treatment and relocation combined with enterprise technological progress project" approved by the national development and Reform Commission, and the production base was relocated to Jiangjin Degan Industrial Park in Chongqing. The new production base covers an area of 130000 square meters and has more than 300 employees.
The company has a GMP compliant API production workshop and solid preparation production workshop, mainly producing API and OEM pharmaceutical and chemical intermediates. The enterprise has the autonomy of foreign trade import and export, and has established trade exchanges with many countries and regions in the world.
Registered capital:RMB 100 million
Producer:Changzhou Pharmaceutical Factory Co., Ltd. is a state-owned core enterprise of Shanghai Pharmaceutical. It is a comprehensive pharmaceutical enterprise with equal emphasis on chemical raw materials and chemical preparations and all-round development of science, industry and trade.
The company produces more than 30 kinds of APIs and more than 150 varieties of needles, tablets and capsules throughout the year. In 2016, the company's rosuvastatin calcium tablets passed the on-site inspection of Anda in the United States. In November 2007, the company passed the EU GMP certification. It has become the second enterprise in Jiangsu and the seventh enterprise in China that has passed the EU GMP certification. In 2012, it passed the EU GMP certification again.
Registered capital:RMB 108 million
Producer:Zhongfu Pharmaceutical Co., Ltd. (formerly Shandong Weifang Pharmaceutical Factory Co., Ltd.), founded in 1966 and restructured in 2000, now covers an area of about 100 mu.
The company produces five series of products with 74 varieties and 120 specifications throughout the year. The main production capacity is 300 million small volume injections, 200 million sterile powder injections, 1 billion tablets, 500 million capsules and 350 tons of API. At present, all the production workshops have passed the GMP certification of the State Food and drug administration, of which captopril API has passed the FDA certification of the United States and obtained the cos certificate of EU EDQM.
Registered capital:RMB 78.364 million
Producer:Taicang pharmaceutical factory was founded in 1958. The new factory covers an area of 46690 square meters, a construction area of 25300 square meters, and the existing fixed assets are 43 million yuan. The new factory has built seven sets of GMP standard API fine drying car rooms according to the requirements of the national GMP specification, each with an annual production capacity of more than 100 tons, and has built a tablet workshop with an annual output of 450 million tablets required by the GMP specification, The factory passed GMP standard acceptance in May 2004 and GMP certificate renewal acceptance in April 2009.
Registered capital:RMB 500 thousand
Producer:Huazhong Pharmaceutical Co., Ltd. is subordinate to China Ordnance Equipment Group Corporation. It is located in Xiangyang City, an important town in Northwest Hubei Province with beautiful scenery and rich resources. It covers an area of 700000 square meters. It is a modern comprehensive pharmaceutical enterprise integrating R & D, production and sales of pharmaceutical products. The company has strong technical force, complete quality testing equipment and quality assurance system, advanced production technology and equipment, and has passed GMP, fami-qs, HACCP, ISO9001, ISO22000, kosher, halal and other certifications.
Subsidiaries of Huazhong Pharmaceutical Co., Ltd.: Hubei 295 Technology Co., Ltd. and Xiangfan 295 Pharmaceutical Trading Co., Ltd. We are the earliest manufacturer of vitamin B1 raw materials in China and the largest in the world. The product quality meets the quality standards of CP, BP, USP, EP and JP. At the same time, we have also developed VB1 Granule Series and VB1 derivative series products.
Staff size:600-699 persons
Registered capital:RMB 245 million 148 thousand and 515
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