Gemfibrozil
CAS number： 25812-30-0
Molecular formula： C15H22O3
molecular weight： 250.3334
Chemical structure：
Producers shown on SFDA
(Record date:02/09/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Zhejiang Excel Pharmaceutical Co., Ltd. | GMP, DMF | Valid till August 2020 |
Zhongfu Pharmaceutical Co., Ltd. | GMP | Valid till January 2019 |
Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd. | GMP | Valid till June 2019 |
Producers shown on EP
(Quoted from EP website；record date:02/09/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Gemfibrozil | Recordati S.p.A. IT 20148 Milano | R0-CEP 2009-189-Rev 00 | 15/09/2010 | EXPIRED | 17/09/2015 | Chemistry |
| Gemfibrozil | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2006-210-Rev 04 | 16/10/2020 | VALID | / | Chemistry |
| Gemfibrozil | ZHEJIANG EXCEL PHARMACEUTICAL CO., LTD. CN 318 020 Taizhou | R1-CEP 2008-118-Rev 00 | 22/01/2016 | VALID | / | Chemistry |
| Gemfibrozil | HIKAL LIMITED IN 560 105 Bangalore | R1-CEP 2007-089-Rev 04 | 05/04/2018 | VALID | / | Chemistry |
| Gemfibrozil | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2006-221-Rev 04 | 09/01/2020 | VALID | / | Chemistry |
Producer:Zhejiang Excel Pharmaceutical Co., Ltd. was established in 2000, The company is mainly engaged in the production of pharmaceutical APIs and key intermediates. The product quality meets the requirements of USP, BP, EP and JP Pharmacopoeia. Intermediates are mainly high-end chemicals customized by customers.
The company has established a perfect GMP quality management system and a number of standardized GMP production workshops. In 2005, the company passed the national CFDA certification and obtained the GMP certificate; In 2009, 2013 and 2016, it passed the on-site inspection of FDA with zero defects; Obtained the EU cos Certificate in 2011 and 2016; Obtained ISO9001 certificate in 2016.
Registered capital:RMB 25.8 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.
Staff size:200-299 persons
Registered capital:RMB 78.364 million
Producer:Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd. was restructured and established by the former Zhuzhou Xiangjiang pharmaceutical factory in 1998. It is a holding subsidiary of the listed company "Qianjin pharmaceutical".
It is mainly engaged in the production and sales of chemical synthetic drugs and preparation products, including bulk drugs, tablets, capsules, granules, powders, pills and other dosage forms, all of which have passed the national GMP certification. The company's main products include 19 varieties such as lamivudine tablets, valsartan capsules and enalapril maleate tablets. At present, the company has 13 invention patents, 10 utility model patents, 28 design patents, 43 registered trademarks and more than 50 drug production approvals.
Registered capital:RMB 48 million
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