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.

Staff size:100-199 persons

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.

Staff size:1000-1999 persons

Registered capital:RMB 48 million

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