Enalapril Maleate

CAS number： 76095-16-4

Molecular formula： C24H32N2O9

molecular weight： 492.52

Chemical structure：

Producers shown on SFDA

(Record date:02/09/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Zhejiang Changming Pharmaceutical Co., Ltd.	GMP, DMF	Valid till February 2024
Zhejiang Huahai Pharmaceutical Co., Ltd.	GMP, DMF	Valid till October 2021
Shanghai Xiandai Hasen(Shangqiu) Pharmaceutical Co., Ltd.	GMP	Valid till January 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
Enalapril maleate	Wockhardt Limited IN 393 002 Ankleshwar	R0-CEP 2001-062-Rev 00	17/01/2005	EXPIRED	17/01/2010	Chemistry
Enalapril maleate	DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad	R1-CEP 2002-076-Rev 05	28/08/2018	VALID	/	Chemistry
Enalapril maleate	Ranbaxy Laboratories Limited IN 122 015 Gurgaon	R1-CEP 2000-084-Rev 01	14/03/2008	WITHDRAWN BY HOLDER	23/07/2010	Chemistry
Enalapril maleate	EXCELLA GMBH DE 90537 Feucht	R0-CEP 2002-179-Rev 01	13/06/2008	EXPIRED	28/01/2010	Chemistry
Enalapril maleate	ESTEVE QUIMICA S.A. ES 08038 Barcelona	R1-CEP 2000-258-Rev 04	28/10/2020	VALID	/	Chemistry
Enalapril maleate	GEDEON RICHTER PLC HU 1103 Budapest	R1-CEP 2001-408-Rev 03	25/11/2010	WITHDRAWN BY HOLDER	31/07/2013	Chemistry
Enalapril maleate	GULF OIL Corporation Limited IN 500 018 Hyderabad	R0-CEP 2005-206-Rev 00	01/08/2007	WITHDRAWN BY EDQM	13/10/2010	Chemistry
Enalapril maleate	Farmhispania, S.A. ES 08160 Montmeló	R1-CEP 2006-104-Rev 01	14/03/2013	VALID	/	Chemistry
Enalapril maleate	ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. CN 317 200 Tiantai	R1-CEP 2009-367-Rev 01	27/05/2016	VALID	/	Chemistry
Enalapril maleate	KRKA d.d. SI 8501 Novo Mesto	R1-CEP 2000-212-Rev 02	10/09/2010	VALID	/	Chemistry
Enalapril maleate	Inke, S.A. ES 08755 Castellbisbal	R1-CEP 2000-070-Rev 04	21/02/2019	VALID	/	Chemistry
Enalapril maleate	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai	R1-CEP 2000-053-Rev 05	17/12/2019	VALID	/	Chemistry
Enalapril maleate	SRI KRISHNA PHARMACEUTICALS LIMITED IN 500 039 Hyderabad	R1-CEP 2001-308-Rev 05	02/10/2020	VALID	/	Chemistry
Enalapril maleate	Neuland Laboratories Limited IN 500 034 Hyderabad	R1-CEP 2003-078-Rev 11	04/09/2020	VALID	/	Chemistry

Producer:Zhejiang Changming Pharmaceutical 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.

Staff size:200-299 persons

Registered capital:RMB 50 million

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:Shanghai Xiandai Hasen(Shangqiu) Pharmaceutical Co., Ltd.is a holding company invested and established by the listed company Shanghai Hyundai Pharmaceutical Co., Ltd. (stock code 600420). The major shareholder is China Pharmaceutical Group Corporation. It is a pharmaceutical enterprise built in strict accordance with the modern enterprise system and the requirements of national GMP. It is a diversified enterprise integrating drug R & D, production and sales Modern national essential drug production base. The company covers an area of more than 500 mu, has a registered capital of 83.29 million yuan, a total asset of more than 600 million yuan, and has more than 1600 employees, including more than 800 professional and technical personnel; The company has obtained 163 drug production approval products, and has GMP production lines for small volume injections, oral solid preparations (tablets, capsules, granules), APIs and other dosage forms. The annual production capacity of small volume injections is 4 billion tubes, 6 billion tablets (granules and bags) of oral solid preparations and 1200 tons of API.

Staff size:1000-1999 persons

Registered capital:RMB 83.29 million

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