Lisinopril

CAS number： 76547-98-3

Molecular formula： C21H31N3O5

molecular weight： 405.49

Chemical structure：

Producers shown on SFDA

(Record date:02/09/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Zhongfu Pharmaceutical Co., Ltd.	GMP	Valid till October 2021
Zhejiang Huahai Pharmaceutical Co., Ltd.	GMP, DMF	Valid till October 2021

Producers shown on EP

(Quoted from EP website；record date:02/09/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Lisinopril dihydrate Process II	HETERO DRUGS LIMITED IN 500 018 Hyderabad	R0-CEP 2016-197-Rev 04	21/10/2020	VALID	/	Chemistry
Lisinopril dihydrate	GEDEON RICHTER PLC HU 1103 Budapest	R1-CEP 1999-051-Rev 03	23/03/2011	WITHDRAWN BY HOLDER	16/04/2015	Chemistry
Lisinopril dihydrate	Ranbaxy Laboratories Limited IN 122 015 Gurgaon	R1-CEP 2000-121-Rev 04	16/03/2011	WITHDRAWN BY HOLDER	24/03/2015	Chemistry
Lisinopril dihydrate	LEK PHARMACEUTICALS D.D. SI 1526 Ljubljana	R0-CEP 2006-065-Rev 00	12/08/2008	WITHDRAWN BY HOLDER	13/12/2012	Chemistry
Lisinopril dihydrate	MYLAN LABORATORIES LIMITED IN 502 325 Hyderabad	R1-CEP 2008-134-Rev 01	29/09/2014	WITHDRAWN BY HOLDER	18/02/2019	Chemistry
Lisinopril dihydrate	ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. CN 317 200 Tiantai	R1-CEP 2011-002-Rev 00	23/01/2017	VALID	/	Chemistry
Lisinopril dihydrate	AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad	R1-CEP 2003-211-Rev 04	13/12/2017	WITHDRAWN BY HOLDER	25/11/2019	Chemistry
Lisinopril dihydrate	EVONIK OPERATIONS GMBH DE 45128 Essen	R1-CEP 2004-011-Rev 07	09/12/2020	VALID	/	Chemistry
Lisinopril dihydrate	Farmhispania, S.A. ES 08160 Montmeló	R1-CEP 2005-249-Rev 02	02/04/2015	VALID	/	Chemistry
Lisinopril dihydrate	LUPIN LIMITED IN 400 055 Mumbai	R1-CEP 2001-311-Rev 04	27/09/2019	VALID	/	Chemistry
Lisinopril dihydrate	ESTEVE QUIMICA S.A. ES 08024 Barcelona	R1-CEP 1999-024-Rev 04	30/06/2015	WITHDRAWN BY HOLDER	12/09/2018	Chemistry
Lisinopril dihydrate	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai	R1-CEP 2003-064-Rev 04	04/12/2018	VALID	/	Chemistry
Lisinopril dihydrate	UNIMARK REMEDIES LIMITED IN 400 062 Mumbai	R1-CEP 2004-063-Rev 04	11/03/2020	VALID	/	Chemistry
Lisinopril dihydrate	HETERO DRUGS LIMITED IN 500 018 Hyderabad	R1-CEP 2012-370-Rev 00	21/02/2020	VALID	/	Chemistry
Lisinopril dihydrate	RICHTER THEMIS MEDICARE (I) PVT. LTD. IN 396 195 Vapi	R0-CEP 2018-223-Rev 00	14/05/2020	VALID	/	Chemistry

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: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

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