Gabapentin

CAS number： 60142-96-3

Molecular formula： C9H17NO2

molecular weight： 171.237

Chemical structure：

Producers shown on SFDA

(Record date:30/08/2021）

Produce	Documents	GMP Valid till(based on SFDA)
Zhejiang Chiral Medicine Chemicals Co., Ltd.	GMP	Valid till August 2024
Jiangsu Nhwa Pharmaceutical Co., Ltd.	GMP	Valid till October 2020
Jiangsu Hengrui Pharmaceutical Co., Ltd.	GMP	Valid till January 2020

Producers shown on EP

(Quoted from EP website；record date:30/08/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Gabapentin	MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad	R1-CEP 2011-185-Rev 01	20/10/2017	VALID	/	Chemistry
Gabapentin Butanol process	TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva	R1-CEP 2013-327-Rev 01	28/04/2021	VALID	/	Chemistry
Gabapentin	SARACA LABORATORIES LIMITED IN 502 319 Gaddapotharam Village	R0-CEP 2016-092-Rev 02	04/01/2019	VALID	/	Chemistry
Gabapentin	AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad	R1-CEP 2012-009-Rev 01	06/05/2021	VALID	/	Chemistry
Gabapentin	SOLARA ACTIVE PHARMA SCIENCES LIMITED IN 600 032 Chennai	R1-CEP 2011-154-Rev 01	08/08/2018	VALID	/	Chemistry
Gabapentin Process II	HIKAL LIMITED IN 560 105 Bangalore	R1-CEP 2013-055-Rev 01	24/03/2020	VALID	/	Chemistry
Gabapentin	F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. IT 36075 Montecchio Maggiore	R1-CEP 2013-173-Rev 00	27/08/2019	VALID	/	Chemistry
Gabapentin	Jiangxi Synergy Pharmaceutical Co., Ltd. CN 330 700 Fengxin	R1-CEP 2011-264-Rev 00	25/10/2017	VALID	/	Chemistry
Gabapentin	DIVI'S LABORATORIES LIMITED IN 500 032 Hyderabad	R1-CEP 2013-208-Rev 00	31/10/2019	VALID	/	Chemistry
Gabapentin	Erregierre S.p.A. IT 24060 San Paolo D'Argon	R1-CEP 2012-210-Rev 00	27/09/2018	VALID	/	Chemistry
Gabapentin	Medichem, S.A. ES 08970 Sant Joan Despí	R1-CEP 2011-225-Rev 00	04/07/2017	VALID	/	Chemistry
Gabapentin	TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva	R1-CEP 2011-167-Rev 01	17/04/2018	VALID	/	Chemistry
Gabapentin	HIKAL LIMITED IN 560 105 Bangalore	R1-CEP 2011-330-Rev 03	11/01/2021	VALID	/	Chemistry
Gabapentin	OLON S.P.A. IT 20053 Rodano	R1-CEP 2011-344-Rev 01	15/06/2021	VALID	/	Chemistry
Gabapentin Alternative process	DIVI'S LABORATORIES LIMITED IN 500 032 Hyderabad	R0-CEP 2019-200-Rev 00	29/06/2020	VALID	/	Chemistry
Gabapentin	Zhejiang Chiral Medicine Chemicals Co., Ltd. CN 311 227 Hangzhou	R1-CEP 2011-258-Rev 00	24/07/2017	VALID	/	Chemistry
Gabapentin	ANJAN DRUG PRIVATE LIMITED IN 600 029 Chennai	R1-CEP 2013-164-Rev 00	16/10/2020	VALID	/	Chemistry
Gabapentin Tributylamine route	AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad	R0-CEP 2017-256-Rev 00	26/01/2018	VALID	/	Chemistry
Gabapentin	GRANULES INDIA LIMITED IN 500 081 Hyderabad	R0-CEP 2019-167-Rev 00	16/07/2020	VALID	/	Chemistry
Gabapentin	HETERO DRUGS LIMITED IN 500 018 Hyderabad	R1-CEP 2013-167-Rev 00	12/12/2019	VALID	/	Chemistry
Gabapentin Process II	Jiangxi Synergy Pharmaceutical Co., Ltd. CN 330 700 Fengxin	R0-CEP 2019-343-Rev 00	15/05/2020	VALID	/	Chemistry

Producer:Zhejiang Chiral Medicine Chemicals Co., Ltd.was established in 1998 and acquired by Zhejiang Yongtai Technology Co., Ltd. in 2016, becoming a wholly-owned subsidiary of Yongtai technology.

The company is located in Xiaoshan Nanyang Development Zone, covering an area of 15000 m2. It is a high-tech drug production enterprise approved and supported by the state, specializing in the research, development, production, operation and sales of biological API. At present, the company has more than 300 employees, of which middle and senior professional technicians and managers account for 25%. The company has unique advantages and capabilities in the development of new products and the transformation of scientific research achievements into industrial production. At the same time, it has high-quality and high-level market sales personnel, and has established a one-stop system of research and development, production, market research and product sales. At the same time, the company has two U.S. patents and seven invention patents. The APIs (gabapentin, carbidopa and etodolic acid) produced by the company have passed the certification of FDA of the United States, Australian officials and KFDA of South Korea, and have EU CEP certificate and Chinese GMP certificate. The API (gabapentin) produced by the company has become one of the main suppliers in the global market.

Staff size:200-299 persons

Registered capital:RMB 20.348152 million

Producer:Jiangsu Nhwa Pharmaceutical Co., Ltd. founded in 1978 and listed on Shenzhen Stock Exchange in 2008, is a pharmaceutical enterprise integrating science, industry and trade.

It has three large pharmaceutical GMP production bases for APIs and preparations, covering a total area of more than 900 mu. The enterprise has national certified workshops for APIs, solid preparations, water injections and lyophilized powder injections, and more than 10 automatic production lines for tablets, capsules, water injections and powder injections. At present, there are 39 kinds of APIs, 300 tons / year; More than 100 kinds of Western medicine preparations, 4 billion tablets (tablets) of solid preparations per year and 100 million injections per year.

According to the enterprise development strategy, we have made great efforts to save energy, reduce consumption and protect the environment, passed the international environmental certification (ISO14000), vigorously developed the export business of API, carried out EU edmf and FDA certification, and strive to gain a place in the international market.

Staff size:About 5000 persons

Registered capital:RMB 1 billion 8 million

Producer:Hengrui Pharma is a pharmaceutical company engaged in the development and commercialization of innovative and high-quality drugs.

The company has 28000 employees globally, fifth R & D centers were built around the globe and several subsidiaries were established in the US, EU, and Japan

The company has 10 manufacturing facilities and most of them maintain USP, EUP, and JP. We are the first Chinese company that exported injections on a large scale to the US, EU, and Japan markets. All dosage forms of the company have passed the national GMP certification, and ifosfamide, etoposide, mesilar and tiotepa have passed the verification of FDA.

Staff size:About 30000 persons

Registered capital:RMB 6 billion 397 million

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