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
Tel: Cell/WhatsApp/WeChat: +86 18402846978
Email: paulzhang@yinuopharmchem.com
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