Paroxetine HCl, anhydrous
CAS number： 78246-49-8
Molecular formula： C19H20NO3F·HCl
molecular weight： 374.84
Chemical structure：
Producers shown on SFDA
(Record date:07/09/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Zhejiang Huahai Pharmaceutical Co., Ltd. | GMP, DMF | Valid till June 2023 |
Beijing Wansheng Pharmaceutical Co., Ltd. | GMP | Valid till September 2022 |
Zhejiang Jianfeng Pharmaceutical Co., Ltd. | GMP | Valid till September 2020 |
Producers shown on EP
(Quoted from EP website；record date:07/09/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Paroxetine hydrochloride | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R1-CEP 2006-002-Rev 01 | 06/01/2014 | VALID | / | Chemistry |
| Paroxetine hydrochloride | AESICA PHARMACEUTICALS LIMITED GB NE23 3JL Cramlington | R1-CEP 2006-096-Rev 00 | 11/10/2012 | VALID | / | Chemistry |
| Paroxetine hydrochloride | GEDEON RICHTER PLC HU 1103 Budapest | R1-CEP 2003-250-Rev 01 | 14/10/2010 | VALID | / | Chemistry |
| Paroxetine hydrochloride | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2009-155-Rev 03 | 31/08/2021 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | CADILA HEALTHCARE LIMITED IN 391 440 Dabhasa Village | R1-CEP 2004-239-Rev 05 | 12/01/2021 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R1-CEP 2006-192-Rev 01 | 27/06/2017 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | JUBILANT GENERICS LIMITED IN 571 302 Nanjangud | R1-CEP 2009-204-Rev 01 | 26/07/2016 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2009-154-Rev 02 | 31/08/2021 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | IPCA Laboratories Limited IN 400 067 Mumbai | R1-CEP 2014-095-Rev 00 | 11/01/2021 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | Wanbury Limited IN 400 703 Vashi, Navi Mumbai | R1-CEP 2012-376-Rev 00 | 08/03/2019 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | Medichem, S.A. ES 08970 Sant Joan Despí | R1-CEP 2011-200-Rev 00 | 05/03/2018 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | AESICA PHARMACEUTICALS LIMITED GB NE23 3JL Cramlington | R1-CEP 2006-081-Rev 00 | 17/10/2012 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2006-206-Rev 02 | 13/12/2017 | VALID | / | Chemistry |
| Paroxetine hydrochloride hemihydrate | Zhejiang Jiuzhou Pharmaceutical Co., Ltd. CN 318 000 Taizhou City | R0-CEP 2012-298-Rev 01 | 15/09/2015 | EXPIRED | 06/01/2019 | Chemistry |
| Paroxetine hydrochloride hemihydrate | CHEMI S.P.A. IT 03010 Patrica | R1-CEP 2011-188-Rev 02 | 19/06/2020 | VALID | / | Chemistry |
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:Beijing Wansheng Pharmaceutical Co., Ltd. is a holding subsidiary of NHU holding Investment Group Co., Ltd. and has been renamed Beijing Fuyuan Pharmaceutical Co., Ltd.
Covering an area of 27000 square meters, the company has established a production base of API, tablet and capsule that meets the requirements of GMP, with an annual production capacity of 600 million tablets, 100 million capsules and 30 tons of API.
Staff size:About 1000 persons
Registered capital:RMB 360 million
Producer:Zhejiang Jianfeng Pharmaceutical Co., Ltd., established in 1998, is a wholly-owned subsidiary of the listed company Zhejiang Jianfeng Group Co., Ltd. The key varieties of the company include: Amlodipine aspartate tablets, aceclofenac sustained-release tablets, paroxetine hydrochloride tablets, cefotaxime hydrochloride for injection, Yufengningxin dropping pills, penciclovir for injection, sodium hyaluronate eye drops, etc.
Staff size:400-499 persons
Registered capital:RMB 298.53 million
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