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Paroxetine HCl, hemihydrate

CAS number: 110429-35-1

Molecular formula: C19H21ClFNO3

molecular weight: 365.82600

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 hemihydrate
GEDEON RICHTER PLC HU 1103 Budapest
  R1-CEP 2003-250-Rev 01
14/10/2010
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


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