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Chlorphenamine Maleate

CAS number: 113-92-8

Molecular formula: C20H23ClN2O4

molecular weight: 390.86

Chemical structure:

Producers shown on SFDA

(Record date:29/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Shenyang Syndy Pharmaceutical Co., Ltd.

GMP 
Valid till October 2020

Shanghai Xiandai Hasen(Shangqiu) Pharmaceutical Co., Ltd.

GMP 
Valid till April 2022

Henan Jiushi Pharmaceutical Co., Ltd.

GMP 
Valid till April 2024

Producers shown on EP

(Quoted from EP website;record date:29/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Chlorphenamine maleate
Kongo Chemical Co., Ltd JP 930-0912 Toyama City
  R1-CEP 2006-151-Rev 01
17/03/2021
VALID
/Chemistry
Chlorphenamine maleate
SUPRIYA LIFESCIENCE LTD. IN 400 063 Mumbai
  R1-CEP 2008-154-Rev 01
01/04/2015
VALID
/Chemistry
Chlorphenamine maleate
Auro Laboratories Limited IN 400 030 Mumbai
  R0-CEP 2012-018-Rev 00
24/07/2015
VALID
/Chemistry

Producer:Shenyang Syndy Pharmaceutical Co., Ltd., founded in 2002, is mainly engaged in the production of chemical apis and pharmaceutical intermediates.

The main varieties produced are chlorpheniramine maleate, bromopheniramine maleate, chlorpheniramine dextromaleate DMF has been registered in Japan, and through THE J-GMP audit. Product quality conforms to CP2010 / BP2008 / USP32 / JP15 / EP6.0 standards.

Staff size:About 50 persons

Registered capital:RMB 7.9469 million


Producer:Shanghai Xiandai Hasen(Shangqiu) Pharmaceutical Co., Ltd.is a holding company invested and established by the listed company Shanghai Hyundai Pharmaceutical Co., Ltd. (stock code 600420). The major shareholder is China Pharmaceutical Group Corporation. It is a pharmaceutical enterprise built in strict accordance with the modern enterprise system and the requirements of national GMP. It is a diversified enterprise integrating drug R & D, production and sales Modern national essential drug production base. The company covers an area of more than 500 mu, has a registered capital of 83.29 million yuan, a total asset of more than 600 million yuan, and has more than 1600 employees, including more than 800 professional and technical personnel; The company has obtained 163 drug production approval products, and has GMP production lines for small volume injections, oral solid preparations (tablets, capsules, granules), APIs and other dosage forms. The annual production capacity of small volume injections is 4 billion tubes, 6 billion tablets (granules and bags) of oral solid preparations and 1200 tons of API.

Staff size:1000-1999 persons

Registered capital:RMB 83.29 million


Producer:Henan Jiushi Pharmaceutical Co., Ltd., founded in 1993, has developed into an area of 200000 square meters and fixed assets of nearly 100 million.

At present, it has five dosage forms: API, tablet, large infusion, capsule and granule. Among them, the API "chlorphenamine maleate" API accounts for more than 85% of the national market share. It is the largest manufacturer of Chlorphenamine API in China. The annual production capacity of the group company: 1 billion tablets, 50 million bottles of large infusion, 500 million capsules, 50 million bags of granules and 200 tons of API.

Staff size:About 50 prsons

Registered capital:RMB 48 million


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