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Pseudoephedrine Hydrochloride

CAS number: 345-78-8

Molecular formula: C10H16ClNO

molecular weight: 201.69

Chemical structure:

Producers shown on SFDA

(Record date:15/10/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Sinopharm Group Xinjiang Pharmaceutical Co., Ltd.

GMP
Valid till February 2019

Qinghai Lake Pharmaceutical Co., Ltd.

GMP
Valid till April 2019

Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

GMP
Valid till April 2024

Chifeng Aike Pharmaceutical Technology Co., Ltd.

GMP
Valid till December 2020


Producers shown on EP

(Quoted from EP website;record date:15/10/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Pseudoephedrine hydrochloride
Krebs Biochemicals & Industries Limited Hyderabad IN
  R0-CEP 2002-145 - Rev 01
18/11/2004
Withdrawn by Holder
21/07/2008
Chemical
Pseudoephedrine hydrochloride
Xinjiang Heshuo Ephedrine Product Co., Ltd Urumqi CN
  R0-CEP 2004-153 - Rev 00
16/12/2005
Withdrawn by EDQM Failure to CEP procedure
07/03/2011
Chemical
Pseudoephedrine hydrochloride
Novus Fine Chemicals, LLC. Carlstadt US
  R1-CEP 2001-256 - Rev 01
20/06/2008
Valid
/Chemical
Pseudoephedrine hydrochloride
EMBIO LIMITED Powai, Mumbai IN
   R1-CEP 1999-143 - Rev 02
05/10/2009
Valid
/Chemical
Pseudoephedrine hydrochloride
ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO., LTD. Hengdian CN
  R1-CEP 2005-129 - Rev 00
06/06/2012
Valid
/Chemical
Pseudoephedrine hydrochloride
Cheng Fong Chemical Co., Ltd. Dayuan Township TW
  R1-CEP 2003-184 - Rev 01
07/11/2012
Valid
/Chemical
Pseudoephedrine hydrochloride
SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH Minden DE
  R1-CEP 1998-009 - Rev 03
15/12/2015
Valid
/Chemical
Pseudoephedrine hydrochloride
AVON LIFESCIENCES LIMITED Solapur IN
  R1-CEP 2002-038 - Rev 02
28/01/2016
Withdrawn by Holder
27/02/2018
Chemical
Pseudoephedrine hydrochloride
CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO., LTD. Chifeng CN
  R1-CEP 2002-217 - Rev 03
24/08/2017
Valid
/Chemical
Pseudoephedrine hydrochloride
MALLADI DRUGS & PHARMACEUTICALS LIMITED, UNIT-3 Ranipet IN
  R1-CEP 2002-127 - Rev 04
13/09/2021
Valid
/Chemical

Producer:Sinopharm Group Xinjiang Pharmaceutical Co., Ltd., established in 1958, has two preparation workshops and two comprehensive extraction workshops meeting GMP standards. It mainly produces 292 varieties and specifications of preparations and APIs in 13 dosage forms, such as large volume injection preparations, small volume injection preparations, tablets, capsules, granules, pills, oral liquids, syrups, mixtures and decoctions.

Staff size:300-399 persons

Registered capital:RMB 90.964 million


Producer:Qinghai Lake Pharmaceutical Co., Ltd., established in 1987, is a professional licorice product manufacturer certified by GMP of the State Food and Drug Administration and CEP of the European food and drug administration. It covers an area of 43558 ㎡ and a building area of 5200 ㎡. At present, the company has set up four factories in Qinghai, Xinjiang, Afghanistan and Uzbekistan. It has an annual production capacity of 50 tons of ephedrine, 300 tons of Ephedra powder, 300 tons of licorice powder and 300 tons of Astragalus powder, as well as other Chinese herbal medicine extraction equipment, and has relatively perfect testing equipment and testing capacity.

Staff size:/

Registered capital:RMB 168.98 million 


Producer:Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. is subordinate to Apeloa Pharmaceutical Co., Ltd. Apeloa Pharmaceutical Co., Ltd. is a state-level key high-tech enterprise and key enterprise in pharmaceutical industry in Zhejiang Province  .The company is engaged in the research and development, production and sales of pharmaceutical products. The main business is in crude drug (API), contract R & D, production service (CDMO) and preparation (FDF) business. 

 In order to improve market competition, our company build core competitiveness continuesly in quality, EHS and technology . Five of the API plants were certified by GMP, four by FDA, three by PMDA, three by CE in EU, one by WHO, one by KFDA, one by Germany GMP, and all of preparation factory were certified by GMP. In addition to the safety and occupational health management system certification, API plants continue to be audited by EHS audits from international pharmaceutical companies or third parties.

Staff size:1000-1999 persons

Registered capital:RMB 83.75 million


Producer:Chifeng Aike Pharmaceutical Technology Co., Ltd. (hereinafter referred to as our company), established in March 2000, is a manufacturer of various APIs and chemical intermediates, a ephedrine manufacturer designated by the State Food and drug administration, and a national high-tech enterprise. At present, it is a member enterprise of Shanghai Pharmaceutical Group Co., Ltd.

The company's products are exported at home and abroad, and its export business covers Europe, Asia, America and other places. The domestic business covers all provinces except Tibet, and the domestic market share of the products is nearly 50%. The company has successively passed the quality audit of international famous pharmaceutical enterprises such as Sino US Stryker, Wyeth Baigong pharmaceutical, Shanghai Squibb and Shanghai Johnson & Johnson pharmaceutical, and has become their stable supplier.

Staff size:200-299 persons

Registered capital:RMB 40.9 million


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