Dextromethorphan Hydrobromide

CAS number： 125-69-9

Molecular formula： C18H26BrNO

molecular weight： 352.309

Chemical structure：

Producers shown on SFDA

(Record date:11/10/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Chifeng Aike Pharmaceutical Technology Co., Ltd.	GMP	Valid till December 2020
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.	GMP	Valid till August 2024

Producers shown on EP

(Quoted from EP website；record date:11/10/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Dextromethorphan hydrobromide	DSM Nutritional Products Ltd. Kaiseraugst CH	R2-CEP 1995-041 - Rev 02	04/05/2010	Withdrawn by Holder	03/04/2019	Chemical
Dextromethorphan hydrobromide	ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO., LTD. Hengdian CN	R0-CEP 2014-094 - Rev 01	18/05/2016	Withdrawn by Holder	06/11/2020	Chemical
Dextromethorphan hydrobromide	Wockhardt Limited Mumbai IN	R1-CEP 1998-053 - Rev 04	21/03/2017	Valid	/	Chemical
Dextromethorphan hydrobromide	DIVI'S LABORATORIES LIMITED Hyderabad IN	R1-CEP 1999-103 - Rev 06	20/07/2018	Valid	/	Chemical
Dextromethorphan hydrobromide	SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN	R0-CEP 2013-288 - Rev 01	08/08/2018	Valid	/	Chemical
Dextromethorphan hydrobromide	MALLADI DRUGS & PHARMACEUTICALS LIMITED Chennai IN	R0-CEP 2018-133 - Rev 00	27/02/2020	Valid	/	Chemical
Dextromethorphan hydrobromide	HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED Secunderabad IN	R1-CEP 2014-023 - Rev 00	23/07/2020	Valid	/	Chemical
Dextromethorphan hydrobromide	SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN	R0-CEP 2018-201 - Rev 00	17/03/2021	Valid	/	Chemical
Dextromethorphan hydrobromide	CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO., LTD. Chifeng CN	R0-CEP 2019-218 - Rev 00	30/04/2021	Valid	/	Chemical

Producer:Chifeng Aike Pharmaceutical Technology Co., Ltd. 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

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

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

Dextromethorphan Hydrobromide

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