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Amantadine Hydrochloride

CAS number: 665-66-7

Molecular formula: C10H18ClN

molecular weight: 187.71

Chemical structure:

Producers shown on SFDA

(Record date:09/10/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Deyer Pharmaceutical Co., Ltd.

GMP
Valid till August 2021

Tonghua Maoxiang Pharmaceutical Co., Ltd.

GMP
Valid till October 2019

Northeast Pharmaceutical Group Co., Ltd.

GMP
Valid till February 2020
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
GMP
Valid till April 2024

Tianjin Minxiang Pharmaceutical Co., Ltd.

GMP
Valid till October 2023


Producers shown on EP

(Quoted from EP website;record date:09/10/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Amantadine hydrochloride
JSC OLAINFARM LV LV-2114 Olaine
  R0-CEP 2017-284-Rev 00
28/03/2019
VALID
/Chemistry
Amantadine hydrochloride
Moehs Iberica S.L. ES 08191 Rubi
  R1-CEP 2000-014-Rev 06
07/05/2019
VALID
/Chemistry

Producer:Zhejiang Deyer Pharmaceutical Co., Ltd. was founded in 1962. From 2015 to 2016, it invested about 70 million yuan in technical transformation, built 9 modern preparation and API production lines that meet the current GMP requirements, and formed 1.2 billion tablets / year, 1.2 billion capsules / year, 800 tons / year of oral liquid (including syrup, oral solution and oral suspension), 25 million external preparations / year The production capacity of API is 300 tons / year. All dosage forms such as powder injection, capsule and solution and API workshops have obtained GMP certificates, and the production of pharmaceutical intermediate taurine has obtained ISO9000 certification.

Staff size:100-199 persons

Registered capital:RMB 10 million



Producer:Tonghua Maoxiang Pharmaceutical Co., Ltd. was founded in 1992 and is now a subsidiary of China Maoxiang group. The group has many pharmaceutical production lines such as antibiotic powder for injection, solid preparations and liquid preparations designed according to the national GMP standard, which can produce chemical synthetic API, capsule (including sustained-release and controlled-release preparations), tablet (including sustained-release and controlled-release agents), granule, powder injection There are 13 dosage forms including water injection, soft capsule, dropping pill, oral liquid, syrup, ointment, suppository and honey pill, with 289 varieties.


Staff size:100-199 persons


Registered capital:RMB 50 million



Producer:Northeast Pharmaceutical Group Co., Ltd. is a listed company of Liaoning Fangda Group Industry Co., Ltd. The company, formerly known as Northeast Pharmaceutical General Factory, was founded in 1946.

The preparation production base covers an area of 180000 square meters, with more than 30 production lines and an annual production capacity of 10 billion tablets (sticks, pills, granules, pieces and bottles). The API production base covers an area of 910000 square meters. It is a national intelligent manufacturing demonstration factory for bulk APIs and pharmaceutical intermediates.

The product quality complies with the latest quality standards such as GMP, EP, USP, JP, BP and CP. Many products have passed international high-end certification such as EDQM, FDA, Japan's Ministry of health and welfare, BRC, halal, kosher, etc. The leading products have passed the registration and quality audit in the United States, Europe, Japan, Brazil, Russia, Poland and other countries and regions.

Staff size:About 8000 persons

Registered capital:RMB 1 billion 348 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:Tianjin Minxiang biomedical Co., Ltd. was established in 2005. Its products include pharmaceutical APIs, advanced intermediates, cdmo (customized R & D and production of pharmaceutical contracts) and hemodialysis consumables.

The company has passed ISO 9001:2015 quality management system certification, ISO 14001:2015 environmental management system certification, ISO 45001:2018 occupational health and safety management system certification, ISO 13485:2016 medical device quality management system certification, CE certification and GMP certification.

Staff size:200-299 persons


Registered capital:RMB 185 million


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