01 1Zhejiang Apeloa Kangyu Pharmaceutical Co. , Ltd.
01 1Amantadine hydrochloride
01 1China
Registration Number : 223MF10070
Registrant's Address : 333, Jiangnan Road, Hengdian, Dongyang, Zhejiang, 322118, China.
Initial Date of Registration : 2011-05-27
Latest Date of Registration : 2011-05-27
A Amantadine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amantadine Hydrochloride, including repackagers and relabelers. The FDA regulates Amantadine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amantadine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Amantadine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amantadine Hydrochloride supplier is an individual or a company that provides Amantadine Hydrochloride active pharmaceutical ingredient (API) or Amantadine Hydrochloride finished formulations upon request. The Amantadine Hydrochloride suppliers may include Amantadine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Amantadine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Amantadine Hydrochloride Drug Master File in Japan (Amantadine Hydrochloride JDMF) empowers Amantadine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Amantadine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Amantadine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Amantadine Hydrochloride suppliers with JDMF on PharmaCompass.
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