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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amantadine, including repackagers and relabelers. The FDA regulates Amantadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amantadine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amantadine supplier is an individual or a company that provides Amantadine active pharmaceutical ingredient (API) or Amantadine finished formulations upon request. The Amantadine suppliers may include Amantadine API manufacturers, exporters, distributors and traders.
click here to find a list of Amantadine 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 Drug Master File in Japan (Amantadine JDMF) empowers Amantadine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Amantadine 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 suppliers with JDMF on PharmaCompass.
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