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
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A adamantan-1-amine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of adamantan-1-amine hydrochloride, including repackagers and relabelers. The FDA regulates adamantan-1-amine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. adamantan-1-amine 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.
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A adamantan-1-amine hydrochloride supplier is an individual or a company that provides adamantan-1-amine hydrochloride active pharmaceutical ingredient (API) or adamantan-1-amine hydrochloride finished formulations upon request. The adamantan-1-amine hydrochloride suppliers may include adamantan-1-amine hydrochloride API manufacturers, exporters, distributors and traders.
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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 adamantan-1-amine hydrochloride Drug Master File in Japan (adamantan-1-amine hydrochloride JDMF) empowers adamantan-1-amine 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 adamantan-1-amine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of adamantan-1-amine hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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