01 1Nippon Rikagaku Yakuhin Co., Ltd.
01 1Outsiders regulations malic acid cysteine
01 1Japan
Non-pharmacopoeia cysteine malate
Registration Number : 217MF10062
Registrant's Address : 4-2-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2007-01-10
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A Apple acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apple acid, including repackagers and relabelers. The FDA regulates Apple acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apple acid 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 Apple acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Apple acid supplier is an individual or a company that provides Apple acid active pharmaceutical ingredient (API) or Apple acid finished formulations upon request. The Apple acid suppliers may include Apple acid API manufacturers, exporters, distributors and traders.
click here to find a list of Apple acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Apple acid Drug Master File in Japan (Apple acid JDMF) empowers Apple acid 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 Apple acid JDMF during the approval evaluation for pharmaceutical products. At the time of Apple acid 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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