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