01 1Nippon Rika Pharmaceuticals Co., Ltd.
01 1Outsiders regulations hydrochloric acid L- methyl-cysteine
01 1Japan
Extra-official regulation L-methylcysteine hydrochloride
Registration Number : 217MF10063
Registrant's Address : 2-2 Nihonbashi Honcho 4-chome, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2006-09-22
A S-Methyl-L-Cysteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of S-Methyl-L-Cysteine, including repackagers and relabelers. The FDA regulates S-Methyl-L-Cysteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. S-Methyl-L-Cysteine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A S-Methyl-L-Cysteine supplier is an individual or a company that provides S-Methyl-L-Cysteine active pharmaceutical ingredient (API) or S-Methyl-L-Cysteine finished formulations upon request. The S-Methyl-L-Cysteine suppliers may include S-Methyl-L-Cysteine API manufacturers, exporters, distributors and traders.
click here to find a list of S-Methyl-L-Cysteine 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 S-Methyl-L-Cysteine Drug Master File in Japan (S-Methyl-L-Cysteine JDMF) empowers S-Methyl-L-Cysteine 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 S-Methyl-L-Cysteine JDMF during the approval evaluation for pharmaceutical products. At the time of S-Methyl-L-Cysteine 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 S-Methyl-L-Cysteine suppliers with JDMF on PharmaCompass.
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