01 1Nippon Protein Co., Ltd.
02 3Taenaka Mining Co., Ltd.
01 1Cysteine [F]
02 1Cysteine [etch]
03 1Japanese Pharmacopoeia L- cysteine
04 1Japanese Pharmacopoeia L- cysteine (production only)
01 4Japan
Japanese Pharmacopoeia L-Cysteine "For manufacturing purposes only"
Registration Number : 220MF10015
Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2008-01-09
Latest Date of Registration : 2008-01-09
Japanese Pharmacopoeia L-Cysteine (for manufacturing only)
Registration Number : 220MF10209
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2008-09-29
Latest Date of Registration : 2008-09-29
Registration Number : 217MF10280
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2005-06-20
Latest Date of Registration : 2006-05-18
Registration Number : 217MF10281
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2005-06-20
Latest Date of Registration : 2006-12-08
A L-Cysteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Cysteine, including repackagers and relabelers. The FDA regulates L-Cysteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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.
click here to find a list of L-Cysteine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Cysteine supplier is an individual or a company that provides L-Cysteine active pharmaceutical ingredient (API) or L-Cysteine finished formulations upon request. The L-Cysteine suppliers may include L-Cysteine API manufacturers, exporters, distributors and traders.
click here to find a list of 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 L-Cysteine Drug Master File in Japan (L-Cysteine JDMF) empowers 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 L-Cysteine JDMF during the approval evaluation for pharmaceutical products. At the time of 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 L-Cysteine suppliers with JDMF on PharmaCompass.
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