01 2Nippon Protein Co., Ltd.
02 1Nippon Rika Pharmaceuticals Co., Ltd.
03 1Taenaka Mining Co., Ltd.
01 1Japanese Pharmacopoeia L- cysteine hydrochloride hydrate "production-only"
02 1Japanese Pharmacopoeia L- cysteine hydrochloride hydrate (production only)
03 1Japanese Pharmacopoeia L- ethyl cysteine hydrochloride
04 1L- cysteine hydrochloride (monohydrate) (day professional)
01 4Japan
Japanese Pharmacopoeia L-Ethylcysteine Hydrochloride
Registration Number : 219MF10005
Registrant's Address : 4-2-2 Nihonbashi Honcho, Chuo Ward, Tokyo
Initial Date of Registration : 2007-01-18
Latest Date of Registration : 2007-01-18
Japanese Pharmacopoeia L-Cysteine Hydrochloride Hydrate "For manufacturing purposes only"
Registration Number : 220MF10016
Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2008-01-09
Latest Date of Registration : 2008-01-09
L-Cysteine hydrochloride (monohydrate) (Nippon Pro)
Registration Number : 217MF10553
Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2007-08-07
Japanese Pharmacopoeia L-Cysteine Hydrochloride Hydrate (For manufacturing only)
Registration Number : 220MF10229
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2008-11-17
Latest Date of Registration : 2008-11-17
A L-Cysteine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Cysteine Hydrochloride, including repackagers and relabelers. The FDA regulates L-Cysteine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Cysteine 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.
click here to find a list of L-Cysteine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Cysteine Hydrochloride supplier is an individual or a company that provides L-Cysteine Hydrochloride active pharmaceutical ingredient (API) or L-Cysteine Hydrochloride finished formulations upon request. The L-Cysteine Hydrochloride suppliers may include L-Cysteine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L-Cysteine Hydrochloride 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 Hydrochloride Drug Master File in Japan (L-Cysteine Hydrochloride JDMF) empowers L-Cysteine 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 L-Cysteine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of L-Cysteine Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
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