01 1Nippon Protein Co., Ltd. Ashikaga-shi JP
01 1Cysteine Hydrochloride Monohydrate
01 1Japan
01 1Valid
Cysteine Hydrochloride Monohydrate
Certificate Number : R1-CEP 2003-159 - Rev 03
Status : Valid
Issue Date : 2014-08-05
Type : Chemical
Substance Number : 895
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.
A L-Cysteine CEP of the European Pharmacopoeia monograph is often referred to as a L-Cysteine Certificate of Suitability (COS). The purpose of a L-Cysteine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Cysteine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Cysteine to their clients by showing that a L-Cysteine CEP has been issued for it. The manufacturer submits a L-Cysteine CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Cysteine CEP holder for the record. Additionally, the data presented in the L-Cysteine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Cysteine DMF.
A L-Cysteine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Cysteine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of L-Cysteine suppliers with CEP (COS) on PharmaCompass.
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