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 Cysteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cysteine, including repackagers and relabelers. The FDA regulates Cysteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Cysteine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cysteine supplier is an individual or a company that provides Cysteine active pharmaceutical ingredient (API) or Cysteine finished formulations upon request. The Cysteine suppliers may include Cysteine API manufacturers, exporters, distributors and traders.
click here to find a list of Cysteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cysteine CEP of the European Pharmacopoeia monograph is often referred to as a Cysteine Certificate of Suitability (COS). The purpose of a Cysteine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cysteine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cysteine to their clients by showing that a Cysteine CEP has been issued for it. The manufacturer submits a Cysteine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cysteine CEP holder for the record. Additionally, the data presented in the Cysteine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cysteine DMF.
A Cysteine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 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 Cysteine suppliers with CEP (COS) on PharmaCompass.
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