01 2KYOWA HAKKO BIO CO., LTD. Tokyo JP
01 2Glutathione
01 2Japan
01 1Valid
02 1Withdrawn by Holder
Certificate Number : R0-CEP 2020-328 - Rev 00
Status : Valid
Issue Date : 2023-01-13
Type : Chemical
Substance Number : 1670
Certificate Number : R0-CEP 2014-174 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-06-09
Type : Chemical
Substance Number : 1670
A Glutathione manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glutathione, including repackagers and relabelers. The FDA regulates Glutathione manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glutathione 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 Glutathione manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glutathione supplier is an individual or a company that provides Glutathione active pharmaceutical ingredient (API) or Glutathione finished formulations upon request. The Glutathione suppliers may include Glutathione API manufacturers, exporters, distributors and traders.
click here to find a list of Glutathione suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glutathione CEP of the European Pharmacopoeia monograph is often referred to as a Glutathione Certificate of Suitability (COS). The purpose of a Glutathione CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glutathione EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glutathione to their clients by showing that a Glutathione CEP has been issued for it. The manufacturer submits a Glutathione CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glutathione CEP holder for the record. Additionally, the data presented in the Glutathione CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glutathione DMF.
A Glutathione CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glutathione 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 Glutathione suppliers with CEP (COS) on PharmaCompass.
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