01 1AMINO GMBH Frellstedt DE
02 3Ajinomoto Co., Inc. Tokyo JP
03 2KYOWA HAKKO BIO CO., LTD. Tokyo JP
04 2SHANGHAI KYOWA AMINO ACID CO., LTD. Shanghai CN
01 4Histidine
02 3Histidine Hydrochloride Monohydrate
03 1Histidine, SA
01 1Germany
02 7Japan
01 8Valid
Certificate Number : R1-CEP 1998-107 - Rev 04
Status : Valid
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 911
Histidine Hydrochloride Monohydrate
Certificate Number : R1-CEP 1998-121 - Rev 04
Status : Valid
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 910
Certificate Number : CEP 2014-269 - Rev 01
Status : Valid
Issue Date : 2023-09-15
Type : Chemical
Substance Number : 911
Certificate Number : R1-CEP 2016-114 - Rev 00
Status : Valid
Issue Date : 2022-11-22
Type : Chemical
Substance Number : 911
Certificate Number : R1-CEP 1999-027 - Rev 04
Status : Valid
Issue Date : 2022-05-20
Type : Chemical
Substance Number : 911
Histidine Hydrochloride Monohydrate
Certificate Number : R1-CEP 1999-026 - Rev 05
Status : Valid
Issue Date : 2022-06-03
Type : Chemical
Substance Number : 910
Histidine Hydrochloride Monohydrate
Certificate Number : R1-CEP 2010-047 - Rev 01
Status : Valid
Issue Date : 2017-06-01
Type : Chemical
Substance Number : 910
Certificate Number : R1-CEP 2010-046 - Rev 01
Status : Valid
Issue Date : 2017-04-28
Type : Chemical
Substance Number : 911
A L-Histidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Histidine, including repackagers and relabelers. The FDA regulates L-Histidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Histidine 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-Histidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Histidine supplier is an individual or a company that provides L-Histidine active pharmaceutical ingredient (API) or L-Histidine finished formulations upon request. The L-Histidine suppliers may include L-Histidine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Histidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Histidine CEP of the European Pharmacopoeia monograph is often referred to as a L-Histidine Certificate of Suitability (COS). The purpose of a L-Histidine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Histidine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Histidine to their clients by showing that a L-Histidine CEP has been issued for it. The manufacturer submits a L-Histidine CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Histidine CEP holder for the record. Additionally, the data presented in the L-Histidine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Histidine DMF.
A L-Histidine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Histidine 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-Histidine suppliers with CEP (COS) on PharmaCompass.
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