01 1Ajinomoto Co., Inc. Tokyo JP
01 1Arginine, SA
01 1Japan
01 1Valid
Certificate Number : R0-CEP 2022-190 - Rev 00
Status : Valid
Issue Date : 2022-09-29
Type : Chemical
Substance Number : 806
A L-Arginine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Arginine, including repackagers and relabelers. The FDA regulates L-Arginine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Arginine 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-Arginine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Arginine supplier is an individual or a company that provides L-Arginine active pharmaceutical ingredient (API) or L-Arginine finished formulations upon request. The L-Arginine suppliers may include L-Arginine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Arginine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Arginine CEP of the European Pharmacopoeia monograph is often referred to as a L-Arginine Certificate of Suitability (COS). The purpose of a L-Arginine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Arginine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Arginine to their clients by showing that a L-Arginine CEP has been issued for it. The manufacturer submits a L-Arginine CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Arginine CEP holder for the record. Additionally, the data presented in the L-Arginine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Arginine DMF.
A L-Arginine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Arginine 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-Arginine suppliers with CEP (COS) on PharmaCompass.
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