01 1Ajinomoto Co., Inc. Tokyo JP
01 1Isoleucine, Limeira Amino Acid site
01 1Japan
01 1Valid
Isoleucine, Limeira Amino Acid Site
Certificate Number : R1-CEP 2009-100 - Rev 00
Status : Valid
Issue Date : 2014-12-16
Type : Chemical
Substance Number : 770
A AMINO ACIDS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMINO ACIDS, including repackagers and relabelers. The FDA regulates AMINO ACIDS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMINO ACIDS API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A AMINO ACIDS supplier is an individual or a company that provides AMINO ACIDS active pharmaceutical ingredient (API) or AMINO ACIDS finished formulations upon request. The AMINO ACIDS suppliers may include AMINO ACIDS API manufacturers, exporters, distributors and traders.
click here to find a list of AMINO ACIDS suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AMINO ACIDS CEP of the European Pharmacopoeia monograph is often referred to as a AMINO ACIDS Certificate of Suitability (COS). The purpose of a AMINO ACIDS CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AMINO ACIDS EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AMINO ACIDS to their clients by showing that a AMINO ACIDS CEP has been issued for it. The manufacturer submits a AMINO ACIDS CEP (COS) as part of the market authorization procedure, and it takes on the role of a AMINO ACIDS CEP holder for the record. Additionally, the data presented in the AMINO ACIDS CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AMINO ACIDS DMF.
A AMINO ACIDS CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AMINO ACIDS 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 AMINO ACIDS suppliers with CEP (COS) on PharmaCompass.
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