01 1Purac Bioquimica S.A. Montmelo ES
01 1(S)-Lactic acid
01 1Netherlands
01 1Valid
Certificate Number : R1-CEP 2006-124 - Rev 01
Status : Valid
Issue Date : 2023-04-27
Type : Chemical
Substance Number : 1771
A L-Lactic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Lactic Acid, including repackagers and relabelers. The FDA regulates L-Lactic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Lactic Acid 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 L-Lactic Acid supplier is an individual or a company that provides L-Lactic Acid active pharmaceutical ingredient (API) or L-Lactic Acid finished formulations upon request. The L-Lactic Acid suppliers may include L-Lactic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of L-Lactic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Lactic Acid CEP of the European Pharmacopoeia monograph is often referred to as a L-Lactic Acid Certificate of Suitability (COS). The purpose of a L-Lactic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Lactic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Lactic Acid to their clients by showing that a L-Lactic Acid CEP has been issued for it. The manufacturer submits a L-Lactic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Lactic Acid CEP holder for the record. Additionally, the data presented in the L-Lactic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Lactic Acid DMF.
A L-Lactic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Lactic Acid 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-Lactic Acid suppliers with CEP (COS) on PharmaCompass.
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