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
22
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A Pleo sanvis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pleo sanvis, including repackagers and relabelers. The FDA regulates Pleo sanvis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pleo sanvis 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 Pleo sanvis supplier is an individual or a company that provides Pleo sanvis active pharmaceutical ingredient (API) or Pleo sanvis finished formulations upon request. The Pleo sanvis suppliers may include Pleo sanvis API manufacturers, exporters, distributors and traders.
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A Pleo sanvis CEP of the European Pharmacopoeia monograph is often referred to as a Pleo sanvis Certificate of Suitability (COS). The purpose of a Pleo sanvis CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pleo sanvis EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pleo sanvis to their clients by showing that a Pleo sanvis CEP has been issued for it. The manufacturer submits a Pleo sanvis CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pleo sanvis CEP holder for the record. Additionally, the data presented in the Pleo sanvis CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pleo sanvis DMF.
A Pleo sanvis CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pleo sanvis CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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