01 1DSP Chauny FR
01 1Colestyramine, Powder, grade AP143/1073
01 1U.S.A
01 1Valid
Colestyramine, Powder, Grade AP143/1073
Certificate Number : R1-CEP 2013-343 - Rev 00
Status : Valid
Issue Date : 2020-06-02
Type : Chemical
Substance Number : 1775
83
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A LOCHOLEST manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LOCHOLEST, including repackagers and relabelers. The FDA regulates LOCHOLEST manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LOCHOLEST API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A LOCHOLEST supplier is an individual or a company that provides LOCHOLEST active pharmaceutical ingredient (API) or LOCHOLEST finished formulations upon request. The LOCHOLEST suppliers may include LOCHOLEST API manufacturers, exporters, distributors and traders.
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A LOCHOLEST CEP of the European Pharmacopoeia monograph is often referred to as a LOCHOLEST Certificate of Suitability (COS). The purpose of a LOCHOLEST CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LOCHOLEST EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LOCHOLEST to their clients by showing that a LOCHOLEST CEP has been issued for it. The manufacturer submits a LOCHOLEST CEP (COS) as part of the market authorization procedure, and it takes on the role of a LOCHOLEST CEP holder for the record. Additionally, the data presented in the LOCHOLEST CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LOCHOLEST DMF.
A LOCHOLEST CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LOCHOLEST 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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