01 1CHEMPORT INC. Naju-si KR
02 1SELJEL JELATIN SANAYI VE TICARET A.Ş Istanbul TR
01 1Fish oil, rich in omega-3-acids, Type I
02 1Gelatin, Caustic and lime hide gelatin
01 1Turkey
02 1United Kingdom
01 2Valid
Fish Oil, Rich In Omega-3-acids, Type I
Certificate Number : CEP 2015-282 - Rev 01
Status : Valid
Issue Date : 2025-03-20
Type : Chemical
Substance Number : 1912
Gelatin, Caustic And Lime Hide Gelatin
Certificate Number : R0-CEP 2021-504 - Rev 00
Status : Valid
Issue Date : 2022-06-02
Type : TSE
Substance Number : 330
93
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A MaxEPA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MaxEPA, including repackagers and relabelers. The FDA regulates MaxEPA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MaxEPA 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 MaxEPA supplier is an individual or a company that provides MaxEPA active pharmaceutical ingredient (API) or MaxEPA finished formulations upon request. The MaxEPA suppliers may include MaxEPA API manufacturers, exporters, distributors and traders.
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A MaxEPA CEP of the European Pharmacopoeia monograph is often referred to as a MaxEPA Certificate of Suitability (COS). The purpose of a MaxEPA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MaxEPA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MaxEPA to their clients by showing that a MaxEPA CEP has been issued for it. The manufacturer submits a MaxEPA CEP (COS) as part of the market authorization procedure, and it takes on the role of a MaxEPA CEP holder for the record. Additionally, the data presented in the MaxEPA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MaxEPA DMF.
A MaxEPA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MaxEPA 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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