A UREA, U.S.P. CEP of the European Pharmacopoeia monograph is often referred to as a UREA, U.S.P. Certificate of Suitability (COS). The purpose of a UREA, U.S.P. CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of UREA, U.S.P. EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of UREA, U.S.P. to their clients by showing that a UREA, U.S.P. CEP has been issued for it. The manufacturer submits a UREA, U.S.P. CEP (COS) as part of the market authorization procedure, and it takes on the role of a UREA, U.S.P. CEP holder for the record. Additionally, the data presented in the UREA, U.S.P. CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the UREA, U.S.P. DMF.
A UREA, U.S.P. CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. UREA, U.S.P. 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 UREA, U.S.P. suppliers with CEP (COS) on PharmaCompass.