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