Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login
CEP (Certificate of Suitability) is issued by EDQM (European Directorate for the Quality of Medicines) confirming that an API complies with the European Pharmacopoeia (Ph. Eur.) monograph. EU pharmaceutical manufacturers require CEP from their API suppliers. CEP application: submit an EDQM application with full dossier of your manufacturing process, impurity profile, and quality specifications. CEP process takes 12-18 months. CEP is the primary market access credential for Indian API exporters to EU.
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