Pharmail

EDQM Grants New CEPs for Three Life Science API Products

The “Certificate of Suitability to the monograph of the European Pharmacopoeia” (CEP) is granted upon demonstration that the quality of a substance is suitably controlled by the relevant monograph of the European Pharmacopoeia. The European Directorate for the Quality of Medicines and Healthcare (EDQM) grants a CEP after successful assessment of data with regards to chemistry, manufacture, control, stability and packaging materials. A positive assessment of a dossier certifies that the manufacturing process results in a product of API grade quality that can be referenced for medicinal product approval in the Marketing Authorization Application.

Our customers use CEPs in the marketing authorization process for medicinal products because they help to accelerate the process. The use of a CEP is an advantageous and simple way for the approbation of an active substance. They also simplify the lifecycle management of a market authorization dossier owned by the customer.

We are happy to provide access to CEPs for your drug product application that will be issued upon request.

New CEPs are now available for the following products:

• 100164 Boric acid cryst., suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur, BP, NF
• 108815 Zinc chloride suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur, BP, USP
• 109828 di-Potassium hydrogen phosphate anhydrous, low in sodium suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur, BP, USP

For more information, please contact us.

In This Same Issue

• Clarification Solution for High-Density Cell Culture Harvests
• New Webinar: How Excipient Suppliers Can Support QbD
• Updated Sterile Filtration Selection Guide Simplifies Process
• New Webinar Highlights Benefits of Single-Pass TFF

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