EDQM had granted a CEP for Leuprorelin

It is our pleasure to inform you that the European Directorate for the Quality of Medicines (EDQM) has granted a CEP for Leuprorelin to Aspen Oss on September 26^th, 2017. Leuprorelin is the 20th CEP obtained by Aspen Oss and is another example of Aspen Oss’ broad global regulatory experience. It furthermore underlines our commitment to support our customers with a high level of quality and regulatory support and help facilitate customer’s new product authorisation globally.

A CEP or “Certificate of Suitability to the monograph of the European Pharmacopoeia” is granted upon demonstration that the quality of a substance is suitably controlled by the relevant monograph of the European Pharmacopoeia. The 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.