European Directorate for the Quality of Medicines (EDQM) has granted a quality certificate 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 26th, 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.