Aspen Oss at CPhI Worldwide 2018 in Madrid

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Aspen Oss will be present at CPhI Worldwide 2018, the largest fair in the pharmaceutical industry, this year being organized in Madrid from Tuesday October 9th until Thursday October 11th.

You can visit our booth and meet your regular contact person from Aspen Oss in hall 10, stand number F20.

Should you wish to make an appointment, please click here to send us an e-mail and we will get in touch with you.

We look forward to seeing you!

 

Aspen Oss at CPhI China from June 20-22, 2018

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Representatives of our Global Marketing & Sales office will be visiting CPhI China in Shanghai New Int'l Expo Centre (SNIEC).

Should you wish to make an appointment, please click here to send us an e-mail and we will get in touch with you.

EDQM has granted a CEP for Leuprorelin

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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.