EDQM has granted a CEP for Leuprorelin

on .

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.

Aspen Oss at CPhI Worldwide in Frankfurt 2017

on .

Aspen Oss will be present at CPhI Worldwide 2017, the largest fair in the pharmaceutical industry, this year being organized in Frankfurt from Tuesday October 24th until Thursday October 26th.

You can visit our booth and meet your regular contact person from Aspen Oss in hall 9.2, stand number C88. We look forward to seeing you!

Aspen Oss at CPhI Japan on 19-21 April 2017 in Tokyo, Japan

on .

A representative of our Japanese sales office will be visiting CPhI Japan. We especially invite Japanese companies to make an appointment. Please click here to send us an e-mail and we will get in touch with you.

On April 20th at 15:45 PM, our Global Regulatory Specialist and board member of APIC (Active Pharmaceutical Ingredients Committee) organisation, Mrs. Marieke van Dalen, will present about the practical aspects of implementing ICH Q11 guidelines from an industry perspective.

Please see the link for more information and for registering for this interesting seminar (Keynote seminar K-10).

We look forward to meeting you!

 

Aspen Oss at CPhI Russia

on .

Aspen Oss will be present at CPhI Russia on 28-30 March 2017 in Moscow, Russia

We welcome you to visit us at stand 320. Do you want to make an appointment? Please click here 

We look forward to seeing you!

Successful GMP inspection for Aspen Oss

on .

Aspen Oss B.V. is proud to announce the extension of our GMP Compliance for the production locations Diosite and Moleneind in Oss - The Netherlands.

During the 5 days inspection held from September 26th to September 30th, 2016 the Dutch Health Care Inspectorate (DHI) had a close look on the operations related to our biochemical, chemical and peptide APIs.

They found our operations to be in compliance with Good Manufacturing Practices. As a result from this successful inspection, a GMP Certificate has been issued extending our GMP status for the next three years.