Since October 2007, Aseptic Technologies operates its own filling suite using the Crystal^® Technology. This facility has been inspected by the Belgian authorities and has been approved in the frame of PIC/S (Pharmaceutical Inspection Co-operation Scheme) as an EMEA GMP manufacturing site to fill stability batches of injectable drugs developed for human use, registered under the reference 1.633 H.

In parallel, Drug Master Files (DMF) have been registered to the American FDA, at CBER (US Center for Biologics Evaluation and Research) under the reference BB-MF-13382 and CDER (US Center for Drug Evaluation and Research) under the reference 20555. 

Contact-us to fill stability batches in our GMP manufacturing site or to receive the list of facilities operating a Crystal^® Filling Line.