Novasep has successfully completed FDA pre-approval inspections at two of its sites in Chasse-sur-Rhone and Pompey, France. The company is now authorized to produce a new molecular entity (NME) currently approved in the U.S.
The inspection covered a multi-site project Novasep manages for synthesizing and purifying a kinase inhibitor active ingredient. The Chasse-sur-Rhone site is responsible for the synthesis of late stage intermediates and the API, and the Pompey site is responsible for the last purification step.
“We are proud of the results achieved during these two FDA inspections,” said Thierry Van Nieuwenhove, president of the Synthesis BU at Novasep. This positive outcome is a real testimony to Novasep’s strength in offering specialized technologies and its ability to combine expertise and skills across all of its sites. For this particular success, the CSR team aligned its skills and long experience in the scale-up, validation and commercial launch of APIs in collaboration with Pompey, our center of excellence for cGMP chromatographic purification. Novasep has a genuine know-how in bringing together top European quality level services and technologies.”