Novasep has announced that it has successfully completed FDA (US Food and Drug Administration) pre-approval inspections carried out at two of its sites in France.
Novasep is now an authorized producer of a new molecular entity (NME) already approved in the US. The inspection concerned a multi-site project Novasep manages for synthesizing and purifying a kinase inhibitor active ingredient.
The FDA inspections took place during June 2014 at Novasep’s Chasse-sur-Rhone and Pompey sites in France. The Chasse-sur-Rhone site is responsible for the synthesis of late stage intermediates and the active pharmaceutical ingredient (API), while the Pompey site takes charge of the last purification step.
“These two FDA inspections, along with those we successfully passed in 2013 at our plants in Le Mans, Mourenx and Leverkusen, show that Novasep operates a high-performance quality management system in line with Good Manufacturing Practices. We achieve this level of performance not only at these sites but across all of the group's different sites,” said Jean Claude Romain, VP Quality at Novasep. “Our teams at Novasep invest in and conduct continuous upgrades to ensure that ever stricter regulatory standards meet the highest level of compliance at all Novasep plants.”
“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 centre of excellence for cGMP chromatographic purification. Novasep has a genuine know-how in bringing together top European quality level services and technologies.”