Novasep sites approved by US FDA
French active ingredients company Novasep has successfully completed US Food and Drug Administration pre-approval inspections carried out at two of its sites in France.
The company is now an authorized producer of a new molecular entity (NME) already approved in the USA. 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 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 (pictured) takes charge of the last purification step.
Novasep pharmaceutical production approved in USA
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