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Novasep Completes FDA Inspections at France Sites

Will produce NME for U.S. market

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By: Kristin Brooks

Managing Editor, Contract Pharma

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 l...

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