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Novasep’s European Sites Pass FDA Inspections

Audits demonstrate custom manufacturing capabilities

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Novasep’s European custom manufacturing sites in Le Mans, France and Leverkusen, Germany have successfully passed FDA inspections. The audits took place at the two facilities in June and July 2013.   The FDA audit at the Le Mans site was a pre-approval inspection for production of paclitaxel, an anticancer parenteral active ingredient. The audit demonstrates the team’s capability to handle highly potent active pharmaceutical ingredients (HPAPI), including paclitaxel. The Leverkusen facility audi...

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