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Carbogen Amcis API Site Passes FDA PAI

Completes successful FDA inspection of its Neuland site in Hunzenschwil, Switzerland with no Form 483s

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Switzerland-based Carbogen Amcis AG, a pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company, said its Hunzenschwil (Neuland), Switzerland API manufacturing site has successfully completed a U.S. Food and Drug Administration (FDA) pre-approval inspection.   The four-day, pre-approval inspection was undertaken by an FDA investigator from July 8-11, 2019. The inspection was concluded with no Form 483’s filed, thus confirming that no critical or major o...

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