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FDA Inspection of Asymchem Dunhua 1 API Manufacturing Facility is Successful

No 483s were issued

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By: Tim Wright

Editor-in-Chief, Contract Pharma

China-based Asymchem, a leading manufacturer of intermediates and active pharmaceutical ingredients (APIs) for the pharmaceutical industry, said that its Dunhua 1 site, a small molecule custom manufacturing API facility, successfully completed a U.S. Food and Drug Administration (FDA) general GMP re-inspection conducted between April 8-12, 2019. The EIR states the inspection outcome as closed, and classified with a “VAI” status (Voluntary Action Indicated). The previous inspection of...

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