FDA Inspection of Asymchem Dunhua 1 API Manufacturing Facility is Successful

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 Dunhua 1 took place in 2017 with no 483 issued.
 
Jilin Asymchem Laboratories, Co., Ltd. (Dunhua 1 site), established in 2007, manufactures APIs and API intermediates for the global pharma industry.
 
"I am grateful yet again for the successful inspection by the FDA," said Hao Hong, chairman and chief executive officer, Asymchem Group. "This is the second successful inspection for the Dunhua 1 site, and 13th successful western agency audit in total across all Asymchem's seven manufacturing sites. We are committed to continue enhancing existing quality systems for unyielding quality standards in the manufacturing of GMP products."
 
Asymchem is a full-service CMC CDMO of APIs for the global pharmaceutical industry. Capabilities include dedicated HPAPI, in-house enzyme evolution and fermentation for biotransformations, end-to-end continuous flow development and application, hydrogenation, cryogenic capabilities, dedicated carbapenem manufacture, and others. Founded in 1997, Asymchem employs 3,320 personnel within China over 7 manufacturing sites. The company has been inspected by regulatory authorities from U.S., China, Australia and South Korea.

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