Successful USFDA inspection of Asymchem Dunhua 1 API manufacturing facility

TIANJIN, China, May 31, 2019 /PRNewswire/ -- Asymchem, a leading custom manufacturer of Intermediates and API's for the pharmaceutical industry, today announced that its Dunhua 1 site, a small molecule custom manufacturing API facility, successfully completed a U.S. Food and Drug Administration (USFDA) general GMP reinspection 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 USFDA 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.

Dr. Hao Hong, Chairman and CEO of Asymchem Group, states: "I am grateful yet again for the successful inspection by the FDA. This is the second successful inspection for the Dunhua 1 site, and 13^th successful western agency audit in total across all Asymchem's 7 manufacturing sites. We are committed to continue enhancing existing quality systems for unyielding quality standards in the manufacturing of GMP products."

About Asymchem
Asymchem is a full-service CMC CDMO of API's for the global pharmaceutical industry, providing compliant and sustainable manufacturing solutions worldwide over the lifecycle of a drug. 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 3320 personnel within China over 7 manufacturing sites. The company has been inspected by regulatory authorities from USA, China, Australia, and South Korea.

SOURCE Asymchem