Asymchem Passes FDA Inspection at API Mfg. Site

Asymchem, a custom manufacturer of intermediates and active pharmaceutical ingredients (APIs) for the life sciences industry, announced that its Tianjin 2 site, a multi-purpose development and commercial API manufacturing facility, passed the U.S. Food and Drug Administration (USFDA) general GMP re-inspection conducted between July 23-26, 2018 with no Form 483 issued.

"Our teams invest in and conduct continuous improvements to ensure the highest level of compliance and inspection readiness across all Asymchem sites," said Dr. Zhou Yan, vice president, quality, Asymchem. "Asymchem's previous FDA inspection of the Tianjin 2 site in 2014, as well as the most recent Asymchem Dunhua 1 and Fuxin 1 facilities in March 2017 and March 2018 respectively, also resulted in no Form 483 observations."

Dr. Hao Hong, chairman and chief executive officer, Asymchem Group, said, "I am extremely proud of the result as the Asymchem team proves yet again our robust quality system together with unyielding management commitment meets the highest quality standards in the manufacture of GMP products."

To keep up with increasing demand, Asymchem is expanding the Tianjin 2 site to include peptide manufacturing capability as well as expanding low volume API manufacturing capacity. Both will be operational by late 2018.

Asymchem is a full service CMC CDMO of API's 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.

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