Successful USFDA inspection of Asymchem Tianjin 1 HPAPI development and manufacturing facility

TIANJIN, China, March 25, 2019 /PRNewswire/ — Asymchem, a leading custom manufacturer of Intermediates and API’s for the life sciences industry, today announced that its Tianjin1 site, a dedicated High Potency Active Pharmaceutical Ingredients (HPAPI) development and manufacturing facility, successfully completed a U.S. Food and Drug Administration (USFDA) general GMP reinspection conducted between January 14-18, 2019. No Form 483 was issued. Previous USFDA inspections of Tianjin1 took place in 2014, also with no 483. Asymchem Laboratories (Tianjin) Co., Ltd., otherwise known as Tianjin1, produces Dexmedetomidine HCl, for which Asymchem holds an active Drug Master File, as well as other development HPAPI ...

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