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By the US FDA at their Tianjin1 site, a dedicated HPAPI development and manufacturing facility
March 27, 2019
By: Betsy Louda
Asymchem has 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 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 Asymche...
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