Successful US FDA Inspection of Asymchem Tianjin 1 HPAPI Development and Manufacturing Facility

Successful US FDA Inspection of Asymchem Tianjin 1 HPAPI Development and Manufacturing Facility

March 27, 2019PR-M03-19-NI-077

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 candidates.

Dr. Hao Hong, Chairman and CEO of Asymchem Group, speaking on the outcome of the inspection: "I'm very pleased once again to receive a positive outcome from a USFDA inspection. The result is the culmination of many years' commitment to unyielding quality standards in the manufacturing of GMP products, and highlights the robust system implemented by Asymchem' s QA team. We will continue to improve and provide only the highest standards as our customers expect moving forward."

 

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