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.”
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 3220 personnel within China over 6 manufacturing sites. The company has been USFDA, TGA, NMPAA and MFDS inspected.