WuXi AppTec Co. Ltd. announced that the small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility located in Jinshan Shanghai, which is part of its subsidiary Shanghai SynTheAll Pharmaceutical Co., Ltd. (STA), recently successfully passed a general GMP and Pre-Approval Inspection from the U.S. FDA with no Form 483s issued. This is the third time that STA’s Jinshan facility passed the U.S. FDA inspection.
As a contract development and manufacturing organization (CDMO), STA has received multiple approvals to supply APIs and GMP intermediates for branded commercial drugs from regulatory agencies in the United States, Canada, the European Union, Switzerland, China, Japan, Australia, and New Zealand.
“Passing the third U.S. FDA inspection with no observations once again demonstrated our commitment and ability to provide the highest quality services to global life science community,” said Dr. Minzhang Chen, CEO of STA.
“I’m very pleased about STA’s continued track record in securing FDA inspection approvals,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec, “it further confirms our reliability and credibility towards our business partners as well as the millions of patients that we proudly serve together.”