We are pleased to announce that the small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility located in Jinshan Shanghai, which is part of our subsidiary Shanghai SynTheAll Pharmaceutical Co., Ltd. (STA), has successfully passed a general GMP and Pre-Approval Inspection from the U.S. Food and Drug Administration with no Form 483s issued. This is the third time that STA’s Jinshan facility passed the U.S. FDA inspection.

As a world-leading 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.

STA’s continued track record in securing FDA inspection approvals further confirms our reliability and credibility towards our business partners as well as the millions of patients that we proudly serve together.

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