We are excited to announce that we have passed a second FDA inspection of our manufacturing facilities. A manufacturing facility of WuXi’s wholly owned subsidiary Shanghai SynTheAll Pharmaceutical Co. Ltd (STA) passed an FDA inspection in July for the manufacture of the active pharmaceutical ingredient (API) for a branded commercial drug. This is the first FDA inspection of STA’s facilities for the manufacture of an API. Last year, STA’s manufacturing operations passed an inspection by the FDA for the manufacture of an advanced intermediate. These favorable outcomes from the FDA inspections reflect our dedication to maintaining the highest quality standards throughout WuXi.
See official press release here.
WuXi Begins Operation of New High-Potency API Laboratory
WuXi Begins Construction of New R&D and cGMP Manufacturing Campus in Changzhou
WuXi Manufacturing Facility Passes FDA Inspection