On April 1, WuXi AppTec officially announced that its two active pharmaceutical ingredient (API) facilities in Changzhou and Taixing, Jiangsu, successfully passed the U.S. FDA inspections in March with zero deficiencies. The FDA did not issue any "Form 483" (Inspectional Observations Report).
On March 4, the U.S. FDA conducted an unannounced GMP compliance inspection (also known as a "surprise inspection") at the Changzhou API facility, covering six major GMP systems and 21 FDA-approved products. The FDA inspector completed all verifications a day ahead of schedule and found no non-compliance issues.
On March 21, the Taixing API facility successfully passed the U.S. FDA's Pre-Approval Inspection (PAI) for the commercial production of an innovative peptide drug. No compliance issues were found during the inspection. The Taixing facility demonstrated a high level of compliance in terms of infrastructure, technical team capabilities, system operation, document management, and record-keeping. Officially commissioned in September 2023, the facility covers an area of 684,000 square meters and is WuXi AppTec’s newest and largest API manufacturing site.
The Changzhou and Taixing facilities are crucial components of STA Pharmaceutical (WuXi AppTec’s small molecule CDMO platform) and WuXi TIDES (an integrated CRDMO platform providing development services for oligonucleotides, peptides, and complex chemical conjugates). Both facilities offer API and intermediate manufacturing services for the development of various complex synthetic molecules.
