WuXi AppTec’s Changzhou and Taixing API Sites Pass FDA Inspections with No Observations

• WuXi AppTec’s API manufacturing sites in Changzhou and Taixing, China, successfully passed FDA inspections in March 2025, with no Form 483 issued.

• The inspections covered GMP surveillance and pre-approval processes, confirming the company’s commitment to quality and regulatory compliance.

WuXi AppTec’s Active Pharmaceutical Ingredient (API) manufacturing facilities in Changzhou and Taixing, China, successfully passed U.S. Food and Drug Administration (FDA) inspections in March 2025. Both sites cleared their respective reviews without a single observation, reinforcing the company’s commitment to high-quality manufacturing and regulatory compliance.

The FDA conducted a GMP surveillance inspection at WuXi AppTec’s Changzhou site starting on 4 March, covering 21 FDA-approved products under the agency’s six-system inspection model. Inspectors completed the review ahead of schedule without identifying any issues. On 21 March, the Taixing site underwent a Pre-Approval Inspection (PAI) for the commercial production of a peptide-based therapeutic, also concluding with no observations. Operational since September 2023, the 169-acre Taixing site is the company’s largest API facility, and the inspection confirmed its readiness to support global commercial API supply.

“Our team’s consistent focus on quality and compliance is key to enabling our global partners,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. “We’re pleased that both the Changzhou and Taixing sites passed their FDA inspections with no observation. These successful results further reinforce WuXi AppTec’s dedication to providing high-quality R&D and manufacturing solutions that support our customers worldwide in accelerating new drug development and commercialization for the benefit of patients.”

The Changzhou and Taixing facilities form part of WuXi STA, the company’s small molecule CDMO platform, and WuXi TIDES, which provides integrated CRDMO services for oligonucleotides, peptides, and synthetic conjugates. Both sites manufacture APIs and intermediates across diverse chemical modalities.

WuXi AppTec continues to expand its global manufacturing footprint, doubling oral dose capacity at its Couvet, Switzerland, site in 2024 and advancing its U.S. (Middletown, DE) facility, slated for operations in 2026. The company also broke ground on a new R&D and manufacturing site in Singapore in May 2024, with Phase I expected to be operational by 2027.