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WuXi AppTec's Changzhou and Taixing API Sites Successfully Pass FDA Inspections

WuXi AppTec's API manufacturing sites in Changzhou and Taixing, Jiangsu, China, successfully underwent FDA inspections in March 2025, with no observations noted.
These inspections demonstrate WuXi AppTec's commitment to upholding high quality standards in R&D and manufacturing solutions to support global healthcare innovation.
The Changzhou site underwent a GMP surveillance inspection beginning March 4, covering 21 FDA-approved products and following the FDA's six-system inspection model, while the Taixing site completed a Pre-Approval Inspection on March 21 for commercial manufacturing of a peptide-based therapeutic.
According to 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" and the team's focus on quality and compliance is key to enabling global partners.
WuXi AppTec continues to invest in capacity expansion to meet growing global demand, including doubling oral dose capacity at its Couvet, Switzerland site in 2024, building its Middletown, DE site expected to commence operations by the end of 2026, and groundbreaking of a Singapore R&D and manufacturing site with Phase I expected to commence operations in 2027.

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WuXi AppTec's Changzhou and Taixing API Sites Successfully Pass FDA Inspections

SHANGHAI, March 31, 2025 /PRNewswire/ -- WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, today announced that its Active Pharmaceutical Ingredient (API) manufacturing…

2 days ago·Altavista, United States

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WuXi AppTec Scores Flawless FDA Inspections: Zero Issues at Major API Manufacturing Hubs

Two WuXi AppTec API facilities pass rigorous FDA inspections with zero observations. Taixing site approved for peptide therapeutics manufacturing. Full analysis inside.

2 days ago

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