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

Rhea-AI Summary

WuXi AppTec announced that its Active Pharmaceutical Ingredient (API) manufacturing sites in Changzhou and Taixing, China, have successfully passed U.S. FDA inspections in March 2025 with no observations or Form 483 issues.

The Changzhou facility's GMP surveillance inspection covered 21 FDA-approved products, while Taixing completed a Pre-Approval Inspection for commercial manufacturing of a peptide-based therapeutic. The 169-acre Taixing site, operational since September 2023, is the company's newest and largest API manufacturing facility.

WuXi AppTec is expanding globally with recent developments including:

• Doubled oral dose capacity at Couvet, Switzerland facility in 2024
• Ongoing construction of Middletown, Delaware site (operations expected by 2026)
• New Singapore R&D and manufacturing site groundbreaking (Phase I operations planned for 2027)

Positive

• Successfully passed FDA inspections at two major API manufacturing sites with zero observations
• Operational approval for commercial manufacturing of peptide-based therapeutic at Taixing facility
• Significant global expansion with new facilities in Switzerland, USA, and Singapore
• Portfolio includes 21 FDA-approved products at Changzhou facility

Negative

• None.

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 sites at Changzhou and Taixing in Jiangsu province of China, successfully passed U.S. Food and Drug Administration (FDA) inspections back-to-back in March — both without a single observation and with no Form 483 issued. These achievements further demonstrate WuXi AppTec's unwavering commitment to upholding the highest quality standards and to supporting global healthcare innovators in reliably delivering needed therapies to patients worldwide.

The Company's API site at Changzhou underwent a GMP surveillance inspection by the FDA that began on March 4. Covering 21 FDA-approved products, the inspection followed the FDA's six-system inspection model. The FDA inspectors concluded the review one day ahead of schedule. No observation was raised.

On March 21, 2025, the API site at Taixing also completed a Pre-Approval Inspection (PAI) for the commercial manufacturing of a peptide-based therapeutic, with no observation. The site presented its state-of-the-art infrastructure, the team's strong technical expertise, and the high level of compliance demonstrated through its systems, documentation, and records. Operational since September 2023, the 169-acre Taixing site is the company's newest and largest API manufacturing facility. The successful inspection confirms the site's readiness to support commercial API supply to the global market.

"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 sites are critical manufacturing bases 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 support the manufacturing of APIs and intermediates across a wide range of chemical modalities.

WuXi AppTec continues to invest in capacity expansion to meet growing global demand. The company's investment in its Couvet, Switzerland, site resulted in doubling oral dose capacity over the course of 2024. Meanwhile, WuXi AppTec continued to build its U.S. (Middletown, DE) site, which is expected to commence operations by the end of 2026. In May 2024, the company announced the groundbreaking of Singapore R&D and manufacturing site; Phase I expects to commence operations in 2027. 

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024 and its open-access platform is enabling around 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated." Please visit: http://www.wuxiapptec.com

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SOURCE WuXi AppTec

FAQ

What was the outcome of WuXi AppTec's FDA inspections at Changzhou and Taixing sites in March 2025?

Both sites passed FDA inspections with zero observations and no Form 483 issues, demonstrating full compliance with regulatory standards.

How many FDA-approved products are manufactured at WuXi AppTec's Changzhou facility?

The Changzhou facility manufactures 21 FDA-approved products.

What is the size and significance of WuXi AppTec's new Taixing API manufacturing facility?

The Taixing facility spans 169 acres and is the company's newest and largest API manufacturing facility, operational since September 2023.

What are WuXi AppTec's global expansion plans for 2026-2027?

The company plans to commence operations at its Middletown, Delaware site by 2026 and Phase I of its Singapore R&D and manufacturing site by 2027.

What manufacturing capabilities were expanded at WuXi AppTec's Couvet, Switzerland facility in 2024?

The Couvet facility doubled its oral dose manufacturing capacity during 2024.