#China #WuXi AppTec #API Manufacturing #FDA Inspections #Changzhou and Taixing

WuXi AppTec Achieves Significant FDA Inspection Milestones

WuXi AppTec, a leading global provider of R&D and manufacturing services for the pharmaceutical and life sciences industries, has recently announced a remarkable achievement. Their Active Pharmaceutical Ingredient (API) manufacturing facilities located in Changzhou and Taixing, Jiangsu province, have successfully passed rigorous inspections conducted by the U.S. Food and Drug Administration (FDA). Notably, both inspections took place in March 2025 and were completed with no observations or any Form 483 issued, which highlights the high standards of quality maintained at these facilities.

The inspection of the Changzhou site began on March 4, 2025. This site underwent a Good Manufacturing Practices (GMP) surveillance inspection covering 21 FDA-approved products. The review was completed ahead of schedule, which is a rare achievement in the industry. Following this, the Taixing site also concluded its Pre-Approval Inspection (PAI) on March 21, 2025, for a peptide-based therapeutic, once again with no observations noted. This successful outcome indicates that both sites are well-prepared to manufacture high-quality drug ingredients that meet global market demands.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec, expressed pride in the teams at both sites, stating, "Our team's consistent focus on quality and compliance is key to enabling our global partners. We are 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."

The Changzhou and Taixing facilities are pivotal to WuXi STA, which is the company’s development and manufacturing organization (CDMO) platform for small molecules. Additionally, WuXi TIDES operates within the same framework, focusing on the integrated services for oligonucleotides, peptides, and synthetic conjugates. The facilities are equipped to produce a wide range of APIs and intermediates across various chemical modalities.

WuXi AppTec is continually investing in expansion strategies to meet the increasing global demand for pharmaceutical production. An example of this is their site in Couvet, Switzerland, which recently doubled its oral dose capacity within just a year. Furthermore, the company is developing its operations in the U.S. with a new facility in Middletown, Delaware, anticipated to start operations by the end of 2026. They are also expanding their footprint in Asia, with plans for a new R&D and manufacturing site in Singapore, expected to initiate operations by 2027.

This commitment to growth and quality service renders WuXi AppTec a vital player in the global pharmaceutical supply chain. Established with a mission to bridge the gap between innovation and effective healthcare solutions, WuXi AppTec supports over 6,000 customers across more than 30 countries. Their integrated, end-to-end service approach leverages CRDMO partnerships, biology exploration, preclinical testing, and clinical research services that assist in expediting new drug developments. The firm proudly boasts an AA ESG rating from MSCI for four consecutive years, emphasizing its commitment to high ethical standards and sustainable practices in the pharmaceutical manufacturing sector.

In conclusion, the successful FDA inspections of WuXi AppTec's Changzhou and Taixing sites underscore the company's unwavering dedication to quality and its role in facilitating healthcare innovations worldwide. As the industry evolves, WuXi AppTec continues to play a pivotal role in advancing drug development and delivering essential therapies to patients around the globe.