WuXi Biologics announced that its drug substance and drug product manufacturing facilities at its Wuxi Mashan site in China successfully passed a two-week inspection by the U.S. Food and Drug Administration (FDA). The inspection covered multiple FDA-approved products, including monoclonal antibodies, bispecific antibodies, fusion proteins, and enzymes, demonstrating the company’s continued compliance with Good Manufacturing Practice (GMP) requirements. The site has passed more than 600 regulatory and client audits over 13 years and supported the global launch of over 20 biologic medicines, strengthening its ability to supply commercial products to the U.S. market.
