WuXi Biologics Passes Another FDA GMP Inspection, Reinforcing Its Quality Track Record and Commercial Supply Reliability

WUXI, China, Sept. 24, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its drug substance (DS) and drug product (DP) manufacturing facilities at the Wuxi Mashan site successfully passed a two-week GMP inspection conducted by the U.S. Food and Drug Administration (FDA). The successful inspection further strengthens the Company's capabilities to ensure the reliable supply of its partners' commercial products to the U.S. market. The unannounced FDA GMP inspection covered multiple FDA-approved products, including monoclonal antibodies, bispecific antibodies, fusion proteins, and enzyme products.