WuXi BiologicsReceived GMP certification from Brazil's ANVISA, enabling commercial production and entry into Latin America.

WuXi Biologics has received GMP certification from Brazil's ANVISA for two manufacturing facilities and a packaging center in Wuxi, enabling end-to-end commercial production of an anti-PD-L1 monoclonal antibody for cancer immunotherapy. The five-day inspection of Drug Substance Facility 2, Drug Product Facility 1, and the Drug Product Packaging Center concluded with zero findings. The certification allows WuXi Biologics to provide integrated drug substance and drug product manufacturing for global commercial supply, including entry into Latin America. The company has now passed 46 regulatory inspections and holds a 100% pass rate for FDA Pre-License Inspections.
WuXi BiologicsReceived GMP certification from Brazil's ANVISA, enabling commercial production and entry into Latin America.