WuXi Vaccines receives second ANVISA GMP certification for vaccine manufacturing

WuXi Vaccines, a vaccine contract development and manufacturing organization (CDMO) and wholly owned subsidiary of WuXi Biologics headquartered in Shanghai, China, has received Good Manufacturing Practices certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) for its drug substance manufacturing facility MFG23 in Suzhou, China.

The certification was granted following comprehensive on-site inspections, including quality assurance, quality control, manufacturing science and technology, warehouse, and utilities operations, according to the announcement. The MFG23 facility is providing integrated manufacturing services for Instituto Butantan’s dengue vaccine program, the company said.

Under a commercial manufacturing agreement with Instituto Butantan and Fundação Butantan, WuXi Vaccines will provide end-to-end services including drug substance and drug product manufacturing and quality control for the five-dose dengue vaccine, with the partnership aiming to deliver millions of doses to Brazil’s population. The single-dose Butantan-DV received ANVISA approval in November 2025.

The latest certification follows WuXi Vaccines’ receipt of ANVISA GMP certification in February for its DP17 fill-finish facility at the same Suzhou site, which also passed a European Union Qualified Person audit in 2024, completing regulatory coverage across both drug substance and drug product manufacturing for the dengue vaccine program.