- WuXi Vaccines has received ANVISA GMP certification for its MFG23 drug substance facility in Suzhou, China, supporting Instituto Butantan’s dengue vaccine project.
- The company is providing integrated drug substance and drug product manufacturing services for the dengue vaccine under a commercial agreement with Instituto Butantan and Fundação Butantan.
WuXi Vaccines, a subsidiary of WuXi Biologics focused on vaccine CDMO services, has received Good Manufacturing Practices (GMP) certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) for its MFG23 drug substance manufacturing facility in Suzhou, China.
The certification followed inspections covering the facility’s drug substance manufacturing operations as well as its quality assurance, quality control, MSAT, warehouse, and utility systems. The facility supports manufacturing activities for Instituto Butantan’s dengue vaccine program. WuXi Vaccines stated that its drug product facility, DP17, at the same Suzhou site previously received ANVISA GMP certification for the same project in February 2026.
Under a commercial manufacturing agreement with Instituto Butantan and Fundação Butantan, WuXi Vaccines is providing integrated services including drug substance manufacturing, drug product manufacturing, and quality control support for the dengue vaccine program. The partnership aims to expand vaccine manufacturing capacity to supply millions of doses in Brazil.
“The GMP certification of our DS facility, our second certification from ANVISA, represents a pivotal step in advancing our dengue vaccine project with Instituto Butantan and establishing a solid foundation to deliver on our shared commitment to expand access to high-quality dengue vaccines.”
Jian Dong, CEO of WuXi Vaccines
WuXi Vaccines noted that the collaboration supports manufacturing for the Butantan-DV dengue vaccine, which received ANVISA approval in November 2025 for use in individuals aged 12 to 59. The agreement further expands the company’s vaccine CDMO and contract manufacturing operations in Latin America.
