WuXi Vaccines earns Brazil’s ANVISA GMP certification for fill-finish site

The facility in Suzhou, China, which also passed an EU audit in 2024, will support commercial production of the dengue vaccine for Brazil.

Feb. 13, 2026

2 min read

Exterior shot of WuXi building in Suzhou, China

WuXi Vaccines, a contract development and manufacturing organization and wholly owned subsidiary of WuXi Biologics headquartered in Shanghai, China, received Good Manufacturing Practices certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) for its DP17 fill-finish facility in Suzhou, according to the company.

The commercial facility provides liquid and lyophilized fill-finish capabilities along with quality assurance, quality control, warehousing, and utilities. The site also passed a European Union Qualified Person audit in 2024, according to the announcement.

WuXi Vaccines said the certification followed on-site inspections and enables the site to support commercial manufacturing for Instituto Butantan, a Brazilian biomedical research center and vaccine producer, and Fundação Butantan, its affiliated nonprofit foundation that supports vaccine development and distribution. The work is tied to the partners’ dengue vaccine program intended for use in Brazil.

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 dengue vaccine. The partnership is intended to scale production to deliver millions of doses for Brazil’s population. The single-dose vaccine received ANVISA approval in November 2025 for individuals ages 12 to 59, according to the company.

“We are very excited to achieve our first regulatory milestone at our Suzhou site. It not only validates the excellence of our world-class quality system, but also underscores our shared commitment with Instituto Butantan to enhancing access to high-quality dengue vaccines,” WuXi Vaccines CEO Jian Dong said in a statement.

In related developments, parent company WuXi Biologics recently signed a license and research service agreement with Vertex Pharmaceuticals for a preclinical trispecific T-cell engager program. The company also reported collaborations with Sinorda Biomedicine for a bispecific antibody program and with HanchorBio to support CMC execution and GMP manufacturing for multiple fusion protein programs.

This piece was created with the help of generative AI tools and edited by our content team for clarity and accuracy.