Big Step Forward for Dengue Vaccine Production
WuXi Vaccines has received Good Manufacturing Practices (GMP) certification from Agência Nacional de Vigilância Sanitária, also known as ANVISA, for its drug substance manufacturing facility in Suzhou, China.
This approval is important because the facility is helping produce the dengue vaccine for Instituto Butantan, one of Brazil’s leading public health institutions.
The certified facility is called MFG23. It is used for commercial drug substance manufacturing and plays a major role in the production of the dengue vaccine project known as Butantan-DV.
What ANVISA Inspected
Before giving the GMP certification, ANVISA carried out detailed inspections at the Suzhou site. The inspection covered several important areas, including:
This is the second GMP certification received from ANVISA for the dengue vaccine project.
Earlier, in February 2026, the drug product manufacturing facility called DP17 at the same Suzhou site also received ANVISA GMP approval.
Why This Certification Matters
This approval helps move the dengue vaccine project closer to large-scale commercial supply in Brazil.
Dengue fever continues to be a major public health problem in many parts of the world, especially in Brazil and other tropical countries. Because of this, increasing vaccine production capacity has become very important.
The partnership between WuXi Vaccines and Instituto Butantan aims to manufacture millions of vaccine doses to help protect people from dengue infections.
The project is especially important because the vaccine has already received regulatory approval in Brazil.
In November 2025, the single-dose Butantan-DV vaccine was approved by ANVISA for people aged 12 to 59 years.
What WuXi Vaccines Said
Jian Dong, CEO of WuXi Vaccines, said the GMP certification is an important milestone for the company and for its partnership with Instituto Butantan.
According to him, the approval strengthens their shared goal of improving access to high-quality dengue vaccines. He also explained that the company will continue focusing on safe, effective, and affordable vaccine manufacturing using integrated technologies and quality standards.
What Services WuXi Vaccines Will Provide
Under the commercial manufacturing agreement signed with Instituto Butantan and Fundação Butantan, WuXi Vaccines will provide complete end-to-end manufacturing support for the dengue vaccine project.
The company’s responsibilities include:
The vaccine project involves a five-dose dengue vaccine manufacturing program that will support Brazil’s growing healthcare needs.
About WuXi Vaccines
WuXi Biologics owns WuXi Vaccines as a wholly-owned subsidiary.
WuXi Vaccines works as a contract development and manufacturing organization (CDMO) focused on vaccines and preventive antibodies.
The company supports vaccine development and commercial manufacturing for different vaccine technologies, including:
The company provides integrated development and manufacturing services to help vaccine partners move products from development stages to commercial launch faster.
Conclusion
The ANVISA GMP certification for WuXi Vaccines’ MFG23 facility is a major development for the global dengue vaccine market. It strengthens the manufacturing partnership between WuXi Vaccines and Instituto Butantan and supports Brazil’s efforts to improve dengue prevention.
With both drug substance and drug product facilities now approved by ANVISA, the project is moving closer to large-scale vaccine production that could help millions of people in Brazil.