WuXi’s Facility in China Receives Brazilian GMP Certification for Dengue Vaccine Manufacturing

CDMO WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, reports that its drug substance facility (MFG23) located in Suzhou, China, has received GMP certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA). The facility provides integrated manufacturing services for Instituto Butantan’s dengue vaccine (Butantan-DV) production project.

“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,” said Jian Dong, CEO of WuXi Vaccines. “Adhered to premier quality standards and powered by our integrated solutions and technologies, we remain committed to driving greater access to safe, effective, and affordable vaccines worldwide.”

Based on the 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 5-dose dengue vaccine, according to Dong. The partnership plans to rapidly scale up vaccine capacity, aiming to deliver millions of doses to shield Brazil’s population from dengue. In November 2025, the single-dose Butantan-DV received ANVISA approval for use with individuals aged 12 to 59.

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