WuXi Vaccines Receives Brazil's ANVISA GMP Certification

SUZHOU, China, Feb. 11, 2026 /PRNewswire/ -- WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, dedicated to vaccine Contract Development and Manufacturing Organization (CDMO), announced today that it has received Good Manufacturing Practices (GMP) certification for its fill and finish facility (DP17) in Suzhou from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA). The facility is providing integrated manufacturing services for Instituto Butantan's dengue vaccine (Butantan-DV) production project.

Following comprehensive on-site inspections of DP17, a commercial fill and finish facility with both liquid and lyo capabilities, as well as QA, QC, warehouse and utilities, the GMP certification was granted. The Suzhou site previously passed the EU Qualified Person (QP) audit in 2024.

Jian Dong, CEO of WuXi Vaccines, commented, "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. Adhering to premier quality standards and providing end-to-end services with our integrated technologies, we remain committed to enabling greater vaccine accessibility and affordability for the global public health community."

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. The partnership will rapidly scale up vaccine capacity to help protect Brazil's population from dengue, with a goal to deliver several millions of doses. In November 2025, the single-dose Butantan-DV received ANVISA approval for use with individuals aged 12 to 59.

About WuXi Vaccines

WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, is a leading contract development and manufacturing organization (CDMO) that focuses on vaccine and preventive antibody's development and manufacturing. It provides world-class, integrated development and manufacturing platforms to expedite partners' vaccines and preventive antibodies to the clinical stage and the market, regardless of the modality (i.e., recombinant protein, viral, viral vectored, VLP, OMV, nucleic acid, conjugated vaccines). With its technical expertise, broad regulatory knowledge, premium quality system, advanced CMC development capabilities, multiple production platforms (cell culture, viral, microbial, polysaccharide and protein conjugation), and extensive GMP manufacturing capacities, WuXi Vaccines provides an end-to-end service – from vaccine development to large-scale commercial production and distribution. The company can enable global clients to deliver critical vaccines and preventive antibodies anywhere in the world, making it an essential partner in protecting public health. For more information about WuXi Vaccines, please visit: https://wuxivaccines.com.

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SOURCE WuXi Vaccines