Adimmune Corporation announced yesterday (26th) that it has received official notification from Brazil’s National Health Surveillance Agency (ANVISA) confirming Good Manufacturing Practice (GMP) certification. The company stated that this certification marks a significant milestone in advancing its influenza vaccine registration process in Brazil. Adimmune expects to obtain regulatory approval for its influenza vaccine in Brazil by the end of 2026, enabling its formal entry into the Southern Hemisphere market.

This is Adimmune’s second GMP certification from Brazil. The first was granted in 2017, when the company partnered internationally to manufacture Sanofi vaccines and successfully passed ANVISA’s inspection with outstanding results. This year’s GMP audit was triggered by Adimmune’s submission at the end of 2023 for market authorization of its quadrivalent influenza vaccine in Brazil. In June, an ANVISA inspection team visited Adimmune’s Tanzi manufacturing facility to conduct an on-site review of its influenza vaccine production processes. The audit was successfully completed, and on August 25, ANVISA issued the GMP certification.

Adimmune emphasized that securing Brazil’s GMP certification once again not only reaffirms the quality of domestically manufactured vaccines, but also represents a major step forward in the regulatory approval process of its influenza vaccine in Brazil. The company remains confident in obtaining marketing authorization by the end of 2026. This will enable Adimmune’s influenza plant, which currently produces only Northern Hemisphere influenza vaccines, to maximize production capacity while also paving the way for Taiwan-made influenza vaccines to enter the Southern Hemisphere market. Brazil, as the most populous country in the Southern Hemisphere and a key nation for vaccine promotion, holds strategic importance for Adimmune’s expansion.

Adimmune is actively seeking partners in Brazil to promote its Southern Hemisphere influenza vaccine business. The company noted that it is closely monitoring the upcoming announcement by the World Health Organization (WHO) in late September regarding the influenza strains recommended for the Southern Hemisphere. Commercial batch production could begin as early as the end of next year, with full-scale utilization of its influenza plant expected by 2027, contributing significantly to the company’s revenue.

Resource: 國光生再獲巴西GMP認證 南半球流感領證跨大步