Anvisa approves new cannabis-based product in Brazil
Pharmaceutical company Ephar has obtained registration for its Cannabidiol in two concentrations, 50 mg/mL and 100 mg/mL, which will be marketed in a low THC content drop solution.
The National Health Surveillance Agency (Anvisa) granted sanitary authorization for another medicinal product based on Cannabis in Brazil. The new permission was granted to the company Ephar Pesquisa e Desenvolvimento LTDA. for the commercialization of its Cannabidiol in two concentrations.
The decision was officially published in the Official Gazette of the Union through Resolution-RE No. 3,976, dated October 9, 2025. The authorized products are Cannabidiol Ephar 50 mg/mL and Cannabidiol Ephar 100 mg/mL. Both formulations comply with the guidelines of RDC 327/2019, which establishes the criteria for the commercialization of such products for medicinal purposes in the country.
The authorization is specific to formulas with tetrahydrocannabinol (THC) content of up to 0.2%. The products will be presented in oral solution (drops), in 30 ml bottles, to facilitate administration to patients.