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.
Published on 10/14/2025
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. Image: Canva Pro
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.
