Anvisa approves new pharmaceutical product based on cannabis in Brazil
Extract from the company Endogen expands the portfolio of options for medicinal treatments and already has sanitary authorization for commercialization
The National Health Surveillance Agency (Anvisa) has granted a new sanitary authorization for a cannabis-based product in the Brazilian market. The decision officially permits the company Endogen to market its Cannabis Sativa Extract.
The measure was published in the Official Gazette of the Union through Resolution-RE No. 3,450, dated September 5, 2025. The authorized extract has a concentration of 133.33 mg/mL and complies with the guidelines of RDC 327/2019, which regulates the commercialization of such products for medicinal purposes.
The authorization is specific to the formula with a tetrahydrocannabinol (THC) content of less than 0.2%. The product will be presented in a 30 mL bottle, accompanied by a dosing syringe to facilitate administration.
Expansion of therapeutic options
In a statement, Endogen reported that each bottle contains 3,000 mg of cannabidiol (CBD) and nearly 4,000 mg of extract with dominant cannabidiol. The approval of this cannabis-based product is an important step for medicine.
With this release, the portfolio of available medications under RDC 327 is expanded. This offers another safe therapeutic option for medical prescription in the treatment of various pathologies, reinforcing the relevance of cannabinoid use.