Anvisa grants sanitary authorization for new cannabidiol product from pharmaceutical company
Publication in the Official Gazette of this Monday (8) details the approval of the 100 mg/ml oral solution
Published on 12/08/2025
According to the official document, the product falls under the category of sanitary authorization for Cannabis products with a tetrahydrocannabinol (THC) concentration of up to 0.2%. Image: Canva Pro
The National Health Surveillance Agency (Anvisa) published, this Monday (8), the Resolution-RE No. 4,944 in the Official Gazette (DOU), granting sanitary authorization for a new Cannabis-based product from the company Endogen. The approval allows the commercialization of Endogen Cannabidiol in a concentration of 100 mg/ml.
According to the official document, the product falls under the category of sanitary authorization for Cannabis products with a tetrahydrocannabinol (THC) concentration of up to 0.2%. The approved presentation consists of an oral solution, available in a 30 ml plastic bottle accompanied by a dosing syringe.
The resolution establishes that the product's shelf life is 24 months. The sanitary authorization linked to the process (No. 25351.364747/2024-10) remains valid until December 2030.
"The product will help doctors address an increasing number of therapeutic indications and, at the same time, offer patients excellent cost-benefit, facilitating access to cannabinoid therapy," highlights Lukas Fischer, CEO of Endogen.
