A Brains Bioceutical Corporation, a company based in Vancouver, Canada, will supply the raw material to produce the first Brazilian cannabis drug approved by Anvisa. The pharmaceutical company authorized to market the phytopharmaceutical is Prati-Donaduzzi, from Paraná, which will have to import the extract, since the cultivation of cannabis has not been authorized in Brazil.
The product will be an oral solution of cannabidiol (CBD) in a 30 ml bottle, with a concentration of 200 mg/ml and <0,2% THC. The company did not disclose the value for which the product will be sold to pharmacies and distributors. However, according to a medical source in Paraná heard by CannaReporter, the oil will be sold to pharmacies for around 300 euros. “I received a visit from a sales representative (from Prati-Donaduzzi). She knew I was prescribing (cannabis) and came to visit me to show them their product.”
Anvisa does not consider CBD a medicine
The authorized oil is not considered a medicine by Anvisa, but a separate category, “Products with Cannabis”. It was the solution that the agency found so that plant derivatives could enter the market faster, without going through clinical tests, which take years. For this reason, the price of the product will not need approval from the Brazilian Medicines Market Regulation Chamber, being the responsibility of the pharmaceutical company itself.
According to Prati-Donaduzzi, the oil will be produced at the pharmaceutical factory in the city of Toledo, in the interior of Paraná. The expectation is that the product will be available in pharmacies before Mother's Day in Brazil, May 10.
Brains Bioceutical presents itself as the global leader in the production of Active Pharmaceutical Ingredients (API) based on pharmaceutical, wellness and veterinary cannabidiol. The company will export the European GMP API from the UK to the Brazilian pharmaceutical company to formulate the product that will be sold in pharmacies and distributors. In a statement, the company announced the partnership as “a historic achievement to bring the first registered medical cannabis product to Brazil”.
“Our partners in Brazil are global leaders in pharmaceutical production and clinical trials. I am very proud of this historic moment, in which we combined our strengths to create the first product registered under the new regime. The standard we set for Brains' team of world-renowned scientists and executives continues to achieve benchmarks with a relentless pursuit of historic innovations in the CBD sector. We look forward to capitalizing on the resulting market opportunities. We have now registered the CBD product in the epicenter of the European continent in the UK and supplied the CBD material to our South American partner to obtain the first cannabis product registered under the new Anvisa regulations in Brazil. ” concluded Rick Brar, President and CEO of Brains Bioceutical.
________________________________________________________________
Featured Image: Michal Wozniak @ Unsplash