- It is the first full-spectrum extract manufactured locally and approved by the regulatory agency;
- Studies indicate that the product may bring benefits in the treatment of fibromyalgia, dementia and chronic pain.
SÃO PAULO, Jan. 24, 2024 /PRNewswire/ -- Ease Labs Pharma, a GMP Certified Pharmaceutical Company pioneer in the Cannabis market in Brazil, has just received the approval from the Brazilian Health Regulatory Agency to commercialize the Cannabis sativa Extract locally, containing 750mg (25mg/mL) of CBD, up-to 0.2% THC, and other cannabinoids - a full-spectrum extract, that was developed and formulated at the pharmaceutical facility, located in Belo Horizonte (MG). The product will be available for sale in pharmacies, with a medical prescription, from March this year.
Brazil's current regulation for pharmaceutical Cannabis was approved in 2019, which classifies cannabinoids as pharmaceutical drugs, and requires complex safety data and restricted pharmaceutical certifications to enable production, registration and sale in pharmacies. According to Kaya Mind, the market has grown substantially - 96% from 2022 to 2023, reaching $140M and is expected to double in 2024 with the distribution of products by the government and entry of big-pharma companies.
"It is the first product containing THC manufactured in Brazil approved by Anvisa, which will help patients with different diseases. The approval was possible because of our strict safety and quality standards, our team's outstanding technical expertise and our agility," explains Gustavo Palhares, Ease Labs CEO and co-founder. According to him, until now, patients were relying exclusively on imported products that are sold at much higher prices.
The full-spectrum Cannabis extract preserves various components of the plant and brings a variety of phytocannabinoids in addition to CBD and THC. The product was approved at all safety and quality tests required within GMP standards, at affordable prices - lower than currently practiced, with imported extracts - with discounts representing a reduction between 40% and 70%.
"Scientific studies indicate that Cannabis extracts can bring benefits in conditions such as fibromyalgia, dementia and chronic pain," says Flávia Guimarães, head of the Scientific Intelligence (SI) area at Ease Labs, who highlights that the doctor will always be responsible for prescribing the treatment.
This is the third product approved in Brazil by Ease Labs. In 2023, the company started selling CBD isolate in pharmacies across the country - It currently sells the product in more than 4K, in 27 states.
CONTACT:
Giuliana Gonçalves
e-mail: giuliana.goncalves@nr7.ag
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