MediPharm Labs will supply premium, GMP-certified formulated cannabis oil to XLR8 BRAZIL, a Rio de Janeiro based value-added distributor serving Brazil, Latin America’s largest medical cannabis market.
Under the two-year agreement commencing from the time of product authorization, MediPharm Labs Inc. will provide a variety of cannabis concentrate formats for patient-ready formulated products that will be distributed by XLR8 to leading pharmacies and other authorized channels in Brazil. The initial product SKUS include a 20:1 CBD rich product and a 10:10 balanced THC and CBD formulation. XLR8 will obtain ANVISA Sanitary Product Authorization and undertake the process for final Product Registrations.
“By virtue of its large population, forward-thinking legislative eco-system and economic strength, Brazil is one of the world’s most promising medical cannabis markets and the natural next port of call for our international expansion and growth strategy,” said Pat McCutcheon, CEO of MediPharm Labs. “Given Brazil’s potential as one of our key target markets, we have chosen to partner with XLR8 because of their focus on quality and compliance, their extensive relationships with local healthcare professionals and dedicated focus on the advancement of medical cannabis scientific validation and education. They are the perfect complement to and outlet for our pharma-quality production.”
This is MediPharm Labs’ second distribution agreement in Latin America and evidence of growing international momentum with its strategy of targeting emerging jurisdictions that offer excellent opportunity for sustainable revenue expansion.
“As early participants in the Brazilian medical cannabis industry dating back to its involvement in the pioneering import of medical cannabis oil for patient use from Canada to Brazil in 2017, XLR8 is pleased to have entered into this supply agreement with one of the only PIC/S GMP certified manufacturers of medical cannabis derivatives,” says Mike Dacks of Type 2 Ventures who acts as a strategic advisor to XLR8. “We look forward to bringing these products to market and to working with ANVISA as well as our ecosystem of local partners to bring the required clinical validation for final Product Registrations under the new Brazilian legislative framework.”
“In our view, Brazil is destined to be a global powerhouse in medical cannabis,” said Thiago Callado, Founder and CEO of XLR8. “To make this exciting future a reality, Brazilians need reliable access to formulations that are constructed using proven methodologies that meet the most rigorous international standards of care. By aligning with MediPharm Labs, a company that has GMP certification, the veritable gold seal in pharma-grade production, XLR8 can now begin to fulfill our mission of market leadership.”
The Brazil’s Market
Using a range of pricing, consumption and patient datasets, the LATAM Cannabis Report™ by Prohibition Partners(1) forecasts that the LATAM market is expected to exceed US$12 billion by 2028, offering “serious growth potential to global cannabis companies.” Today, Brazil is the region’s largest addressable market with a population of nearly 210 million, and according to Prohibition Partners, Brazil could potentially have one of the world’s highest potential patient counts.
In December 2019, Brazil established a new legalized environment for the sale and consumption of cannabis for medical use. As part of the announcement by the National Agency for Health Surveillance of Brazil (“ANVISA”), a new class of medical cannabis products can be prescribed by doctors and sold through pharmacies, enabling safe and legal patient access.
The regulatory framework, valid for an initial three-year term, governs the manufacture and import of medical cannabis products as well as the requirements for commercialization, prescription, dispensing, monitoring and supervision. ANVISA’s rules apply to medicines whose therapeutic indication is restricted to patients with severe and/or life-threatening debilitating diseases and without alternative therapy.
Since 2015, ANVISA has allowed for the importation of cannabidiol-based medicines and other cannabinoids for “compassionate use”.
MediPharm Labs’ facilities were recently certified by the Australian Therapeutic Goods Administration (“TGA”) as meeting the GMP standard of production. The TGA is one of 53-members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Many PIC/S members enter into mutual recognition agreements whereby each participating country’s regulatory authority specifically recognizes certain processes and procedures of the other country to expedite the international flow of goods. For cannabis extracts, Brazil requires PIC/S GMP certification for foreign produced goods and recognizes MediPharm Labs’ TGA GMP certification. XLR8 intends to obtain its ANVISA Sanitary Authorization and approvals required for importation.
For more information:
MediPharm Labs
151 John Street, Barrie
+1 705 719 7425
medipharmlabs.com