Mr. David Pidduck reports
MEDIPHARM LABS ENTERS LANDMARK COMMERCIAL AGREEMENT WITH LABORATORIO TEUTO IN BRAZIL
Medipharm Labs Corp. has signed a commercial agreement with Laboratorio Teuto, a leading pharmaceutical manufacturer and marketer in Brazil. This partnership signifies a significant milestone as Medipharm expands its reach into one of the most tightly regulated medical cannabis markets globally.
ANVISA (Agencia Nacional de Vigilancia Sanitaria) product approval marks commercial milestone achievement
ANVISA granted Teuto sanitary authorizations for two products manufactured by Medipharm. The approvals, published on Dec. 30, 2024, mark the culmination of a rigorous process that underscores Medipharm's commitment to compliance, quality and innovation in the global medical cannabis space. Medipharm and Teuto have been working closely together on the ANVISA approvals, which included pharmaceutical-level product filings, extensive quality control documentation and responding to multiple requests for information over many months. Initial shipments are expected to begin in the new year after applicable import and export permits from ANVISA and Health Canada are received.
Brazil's medical cannabis market is known for its stringent regulatory requirements, including:
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ANVISA on-site GMP (good manufacturing practice) inspections -- ensuring adherence to the highest pharmaceutical standards;
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Comprehensive product dossier submissions -- requiring a minimum of 12 months of stability testing and rigorous quality assurance;
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Extended product approval timelines -- reflecting Brazil's commitment to patient safety and product efficacy.
There are currently only 36 valid cannabis product authorizations issued by ANVISA under RDC 327/2019.
Medipharm Labs is one of just a few North American companies with products to receive multiple sanitary authorizations for cannabis products while holding an ANVISA GMP licence. The Brazilian medical cannabis market is growing over 20 per cent annually and is projected to exceed $260-million by 2026. Teuto can use its existing deep roots in Brazil and sales and marketing expertise to position itself as a leader in pharmaceutical cannabis.
Teuto -- a trusted partner in Brazil
Teuto, a household name for trusted medicines in Brazil, boasts over 77 years of industry leadership. As one of the largest pharmaceutical companies in the country, Teuto operates a state-of-the-art manufacturing facility spanning over 140,000 square metres and produces more than 500 pharmaceutical products annually. Teuto's extensive distribution network, national sales force and commitment to quality make it an ideal partner for Medipharm as the company brings pharmaceutical-grade cannabis solutions to Brazilian patients. This agreement reflects Medipharm's strategic focus on leveraging its pharmaceutical GMP-certified platform to expand globally into large, complex and highly regulated markets. Medipharm's expertise aligns seamlessly with Teuto's vision to provide innovative health care solutions to the Brazilian market, including over 215 million people.
Management commentary
"Globally, we believe that the higher the regulatory bar, the more complex and stringent the quality standards are in a country, the better for Medipharm. Brazil is a perfect example of a large complex market, and we are very fortunate to have a long-term partnership with Teuto, one of the leading Brazilian pharmaceutical companies," said David Pidduck, chief executive officer at Medipharm Labs.
"Medical cannabis is an important product for our line of specialty care, increasing our relationship with physicians, completing our CNS [central nervous system] portfolio and oncology on palliative care. Our partnership with Medipharm will allow Teuto to grow faster in this market, bringing more full-spectrum products with the highest quality to Brazilian patients in need," said Marcelo Henriques, chief executive officer of Teuto.
About Medipharm Labs
Corp.
Founded in 2015, Medipharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (APIs) and advanced derivative products utilizing a GMP-certified facility with ISO (International Organization for Standardization) standard built clean rooms. Medipharm Labs has invested in an expert, research-driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities for delivery of pure, trusted and precision-dosed cannabis products for its customers. Medipharm Labs develops, formulates, processes, packages and distributes cannabis and advanced cannabinoid-based products to domestic and international medical markets.
In 2021, Medipharm Labs received a pharmaceutical drug establishment licence from Health Canada, becoming the only company in North America to hold a commercial-scale domestic GMP licence for the extraction of multiple natural cannabinoids. This GMP licence was the first step in the company's current foreign drug manufacturing site registration with the U.S. Food and Drug Administration.
In 2023, Medipharm acquired Vivo Cannabis Inc., which expanded Medipharm's reach to medical patients in Canada through the Canna Farms medical e-commerce platform and in Australia and Germany through Beacon Medical Pty. and Beacon Medical GmbH. This acquisition also included Harvest Medical Clinics in Canada, which provides medical cannabis patients with physician consultations for medical cannabis education and prescriptions.
The company carries out its operations in compliance with all applicable laws in the countries in which it operates.
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