MediPharm Labs announced the receipt of GMP certification for their Barrie, Ontario facility from ANVISA, the governing body of Brazil’s pharmaceutical industry. MediPharm Labs now has GMP certification from the United States FDA, European Union, and Australia’s TGA and holds a drug establishment license from Health Canada.
Commercial opportunity
This ANVISA GMP certification inspection is the first of its kind for a purpose-built cannabis facility in North America and rare for a global GMP facility that manufactures botanical CBD and THC. The ANVISA GMP certification further solidifies MediPharm’s position as a global leader in the development and production of pharmaceutical cannabinoids. The ANVISA GMP means Brazilian patients can now purchase products that adhere to the strictest manufacturing processes completed in an ANVISA-accredited facility. This distinction will provide further access to the Brazilian medical cannabis market as well as facilitate access to additional global markets that recognize MediPharm’s growing list of pharmaceutical certifications.
The Brazilian medical cannabis market is expected to reach $380 million CAD in 2025, according to a 2023 report by industry observer Kaya Mind.
MediPharm Labs currently manufactures two medical cannabis products with full ANVISA product authorization under Brazil’s Resolution 327/19, which governs high-value prescription cannabis products in Brazil. Additional product authorizations are currently under review with ANVISA.
In addition to existing Brazilian customers, the Company entered into a supply agreement with a top-tier generic pharmaceutical company in Brazil in July 2023. Since signing the agreement, the customer has applied to ANVISA for a number of MediPharm-produced cannabis product marketing authorizations. The receipt of GMP certification is a key milestone and critical required element of the rigorous ANVISA Pharma product approval process.
GMP certification details
The five-day in-person inspection, completed in December 2023, was initiated in relation to MediPharm’s current medical cannabis product authorizations through its Brazilian customer base. A product authorization was only possible based on the Company’s Health Canada pharmaceutical Drug Establishment License, product-specific GMP validation, and various long-term stability studies.
The inspection focused on MediPharm’s quality management system and manufacturing capabilities for finished goods in relation to ANVISA GMP regulations, which have an international pharmaceutical industry reputation of strict compliance. Following the inspection, MediPharm was presented with observations. MediPharm responded in writing to all observations via a voluntary corrective action plan. Brazilian clients and ANVISA accepted these actions, resulting in a compliant GMP status.
Management commentary
“This GMP certification from Brazil strengthens MediPharm’s position as one of the most pharmaceutically focused medical cannabis companies in the world. The certification joins our long list of global regulatory achievements, including US FDA, Australian TGA, European Union pharmaceutical GMP, and Canadian pharmaceutical GMP authorizations. Whether it is the production of cannabis-based drug research, international cannabis medical programs, or future marketable cannabis drugs, MediPharm has invested in and executed the development of global pharmaceutical and medical channels. We believe this positions us well for future growth with a suite of capabilities, certifications, and approvals unmatched globally,” commented David Pidduck, MediPharm Labs CEO.
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MediPharm Labs
medipharmlabs.com