Canadian drug developer MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) says it’s set to be the first Canadian player entering the United States’ cannabinoid-based medicine industry, after registering a pharmaceutical-grade CBD extraction with the Federal Drug Administration.
On Wednesday, the Toronto-based company said it has completed a drug master file application for a CBD-based active pharmaceutical ingredient (API) for the FDA. Once the master file is accepted by the FDA, pharmaceutical companies can reference it when making a regulatory submission.
The company used its Canadian drug establishment licence to register the API with the FDA, for commercial opportunities in new drug development.
Medipharm received the licence in 2021 from Health Canada, making it the first company to hold a domestic GMP licence for extracting natural cannabinoids.
The cannabis-based drug market is forecasted to be worth over US$25 million by 2025, according to Prohibition Partners.
CEO Bryan Howcroft says filing the drug advances his firm’s objective of becoming a dominant supplier of APIs to pharmaceutical companies.
“This is a high-value, high-margin opportunity, and with the only purpose-built facility in North America to receive a domestic GMP licence specifically for the extraction of natural cannabinoids, MediPharm is positioned to capture share in this growing market,” he said in a statement.
In the short-to-medium term, the drug master file unlocks new sales channels and allows the company to leverage investments made in its high-quality manufacturing platform, Howcroft says.
The company was recently approved by Health Canada to run the first clinical trials testing the efficacy and safety of two CBD-dominant oils for treating insomnia in people suffering from major depressive disorder.
MediPharm produces and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets for wholesale and white-label platforms.