-- Completed a Drug Master File ("DMF") process for CBD Active Pharmaceutical Ingredient ("API") for the US Federal Drug Administration ("FDA"). -- Use of Canadian Drug Establishment Licence ("DEL") to register API with the FDA for commercial opportunities in pharmaceutical development, novel drugs and generic drugs. -- The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025(i). -- This is the only US FDA for CBD by a Canadian company and the second natural CBD DMF at commercial scale in all of North America(ii). TORONTO, Feb. 23, 2022 /CNW/ - MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) ("MediPharm" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has completed a US FDA DMF for pure natural CBD API. The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research. The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025, and there are over 20 strong novel cannabinoid-based drugs currently in the late-stage research process. These projects will all require pharmaceutical approved API if commercialized. MediPharm has already shipped good manufacturing practice ("GMP") CBD for development purposes to multiple established pharmaceutical companies.
Management Commentary
Bryan Howcroft, CEO, MediPharm, commented, "The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API 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. In the short to medium term, the DMF unlocks new sales channels and will enable us to further leverage the investments made to date on our high-quality pharmaceutical manufacturing platform. Over the longer-term, it ensures the Company is positioned as the go-to cannabinoid partner for pharmaceutical companies around the world."