CBD-based pharmaceutical company MediPharm Labs Corp. (TSX:LABS) (OTCQX:MEDIF) (FSE: MLZ) has completed a Drug Master File (DMF) process for CBD Active Pharmaceutical Ingredient (API) for the US Federal Drug Administration (FDA).
Why It Matters?
The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research.
Currently, 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.
The Toronto-based company said that it has already shipped good manufacturing practice CBD for development purposes to multiple established pharmaceutical companies.
Management Commentary
"The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API to pharmaceutical companies,” Bryan Howcroft, CEO of MediPharm, commented. “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."
Additional Information
DMFs are regulatory submissions filed with the FDA containing confidential, detailed information about manufacturing, processes, packaging, and stability of APIs to be used in medicinal products for human use.
Once the DMF filing is accepted by the FDA, pharmaceutical companies can reference the DMF when making a regulatory submission.
Photo: Courtesy of Hal Gatewood on Unsplash
