CBD-based pharmaceutical company MediPharm Labs Corp. LABS MEDIF 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.
"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."
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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
The Benzinga Cannabis Capital Conference is coming to Florida
The Benzinga Cannabis Capital Conference is returning to Florida, in a new venue in Hollywood, on April 16 and 17, 2024. The two-day event at The Diplomat Beach Resort will be a chance for entrepreneurs, both large and small, to network, learn and grow. Renowned for its trendsetting abilities and influence on the future of cannabis, mark your calendars – this conference is the go-to event of the year for the cannabis world.