MediPharm Labs Corp. MEDIF LABS MLZ has made its first delivery to the United States, and has completed the US FDA drug API manufacturer inspection at the company's Barrie, Ontario facility.
First Delivery of Pharmaceutical Cannabis Product to the US
On July 28, 2023, MediPharm completed a commercial shipment of cannabis clinical trial materials to the US, for use in an NIH funded clinical trial. This clinical trial material is finished good cannabis oil that contains both CBD and THC. To the company's knowledge, this is the first phase 2 clinical trial of its kind sourced from a Canadian Licensed Producer.
The process relied on MediPharm's GMP Drug Establishment License, product stability data, US FDA Innovative New Drug Approval, and US DEA narcotic import approval.
US FDA Status Update
MediPharm completed a US FDA five day in-person inspection from November 21 to 25, 2022. This was initiated in relation to MediPharm's cannabidiol active pharmaceutical ingredient (API) drug master file (DMF) being referenced in an abbreviated new drug application (ANDA) submitted to the FDA in September 2023 by a global pharmaceutical company. Following the inspection, MediPharm was presented with inspection observations. MediPharm has responded in writing to all observations via a corrective action plan. These actions have now been implemented and any additional FDA feedback is expected by way of comments on the company's DMF and partner's ANDA filings. As this process is completed, MediPharm continues to be a registered foreign drug manufacturing site with the US FDA. The company believes it is the only Canadian Pharmaceutical company or LP with this registration.
The full acceptance of MediPharm's API DMF, of which the FDA inspection is a major step, allows for a number of commercial opportunities for the company. This will allow MediPharm to further market cannabidiol API to pharmaceutical companies for new novel drugs, generic drugs, modified generics drugs (FDA 505(b)(2)), and clinical trial materials.
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Photo by Esteban López on Unsplash
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