MediPharm Labs, a Canadian pharmaceutical company specializing in cannabis, just made its first delivery of clinical trial materials to the U.S. on July 28.
The materials are finished goods cannabis oils that contain both CBD and THC. This is the first Phase 2 clinical trial of its kind sourced from a Canadian Licensed Producer.
In a news release, MediPharm said the export process relied on:
- Its Drug Establishment License and product stability data.
- The United States’ Innovative New Drug Approval.
- U.S. Drug Enforcement Administration import approval.
“This development is significant as the majority of cannabis operators in the U.S. are operating under state specific regulations that prohibit them from manufacturing for FDA sanctioned research activities and DEA approved shipments under federal narcotic laws,” MediPharm’s release noted.
MediPharm Labs’ U.S. FDA Update
The news release also mentioned how MediPharm completed a U.S. FDA five day in-person inspection from November 21-25, 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, to which the company then devised a corrective action plan to address. The FDA inspection is a major step and allows for a slew of new opportunities for the pharmaceutical company, such as allowing it 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.
