MediPharm Labs Corp., a pharmaceutical company specialized in research-driven development and manufacturing of cannabis API and finished products, has received a Drug Establishment Licence (the “DEL”) issued by Health Canada in accordance with the Food and Drugs Act and Regulations. The DEL serves to confirm compliance to Good Manufacturing Practice (“GMP”) standards.
The DEL is a first-of-its-kind license for cannabis manufacturing in North America. A Canadian GMP DEL complements MediPharm Labs’ existing Australian TGA GMP certification. The license can be used for the manufacturing, testing and sale of Active Pharmaceutical Ingredients (“API”) and pharmaceutical drug products containing cannabis. This includes drugs that have marketing authorizations as either novel or generic pharmaceutical drug products containing cannabis.
The DEL allows MediPharm Labs to leverage the Mutual Recognition Agreements (“MRA”) established between Canada and other global regulatory authorities including the European Economic Area consisting of all EU member states as well as the three countries of the European Free Trade Association, Australia, the UK and Switzerland. This differentiates MediPharm Labs from other Canadian cannabis manufacturers.
With the DEL, MediPharm Labs would be eligible for a US Food and Drug Administration (“FDA”) foreign inspection if a US or other global pharmaceutical customer files a registration application for a pharmaceutical drug product containing MediPharm Labs’ API
When paired with MediPharm Labs’ existing Cannabis Drug Licence received earlier this year, the DEL will allow for the commercial distribution of drugs containing cannabis. With many global pharmaceutical trials underway in which cannabis is an active ingredient, many drug producers will need a manufacturing partner. MediPharm Labs is now strategically positioned to provide that service to all global pharma partners. This includes clinical trial material, which MediPharm Labs already supplies to researchers, and pharmaceutical drug products. Physician-prescribed pharmaceutical drug products containing cannabis are being used to treat various indications around the world and will continue to grow with additional new drugs and abbreviated new drug applications. Grandview Research predicts this segment of the pharmaceutical industry will be a $5.8 billion (USD) market by 2027.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox!
Sign up now!