MediPharm Labs has received a Drug Establishment Licence 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 licence for cannabis manufacturing in North America. A Canadian GMP DEL complements MediPharm Labs’ existing Australian TGA GMP certification. The licence 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.
In addition, as a member of the International Pharmaceutical Inspection Co-operation Scheme, the Health Canada DEL can be recognized in over 50 different countries including the US and the majority of the EU. 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. In 2020, 64% of drugs exported from Canadian Drug Establishment Licence holders were exported to the US with FDA approval. MediPharm Labs will use the DEL in conjunction with its Australian facility TGA GMP to optimize the supply chain via MRAs for export of its products to over five countries in 2021.
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.
“MediPharm Labs has achieved a great milestone with the issuance of our Drug Establishment Licence. This truly makes us a full-service pharmaceutical company that can support global pharma’s entry into the drugs containing cannabis space,” explained Keith Strachan, President and Interim CEO, MediPharm Labs. “This adds to our growing portfolio of advanced regulatory licences globally. MediPharm Labs now becomes one of a small number of companies who can take cannabis plant material and produce an API or a pharmaceutical drug product that could have marketing authorization by regulatory bodies such as the European Medicines Agency and FDA.”
For more information:
MediPharm Labs
151 John Street, Barrie
+1 705 719 7425
medipharmlabs.com