MediPharm Labs receives Canadian GMP pharmaceutical licence
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.
Alcohol & Cannabis
BARRIE — MediPharm Labs Corp., a pharmaceutical company specialized in research-driven development and the manufacturing of cannabis API and finished products, announces that it 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 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 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 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 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.
“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.