MediPharm Labs Receives Canadian GMP Pharmaceutical DEL

MediPharm Labs Corp., a pharma company specialized in research-driven development and manufacturing of cannabis API and finished products, received a Drug Establishment License (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.

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 U.S. and the majority of the EU.

“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.”