MMJ Group Holdings Ltd (ASX:MMJ) investee MediPharm Labs Corp (TSX:LABS) (OTCQX:MEDIF) (FSE:MLZ) has received Australian Therapeutic Goods Administration (TGA) confirmation that its Canadian manufacturing facility meets the requirements for Good Manufacturing Practice for medicinal products.
This marks a key business breakthrough and will increase MediPharm’s global manufacturing capabilities.
The TGA is the branch of the Australian Government’s Department of Health responsible for regulating therapeutic goods, including prescription medicines, vaccines and medical devices.
Confirmation came after an intensive audit under the TGA’s clearance program for the overseas manufacture of medicine and Active Pharmaceutical Ingredients (APIs) for supply to Australia.
MediPharm Labs demonstrated that its state-of-the-art Canadian facility met the PIC/S GMP requirements as a Medicines Manufacturer of cannabis as a medicine (oral liquids) in accordance with Part I of the PIC/S GMP guide and cannabis as an API in accordance with Part II of the PIC/S GMP.
The site was also successfully audited for chemical testing and analysis of cannabis as a medicine.
MediPharm Labs received its certification less than 60 days from its TGA inspection, which was completed between October 14 and 16.
While the certificate was issued by Australia’s TGA to permit MediPharm Labs’ Canadian facility to deliver APIs and final medicinal products to the Australian medical cannabis market, upon MediPharm Labs’ Australian production facility receiving its GMP certificate, the company will be positioned to leverage a global supply chain to sell cannabis APIs and finished products to countries across Europe due to a Mutual Recognition Agreement between Australia and the EU.
MediPharm Labs chief executive officer Pat McCutcheon said: “I cannot overstate the importance and prestige of earning our first GMP certification.
“GMP certification is the ticket to gaining access to the rapidly growing global medical cannabis market and it is the recognised standard by which pharmaceutical manufacturers and consumer packaged goods companies worldwide judge their supply partners.
"We thank the TGA for being the first to formally recognise the quality of our facilities and processes.
"Although this certification specifically applies to the Australian market, it adds to a body of evidence that will assist us in our quest to obtain the EU-GMP certification to directly sell into the EU market.”
First for an extraction-only company in Canada
With the formal certificate now issued, MediPharm Labs is the first Canadian extraction-only cannabis company to announce TGA GMP certification, reflecting that the company’s Canadian facility was purpose-built to GMP standards.
This internationally recognised certification is only granted to companies that can demonstrate consistency, precision and quality in all stages of production and are able to comply with GMP principles for manufacturing Active Pharmaceutical Ingredients and final medicinal products.