Canada’s MediPharm Labs Corp. announced late last week its Australian subsidiary has been granted GMP Certification and Licence to Manufacture Therapeutic Goods by Australia’s Therapeutic Goods Administration (TGA).
Good Manufacturing Practice (“GMP”) is a system ensuring pharmaceutical products are produced and controlled according to quality standards consistently.
Medipharm Labs CEO Asia Pacific Warren Everitt, said the certification and licence for Medipharm Labs Australia now clears the way for the company to accelerate its activities, both locally and abroad; plus begin fulfilling customer orders of finished products.
“MediPharm Labs Australia can now serve as a key link in the Company’s international GMP-compliant supply chain complementing our state-of-the-art GMP certified facility in Canada,” said Mr. Everitt.
CEO of Medipharm Labs Pat McCutcheon stated the TGA has mutual recognition agreements with various other PIC/S members*, so products manufactured in Australia will satisfy requirements in those jurisdictions where the company intends seeking import permits for its products.
It’s been a busy few weeks for MediPharm Labs Australia. Last week we reported the company had signed its second white-label supply agreement with New Zealand medical cannabis companies, following a 3-year white-label supply agreement with an Australian company.
MediPharm Labs Australia’s cannabis extraction facility in Wonthaggi, Victoria was opened last year and built to the same standards to mirror the company’s Canadian facility. The plant will service Australia’s medical cannabis industry while also being an import-export hub for the Asia-Pacific region. Under the new licence, MediPharm Labs Australia is permitted to store cannabis resin as an Active Pharmaceutical Ingredient (“API”) and can carry out packaging, storage and release for supply activities as a Medicine Manufacturer of Oral Liquids.
The company also holds an Office of Drug Control (ODC) issued Cannabis Manufacturing Licence and the necessary Import and Export Licences.
Last year Medipharm Labs generated CAD $129.3M in revenue across its operations, a 1,168% increase vs. $10.2M in 2018. It’ gross profit before tax was $42.9M in FY/19, a 973% increase vs. $4M in 2018. While its net income before tax was a loss of $6.8 million, it was a significant improvement on the $8.5 million loss in 2018.
*Australia’s Therapeutics Goods Administration is one of 53 regulatory authority members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
