MediPharm Labs has announced that the Australian Therapeutic Goods Administration (the “TGA”) has notified the Company that its Canadian manufacturing facility meets the requirements for Good Manufacturing Practice for Medicinal Products (“GMP”).
The TGA is the branch of the of the Australian Government’s Department of Health responsible for regulating therapeutic goods including prescription medicines, vaccines and medical devices, and is one of 52 regulatory authority members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international co-operative that harmonizes GMP standards and quality systems of inspectorates in the field of medicinal products.
"During 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 both 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 team with the company explains. "The site was also successfully audited for chemical testing and analysis of cannabis as a medicine."
GMP Status: A Catalyst for Global Growth
According to the company, MediPharm Labs received its certification less than 60 days from its TGA inspection, which was completed between October 14-16, 2019. "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 the EU, including Germany, due to a Mutual Recognition Agreement between Australia and the EU."
“I cannot overstate the importance and prestige of earning our first GMP certification,” said Pat McCutcheon, Chief Executive Officer of MediPharm Labs. “GMP certification is the ticket to gaining access to the rapidly growing global medical cannabis market. And it is the recognized 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 recognize 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," they further explain. "This internationally recognized 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."
"MediPharm Labs’ 70,000 square foot Canadian production facility in Canada features ISO standard built clean rooms, critical environments laboratories, commercial-scale distillation and chromatography R&D as well as multi-phase supercritical CO2 primary extraction lines. The facility was built to be scalable and to serve markets inside and outside Canada. MediPharm Labs is permitted to conduct controlled human administration trials of dried cannabis, cannabis extracts and concentrates, distillates, oil, edibles, topicals and terpenes before they are used in the downstream formulation process as a result of receiving its Cannabis Research Licence under Health Canada’s Cannabis Act and Cannabis Regulations in October 2019."
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