Canadian cannabis company spreads its wings in Australia
MediPharm Labs Corp. (TSX:LABS) (OTCQX: MEDIF) (FSE: MLZ) a global leader in specialised research-driven cannabis extraction, distillation and purification, was recently notified by the Australian Therapeutic Goods Administration (TGA) in relation to its its Canadian manufacturing facility meeting the requirements for Good Manufacturing Practice for Medicinal Products (GMP).
This was a key business breakthrough for MediPharm that increases its global manufacturing capabilities.
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 site was also successfully audited for chemical testing and analysis of cannabis as a medicine.
GMP Status: A Catalyst for Global Growth
MediPharm Labs received its certification less than 60 days from its TGA inspection, which was completed between 14-16 October, 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 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.
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.
“The announcement is a key business breakthrough for MediPharm Labs that reflects the tremendous scientific and production knowledge resident in our workforce and our rigorous design, monitoring and production control environments,” said Mr. McCutcheon. “This is a well-earned achievement shared by all members of our team and one that sets us up for the next era of international growth as a competitively advantaged company.”
About the Pharmaceutical Inspection Co-operation Scheme
PIC/S seeks to harmonise inspection procedures worldwide by developing common standards in the field of GMP and by providing training to inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. This is reflected in PIC/S’ mission, which is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products.
For more information, visit www.picscheme.org
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