MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a global leader in specialized, research-driven cannabis extraction, distillation, purification and cannabinoid isolation, is pleased to announce the receipt of a key importation licence for its Australian business. This licence is a critical step to building the Company’s international supply chain that will be used to create additional synergies between MediPharm Labs’ Canadian and Australian operations.
The Australian Department of Health, Drug Control Section has issued an import licence to MediPharm Labs Australia Pty. Ltd. (“MediPharm Labs Australia”), a subsidiary of MediPharm Labs, for the importation of drugs listed in Schedule 4 of the Customs (Prohibited Imports) Regulations 1956, which includes cannabis, cannabinoids and cannabis resin. Upon the receipt of the applicable import permits, this licence will allow for the importation of cannabis, cannabinoids and cannabis resin from MediPharm Labs in Canada, and other global authorized exporters, for finalization into tinctures and other product forms in Australia.
“Receiving this licence is an important milestone as we continue to build a multi-jurisdictional GMP-certified pharmaceutical-quality platform to serve the world’s most attractive medical cannabis markets”, said Pat McCutcheon, Chief Executive Officer of MediPharm Labs. “With the initial phases of our Australian facility built-out, we are on track to establishing a global cannabis supply chain leveraging our GMP-certified Canadian facility, technology and access to high quality, fully traceable, cannabis biomass converted to pharma quality concentrates in Canada, to supply MediPharm Labs Australia, its local market, and other permissible global jurisdictions.”
Upon MediPharm Labs Australia receiving its GMP certificate from the Therapeutic Goods Association (“TGA”), 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.
Australia is one of the 49 member countries of Pharmaceutical Inspection Co-operation Scheme (PIC/S), TGA GMP certification could also allow for the easier movement of global product. For example, in Brazil, where new cannabis regulations will be effective April 2020, the Agência Nacional de Vigilância Sanitária (ANVISA) has stated that PIC/s approved cannabis facilities will be permitted to import medical cannabis into the Brazilian market. This recognition will be in effect until 2022 at which time ANVISA will develop their own GMP certification program for international cannabis imports.
Progress in Australia
Australian Facility GMP and Commercialization – Since receiving its State Licences for cannabis substances from the Victorian Department of Health and Human Services, and finishing the initial phases of construction of its 10,000 sq. ft. specialized extraction facility in Wonthaggi in December 2019, MediPharm Labs Australia has completed the first of two stages of a TGA Audit (related to its storage facilities and release for supply) and submitted an evidence package in January 2020. The next TGA Audits of its full production capabilities (including laboratory) are expected in the first half of 2020. This positions the facility to receive Australian GMP certification and full production by H2 2020.
As part of the stepwise build out of its facility, MediPharm Labs Australia recently operationalized its multi-phase supercritical CO2 extraction equipment, installed and started Installation Qualification and Operational Qualification of its vacuum ovens and milling machines, and is in the process of qualifying its softgel capsule filling equipment.
Canadian Facility GMP and Export Readiness – On December 13, 2019, the Company received notification from the Australian TGA that its Canadian manufacturing facility met the requirements for GMP as a Medicines Manufacturer of both Cannabis as a Medicine (oral liquids) and Cannabis as an Active Pharmaceutical Ingredient (“API”). Although this certification specifically applies to the Australian market, it adds to a body of evidence that will assist MediPharm Labs qualifying to supply other medical cannabis markets globally.
About MediPharm Labs
Founded in 2015, MediPharm Labs specializes in the production of purified, pharmaceutical quality cannabis oil and concentrates and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets. As a global leader, MediPharm Labs has completed commercial exports to Australia and is nearing commercialization of its Australian extraction facility. MediPharm Labs Australia was established in 2017.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION:
This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, importation of drugs (including various forms of cannabis) by MediPharm Labs Australia, receipt of importation permits by MediPharm Labs Australia, realization of synergies between MediPharm Labs and MediPharm Labs Australia, finalization of cannabis products within Australia, serving the global medical cannabis markets, establishment of a global supply chain, receipt of TGA GMP and full production authorization by H2 2020 by MediPharm Labs Australia, regulatory developments in Brazil, utilization of the PIC/S network and/or mutual recognition agreements to allow global product flow, IQ/OQ and qualification of equipment. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm Labs’ filings, available on the SEDAR website at www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.
Published at Fri, 31 Jan 2020 11:36:47 +0000