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.
For further information, please contact: Laura
Lepore, VP, Investor Relations and CommunicationsTelephone:
416-913-7425 ext. 1525 Email:
investors@medipharmlabs.com Website:
www.medipharmlabs.com
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.
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