MediPharm Labs Achieves Major Pharmaceutical Manufacturing Milestone: Receives Canadian GMP Pharmaceutical Drug Establishment...
2021年7月14日 - 8:00PM
MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF)
(FSE: MLZ) (“MediPharm Labs” or the “Company”), a pharmaceutical
company specialized in research-driven development and
manufacturing of cannabis API and finished products, is pleased to
announce it has received a Drug Establishment Licence (the “DEL”)
issued by Health Canada in accordance with the Food and Drugs Act
and Regulations. The DEL serves to confirm compliance to Good
Manufacturing Practice (“GMP”) standards.
The DEL is a first of its kind licence for
cannabis manufacturing in North America. A Canadian GMP DEL
complements MediPharm Labs’ existing Australian TGA GMP
certification. The licence can be used for the manufacturing,
testing and sale of Active Pharmaceutical Ingredients (“API”) and
pharmaceutical drug products containing cannabis. This includes
drugs that have marketing authorizations as either novel or generic
pharmaceutical drug products containing cannabis.
The DEL allows MediPharm Labs to leverage the
Mutual Recognition Agreements (“MRA”) established between Canada
and other global regulatory authorities including the European
Economic Area consisting of all EU member states as well as the
three countries of the European Free Trade Association, Australia,
the UK and Switzerland. This differentiates MediPharm Labs from
other Canadian cannabis manufacturers.
In addition, as a member of the International
Pharmaceutical Inspection Co-operation Scheme, the Health Canada
DEL can be recognized in over 50 different countries including the
US and the majority of the EU. With the DEL, MediPharm Labs would
be eligible for a US Food and Drug Administration (“FDA”) foreign
inspection if a US or other global pharmaceutical customer files a
registration application for a pharmaceutical drug product
containing MediPharm Labs’ API. In 2020, 64% of drugs exported from
Canadian Drug Establishment Licence holders were exported to the US
with FDA approval.(1) MediPharm Labs will use the DEL in
conjunction with its Australian facility TGA GMP to optimize the
supply chain via MRAs for export of its products to over five
countries in 2021.
When paired with MediPharm Labs’ existing
Cannabis Drug Licence received earlier this year, the DEL will
allow for the commercial distribution of drugs containing cannabis.
With many global pharmaceutical trials underway in which cannabis
is an active ingredient, many drug producers will need a
manufacturing partner. MediPharm Labs is now strategically
positioned to provide that service to all global pharma partners.
This includes clinical trial material, which MediPharm Labs already
supplies to researchers, and pharmaceutical drug products.
Physician prescribed pharmaceutical drug products containing
cannabis are being used to treat various indications around the
world and will continue to grow with additional new drugs and
abbreviated new drug applications. Grandview Research predicts this
segment of the pharmaceutical industry will be a $5.8 billion (USD)
market by 2027.(2)
“MediPharm Labs has achieved a great milestone
with the issuance of our Drug Establishment Licence. This truly
makes us a full-service pharmaceutical company that can support
global pharma’s entry into the drugs containing cannabis space,”
explained Keith Strachan, President and Interim CEO, MediPharm
Labs. “This adds to our growing portfolio of advanced regulatory
licences globally. MediPharm Labs now becomes one of a small number
of companies who can take cannabis plant material and produce an
API or a pharmaceutical drug product that could have marketing
authorization by regulatory bodies such as the European Medicines
Agency and FDA.”
This completes MediPharm Labs pharmaceutical
licencing requirements. Future specialized licencing achievements
are still being pursued in conjunction with specific product
registrations and jurisdictions.
(1) https://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html (2) https://www.grandviewresearch.com/industry-analysis/cannabis-pharmaceuticals-market
About MediPharm Labs
Founded in 2015, MediPharm Labs is a
pharmaceutical company that specializes in the development and
manufacture of purified, pharmaceutical-quality cannabis
concentrates, active pharmaceutical ingredients 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 four 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 completed commercialization of
its Australian extraction facility which generated its first
revenues in H1 2020. MediPharm Labs Australia was established in
2017.
For further information, please contact:
MediPharm Labs Investor Relations Telephone: +1 416.913.7425 ext.
1525
Email: investors@medipharmlabs.comWebsite: 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, conducting pharmaceutical manufacturing;
sale of active pharmaceutical ingredients and pharmaceutical drug
products; global pharma’s entry into the drugs containing cannabis
market; the manufacturing, testing and sale of API and
pharmaceutical drug products containing cannabis; enhanced supply
chain capabilities; strengthened global reach; commercial
distribution of drugs containing cannabis; serving global pharma
partners; growth of physician prescribed pharmaceutical drug
products containing cannabis and this segment of the pharmaceutical
industry; additional new drugs and abbreviated new drug
applications; producing a cannabis pharmaceutical drug product that
would have marketing authorization by regulatory bodies such as the
European Medicines Agency and FDA; and future specialized licencing
achievements. 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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