- MediPharm announces first delivery of pharmaceutical cannabis
product for NIH funded clinical trial, following import permit from
the US Drug Enforcement Agency (DEA) and Health Canada export
permit.
- MediPharm has provided a full response to the US Food and Drug
Administration (FDA) in relation to the initial pre-approval site
inspection of its Barrie facility
regarding a new Drug Master File (DMF) being referenced in a recent
Abbreviated New Drug Application (ANDA).
- This is the first US FDA Audit of a purpose-built commercial
cannabis facility in Canada.
- The US delivery and FDA inspection represent major milestones
in MediPharm Labs being a pharmaceutical cannabis supplier of
choice to the global pharmaceutical industry.
TORONTO, Aug. 1, 2023
/PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF)
(FSE: MLZ) ("MediPharm", "MediPharm Labs" or the "Company") a
pharmaceutical company specialized in precision-based cannabinoids,
is pleased to announce it has made its first delivery to
the United States, and has
completed the US FDA drug API manufacturer inspection at the
Company's Barrie, Ontario
facility.
First Delivery of Pharmaceutical
Cannabis Product to the US
On July 28, 2023, MediPharm
completed a commercial shipment of cannabis clinical trial
materials to the US, for use in an NIH funded clinical trial. This
clinical trial material is finished good cannabis oil that contains
both CBD and THC. To the Company's knowledge, this is the first
Phase 2 clinical trial of its kind sourced from a Canadian Licenced
Producer.
The complex process relied on MediPharm's GMP Drug Establishment
License, product stability data, US FDA Innovative New Drug
Approval, and US DEA narcotic import approval. Steps to meet
these requirements were initiated five years ago and involved large
capital investments, demonstrating a unique pharmaceutical
capability and approach that distinguishes MediPharm from other
cannabis companies.
This development is significant as the majority of cannabis
operators in the US are operating under State specific regulations
that prohibits them from manufacturing for FDA sanctioned research
activities and DEA approved shipments under federal narcotic
laws.
US FDA Status Update
MediPharm completed a US FDA five day in-person inspection from
November 21 to 25, 2022. This was
initiated in relation to MediPharm's Cannabidiol Active
Pharmaceutical Ingredient (API) Drug Master File (DMF) being
referenced in an Abbreviated New Drug Application (ANDA) submitted
to the FDA in September 2023 by a
global pharmaceutical company. Following the inspection, MediPharm
was presented with inspection observations. MediPharm has responded
in writing to all observations via a corrective action plan. These
actions have now been implemented and any additional FDA feedback
is expected by way of comments on the Company's DMF and partner's
ANDA filings. As this process is completed, MediPharm
continues to be a registered foreign drug manufacturing site with
the US FDA. The company believes it is the only Canadian
Pharmaceutical company or LP with this registration.
This US FDA inspection was the first of its kind for a
purpose-built cannabis facility in Canada and rare for a global GMP facility that
also manufactures botanical THC. This further solidifies
MediPharm's position as a global leader in the pharmaceutical
development and production of pharmaceutical cannabinoids. This
distinction will enable the company to be a leader in future
emerging markets, including drugs containing cannabinoids,
international medical cannabis programs, and over the counter CBD
as a non-prescription natural health product.
The full acceptance of MediPharm's API DMF, of which the FDA
inspection is a major step, allows for a number of commercial
opportunities for the Company. This will allow MediPharm to further
market cannabidiol API to pharmaceutical companies for new novel
drugs, generic drugs, modified generics drugs (FDA 505(b)(2)), and
clinical trial materials.
About MediPharm Labs
Founded in 2015, MediPharm Labs specializes in the development
and manufacture of purified, pharmaceutical-quality cannabis
concentrates, active pharmaceutical ingredients (API) 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 for delivery of pure, trusted and
precision-dosed cannabis products for its customers. MediPharm Labs
develops, formulates, processes, packages and distributes cannabis
and advanced cannabinoid-based products to domestic and
international medical markets.
In 2021, MediPharm Labs received a Pharmaceutical Drug
Establishment License from Health Canada, becoming the only company
in North America to hold a
commercial scale domestic Good Manufacturing License for the
extraction of multiple natural cannabinoids. The Company carries
out its operations in compliance with all applicable laws in the
countries in which it operates.
In 2023, MediPharm acquired VIVO Cannabis Inc. which expanded
MediPharm's reach to medical patients in Canada via Canna Farms medical ecommerce
platform, and in Australia and
Germany through Beacon Medical PTY
and Beacon Medical GMBH. This acquisition also included Harvest
Medical Clinics in Canada which
provides medical cannabis patients with physician consultations for
medical cannabis education and prescriptions.
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, opportunities for future clinical
research opportunities and the future supply to the global
pharmaceutical industry, future marketable pharmaceutical products,
opportunities to be a leader in future emerging markets, and future
Canadian and international commercial products that leverage MPL's
unique Pharma expertise. 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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SOURCE MediPharm Labs Corp.