- Completed a Drug Master File ("DMF") process for CBD Active
Pharmaceutical Ingredient ("API") for the US Federal Drug
Administration ("FDA").
- Use of Canadian Drug Establishment Licence ("DEL") to register
API with the FDA for commercial opportunities in pharmaceutical
development, novel drugs and generic drugs.
- The cannabis-based drug opportunity is predicted to be over
USD$25 billion by
2025(i).
- This is the only US FDA for CBD by a Canadian company and the
second natural CBD DMF at commercial scale in all of North America(ii).
TORONTO, Feb. 23, 2022 /CNW/ - MediPharm Labs Corp. (TSX:
LABS) (OTCQX: MEDIF) (FSE: MLZ) ("MediPharm" or the "Company") a
pharmaceutical company specialized in precision-based cannabinoids,
is pleased to announce it has completed a US FDA DMF for pure
natural CBD API. The DMF will enable MediPharm to supply approved
API to pharmaceutical companies currently conducting late-stage
research. The cannabis-based drug opportunity is predicted to be
over USD$25 billion by 2025, and
there are over 20 strong novel cannabinoid-based drugs currently in
the late-stage research process. These projects will all require
pharmaceutical approved API if commercialized. MediPharm has
already shipped good manufacturing practice ("GMP") CBD for
development purposes to multiple established pharmaceutical
companies.
Management Commentary
Bryan Howcroft, CEO,
MediPharm, commented, "The filing of a US DMF further
advances MediPharm toward its ultimate objective of becoming a
dominant supplier of API to pharmaceutical companies. This is a
high value, high margin opportunity, and with the only
purpose-built facility in North
America to receive a domestic GMP licence specifically for
the extraction of natural cannabinoids, MediPharm is positioned to
capture share in this growing market. In the short to medium term,
the DMF unlocks new sales channels and will enable us to further
leverage the investments made to date on our high-quality
pharmaceutical manufacturing platform. Over the longer-term, it
ensures the Company is positioned as the go-to cannabinoid partner
for pharmaceutical companies around the world."
Additional Information
DMFs are regulatory submissions filed with the FDA containing
confidential, detailed information about manufacturing, processes,
packaging, and stability of APIs to be used in medicinal products
for human use. Once the DMF filing is accepted by the FDA,
pharmaceutical companies can reference the DMF when making a
regulatory submission.
There are many large commercial opportunities for an API in new
drug applications ("NDAs") and abbreviated new drug applications
("ANDAs"). NDAs and ANDAs can be divided into the following four
categories:
- A standalone NDA for new novel drugs.
- A 505(b)(2) application is a NDA where at least some of the
information required for approval comes from studies not conducted
by or for the applicant.
- An ANDA for a previous approved drug creating a new generic
drug.
- A petitioned ANDA is a type of ANDA for a drug product that
differs from the novel drug in dosage form, route of
administration, strength, or active ingredient.
About MediPharm Labs
Founded in 2015, MediPharm specializes in the development and
manufacture of purified, pharmaceutical-quality cannabis
concentrates, API and advanced derivative products utilizing a Good
Manufacturing Practices certified facility with ISO standard-built
clean rooms. MediPharm 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 formulates, develops (including
through sensory testing), processes, packages and distributes
cannabis extracts and advanced cannabinoid-based products to
domestic and international markets.
In 2021, MediPharm received a DEL from Health Canada, becoming
the only company in North America
to hold a domestic GMP License for the extraction of natural
cannabinoids. The Company carries out its operations in compliance
with all applicable laws in the countries in which it operates.
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, statements regarding: acceptance of the DMF
by the FDA and timing thereof; registering API with the FDA for
commercial opportunities in pharmaceutical development, novel drugs
and generic drugs; predictions regarding the cannabis-based drug
opportunity; supplying approved API to pharmaceutical companies
currently conducting late-stage research; becoming a dominant
supplier of API to pharmaceutical companies; unlocking new sales
channels; enabling the Company to further leverage the investments
made to date on its high-quality pharmaceutical manufacturing
platform; and positioning the Company as the go-to cannabinoid
partner for pharmaceutical companies around the world.
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 to obtain adequate
financing; the delay or failure to receive regulatory approvals;
and other factors discussed in MediPharm's 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 assumes no obligation to update the forward-looking
statements of beliefs, opinions, projections, or other factors,
should they change.
_________________________________
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i
Prohibition Partners
|
ii FDA
2021 Q4 report
|
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SOURCE MediPharm Labs Corp.