HYTN Secures Cannabis Drug Licence, Advancing Prescription Drug Pathway for Cannabinoid-Based Medicines
Source: HYTN Innovations Inc.
July 14, 2025 08:00 ET
HYTN Secures Cannabis Drug
Licence, Advancing
Prescription Drug Pathway for
Cannabinoid-Based Medicines
VANCOUVER, British Columbia, July 14, 2025 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE:
HYTN, FSE: 85W0, OTC PINK: HYTNF) (“HYTN” or the “Company”), a leader in pharmaceutical-grade
cannabis manufacturing, is pleased to announce it has received a Cannabis Drug Licence (CDL)
from Health Canada. The CDL, issued July 2, 2025, complements HYTN’s existing Drug
Establishment Licence (DEL) and federally issued Cannabis Licences, placing the Company among
a limited group of organizations authorized to manufacture cannabis-derived pharmaceutical
drugs in Canada.
As an existing Good Manufacturing Practices (GMP)-certied manufacturer, HYTN currently services
international markets with cannabinoid products under GMP-cannabis frameworks. The newly
issued CDL provides new and distinct regulatory pathways to the Company, enabling the
fabrication, packaging, labelling, and distribution of prescription pharmaceutical products (Rx). This
advancement permits HYTN to support clinical research, generate regulatory data, and pursue
future drug approvals and market authorisations.
“Securing the CDL is an important milestone in HYTN’s evolution,” said Jason Broome, Chief
Operations Ofcer of HYTN. “This achievement enhances our capabilities, allowing us to strategically
expand beyond GMP-cannabis frameworks and participate directly in pharmaceutical drug
development.”
With the CDL in place, HYTN has expanded its capabilities to serve both the regulated cannabis
market and the regulated pharmaceutical market, supported by the following strategic
advantages:
Export-Ready GMP-Certied Manufacturing: HYTN operates under a DEL for non-sterile
pharmaceuticals and is compliant with international GMP standards recognized by the United
Kingdom, European Union and Australia.
Prescription Drug Development Pathway: With the CDL in place, HYTN can begin
developing cannabis-derived drug products. This opens the door to submissions for Marketing
Authorisations worldwide.
EudraGMDP Registration in Progress: HYTN, in conjunction with European partners, is
progressing with its EudraGMDP registration, which, if granted, would enable the Company to
be listed as an approved active pharmaceutical ingredient (API) and drug product
manufacturer within European pharmaceutical databases.
Contract Development and Manufacturing Organization (CDMO) & Clinical Support: HYTN’s
dual licensing enables it to act as a CDMO partner for clinical-stage biotech and
pharmaceutical companies, providing GMP-compliant cannabinoid production, formulation
development, and product release within a regulated drug framework.
The global pharmaceutical industry is integrating cannabinoids as APIs. Epidiolex, an FDA- and
EMA-approved prescription drug derived from cannabidiol (CBD), is authorized for the treatment of
severe seizure disorders including Lennox–Gastaut syndrome, Dravet syndrome, and tuberous
sclerosis complex. According to its parent company, Jazz Pharmaceuticals, Epidiolex generated net
product sales of USD $972.4 million in 2024, with a reported gross margin of 88.2% of net product
sales1, underscoring the clinical utility and commercial viability of cannabinoid-based
pharmaceuticals.
Despite these advancements, access to GMP-compliant, cannabis-derived APIs and nished drug
products remains limited, due in part to the high regulatory and operational standards required to
serve the pharmaceutical supply chain.
With the recent issuance of its CDL, HYTN joins a small group of global manufacturers equipped to
support:
Clinical-stage pharmaceutical sponsors and biotech companies seeking GMP cannabinoid
inputs.
Distributors and pharmacies in Europe, the UK, and Australia operating under prescription-
only frameworks.
Special access, named patient, and compassionate use programs requiring pharmaceutical-
grade supply.
Government tenders and public health initiatives focused on regulated cannabinoid therapies.
This expanded regulatory scope enables HYTN to participate in the global supply chain for
cannabinoid-based therapeutics through internationally compliant manufacturing and strategic
pharmaceutical partnerships.
1. Jazz Pharmaceuticals. Annual Report on Form 10-K/A for the scal year ended December 31, 2024.
About HYTN Innovations Inc.
HYTN Innovations Inc. is a pharmaceutical company specializing in the formulation, manufacturing,
marketing, and sale of products containing psychoactive and psychotropic compounds, including
cannabis-derived cannabinoids and psilocybe-derived tryptamines. HYTN is dedicated to becoming
a premier provider of these products across all federally regulated markets. The Company
accomplishes this by strategically identifying market opportunities and effectively bringing
innovative products to market through its advanced development platform.
About Cannabis Drug Licenses (CDL)
A CDL is issued by Health Canada under the Food and Drug Regulations and authorizes the
possession, production, packaging, labelling, and distribution of cannabis when used as an active
ingredient in pharmaceutical drug products. The CDL is required for any company intending to
manufacture prescription drugs containing cannabis for human use. It can only be obtained by
holders of a DEL and must meet the same regulatory standards applied to conventional
pharmaceutical manufacturers, including compliance with GMP
About Good Manufacturing Practices (GMP)
GMP guidelines provide guidance for manufacturing, testing, and quality assurance to ensure that
a manufactured product is safe for human consumption or use. Many countries have legislated that
manufacturers follow GMP procedures and create their own GMP guidelines that correspond with
their legislation.
FORWARD-LOOKING STATEMENTS
Certain statements contained in this press release constitute forward-looking information. These
statements relate to future events or future performance. The use of any of the words “could”,
“intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements
relating to matters that are not historical facts are intended to identify forward-looking information
and are based on the Company’s current belief or assumptions as to the outcome and timing of
such future events.
In particular, this press release contains forward-looking information relating to, among other
things: the prospect of the Company’s fabrication, packaging, labelling, and distribution of
cannabis-containing Rx drugs, including Cannabis-based APIs and nished formulations, and the
Company’s ability to produce these products and participate in the supply chain for cannabinoid
based therapeutics; and the Company’s EudraGMDP registration, including the anticipated impact
on the Company of such registration being granted to the Company. Various assumptions or factors
are typically applied in drawing conclusions or making the forecasts or projections set out in
forward-looking information, including the assumption that: the Company will be successful in
partnering with pharmaceutical sponsors, biotech companies, distributors, pharmacies,
governments and/or other participants in the cannabinoid based therapeutics industry, including
that these entities will have demand for the Company’s products and that the Company will be
able to fulll the product specications required by these entities; and that the Company will be
granted its EudraGMDP registration on the terms currently anticipated. Those assumptions and
factors are based on information currently available to the Company. Although such statements are
based on reasonable assumptions of the Company’s management, there can be no assurance that
any conclusions or forecasts will prove to be accurate.
Forward-looking information involves known and unknown risks, uncertainties and other factors
which may cause the actual results, performance or achievements to be materially different from
any future results, performance or achievements expressed or implied by the forward-looking
information. Such factors include: the risk that, even with the CDL, the Company is unsuccessful in
partnering with entities in the cannabinoid based therapeutics industry, whether as a result of a
lack of demand for the Company’s products, a failure by the Company to manufacture desired
products, or otherwise; the risk that the Company is not granted the EudraGMDP license, on the
anticipate terms or at all; operational risks; regulatory risks; and nancing, capitalization and
liquidity risks. The forward-looking information contained in this release is made as of the date
hereof, and the Company is not obligated to update or revise any forward-looking information,
whether as a result of new information, future events or otherwise, except as required by applicable
securities laws. Because of the risks, uncertainties and assumptions contained herein, investors
should not place undue reliance on forward-looking information. The foregoing statements
expressly qualify any forward-looking information contained herein.
For more information contact:
Elliot McKerr
Chief Executive Ofcer
1.866.590.9289
HYTN Investor Relations:
1.866.590.9289
The Canadian Securities Exchange has not reviewed, approved, or disapproved the contents of
this press release.
