VANCOUVER, British Columbia — HYTN Innovations Inc., a leader in pharmaceutical-grade cannabis manufacturing, received a Cannabis Drug Licence (CDL) from Health Canada. The CDL, issued July 2, 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)-certified manufacturer, HYTN serves 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 Officer 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-Certified 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 sales, underscoring the clinical utility and commercial viability of cannabinoid-based pharmaceuticals.
Despite these advancements, access to GMP-compliant, cannabis-derived APIs and finished 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.
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 bringing 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.
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