[PRESS RELEASE] – VANCOUVER, British Columbia, July 14, 2025 – HYTN Inventions Inc., a pace-setter in pharmaceutical-grade hashish production, introduced it has gained a hashish drug license (CDL) from Well being Canada. The CDL, issued July 2, 2025, enhances HYTN’s present drug established order license (DEL) and federally issued hashish licenses, hanging the corporate amongst a restricted crew of organizations approved to fabricate cannabis-derived pharmaceutical medication in Canada.
As an present Just right Production Practices (GMP)-certified producer, HYTN lately products and services world markets with cannabinoid merchandise below GMP-cannabis frameworks. The newly issued CDL supplies new and distinct regulatory pathways to the corporate, enabling the fabrication, packaging, labeling and distribution of prescription pharmaceutical merchandise (Rx). This development allows HYTN to strengthen scientific analysis, generate regulatory knowledge and pursue long term drug approvals and marketplace authorizations.
“Securing the CDL is a very powerful milestone in HYTN’s evolution,” stated Jason Broome, leader operations officer of HYTN. “This success complements our functions, permitting us to strategically enlarge past GMP-cannabis frameworks and take part immediately in pharmaceutical drug construction.”
With the CDL in position, HYTN has expanded its functions to serve each the regulated hashish marketplace and the regulated pharmaceutical marketplace, supported through the next strategic benefits:
- Export-Able GMP-Qualified Production: HYTN operates below a DEL for nonsterile prescribed drugs and is compliant with world GMP requirements known through the UK, Ecu Union and Australia.
- Prescription Drug Construction Pathway: With the CDL in position, HYTN can start growing cannabis-derived drug merchandise. This opens the door to submissions for advertising and marketing authorizations international.
- EudraGMDP Registration in Development: HYTN, along side Ecu companions, is progressing with its EudraGMDP registration, which, if granted, would permit the corporate to be indexed as an permitted lively pharmaceutical component (API) and drug product producer inside of Ecu pharmaceutical databases.
- Contract Construction and Production Group (CDMO) and Medical Enhance: HYTN’s twin licensing allows it to behave as a CDMO spouse for clinical-stage biotech and pharmaceutical firms, offering GMP-compliant cannabinoid manufacturing, system construction and product unlock inside of a regulated drug framework.
The worldwide pharmaceutical trade is integrating cannabinoids as APIs. Epidiolex, an FDA- and EMA-approved prescription drug derived from cannabidiol (CBD), is allowed for the remedy of serious seizure issues, together with Lennox–Gastaut syndrome, Dravet syndrome and tuberous sclerosis complicated. In step with its mother or father corporate, Jazz Prescribed drugs, Epidiolex generated web gross sales of USD $972.4 million in 2024, with a reported gross margin of 88.2% of web gross sales1, underscoring the scientific application and business viability of cannabinoid-based prescribed drugs.
Regardless of those developments, get right of entry to to GMP-compliant, cannabis-derived APIs and completed drug merchandise stays restricted, due partly to the top regulatory and operational requirements required to serve the pharmaceutical provide chain.
With the new issuance of its CDL, HYTN joins a small crew of world producers supplied to strengthen:
- Medical-stage pharmaceutical sponsors and biotech firms searching for GMP cannabinoid inputs.
- Vendors and pharmacies in Europe, the U.Okay. and Australia that function below prescription-only frameworks.
- Particular get right of entry to, named affected person and compassionate-use systems requiring pharmaceutical-grade provide.
- Govt tenders and public well being tasks interested in regulated cannabinoid remedies.
This expanded regulatory scope allows HYTN to take part within the international provide chain for cannabinoid-based therapeutics via the world over compliant production and strategic pharmaceutical partnerships.
1. Jazz Prescribed drugs. Annual Document on Shape 10-Okay/A for the fiscal 12 months ended Dec. 31, 2024.