Announcement • May 09
HYTN Innovations Inc Expands Drug Establishment Licence to Include Active Pharmaceutical Ingredients and Pharmaceutical Oils
HYTN Innovations Inc. had its Health Canada Drug Establishment Licence (DEL) amended following a comprehensive Good Manufacturing Practices (GMP) inspection of its Kelowna, British Columbia Facility. Under the amended licence, issued by Health Canada, HYTN is now authorized to fabricate, package, and label non-sterile Active Pharmaceutical Ingredients (API) in both solid and non-solid forms, and adds Pharmaceutical Oil as an authorized finished dosage form. The updated scope of the license expands the Company's GMP manufacturing activities and supports its ability to service both pharmaceutical and cannabinoid supply chains subject to applicable product-specific, customer-specific, import, release, and jurisdictional requirements. The amended licence, together with its previously announced Cannabis Drug Licence, Cannabis Processing Licence, and expanded DEL dosage form authorizations, permits additional regulated manufacturing activities at HYTN’s Kelowna facility. These activities may support HYTN’s participation in regulated drug-development and pharmaceutical manufacturing programs involving cannabinoid-derived inputs and finished dosage forms, where applicable product-specific, customer-specific, import, release, drug control, and jurisdictional requirements are satisfied. The amendment represents a progression from manufacturing cannabis products to GMP specifications toward additional pharmaceutical manufacturing activities authorized under the DEL. Canada has been added to the European Commission’s list of third countries whose regulatory framework for active substances has been assessed as equivalent for purposes of EU active substance importation. As a result, certain EU written confirmation requirements applicable to active substances imported from non-listed countries may be waived for Canadian-manufactured APIs, subject in all cases to applicable EU, importer, product-specific, and jurisdictional requirements. This does not constitute automatic EU market access, product approval, or authorization to import any specific product in the European Union. The amended DEL will provide greater flexibility to support its regulated activities in domestic and international markets, including the manufacture of cannabinoid-based APIs and finished dosage forms where permitted. HYTN continues to supply products into federally regulated medical and pharmaceutical markets in Germany, the United Kingdom, and Australia, while evaluating opportunities that align with its GMP manufacturing platform, licence portfolio, and quality systems. The amended DEL does not itself announce or imply any new contract, customer, purchase order, product approval, revenue, or market authorization. Export, import, sale, release, or use of any product remains subject to applicable customer, importer, product-specific, drug control, quality, and jurisdictional requirements.
