HYTN Launches GMP Stability Program and Validates Vape Cartridges for International Markets
HYTN Innovations has launched its Good Manufacturing Practice (GMP) Stability Program and validated its cannabis vape cartridges for international distribution. This initiative follows their strategic partnership with SNDL Inc. announced on January 21, 2025, to develop GMP-compliant vape products.
The company is conducting stability studies with a GMP-licensed laboratory partner, aiming to provide an initial six-month stability statement for GMP-compliant vape products—a key requirement for pharmaceutical and medical cannabis markets in Germany, the UK, and Australia. The studies will extend to 12 months for long-term stability validation.
HYTN has selected a cartridge manufacturer and initiated qualification procedures for its ceramic coil 1g vaporizer cartridge. The company has also submitted an amendment to Health Canada to include oil as an approved dosage form, supporting its expansion into live resin and live rosin cannabis vape products.
HYTN Innovations ha lanciato il suo Programma di Stabilità per le Buone Pratiche di Fabbricazione (GMP) e ha convalidato le sue cartucce per vape a base di cannabis per la distribuzione internazionale. Questa iniziativa segue la loro partnership strategica con SNDL Inc. annunciata il 21 gennaio 2025, per sviluppare prodotti per vape conformi al GMP.
L'azienda sta conducendo studi di stabilità con un partner di laboratorio autorizzato GMP, con l'obiettivo di fornire una dichiarazione di stabilità iniziale di sei mesi per i prodotti per vape conformi al GMP, un requisito fondamentale per i mercati farmaceutici e di cannabis medica in Germania, Regno Unito e Australia. Gli studi si estenderanno a 12 mesi per la validazione della stabilità a lungo termine.
HYTN ha selezionato un produttore di cartucce e ha avviato le procedure di qualificazione per la sua cartuccia vaporizzatrice da 1g con bobina in ceramica. L'azienda ha anche presentato un emendamento a Salute Canada per includere l'olio come forma di dosaggio approvata, sostenendo la sua espansione nei prodotti per vape a base di resina viva e rosin viva.
HYTN Innovations ha lanzado su Programa de Estabilidad de Buenas Prácticas de Manufactura (GMP) y ha validado sus cartuchos de vapeo de cannabis para distribución internacional. Esta iniciativa sigue a su asociación estratégica con SNDL Inc. anunciada el 21 de enero de 2025, para desarrollar productos de vapeo que cumplan con el GMP.
La empresa está realizando estudios de estabilidad con un socio de laboratorio autorizado por el GMP, con el objetivo de proporcionar una declaración de estabilidad inicial de seis meses para los productos de vapeo conformes al GMP, un requisito clave para los mercados farmacéuticos y de cannabis medicinal en Alemania, el Reino Unido y Australia. Los estudios se extenderán a 12 meses para la validación de estabilidad a largo plazo.
HYTN ha seleccionado un fabricante de cartuchos y ha iniciado los procedimientos de calificación para su cartucho vaporizador de 1g con bobina de cerámica. La empresa también ha presentado una enmienda a Health Canada para incluir el aceite como forma de dosificación aprobada, apoyando su expansión en productos de vapeo de resina viva y rosin viva.
HYTN Innovations는 우수 제조 관리 기준(GMP) 안정성 프로그램을 시작하고 국제 유통을 위한 대마초 vape 카트리지를 검증했습니다. 이 이니셔티브는 2025년 1월 21일에 발표된 SNDL Inc.와의 전략적 파트너십에 따라 GMP 준수 vape 제품을 개발하기 위한 것입니다.
회사는 GMP 인증 실험실 파트너와 함께 안정성 연구를 수행하고 있으며, 독일, 영국 및 호주의 제약 및 의료 대마초 시장을 위한 핵심 요구 사항인 GMP 준수 vape 제품에 대한 초기 6개월 안정성 성명을 제공하는 것을 목표로 하고 있습니다. 연구는 장기 안정성 검증을 위해 12개월로 연장될 것입니다.
HYTN은 카트리지 제조업체를 선정하고 세라믹 코일 1g 증기 카트리지의 자격 절차를 시작했습니다. 회사는 또한 캐나다 보건부에 기름을 승인된 복용 형태로 포함시키기 위한 수정안을 제출하여 생레진 및 생로진 대마초 vape 제품으로의 확장을 지원하고 있습니다.
HYTN Innovations a lancé son Programme de Stabilité des Bonnes Pratiques de Fabrication (GMP) et a validé ses cartouches de vape au cannabis pour la distribution internationale. Cette initiative fait suite à leur partenariat stratégique avec SNDL Inc. annoncé le 21 janvier 2025, pour développer des produits de vape conformes aux GMP.
L'entreprise réalise des études de stabilité avec un partenaire de laboratoire agréé GMP, visant à fournir une déclaration de stabilité initiale de six mois pour les produits de vape conformes aux GMP, une exigence clé pour les marchés pharmaceutiques et de cannabis médical en Allemagne, au Royaume-Uni et en Australie. Les études s'étendront à 12 mois pour la validation de la stabilité à long terme.
HYTN a sélectionné un fabricant de cartouches et a entamé les procédures de qualification pour sa cartouche de vaporisateur de 1g avec bobine en céramique. L'entreprise a également soumis un amendement à Santé Canada pour inclure l'huile comme forme de dosage approuvée, soutenant son expansion dans les produits de vape à base de résine vivante et de rosin vivant.
HYTN Innovations hat sein Stabilitätsprogramm für die Guten Herstellungspraxen (GMP) gestartet und seine Cannabis-Vape-Kartuschen für den internationalen Vertrieb validiert. Diese Initiative folgt ihrer strategischen Partnerschaft mit SNDL Inc., die am 21. Januar 2025 angekündigt wurde, um GMP-konforme Vape-Produkte zu entwickeln.
Das Unternehmen führt Stabilitätsstudien mit einem GMP-lizenzierten Laborpartner durch, um eine erste Stabilitätserklärung von sechs Monaten für GMP-konforme Vape-Produkte bereitzustellen – eine wichtige Anforderung für die pharmazeutischen und medizinischen Cannabis-Märkte in Deutschland, dem Vereinigten Königreich und Australien. Die Studien werden auf 12 Monate ausgeweitet, um die langfristige Stabilitätsvalidierung zu gewährleisten.
HYTN hat einen Kartuschenhersteller ausgewählt und die Qualifikationsverfahren für seine 1g Vaporizer-Kartusche mit Keramikwicklung eingeleitet. Das Unternehmen hat außerdem eine Änderung bei Health Canada eingereicht, um Öl als zugelassene Darreichungsform aufzunehmen, um seine Expansion in Produkte für Vape mit lebendiger Harz- und lebendiger Rosin-Dampf zu unterstützen.
- Initiated GMP Stability Program for international market compliance
- Strategic partnership with SNDL Inc. for GMP-compliant vape products
- Expansion of product portfolio to include live resin and live rosin vape products
- Targeting growing German medical cannabis market with doubled import volumes
- Pending regulatory approvals from Health Canada for oil dosage form
- Extended timeline required for complete 12-month stability validation
VANCOUVER, British Columbia, Feb. 18, 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 the launch of its Good Manufacturing Practice (GMP) Stability Program and the validation of its cannabis vape cartridges for international distribution. This initiative builds upon HYTN’s January 21, 2025, announcement of its strategic partnership with SNDL Inc. to develop GMP-compliant vape products.
The Stability Program is being conducted in collaboration with HYTN’s GMP-licensed laboratory partner. Upon successful completion, HYTN expects to provide an initial six-month stability statement for its GMP-compliant vape products—an essential regulatory requirement for pharmaceutical and medical cannabis markets in most jurisdictions, including Germany, the United Kingdom, and Australia. Ongoing non-accelerated stability studies aim to extend to 12 months. If successful, this will further validate long-term product stability for international markets.
In parallel with the launch of the Stability Program, HYTN has finalized the selection of a cartridge manufacturer and initiated comprehensive qualification and validation procedures, including equipment qualification and process validation, to ensure compliance with GMP standards for its ceramic coil 1g vaporizer cartridge. These efforts establish a foundation for global distribution while ensuring compliance with evolving regulations and market standards.
To support the expansion of its GMP product portfolio to include live resin and live rosin cannabis vape products, HYTN has submitted an amendment to its existing licensing framework with Health Canada to incorporate oil as an approved dosage form. This amendment, along with anticipated additional GMP approvals, reinforces the Company’s commitment to meeting the highest pharmaceutical and regulatory standards across global markets.
The Company believes that these initiatives further position HYTN to meet the needs of global cannabis markets requiring GMP-certified products under strict regulatory frameworks. Germany's medical cannabis market has grown significantly, driven by increasing patient counts, expanding physician prescriptions, and broader pharmacy distribution.1 In Q3 2024, Germany imported 20,000 kilograms of cannabis—more than double the quarterly average before the April cannabis reform, highlighting the rising global demand for pharmaceutical-grade cannabis.1
1. Debra Borchar, Beyond Germany: Other International Markets for Cannabis Opportunities (2025)
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 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.
For more information contact:
Elliot McKerr
Chief Executive Officer
1.866.590.9289
HYTN Investor Relations:
1.866.590.9289
investments@hytn.life
The Canadian Securities Exchange (CSE) has not reviewed, approved, or disapproved the contents of this press release.
Certain information contained herein constitutes forward-looking information that involves risks and uncertainties. Readers are cautioned not to place undue reliance on forward-looking statements, including, but not limited to, statements regarding the expected outcome of licensing and certification applications and amendments, the Company’s ability to distribute products in new markets or in larger quantities in existing markets, and the Company’s ability to maintain regulatory and licensing requirements. Factors that could cause actual results to vary from forward-looking statements or may affect the operations, performance, development, and results of the Company’s business include, among other things: the Company’s inability to successfully obtain new licenses and certifications, or to amend existing ones, and its inability to distribute products into new markets or in increasing quantities in existing markets, or to continue to maintain licensing and certification standards; changes in regulatory requirements affecting product registration or distribution; shifts in market demand for cannabis beverages; competitive factors within the industry; and general economic and business conditions. Any statements that are not statements of historical fact are deemed to be forward-looking statements. The forward-looking statements contained in this news release are made as of the date of this news release, and, except to the extent required by applicable law, the Company assumes no obligation to update or revise forward-looking statements made herein or otherwise, whether because of new information, future events, or otherwise. The forward-looking statements contained in this news release are expressly qualified by this cautionary note.
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