HYTN Expands GMP Capabilities with New Licensed Activity
HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF) has received an additional Good Manufacturing Practices (GMP) certification for its Kelowna manufacturing facility, expanding its Drug Establishment Licence (DEL) to include distribution as a licensed activity. This builds on HYTN's existing PIC/S GMP certification, which already covers fabrication, packaging, and labeling of non-sterile pharmaceutical products.
The new certification enables HYTN to distribute GMP-certified products directly, although the company may still work with regional distributors as needed. This expansion supports HYTN's growth in non-sterile pharmaceutical production and allows for distribution in markets requiring GMP certification, such as Germany, the UK, Australia, and Poland.
Additionally, HYTN has granted 200,000 Restricted Share Units (RSUs) to certain consultants under the company's Equity Incentive Plan.
HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF) ha ricevuto un ulteriore certificato di Buone Pratiche di Fabbricazione (GMP) per il suo stabilimento di produzione a Kelowna, espandendo la sua Licenza di Stabilimento per Farmaci (DEL) per includere la distribuzione come attività autorizzata. Questo si basa sul certificato GMP PIC/S già esistente di HYTN, che copre già la fabbricazione, l'imballaggio e l'etichettatura di prodotti farmaceutici non sterili.
Il nuovo certificato consente a HYTN di distribuire prodotti certificati GMP direttamente, anche se l'azienda potrà continuare a lavorare con distributori regionali se necessario. Questa espansione sostiene la crescita di HYTN nella produzione di farmaci non sterili e consente la distribuzione in mercati che richiedono la certificazione GMP, come Germania, Regno Unito, Australia e Polonia.
Inoltre, HYTN ha concesso 200.000 Unità di Azioni Riservate (RSU) a determinati consulenti nell'ambito del Piano di Incentivazione Azionaria dell'azienda.
HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF) ha recibido una certificación de Buenas Prácticas de Fabricación (GMP) adicional para su instalación de fabricación en Kelowna, ampliando su Licencia de Establecimiento de Medicamentos (DEL) para incluir la distribución como una actividad autorizada. Esto se basa en la certificación GMP PIC/S existente de HYTN, que ya cubre la fabricación, el envasado y el etiquetado de productos farmacéuticos no estériles.
La nueva certificación permite a HYTN distribuir productos certificados GMP directamente, aunque la empresa todavía puede trabajar con distribuidores regionales según sea necesario. Esta expansión apoya el crecimiento de HYTN en la producción de medicamentos no estériles y permite la distribución en mercados que requieren certificación GMP, como Alemania, el Reino Unido, Australia y Polonia.
Además, HYTN ha otorgado 200,000 Unidades de Acciones Restringidas (RSU) a ciertos consultores bajo el Plan de Incentivo de capital de la empresa.
HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF)는 Kelowna 제조 시설에 대해 우수 제조 관리 기준 (GMP) 인증을 추가로 받아, 의약품 제조업 허가 (DEL)를 배급을 포함하는 라이센스 활동으로 확장했습니다. 이는 비멸균 제약 제품의 제조, 포장 및 라벨링을 이미 포함하는 HYTN의 기존 PIC/S GMP 인증을 기반으로 합니다.
새로운 인증으로 HYTN은 GMP 인증 제품을 직접 배급할 수 있는 능력을 갖추게 되지만, 회사는 필요에 따라 지역 유통업체와 협력할 수 있습니다. 이 확장은 HYTN의 비멸균 제약 생산 성장에 기여하고, 독일, 영국, 호주, 폴란드와 같이 GMP 인증이 요구되는 시장에서의 배급을 가능하게 합니다.
또한, HYTN은 회사의 주식 인센티브 계획에 따라 특정 컨설턴트에게 200,000개의 제한 주식 단위 (RSU)를 부여했습니다.
HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF) a reçu une certification de Bonnes Pratiques de Fabrication (BPF) supplémentaire pour son installation de fabrication à Kelowna, élargissant sa Licence d'Établissement de Médicaments (DEL) pour inclure la distribution comme activité autorisée. Cela s'appuie sur la certification BPF PIC/S existante de HYTN, qui couvre déjà la fabrication, l'emballage et l'étiquetage de produits pharmaceutiques non stériles.
La nouvelle certification permet à HYTN de distribuer directement des produits certifiés BPF, bien que la société puisse continuer à travailler avec des distributeurs régionaux si nécessaire. Cette expansion soutient la croissance de HYTN dans la production de médicaments non stériles et permet la distribution sur des marchés nécessitant une certification BPF, tels que l'Allemagne, le Royaume-Uni, l'Australie et la Pologne.
De plus, HYTN a accordé 200 000 unités d'actions restreintes (RSU) à certains consultants dans le cadre du plan d'incitation en capital de l'entreprise.
HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF) hat eine zusätzliche Zertifizierung für Gute Herstellungspraxis (GMP) für seine Produktionsstätte in Kelowna erhalten und damit seine Arzneimittelbetriebserlaubnis (DEL) um die Verteilung als zulässige Tätigkeit erweitert. Dies baut auf HYTNs bestehendem PIC/S GMP-Zertifikat auf, das bereits die Herstellung, Verpackung und Kennzeichnung von nicht-sterilen pharmazeutischen Produkten umfasst.
Die neue Zertifizierung ermöglicht es HYTN, GMP-zertifizierte Produkte direkt zu vertreiben, obwohl das Unternehmen weiterhin wie erforderlich mit regionalen Distributoren zusammenarbeiten kann. Diese Erweiterung unterstützt das Wachstum von HYTN in der Produktion nicht-steriler pharmazeutischer Produkte und ermöglicht den Vertrieb in Märkten, die eine GMP-Zertifizierung erfordern, wie Deutschland, dem Vereinigten Königreich, Australien und Polen.
Darüber hinaus hat HYTN 200.000 Restricted Share Units (RSUs) an bestimmte Berater im Rahmen des Unternehmens-Aktienbindungsplans gewährt.
- Received additional GMP certification for distribution
- Expanded Drug Establishment Licence capabilities
- Ability to distribute GMP-certified products directly
- Enhanced market access potential in Germany, UK, Australia, and Poland
- None.
HYTN receives certification for GMP distribution to international markets
VANCOUVER, British Columbia, Oct. 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, FSE: 85W0, OTC PINK: HYTNF) (“HYTN” or “the Company”), a pharmaceutical company specializing in the development, formulation, and manufacturing of psychoactive and psychotropic compounds, including cannabis and psilocybin, proudly announces that it has received an additional Good Manufacturing Practices (“GMP”) certification for its Kelowna manufacturing facility. This certification now includes distribution as a licenced activity under HYTN's Drug Establishment Licence (“DEL”) issued by Health Canada.
This new activity builds on HYTN's existing GMP certification, which was issued under the International Pharmaceutical Co-operation Scheme (“PIC/S”) and by Heath Canada. HYTN is already authorized to fabricate, package, and label non-sterile pharmaceutical products. The addition of distribution allows the company to distribute GMP-certified products directly, though HYTN may still collaborate with regional distributors as needed depending on market demands.
“We have once again demonstrated the compliance of our facility and quality systems,” said Jason Broome, HYTN's Chief Operations Officer. “This licence amendment further supports our expansion into non-sterile pharmaceutical production and enables us to distribute our products in markets where this is required.”
GMP certification is critical for the sale of non-sterile pharmaceuticals, including cannabis medicines, in markets such as Germany, the United Kingdom, Australia, and Poland.
The company also announces that it has granted 200,000 Restricted Share Units (“RSU”) to certain consultants of the Company pursuant to the Company’s Equity Incentive Plan.
About HYTN Innovations Inc.
HYTN Innovations Inc. is a pharmaceutical company that specializes 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)
Good manufacturing practice 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.
About Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a global initiative aimed at standardizing Good Manufacturing Practices (GMP) across its 56 member countries, thereby facilitating international trade in pharmaceuticals. Established to ensure the quality and safety of medicines for human and veterinary use, PIC/S promotes harmonized GMP standards and mutual recognition of inspection results among regulatory authorities, streamlining the approval process for pharmaceutical manufacturers
For more information contact:
Elliot McKerr
Chief Executive Officer
1.866.590.9289
HYTN Investor Relations:
1.866.590.9289
investments@hytn.life
Forward-Looking Statements
Certain information contained herein may constitute forward-looking statements that involve risks and uncertainties. Readers are cautioned not to place undue reliance on forward-looking statements, including, but not limited to, statements regarding: (i) The potential for the partnership to expand through additional products or services, facilitated by this licence amendment. (ii) The anticipated growth in market share across the UK, Germany, and Australia, driven by this licence amendment. (iii) The expected benefits of leveraging GMP certifications to access and penetrate new international markets. 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 failure to generate sufficient cash flow from operations to meet its current and future obligations; the Company's failure to access sources of debt and equity capital; changes to the regulatory framework within which the Company operates; competitive factors, pricing pressures, and supply and demand in the Company’s 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.
The Canadian Securities Exchange (CSE) has not reviewed, approved, or disapproved the contents of this press release.
FAQ
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