HYTN Awarded Drug Establishment License from Health Canada, Expanding GMP Capabilities
HYTN Innovations has received a Drug Establishment License (DEL) from Health Canada, allowing it to manufacture, package, and label non-sterile pharmaceuticals containing cannabis and psilocybin. This milestone enhances HYTN's Good Manufacturing Practices (GMP) capabilities, enabling the company to expand into international markets such as the UK, Germany, and Australia. The DEL complements HYTN's existing GMP certification from Australia's Therapeutic Goods Administration, cementing its role as a leading global producer in its field.
This achievement will accelerate HYTN's production and distribution capabilities, meeting the growing demand for these products. The company's officers and operators have been awarded 3,080,000 Restricted Share Units in recognition of this significant achievement.
- HYTN received a Drug Establishment License from Health Canada, enhancing its GMP capabilities.
- The DEL allows HYTN to manufacture, package, and label non-sterile pharmaceuticals containing cannabis and psilocybin.
- HYTN can now expand into regulated global markets including the UK, Germany, and Australia.
- The company already holds a GMP certification from the Australian Therapeutic Goods Administration.
- HYTN is one of the few companies globally with such certifications, strengthening its market position.
- In recognition of this achievement, HYTN's officers and operators were awarded 3,080,000 Restricted Share Units.
- None.
"One of the very few companies globally to achieve these certifications"
VANCOUVER, British Columbia, June 27, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN | FSE: 85W0) “HYTN” or “The Company”, a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis and psilocybin, is pleased to announce that it has been granted a Drug Establishment License (DEL) by Health Canada. This license allows HYTN to engage in the GMP fabrication, packaging, and labeling of non-sterile pharmaceuticals containing both cannabis and psilocybin, significantly enhancing the Company's capabilities and expanding its market reach. With this license, HYTN is now positioned to manufacture and export these pharmaceutical products into regulated global markets, further solidifying its status as one of the very few companies in the sector with these capabilities.
The award of the DEL is a testament to HYTN's expertise and sophistication in GMP drug manufacturing, a requirement for many international markets including the UK, Germany and Australia. This accomplishment builds on the Company’s existing GMP certification under the International Pharmaceutical Inspection Scheme "PIC/S", issued by the Australian Therapeutic Goods Administration (TGA). The new license not only expands HYTN's operational scope but also underscores its commitment to maintaining the highest standards of quality and compliance in the pharmaceutical industry.
"We are thrilled to receive the Drug Establishment License from Health Canada," said Elliot McKerr, HYTN CEO. "This license is a significant milestone for our Company, as it not only demonstrates our rigorous standards and capabilities in GMP drug manufacturing but also opens up new opportunities for the company in global markets. HYTN is now one of a select few companies in Canada that can convert the abundance of premium Canadian cannabis into pharmaceutical products for international medical markets. HYTN is now, also, one of an even more exclusive group that is fully vertically integrated to grow, dry, fabricate, package, and label final dosage forms of pharmaceuticals containing psilocybin.”
Jason Broome, HYTN COO added, "The DEL award is a testament to the hard work and dedication of our entire team. Our existing GMP certification from the TGA has already demonstrated the high standards of our operations, and this new license from Health Canada further enhances our ability to meet and exceed those standards and work with a broader range of products for international markets. We look forward to leveraging this license to rapidly expand our product offerings and continue the commercialization of our capabilities in international pharmaceutical manufacturing."
With the DEL now in hand, HYTN plans to accelerate its production and distribution of non-sterile pharmaceuticals. The Company is strategically positioned to capitalize on the growing demand for these products in regulated markets worldwide.
In accordance with the Company’s approved omnibus plan and in recognition of this achievement, the company’s officers and operators have been granted awards commensurable to their individual agreements totalling 3,080,000 Restricted Share Units.
About HYTN Innovations Inc.
HYTN formulates, manufactures, markets, and sells premium products containing psychoactive and psychotropic compounds, including cannabis-derived cannabinoids. HYTN's mission is to become the top provider of these products in all federally regulated markets. To achieve this, the Company focuses on identifying market opportunities and quickly bringing its innovative products to market through its elevated development platform.
About Good Manufacturing Practices (GMP)
Good Manufacturing Practice (GMP) guidelines are pivotal in enhancing product quality by establishing rigorous standards for manufacturing, testing, and quality assurance. These guidelines are instrumental in managing and mitigating risks, thereby ensuring products are consistently produced and controlled according to quality standards. By prioritizing safety, GMP helps ensure that products do not pose unacceptable risks to consumers. Adherence to GMP is mandated in many countries, aligning with national regulations to uphold global quality standards and facilitate international commerce in regulated products.
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 more than 50 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
The Canadian Securities Exchange (CSE) has not reviewed, approved, or disapproved the contents of this press release.
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 Company manufacturing GMP goods; (ii) the export of finished medical cannabis products to international markets; (iii) significant growth and rising demand within the global medical cannabis markets; (iv) The Company's ability to collaborate with numerous global partners; (v) The Company's ability to grow, dry, fabricate, package, and label final dosage forms of pharmaceuticals containing psilocybin; (vi) The license from Health Canada further enhancing the company's ability to meet and exceed standards and work with a broader range of products for 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 ability to generate sufficient cash flow from operations to meet its current and future obligations; the Company's ability to access sources of debt and equity capital; competitive factors, pricing pressures, and supply and demand in the Company’s industry; general economic and business conditions; and the effects and impacts of the COVID-19 pandemic, the extent and duration of which are uncertain at this time, on the Company's business and general economic and business conditions and markets. 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.
FAQ
What new license did HYTNF recently receive from Health Canada?
How will HYTNF's new DEL impact its market operations?
Which international markets can HYTNF now access with its new DEL?
What products will HYTNF be able to manufacture with its new DEL?
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