VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) — HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit. The audit, which aims to expand the Company’s Good Manufacturing Practices (GMP) capabilities, follows the recent achievement of GMP certification for HYTN’s Kelowna production facility by Australia’s Therapeutic Goods Administration (TGA) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) standard.
Securing a DEL will enhance HYTN’s current GMP manufacturing capabilities, facilitating the development and sale of additional compounds and product variations. The Company has submitted its products, which contain both cannabis and psilocybin, for audit consideration.
“Emerging international markets increasingly demand GMP manufacturing,” said HYTN’s Chief Operating Officer, Jason Broome. “We foresee global growth in cannabis and psychedelic development requiring expertise and experience in the robust regulatory framework associated with drug development. HYTN has demonstrated its ability to manufacture these products according to GMP guidelines. Obtaining a DEL will enable us to pursue expanded clinical and commercial opportunities, including filing Investigational New Drug (IND) submissions with the FDA.”
While the Company cannot provide a timeline for the audit, the recent successful certification under the PIC/S standard underscores the facility’s adherence to high-quality standards in both its operations and quality systems. HYTN is committed to transparency and will provide updates on the audit’s progress as they become available.
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 markets where such products are federally regulated. 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)
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 PIC/S is a global initiative aimed at standardizing GMP across more than 50 member countries, thereby facilitating international trade in pharmaceuticals and ensuring 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 Company achieving a DEL; (iii) The export of finished medical products to international markets; (iv) The development and sale of additional compounds and product variations; (v) The Company’s ability to file Investigational New Drug (IND) submissions with the FDA and other federal regulatory authorities; (vi) The facility’s adherence to high-quality standards in both its operations and quality. 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.
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