HYTN Clears PIC/S GMP Audit, Primed for Global Expansion

Vancouver, British Columbia – March 4, 2024 - HYTN Innovations Inc. (the “Company” or “HYTN”), a company at the forefront of developing, formulating, and manufacturing products with psychoactive and psychotropic compounds, including those from cannabis and psilocybin, proudly announces the successful completion of a Good Manufacturing Practices (“GMP”) audit by Australia's Therapeutic Goods Administration (“TGA”) at their Kelowna facility. The positive outcome of the audit has set the stage for the subsequent issuance of formal GMP certification allowing the company to access international medical markets.

 

The successful GMP audit, in coordination with Australia's Promethean Biopharma, confirms HYTN as one of the few companies in Canada qualified to package and label finished cannabis goods in accordance with GMP regulations for international medical markets; facilitating the supply of high-quality medical cannabis products to international clients and enabling collaboration with global firms.

 

The GMP audit conducted by the TGA was performed in accordance with the standards of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme ("PIC/S"). The successful audit is a key achievement for HYTN, demonstrating the robustness of the company’s infrastructure and the effectiveness of its processes. Once issued, GMP certification under the PIC/S framework allows HYTN to engage with international medical markets that recognize the PIC/S standard, through established reciprocal agreements. This milestone aligns with the growth of robust international cannabis markets which require GMP certification to effectively commercialize.

 

"We're pleased to announce this important milestone," said Elliot McKerr, Chief Executive Officer of HYTN. "Our capability in Canada to convert cannabis biomass into GMP-compliant finished products, combined with our strategic location near top cultivators, positions us well to capitalize on the growing global cannabis market and drive revenue growth. We look forward to serving the global demand for GMP cannabis goods and exploring new partnership possibilities through HYTN's enhanced capabilities.”

 

While HYTN continues to prioritize domestic recreational products, such as its popular 10mg THC Sparkling Beverages and 100mg Nano Shot Citrus, obtaining a GMP license will expand the company's commercial opportunities. Jason Broome, Chief Operating Officer of HYTN, emphasized the significance of this achievement, stating, “Moving towards GMP approval presented significant organizational challenges; however, having overcome them, we are now poised to enter the global cannabis market in new and exciting ways. This step also allows us to elevate our existing systems, bringing our current and future product offerings into compliance with GMP standards.”

 

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 Practices (GMP) guidelines are established to ensure safe manufacturing, testing, and quality assurance of products intended for human consumption or use. Many countries mandate GMP adherence and have developed their own corresponding guidelines.

 

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

 

 

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's anticipation of receiving GMP certification; (ii) The potential for this achievement to enhance HYTN’s partnership with Promethean Biopharma; (iii) The opportunity for the company to collaborate with additional global firms as a result of the audit; (iv) The alignment of this milestone with the expansion of the global cannabis market; (v) The expectation of forging new partnerships due to expanded capabilities; (vi) The aim to elevate existing systems to meet GMP standards. 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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