HYTN Partners with the UK's 4C Labs, Validates GMP Certification
Vancouver, British Columbia - September 10th, 2024 - 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 cannabinoids and psilocybin, is proud to announce the establishment of international manufacturing and pricing agreements (the Agreements) with 4C LABS, a leading importer and distributor of cannabis-based pharmaceuticals in the United Kingdom. These agreements aim to enable the production of cannabis products in bulk and final packaged forms for distribution in the UK and other global markets. Through this partnership HYTN will act as the manufacturer, packager and exporter of pharmaceutical quality cannabis goods that 4C LABS may purchase and subsequently import and distribute into the UK market.
HYTN's Good Manufacturing Practice (GMP) license, granted by Health Canada, and its PIC/S certification from Australia's Therapeutic Goods Administration (TGA), are key credentials that enable partnerships with internationally accredited distributors, these credentials, combined with 4C LABS’ expertise and licences in cannabis operations in the UK, create a robust foundation for the business collaboration with 4C LABS. Under the Agreements, HYTN intends to manufacture new products for 4C LABS while also serving as a co-manufacturing center for the production of existing products currently produced at various locations, with the aim of enhancing operational efficiency for both companies. The agreements do not provide for a fixed, mandatory or minimum order by 4C LABS.
“This partnership validates the ongoing regulatory work HYTN has been undertaking,” stated Elliot McKerr, Chief Executive Officer of HYTN. Adding “By integrating 4C LABS’ deep understanding of cannabis procurement and consumer demand with our advanced GMP-certified manufacturing processes, we are well-positioned to deliver high quality cannabis products to international markets. This collaboration not only highlights our commitment to expanding the company's global presence but also marks a significant milestone in HYTN's advancement into non-sterile pharmaceutical production.”
Greg Dobbin, Chief Executive Officer of 4C LABS, added, “Partnering with HYTN provides us with a significant competitive advantage. HYTN’s proximity to high quality Canadian cannabis flower, coupled with their rigorous adherence to GMP standards and innovative manufacturing platform, will allow us to work towards delivering top quality products and competitive pricing to our customers.”
While the initial focus of this partnership is to supply products to the UK market, both companies recognize substantial growth opportunities in Germany and Australia. The German medical cannabis market is rapidly emerging as one of Europe’s largest, with an estimated value of CAD $2 billion[i], while the Australian market, valued at over AUD $200 million in 2022[ii], continues to expand. As these markets require GMP-certified production and distribution, both firms have identified this partnership as providing the necessary framework to support global expansion.
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 4C LABS Ltd.
4C LABS is a Canadian based Medical Cannabis company which is building a vertically integrated, quality-driven infrastructure for procuring and delivering premium medical cannabis products to the UK, EU and other international regulated markets.
4C LABS focuses on launching products in regulated markets with an additional focus on research and development of new and innovative plant based therapeutic finished product forms that can be introduced to the 4C catalogue.
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
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 potential expansion of the partnership to include additional products or services; (ii) the expected growth in market share within the UK, Germany, and Australia as a result of this partnership; (iii) the anticipated benefits from leveraging GMP certifications in penetrating new international markets; and (iv) the potential to generate sales and manufacturing activity from the partnership with 4C Labs. 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.
[i] J Green. International Cannabis Business Conference (July 8, 2024) - Germany’s Medical Cannabis Industry Is Booming
[ii] J. Ryan, Pennington Institute (December 2023), Cannabis in Australia