HYTN Awarded Drug Establishment License from Health Canada, Expanding GMP Capabilities

Published: June 28, 2024

HYTN Awarded Drug Establishment License from Health Canada, Expanding GMP Capabilities

HYTN Innovations Inc. “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.