HYTN Awarded Drug Establishment License from Health Canada, Expanding GMP Capabilities
27 June 2024 - 10:00PM
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 McKerrChief Executive Officer1.866.590.9289
HYTN Investor Relations:1.866.590.9289investments@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.