[PRESS RELEASE] VANCOUVER,
British Columbia, June 27, 2024 (GLOBE NEWSWIRE) -- 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 totaling 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.