Optimi Health Secures Amendment to Increase Quantities Of MDMA, MDA, And 2C-B Under Controlled Drugs And Substances Dealer’s Licence
January 19 2024 - 7:30AM
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi”
or the “Company”), a Health Canada licensed drug researcher and
formulator specializing in controlled psychedelic substances such
as natural psilocybin and MDMA, is pleased to announce it has been
granted an amendment to its Health Canada Controlled Drugs and
Substances Licence. Effectively implemented on January 16, 2024,
the amendment allows substantial increases in the quantities of
MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the
Food and Drug Regulations.
Terms of the amendment now permit the following
increases:
- N-METHYL-3,4-METHYLENEDIOXY
AMPHETAMINE (MDMA) – from 2kg to 20kg.
- 3,4-METHYLENEDIOXYAMPHETAMINE (MDA)
– from 1kg to 2kg.
- 4-BROMO-2,5-DIMETHOXYBENZENE
ETHANAMINE (2C-B) – from 400g to 4kg.
The obtained amendment is a crucial component of
Optimi's strategy to solidify its position as an industry-leading
psychedelics drug manufacturer, strategically positioning itself in
anticipation of the potential approval of MDMA by the U.S. Food and
Drug Administration in 2024.
Bill Ciprick, Optimi's CEO, underscored the
strategic importance of the amendment, stating, "This marks a
pivotal achievement in Optimi's strategic licensing plan,
positioning us with one of the most robust licensing portfolios
globally. It enhances our competitive advantage and perfectly
aligns with our vision to be the leading global supplier of GMP
MDMA and other psychedelic substances."
In its year end Annual Review, the Company laid
out its 2024 strategic licensing plan which includes approvals for
a Drug Master File (DMF) and Drug Establishment Licence (DEL). This
critical documentation affirms Optimi’s commitment to regulatory
compliance and transparency, laying the foundation for streamlined
communication with regulatory authorities and delivering
high-quality APIs and controlled substances that meet global
standards for pharmaceutical manufacturing and control.
Optimi now has Health Canada approval to
manufacture the following controlled substances:
2,5-DIMETHOXYPHENETHYLAMINE
3,4-METHYLENEDIOXYAMPHETAMINE (MDA)
4-BROMO-2,5-DIMETHOXY-N-(2-METHOXYBENZYL)PHENETHYLAMINE (25-BNBOME)
4-BROMO-2,5-DIMETHOXYBENZENE ETHANAMINE (2C-B)
4-CHLORO-2,5-DIMETHOXY-N-(2METHOXYBENZYL)PHENETHYLAMINE(25C-NBOME)
4-HYDROXYBUTANOIC ACID (GHB)
4-IODO-2,5-DIMETHOXY-N-(2-METHOXYBENZYL)PHENETHYLAMINE (25I-NBOME)
HARMALINE HARMALOL KETAMINE LYSERGIC ACID DIETHYLAMIDE (LSD)
MESCALINE N,N-DIMETHYLTRYPTAMINE (DMT)
N-METHYL-3,4-METHYLENEDIOXY AMPHETAMINE
PHENCYCLIDINE PSILOCIN PSILOCYBIN SALVINORIN A
For media inquiries, please contact Michael
Kydd:
michaelk@optimihealth.ca
For investor inquiries, please
contact:investors@optimihealth.ca
www.optimihealth.ca
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA:
8BN)
Optimi Health Corp. an end-to-end drug
researcher and formulator licensed by Health Canada to produce and
supply, for clinical research purposes, psychedelic substances such
as 3,4-Methylenedioxymethamphetamine (“MDMA”), natural GMP-grade
psilocybin, as well as functional mushrooms that focus on the
health and wellness markets. Built with the purpose of producing
scalable psychedelic formulations for transformational human
experiences, the Company’s goal is to be the number one trusted,
compassionate supplier of safe drug candidates throughout the
world. Optimi’s products are grown and manufactured at its two
facilities comprising a total of 20,000 square feet in Princeton,
British Columbia.
FORWARD‐LOOKING
STATEMENTS
This news release contains forward-looking
statements and forward-looking information within the meaning of
Canadian securities legislation (collectively, “forward-looking
statements”) that relate to Optimi’s current expectations and views
of future events. Any statements that express, or involve
discussions as to, expectations, beliefs, plans, objectives,
assumptions or future events or performance (often, but not always,
through the use of words or phrases such as “will likely result,”
“are expected to,” “expects,” “will continue,” “is anticipated,”
“anticipates,” “believes,” “estimated,” “intends,” “plans,”
“forecast,” “projection,” “strategy,” “objective,” and “outlook”)
are not historical facts and may be forward-looking statements and
may involve estimates, assumptions and uncertainties which could
cause actual results or outcomes to differ materially from those
expressed in such forward-looking statements. No assurance can be
given that these expectations will prove to be correct and such
forward-looking statements included in this news release should not
be unduly relied upon. These statements speak only as of the date
of this news release.
Forward-looking statements are based on a number
of assumptions and are subject to a number of risks and
uncertainties, many of which are beyond Optimi’s control, which
could cause actual results and events to differ materially from
those that are disclosed in or implied by such forward-looking
statements. Such risks and uncertainties include, but are not
limited to, the impact and progression of the COVID-19 pandemic and
other factors set forth under “Forward-Looking Statements” and
“Risk Factors” in the Company’s Annual Information Form dated
January 9, 2023, and other continuous disclosure filings available
under Optimi’s profile at www.sedarplus.ca. Optimi undertakes no
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as may be required by law. New factors emerge from time to
time, and it is not possible for Optimi to predict all of them or
assess the impact of each such factor or the extent to which any
factor, or combination of factors, may cause results to differ
materially from those contained in any forward-looking
statement.
Any forward-looking statements contained in this
news release are expressly qualified in their entirety by this
cautionary statement.
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