Optimi Health (OPTI) receives grant for MDMA production and distribution amendment
Production and analytical testing of MDMA is scheduled for this October
Biden Administration looking to regulate MDMA and psilocybin
Optimi Health (OPTI) is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets
Optimi Health (OPTI) is up today, trading at C$0.37 as of Aug 16, 2022, 11:33am ET
Optimi Health (OPTI) has received a grant for MDMA production and distribution amendment.
The company secures permission from Health Canada to manufacture and distribute additional psychedelic substances, most notably MDMA, under the amended terms outlined in its June 20, 2022 application.
Justin Kirkland, Chief Science Officer, is leading the way as Optimi becomes the wholesale supplier of MDMA and other synthetic psychedelic compounds to approved researchers and drug developers.
The company is scheduled to begin production and analytical testing of MDMA this October in its recently completed EU-GMP pharmaceutical manufacturing facility.
Optimi CEO, Bill Ciprick, says the company’s in-house capacity to produce a wide range of scalable formulations puts Optimi at the forefront of the commercial manufacturing and supply of psychedelics.
Ciprick goes on to say:
“Licensing amendment positions Optimi to be a global leader in the safe supply of EU-GMP Psilocybin, MDMA, and other psychedelics. From lab to market, Optimi has taken every step necessary to build its competitive position as a global leader in the manufacturing of EU-GMP compliant MDMA in North America, and we’ve done that through operational transparency and investing in smart infrastructure.”
He further added:
“On compliance, quality, and scale, we have consistently demonstrated our plan to lead the industry in API synthesis and formulation, which gives our science and operations team the confidence to develop saleable psychedelic products that are supported by rigorous in-house SOPs.”
The terms of the amendment took effect as of Friday, August 5, 2022, and will allow the company to increase the overall output potential of its Princeton, British Columbia facility to better address the needs of the evolving psychedelic market as part of commercialization.
Since applying for the amendment in June, the company has met with industry stakeholders, drug developers, and clinical trial researchers interested in exploring Optimi’s production capabilities, reaffirming the company’s decision to proceed with this phase of its commercialization strategy.
With 130 MDMA clinical trials currently listed between Canada and the United States and the prospect of the Biden Administration looking to regulate MDMA and psilocybin, Optimi is already preparing for a future international and domestic regulatory movement that could positively impact the company.
“The regulatory landscape in the U.S and Canada is always evolving, specifically with the Canadian government’s recent decision to decriminalize MDMA up to 2.5 grams in British Columbia,” said Optimi regulatory affairs advisor, Michael Kydd. “Governments often use incremental shifts in policy to test public sentiment, which sometimes triggers broader policy change down the road. Having a licence to produce EU-GMP MDMA at an unmatched scale will benefit the company when we eventually see these wholesale policy changes.”
Optimi Health (OPTI) is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets.
Optimi Health (OPTI) is up today, trading at C$0.37 as of Aug 16, 2022, 11:33am ET.
