Optimi Health has received approval from Health Canada to manufacture and distribute psychedelic medicines.
Canadian-based Optimi Health has stated that the development positions the company to be a global leader in the safe supply of EU-GMP psilocybin, MDMA, and other psychedelics. These include DMT, mescaline, ketamine, LSD, phencyclidine, GHB, harmaline, harmalol, Salvia Divinorum, Salvinorin A, and, 2C-B.
The approval was granted following amendments to the company’s application to Health Canada, allowing allow the company to increase the overall output potential of its Princeton, British Columbia facility.
Under the leadership of chief science officer Justin Kirkland, Optimi will now act as wholesale supplier of MDMA and other synthetic psychedelic compounds to approved researchers and drug developers.
Optimi CEO, Bill Ciprick, stated: “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.
“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 Standard Operating Procedures (SOP).”
The company is scheduled to begin production and analytical testing of MDMA this October in its recently completed EU-GMP pharmaceutical manufacturing facility.
The development follows the news that the Joe Biden administration was anticipating FDA regulation of MDMA and psilocybin within the next two years and was “exploring the prospect of establishing a federal task force” to review the psychedelic ecosystem.
Optimi regulatory affairs advisor, Michael Kydd, stated: “The regulatory landscape in the US and Canada is always evolving, specifically with the Canadian government’s recent decision to decriminalise MDMA up to 2.5g in British Columbia.
“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.”
The company recently unveiled Blue Serenity Natural Psilocybin in collaboration with renowned psilocybin advocate, Thomas Hartle. The product is now available to patients who face a serious or life-threatening condition and have been approved under Canada’s Special Access Program.
[activecampaign form=52]
