- Optimi Health (CSE:OPTI), a microcap psychedelics manufacturer, has been awarded a Drug Establishment Licence from Health Canada to produce and sell its MDMA and psilocybin capsules to an Australian client
- The designation certifies that the company is compliant with Good Manufacturing Practices, allowing it to manufacture, export and distribute its MDMA and psilocybin capsules to regulated jurisdictions across the world
- Optimi Health is a psychedelics-based pharmaceuticals manufacturer with a focus on psilocybin, MDMA and functional mushrooms
- Optimi Health stock has added 104.35 per cent year-over-year, but remains down by 50 per cent since inception in 2021
Optimi Health (CSE:OPTI), a microcap psychedelics manufacturer, has been awarded a Drug Establishment Licence from Health Canada to produce and sell its MDMA and psilocybin capsules to an Australian client.
The designation certifies that the Vancouver-based company is compliant with Good Manufacturing Practices (GMP), allowing it to manufacture, export and distribute its MDMA and psilocybin capsules to patients with PTSD and treatment-resistant depression under Australia’s Authorised Prescriber Scheme, as well as to regulated jurisdictions across the world.
Australia passed pioneering legislation in 2023 making it the first country in the world to legalize psychedelics to treat mental health conditions. The country will launch its pre-authorized Australian Psychiatrist Portal on June 24, 2024, to approximately 2,800 psychiatrists, granting them ready access to information on the import and export of psychedelics.
Leadership insights
“On a global scale, with the acquisition of the Drug Establishment Licence, Optimi can now provide comprehensive GMP psychedelic drug solutions for worldwide drug commercialization, covering manufacturing, export and distribution. This achievement firmly establishes Optimi as the leader in the rapidly growing psychedelic supply market,” JJ Wilson, chairman and co-founder of Optimi Health, and son to billionaire Lululemon Athletica founder Chip Wilson, said in a statement.
Next steps
Optimi will now focus on registering its capsules with the U.S. Food and Drug Administration, which published first draft guidance on psychedelic clinical trials last June in a landmark move.
The company is also keen to follow up on recent deals in New Zealand and Israel with more partnerships and revenue-producing opportunities, in an effort to strategically scale and stem losses of more than C$5 million per year since its initial public offering in 2021.
About Optimi Health
Optimi is a psychedelics-based pharmaceutical manufacturer with a focus on psilocybin, MDMA and functional mushrooms. The company operates out of two facilities spanning more than 20,000 square feet combined in Princeton, British Columbia.
Optimi Health Corp. stock (CSE:OPTI) last traded at C$0.47 per share. The stock has added 104.35 per cent year-over-year, but remains down by 50 per cent since inception in 2021.
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(Top image: Optimi Health)