Optimi Health Corp. manufactures finished‑dose psilocybin and MDMA capsules in a Health Canada‑licensed facility and distributes them to authorized psychiatrists in Australia under the TGA Authorized Prescriber Scheme. The product line includes natural psilocybin extract, MDMA 60 mg and 40 mg capsules, and a 1 mg microdose formulation, all supplied for treating post‑traumatic stress disorder and treatment‑resistant depression. The company is positioned to expand into additional regulated markets as rescheduling progresses.
Funding
Funding not disclosed
Founders
Product
Problem
Access to psychedelic-based therapies for mental health conditions is limited by strict regulatory frameworks and a lack of pharmaceutical‑grade, ready‑to‑use formulations, restricting treatment options for patients with treatment‑resistant depression and post‑traumatic stress disorder.
Solution
Optimi Health manufactures finished‑dose psilocybin and MDMA capsules in a Health Canada Drug Establishment‑licensed GMP facility and supplies them to authorized psychiatrists under the Australian TGA Authorized Prescriber Scheme. By producing pharmaceutical‑grade capsules that meet Canadian GMP standards and providing a qualified‑person release process, the company ensures consistent potency, purity, and regulatory compliance. Products are distributed through approved clinics, enabling clinicians to prescribe validated doses for depression and PTSD without the need for compounding. The supply chain is designed to scale into additional jurisdictions as regulatory pathways evolve, positioning Optimi Health to meet emerging market demand for psychedelic medicines.
Target Audience
Primary customers are licensed psychiatrists and specialty clinics in Australia treating treatment‑resistant depression and PTSD, as well as research institutions conducting controlled psychedelic studies.
Features
- GMP‑certified manufacturing in a Health Canada Drug Establishment‑licensed facility with qualified‑person batch release
- Finished‑dose capsules of natural psilocybin extract (4‑PO‑DMT) and MDMA (60 mg and 40 mg) meeting USP‑grade impurity specifications
- HPLC‑MS identity and potency testing, validated stability data, and USP‑grade impurity panels for each batch
- Distribution under the TGA Authorized Prescriber Scheme to authorized psychiatrists and clinics in Australia
- Product portfolio includes microdose (1 mg) capsules for research and controlled dosing protocols
- Scalable regulatory strategy to expand supply into the United States, European Union, and other markets as rescheduling occurs