Optimi Health Corp., a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, has announced the completion of a GMP production run of its 5mg psilocybin finished drug product. The capsules are prescribed commercially for treatment-resistant depression (TRD) in Australia, with additional product earmarked for planned clinical trials in the United States and Europe.
Production and Distribution Details
All stages of manufacturing were completed in-house at Optimi's facility under its Health Canada Drug Establishment Licence (DEL), including biomass cultivation, extraction of the active pharmaceutical ingredient (API) using proprietary methods, encapsulation, and packaging. The DEL authorizes Optimi to manufacture, package, label, test, store, and distribute controlled drug products, positioning the company as a vertically integrated GMP supply layer for regulated psychedelic medicine.
The finished psilocybin capsules use the same formulation already prescribed to patients in Australia for TRD. The company has also updated the product's bottling configuration to improve ease of use for prescribers and patients in the Australian market.
Clinical Research and Supply Capacity
Additional product from the same production run is earmarked to support upcoming clinical research in the United States and clinical trials in Europe across various indications. Optimi's pharmaceutical-grade facility is built to institutional security standards, including a Health Canada compliant Level 8 vault capable of securely storing controlled substances valued at up to C$100 million. The company is authorized by Health Canada to hold up to 20 kilograms of psilocybin and approximately 2,000 kilograms of biomass on site, providing commercial-scale supply capacity.
Dane Stevens, CEO and Co-Founder of Optimi, stated: "Optimi is one of the only companies to take naturally derived psilocybin from biomass to a finished drug product, entirely under one roof and on our own licence. What sets Optimi apart is that we serve both sides of this market simultaneously. The same 5mg psilocybin medicine prescribed in-clinic for treatment-resistant depression today, within a fully regulated framework, is the drug also being studied in clinical trials across a range of indications. We are proud to supply patients today and the researchers shaping what comes next."
International Market Reach
Optimi supplies finished psilocybin and MDMA drug products to regulated markets internationally, supporting both patient access and clinical research. Building on its established export capability under the DEL, the company is positioned to serve approved programs across multiple jurisdictions. Inquiries regarding product for special access programs and clinical trial supply may be directed to sales@optimihealth.ca.
About Optimi Health Corp.
Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN0) is a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. As a Health Canada-licensed pharmaceutical manufacturer, Optimi produces validated MDMA and botanical psilocybin drug products at its GMP-compliant facilities in British Columbia, Canada.
