Optimi Health Completes GMP Psilocybin Production Run for Australian TRD Market and Clinical Trials

Optimi Health Corp. has completed a GMP production run of its 5mg psilocybin capsules under a single Health Canada Drug Establishment Licence, covering every manufacturing stage in-house, from biomass cultivation through API extraction, encapsulation, and packaging, a configuration that carries direct implications for QA directors and regulatory leads tracking controlled substance supply chain compliance in emerging psychedelic medicine.

The finished capsules use the same formulation currently prescribed in Australia under that country's Authorized Prescriber Scheme for treatment-resistant depression. Optimi has also updated the product's bottling configuration to improve prescriber and patient usability in the Australian market. Product from the same run is earmarked to support upcoming clinical research in the United States and clinical trials in Europe across multiple indications, extending the supply chain relevance beyond a single jurisdiction.

For plant heads and QA leads, the operational structure is notable. All manufacturing stages were executed at Optimi's British Columbia facility under its Health Canada DEL, which authorises the company to manufacture, package, label, test, store, and distribute controlled drug products. The facility includes a Health Canada-compliant Level 8 vault rated for controlled substances valued at up to C$100 million. Optimi holds authorisation to store up to 20 kilograms of psilocybin and approximately 2,000 kilograms of biomass on site, establishing a defined commercial-scale ceiling under the current licence.

The vertical integration model, one licence, one site, full process ownership from biomass to finished dosage form, reduces the inter-site transfer risk and chain-of-custody complexity that typically accompanies controlled substance manufacturing across multiple DEL holders. For regulatory affairs leads monitoring how Health Canada's controlled substance framework applies to psychedelic drug products, Optimi's structure offers a working reference point as other manufacturers evaluate similar programmes.

Optimi also supplies finished MDMA drug products internationally and has established export capability under the DEL to serve approved programmes across multiple jurisdictions, including Canada's Special Access Program.

The next measurable checkpoint is the initiation of the earmarked clinical trial supply shipments to US and European programmes, which will test the DEL's export authorisation against the import requirements of each receiving jurisdiction's controlled substance regulations.

Source: Optimi Health Corp. via GlobeNewswire, 2 June 2026.