Optimi Health Completes GMP 5mg Psilocybin Run, Updates Bottling, Backs U.S. and Europe Trials
OPTH•Optimi Health completed a GMP production run of 5mg psilocybin capsules for treatment-resistant depression in Australia and updated its bottling configuration. Additional product will support U.S. and European clinical trials, leveraging its in-house Health Canada DEL-authorized facility capable of holding up to 20 kg of psilocybin biomass.
1. Completion of Commercial Psilocybin Production
Optimi Health completed a GMP production run of its 5mg psilocybin finished drug product at its British Columbia facility under Health Canada DEL, using in-house biomass cultivation, API extraction and encapsulation to produce capsules for treatment-resistant depression prescriptions in Australia.
2. Updated Packaging for Australian Market
The company introduced an updated bottling configuration designed to simplify handling for prescribers and patients, aiming to enhance operational efficiency and user experience in the Authorized Prescriber Scheme.
3. Support for U.S. and European Clinical Research
Additional capsules from the production run are allocated to upcoming clinical trials in the United States and Europe across various indications, underscoring Optimi’s strategy to align its commercial and research supply.
4. Facility Capacity and Regulatory Authorization
Optimi’s GMP-compliant facility includes a Health Canada-compliant Level 8 vault with C$100 million storage capacity and DEL authorization to hold up to 20 kg of psilocybin and 2,000 kg of biomass, positioning the company as a fully integrated psychedelic medicine supplier.
