Optimi Health Completes GMP Production Run of 5mg Psilocybin Capsules
OPTH•Optimi Health completed a GMP production run of 5mg psilocybin capsules at its British Columbia facility, consolidating its vertically integrated process under Health Canada’s Drug Establishment Licence. The batch expands supply for treatment-resistant depression patients in Australia and underpins upcoming clinical trials in the U.S. and Europe using new packaging.
1. GMP Production Run Completed
Optimi Health completed a Good Manufacturing Practice production run of its 5mg psilocybin capsules entirely at its British Columbia facility. The batch involved biomass cultivation, psilocybin extraction, encapsulation, and packaging under Health Canada’s Drug Establishment Licence, leveraging the company’s vertically integrated manufacturing process.
2. Strengthening Supply and Packaging Improvements
The new 5mg capsules use the same formulation prescribed under Australia’s regulated treatment framework for treatment-resistant depression, expanding patient supply. Optimi updated the product’s packaging configuration to improve usability for both prescribers and patients, enhancing convenience and safety.
3. Prepping for Clinical Trials in U.S. and Europe
The production run supports Optimi’s upcoming clinical trials in the United States and Europe, ensuring consistent GMP-grade supply for research. This milestone positions the company to meet regulatory requirements and facilitates timely trial initiation across multiple jurisdictions.
