Mr. Dane Stevens reports
OPTIMI HEALTH COMPLETES COMMERCIAL PSILOCYBIN PRODUCTION TO ADDRESS TREATMENT-RESISTANT DEPRESSION IN AUSTRALIA
Optimi Health Corp.
has completed a GMP (good manufacturing practice) production run of its five-milligram psilocybin finished drug product.
The finished psilocybin capsules use the same formulation already prescribed to patients in Australia for treatment-resistant depression (TRD). The company has also updated the product's bottling configuration to improve ease of use for prescribers and patients in the Australian market.
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.
All stages of manufacturing were completed in-house and on-site at Optimi's facility under its Health Canada drug establishment licence (DEL): biomass cultivation, extraction of the active pharmaceutical ingredient (API) using Optimi's proprietary methods, encapsulation of the five mg finished drug product 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 pharmaceutical grade facility is built to institutional security standards, including a Health Canada-compliant Level 8 vault with the capacity to securely store controlled substances valued at up to $100-million. Optimi is authorized by Health Canada to hold up to 20 kilograms of psilocybin and approximately 2,000 kilograms of biomass on site, giving the company commercial-scale supply capacity.
"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," said Dane Stevens, chief executive officer and co-founder of Optimi. "What sets Optimi apart is that we serve both sides of this market simultaneously. The same five mg 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."
Optimi supplies finished psilocybin and MDMA drug products to regulated markets internationally, in support of 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 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.
Optimi supplies both active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, with products currently prescribed to patients in Australia under the country's authorized prescriber scheme and accessible in Canada through the Special Access Program.
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