Reaching the world with EU-GMP natural psilocybin, functional mushrooms, and synthetic psychedelics.
Good Manufacturing Practice (GMP) describes the minimum standard that a medicine manufacturers must meet in their production processes.
Optimi produces at an GMP level, meaning our products are eligible to be sold in the European Union (EU).
The European Medicines Agency coordinates inspections to verify compliance with these standards and plays a key role in harmonizing GMP activities at the EU level.
are of consistent high quality;
are appropriate for their intended use;
meet the requirements of the marketing authorization or clinical trial authorization.
Optimi is the largest supplier of natural psilocybin in North America, and we feel good about setting the safest and most stringent production standards in the industry.
Optimi’s purpose-built, 20,000 square feet of state-of-the-art, technologically advanced grow facilities are dedicated to the cultivation of safe, high-quality, GMP psilocybin, functional mushrooms. and synthetic psychedelics.
We operate under strict adherence to Health Canada, US FDA, and GMP guidelines. Our facilities and processes undergo routine audits and inspections from sponsors and regulatory authorities.
Our cultivation facility is classified as a Level 8 Security Environ with an allowance of $50 million CAD worth of product to be stored on site, making it fully compliant with any requirements under GACP, GMP, and as defined in Health Canada’s Controlled Drugs and Substances Act.
We are fully licensed by Health Canada to grow and possess a quota of up to 5,000kg of dried psilocybin mushrooms – the equivalent of 10kg of psilocybin – and 100g of psilocin.
To sell Optimi products in Europe, the European Medicines Agency (EMA) requires manufacturers to comply with full Good Manufacturing Practice (GMP) no matter where in the world they are located.
“Health Canada’s message sets the right tone, right standard, and right policy when it comes to building a sustainable industry backed by hard, evidence-based, science-driven clinical research that is paramount to the health and wellbeing of Canadians.”
On May 9, 2022, Health Canada made the following declaration regarding the proposed use of psilocybin mushrooms in clinical trials, or as a drug accessed through the Special Access Program (SAP), specifically around the “importance of drug quality and Good Manufacturing Practices (GMP).”
“Research that meets the definition of a clinical trial in the Food and Drug Regulations (FDR) is subject to Part C, Division 5, which is a set of internationally aligned regulations under the FDR that govern the sale and importation of drugs for use in clinical trials. The chemistry and manufacturing requirements set out under division 5 of the FDR require the investigational product to be of GMP quality. This means that any psilocybin product, including psilocybin mushrooms, used in a clinical trial must be manufactured according to GMP standards.”
Optimi supports this statement. Please read our response here.
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Optimi Health Corp.
21 Water St #600, Vancouver, BC V6B 1A1
Legal Counsel: Norton Rose Fulbright
Auditor: Smythe CPA
Transfer Agent: Endeavor Trust
Corporate Visibility & Investor Relations: Kydder Group
Trading Symbol: CSE: OPTI | OTC:OPTHF |
CUSIP Number: 68405H100
ISIN Number: CA68405H1001
Issued & Outstanding: (30/06/2022) 80,451,883
Incorporated: BC / May 27, 2020
Year End: September 30th
Products do not contain psilocybin