Optimi Health Receives Drug Establishment Licence from Health Canada
Optimi Health Corp., a prominent psychedelic pharmaceutical company based in Vancouver, BC, has reached a significant milestone by obtaining a Drug Establishment Licence (DEL) from Health Canada. This license recognizes Optimi's compliance with Good Manufacturing Practices (GMP) and authorizes the company to manufacture and sell MDMA and psilocybin capsules. These capsules are intended to treat patients with Post-Traumatic Stress Disorder (PTSD) and Treatment-Resistant Depression, particularly under Australia's Authorized Prescriber Scheme. The company is now poised to extend its services globally, pending the necessary export documentation from Health Canada.
Key Points:
1. Optimi Health Corp. has been granted a Drug Establishment Licence by Health Canada, which certifies them as a GMP-compliant drug manufacturer.
2. The license allows Optimi to produce and distribute MDMA and psilocybin capsules.
3. These capsules will be available to patients in Australia, among other regulated jurisdictions, upon receipt of export documentation.
4. The company aims to register these drugs with the U.S. Food and Drug Administration through Mutual Recognition Agreements.
Optimi Health Corp. will now focus on registering its psychedelic drugs with the U.S. FDA. This move is part of a broader strategy to expand into global markets. Australian psychiatrists, authorized by the Therapeutic Goods Administration (TGA), can import Optimi's MDMA and psilocybin capsules for therapeutic use. The available options include 40mg and 60mg MDMA capsules for PTSD and 5mg psilocybin capsules for Treatment-Resistant Depression.
The company has recently received an import certificate to supply 160 doses of these treatments to Australian patients through Mind Medicine Australia. To facilitate this, a dedicated portal for pre-authorized Australian psychiatrists is set to launch on June 24, 2024. This portal will serve approximately 2,800 psychiatrists, enabling them to request these treatments for their patients.
With the Drug Establishment Licence, Optimi is now capable of offering comprehensive GMP psychedelic drug solutions that encompass manufacturing, export, and distribution. This milestone positions Optimi as a leader in the burgeoning psychedelic supply market.
A Message from Optimi’s Board:
The board of Optimi expressed its gratitude to shareholders for their support in achieving this milestone. Obtaining the DEL is crucial for Optimi’s mission to supply MDMA and psilocybin capsules to regulated markets, beginning with Australia. The board emphasized the importance of building the necessary infrastructure and obtaining the required licenses to participate in the global psychedelics market. Optimi’s ability to commercialize pharmaceutical-grade psychedelics distinguishes it from many other companies in the industry.
The DEL enables Optimi to provide comprehensive GMP psychedelic drug solutions for global commercialization. This recognition cements Optimi’s status as a leader in the psychedelic supply market. Shareholders have played a pivotal role in bringing these drugs to the prescription market, and the board believes this license will hold substantial value as global markets continue to open.
The board thanked shareholders for their continued support and confidence in Optimi’s vision, expressing optimism about future successes as the company advances its mission to be a global leader in psychedelics.
About Optimi Health Corp.:
Optimi Health Corp. is a licensed manufacturer of psychedelics, specializing in controlled substances like psilocybin and MDMA. The company also focuses on functional mushrooms aimed at the health and wellness markets. Optimi’s mission is to produce scalable psychedelic formulations for transformative human experiences. The company operates from two facilities in Princeton, British Columbia, totaling 20,000 square feet.
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