VANCOUVER, BC, June 3, 2024 /CNW/ – Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a leading Health Canada-licensed psychedelics pharmaceutical manufacturer specializing in controlled substances such as botanical psilocybin and MDMA, is pleased to announce that it has been awarded a Drug Establishment Licence (DEL) from Health Canada for the manufacturing and sale of its MDMA and psilocybin capsules. This milestone designation affirms a compliant rating for Good Manufacturing Practices (GMP), enabling the Company to supply MDMA and psilocybin capsules to patients with PTSD and Treatment-Resistant Depression under Australia’s Authorised Prescriber Scheme, and to regulated jurisdictions globally pending export documentation from Health Canada.
Key Highlights:
- Optimi is officially a GMP-compliant pharmaceutical drug manufacturer after receiving the internationally recognized Drug Establishment Licence for MDMA and psilocybin capsules, and for the fabrication of Active Pharmaceutical Ingredients (API’s) extracted from plant sources.
- The Company will now prioritize the registration of both drugs with the U.S. Food and Drug Administration through the implementation of Mutual Recognition Agreements (MRAs).
- Psychiatrists in Australia who are authorized by the Therapeutic Goods Administration (TGA) can request the importation of Optimi’s MDMA and psilocybin capsules for use in patients. The available drugs include:
- MDMA Capsules (40mg and 60mg) for PTSD; and
- Psilocybin Capsules (5mg) for Treatment-Resistant Depression.
- Optimi was recently issued an import certificate to supply 160 doses of MDMA and psilocybin to fulfill initial patient prescriptions by Mind Medicine Australia.
- The pre-authorized Australian Psychiatrist Portal is expected to launch on June 24th, 2024 to approximately 2,800 psychiatrists.
- The Company can now provide comprehensive GMP psychedelic drug solutions for worldwide drug commercialization, covering manufacturing, export, and distribution.
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A Message from The Board of Optimi:
Dear Shareholders,
Obtaining a Drug Establishment Licence (DEL) from Health Canada is a significant milestone in our efforts to build a robust, GMP-compliant company capable of supplying MDMA and psilocybin capsules to regulated markets. This licence, a requirement set forth by Health Canada, now allows us to ship both MDMA and psilocybin capsules as treatment options to Australia to help patients suffering from PTSD and Treatment-Resistant Depression.
It has been imperative for us to deliver on our promise to build the necessary infrastructure, obtain the required licenses, and develop our business to be ready to participate in the global psychedelics market. Optimi possesses capabilities that very few companies in the world have—the ability to commercialize our pharmaceutical-grade psychedelics, starting with Australia.
On a global scale, with the acquisition of the DEL, Optimi can now provide comprehensive GMP psychedelic drug solutions for worldwide drug commercialization, covering manufacturing, export, and distribution. This achievement firmly establishes Optimi as the leader in the rapidly growing psychedelic supply market.
As a shareholder in Optimi, you have helped us bring two drugs to a prescription market for patient use imminently. We believe this licence has tremendous value going forward as markets around the world open, and we thank you for your continued support and confidence in our vision.
Everyone at Optimi looks forward to sharing more successes with you as we advance our mission to be a global leader in psychedelics.
Thank you,
On Behalf of the Board of Directors
JJ Wilson
Chairman of the Board
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as psilocybin and MDMA, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe drug candidates throughout the world. Optimi’s products are grown and manufactured at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.