Optimi Health Obtains U.S. FDA Drug Establishment Registration
Rhea-AI Summary
Optimi Health (OPTHF) has received its U.S. FDA Establishment Identifier (FEI) number, marking a significant regulatory milestone that enables the company to supply GMP-certified MDMA and psilocybin to authorized entities in the United States. The registration positions Optimi as an FDA-recognized pharmaceutical manufacturer capable of producing both active ingredients and finished drug products.
Operating from its Canada-based facility with a Health Canada Drug Establishment License (DEL), Optimi can now engage in FDA filings and participate in the U.S. pharmaceutical supply chain. The company's capabilities include manufacturing pharmaceutical-grade MDMA and psilocybin in both API form and encapsulated drug products. This development is particularly timely as 25 U.S. states have considered psychedelic legislation through more than 74 bills.
Positive
- Obtained FDA Establishment Identifier (FEI) enabling supply to the U.S. market
- Positioned to file Abbreviated New Drug Applications (ANDAs) for generic MDMA and psilocybin formulations
- Dual regulatory compliance with both U.S. FDA and Health Canada Drug Establishment License
- Manufacturing capabilities for both API and finished dosage forms
- Access to the largest potential market for psychedelic-assisted therapies
Negative
- Pending FDA approval and rescheduling of MDMA/psilocybin required for full commercialization
- Success dependent on regulatory changes across U.S. states
News Market Reaction 1 Alert
On the day this news was published, OPTHF gained 6.11%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
The Company is now recognized by the U.S. FDA to support the cross-border supply of GMP MDMA and psilocybin to authorized entities in the United States.
Vancouver, British Columbia--(Newsfile Corp. - May 5, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a manufacturer of GMP-certified MDMA and psilocybin, has received its U.S. FDA Establishment Identifier (FEI) number—a key regulatory step for engaging in FDA filings and compliant supply into the United States.
According to the U.S. Food and Drug Administration's Drug Establishments Current Registration Site (DECRS), "The publication is a list of currently registered establishments which manufacture, prepare, propagate, compound, or process drugs that are distributed in the U.S. or offered for import to the U.S." Optimi is now publicly listed among these registered drug production facilities.
*Link: https://dps.fda.gov/decrs/searchresult?type=optimi
With this designation, Optimi is formally recognized within the U.S. FDA system for the manufacture of pharmaceutical-grade MDMA and psilocybin, including both active ingredients and finished drug products. Supported by its Health Canada Drug Establishment Licence (DEL), the Company is positioned to supply these substances to authorized parties through controlled, cross-border channels between Canada and the United States.
Optimi's ability to participate in the highly regulated U.S. pharmaceutical supply chain is a critical step, as the country represents the largest potential market for psychedelic-assisted therapies.
This recognition comes as 25 U.S. states have considered psychedelic legislation through more than 74 bills, underscoring the growing need for compliant, scalable, and cost-effective manufacturing to support responsible access to substances like MDMA and psilocybin.
*Source: National Library of Medicine https://pmc.ncbi.nlm.nih.gov/articles/PMC10069558/
Key Highlights
FDA Establishment Identifier (FEI): Confirms Optimi's status as an FDA-registered pharmaceutical manufacturer—required for listing drug products, filing applications, and supplying U.S. distributors directly from its Canada-based facility.
DUNS Registration: Enables Optimi to transact with U.S. government agencies, institutions, and pharmaceutical companies seeking access to GMP-certified psychedelic medicines.
Finished Dosage Form (FDF) Capabilities: The Company produces pharmaceutical-grade MDMA and psilocybin in both active pharmaceutical ingredient (API) form and as encapsulated, ready-to-administer drug products for clinical and research use.
ANDA Pathway: Allows Optimi to file Abbreviated New Drug Applications (ANDAs) to obtain FDA approval for generic MDMA and psilocybin formulations as manufacturer of record.
DEA and U.S. Agent Alignment: Establishes Optimi's ability to apply for import and export permits under DEA oversight, with a U.S. agent in place to support full regulatory compliance under controlled substances law.
CEO Statement
"Securing U.S. FDA registration for our facility reflects our team's commitment to the highest standards in pharmaceutical drug production," said Dane Stevens, CEO of Optimi. "Being recognized now—on both sides of the border—is a strong validation of the infrastructure and manufacturing capabilities we've built at Optimi."
"Should MDMA or psilocybin be formally rescheduled, or approved through an FDA New Drug Application (NDA), we intend to pursue ANDAs to support the supply of these medicines for PTSD, depression, and related indications. This milestone brings us one step closer to our goal of delivering cost-effective, GMP psychedelics at scale."
Ordering From Optimi
Optimi supplies GMP-compliant MDMA and psilocybin in both API and finished, encapsulated dosage forms.
Licensed U.S. distributors and pharmaceutical companies with the appropriate DEA registrations can order directly from Optimi for use in clinical trials, research, or commercial distribution under compliant frameworks.
To initiate procurement, contact:
sales@optimihealth.ca
About Optimi Health Corp.
Optimi Health Corp. is a Health Canada-licensed, GMP-compliant manufacturer and supplier of natural psilocybin and MDMA. Dedicated to producing high-quality psychedelic products, the Company aims to support the global advancement of mental health therapies through rigorous compliance, innovation, and collaboration.
To view an enhanced version of this graphic, please visit:
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On Behalf of the Board
JJ Wilson, Chair of the Board
For more information, please contact:
Optimi Health Corp.
Telephone: (778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements"). Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties, and contingencies, certain of which are unknown. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions, or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct, and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed in the Company's long form prospectus dated February 12, 2021, a copy of which is available on SEDAR+ at www.sedarplus.com. Except as expressly required by applicable law, Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/250789
FAQ
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