Optimi Health Obtains U.S. FDA Drug Establishment Registration
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.
Optimi Health (OPTHF) ha ottenuto il numero di Identificativo di Stabilimento della FDA statunitense (FEI), segnando un importante traguardo normativo che consente all'azienda di fornire MDMA e psilocibina certificati GMP a entità autorizzate negli Stati Uniti. Questa registrazione posiziona Optimi come un produttore farmaceutico riconosciuto dalla FDA, capace di produrre sia principi attivi che prodotti farmaceutici finiti.
Operando dalla sua struttura in Canada, dotata di una Licenza di Stabilimento Farmaceutico di Health Canada (DEL), Optimi può ora effettuare registrazioni presso la FDA e partecipare alla catena di approvvigionamento farmaceutico statunitense. Le capacità dell'azienda includono la produzione di MDMA e psilocibina di qualità farmaceutica sia in forma di principio attivo (API) sia come prodotti farmaceutici incapsulati. Questo sviluppo è particolarmente tempestivo visto che 25 stati degli USA hanno esaminato legislazioni sugli psichedelici tramite più di 74 progetti di legge.
Optimi Health (OPTHF) ha recibido su número de Identificador de Establecimiento de la FDA de EE. UU. (FEI), marcando un hito regulatorio significativo que permite a la empresa suministrar MDMA y psilocibina certificados por GMP a entidades autorizadas en Estados Unidos. El registro posiciona a Optimi como un fabricante farmacéutico reconocido por la FDA, capaz de producir tanto ingredientes activos como productos farmacéuticos terminados.
Operando desde su instalación en Canadá con una Licencia de Establecimiento de Medicamentos de Health Canada (DEL), Optimi ahora puede realizar presentaciones ante la FDA y participar en la cadena de suministro farmacéutico de EE. UU. Las capacidades de la empresa incluyen la fabricación de MDMA y psilocibina de grado farmacéutico tanto en forma de ingrediente activo (API) como en productos farmacéuticos encapsulados. Este desarrollo es especialmente oportuno dado que 25 estados de EE. UU. han considerado legislación sobre psicodélicos a través de más de 74 proyectos de ley.
Optimi Health (OPTHF)가 미국 FDA 설립 식별자(FEI) 번호를 획득하여 회사가 미국 내 허가된 기관에 GMP 인증 MDMA 및 실로시빈을 공급할 수 있는 중요한 규제 이정표를 달성했습니다. 이 등록은 Optimi를 FDA가 인정한 제약 제조업체로 자리매김하며, 활성 성분과 완제 의약품 모두를 생산할 수 있음을 의미합니다.
캐나다에 위치한 시설에서 Health Canada 의약품 설립 허가증(DEL)을 보유한 Optimi는 이제 FDA 제출을 진행하고 미국 제약 공급망에 참여할 수 있습니다. 회사의 역량은 API 형태와 캡슐화된 의약품 형태의 제약 등급 MDMA 및 실로시빈 제조를 포함합니다. 미국 25개 주가 74건 이상의 사이키델릭 관련 법안을 검토하고 있는 상황에서 이 발전은 특히 시기적절합니다.
Optimi Health (OPTHF) a obtenu son numéro d'identification d'établissement de la FDA américaine (FEI), marquant une étape réglementaire importante qui permet à l'entreprise de fournir de la MDMA et de la psilocybine certifiées GMP à des entités autorisées aux États-Unis. Cette inscription positionne Optimi en tant que fabricant pharmaceutique reconnu par la FDA, capable de produire à la fois les ingrédients actifs et les produits pharmaceutiques finis.
Opérant depuis son site au Canada, disposant d'une licence d'établissement de médicaments de Santé Canada (DEL), Optimi peut désormais effectuer des dépôts auprès de la FDA et participer à la chaîne d'approvisionnement pharmaceutique américaine. Les capacités de l'entreprise incluent la fabrication de MDMA et de psilocybine de qualité pharmaceutique, tant sous forme d'ingrédients actifs (API) que de produits encapsulés. Ce développement est particulièrement opportun alors que 25 États américains ont examiné des législations sur les psychédéliques à travers plus de 74 projets de loi.
Optimi Health (OPTHF) hat seine US-amerikanische FDA-Betriebskennnummer (FEI) erhalten, was einen bedeutenden regulatorischen Meilenstein darstellt und es dem Unternehmen ermöglicht, GMP-zertifiziertes MDMA und Psilocybin an autorisierte Stellen in den Vereinigten Staaten zu liefern. Die Registrierung positioniert Optimi als von der FDA anerkannten Pharmahersteller, der sowohl Wirkstoffe als auch fertige Arzneimittel produzieren kann.
Von seiner kanadischen Einrichtung mit einer Health Canada Arzneimittelbetriebs-Lizenz (DEL) aus kann Optimi nun FDA-Anmeldungen vornehmen und sich an der US-Pharma-Lieferkette beteiligen. Die Fähigkeiten des Unternehmens umfassen die Herstellung von pharmazeutischem MDMA und Psilocybin sowohl in API-Form als auch in kapsulierten Arzneimitteln. Diese Entwicklung ist besonders aktuell, da 25 US-Bundesstaaten psychedelische Gesetzgebungen durch mehr als 74 Gesetzentwürfe geprüft haben.
- 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
- Pending FDA approval and rescheduling of MDMA/psilocybin required for full commercialization
- Success dependent on regulatory changes across U.S. states
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.
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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
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