Business
Optimi Health Obtains U.S. FDA Drug Establishment Registration
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 ...
About this update from Optimi Health Corp.
[{"type":"text","content":"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.","length":152,"tagName":"p","attribs":{"class":"nfSubHeading"},"className":""},{"type":"text","content":"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.","length":380,"tagName":"p"},{"type":"text","content":"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.","length":402,"tagName":"p"},{"type":"text","content":"*Link: https://dps.fda.gov/decrs/searchresult?type=optimi","length":57,"tagName":"p"},{"type":"text","content":"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.","length":426,"tagName":"p"},{"type":"text","content":"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.","length":203,"tagName":"p"},{"type":"text","content":"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.","length":266,"tagName":"p"},{"type":"text","content":"*Source: National Library of Medicine https...