Psyence signs a US ibogaine manufacturer, but DEA approvals, import limits, quotas, and clinical filings remain unresolved

Psyence BioMed has assembled key parts of a US ibogaine development program by forming a Texas subsidiary, securing exclusive rights and supply from affiliated company PsyLabs, and contracting Benuvia Operations to manufacture pharmaceutical-grade ibogaine. The arrangement does not yet authorize production or human testing. Benuvia's DEA import registration was still open to objections when announced, and the companies have not publicly clarified how import permits, procurement requirements, and production quotas fit together. The 2026 aggregate US ibogaine production quota is 210 grams, while Benuvia's claim to hold about half of it has not been independently verified. Psyence says no clinical trial application has been filed, and no trial, protocol, site, or state role in Texas has been established. The next meaningful indicators are DEA action on the import registration, the 2027 quota, finalized commercial agreements, and a filed clinical application.