Federal Register #2026-08588

DEA Considers Patheon API Inc. for Bulk Manufacturing of Schedule I Substances for Research

This notice concerns Patheon API Inc.'s application to become a bulk manufacturer of Schedule I controlled substances for research and clinical trials: - Government Buyer: - Drug Enforcement Administration (DEA), under the Department of Justice - OEM/Vendor: - Patheon API Inc. (applicant and proposed manufacturer) - Products/Controlled Substances Requested: - Dimethyltryptamine (drug code 7435) - Psilocybin (drug code 7437) - Psilocyn (drug code 7438) - No specific quantities provided - Unique/Notable Requirements: - Manufacturing authorization is strictly limited to research and clinical trials - No other activities or uses are permitted under this registration - All substances are Schedule I controlled substances, requiring special handling and compliance - No other OEMs or vendors are mentioned - No specific contract value or period of performance is provided - Place of performance is the Patheon API Inc. facility in Florence, South Carolina - DEA headquarters is the contracting office

Description

Patheon API Inc. has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The application is managed by the Drug Enforcement Administration under the Justice Department. The company plans to bulk manufacture controlled substances for research and clinical trials. Comments and objections to the issuance of the proposed registration are due by July 6, 2026.

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