Federal Register #2026-17288

Bulk Manufacture Registration for Schedule I Controlled Substance by Kinetochem LLC

This opportunity concerns Kinetochem LLC's application to become a registered bulk manufacturer of a Schedule I controlled substance, overseen by the Drug Enforcement Administration (DEA). - Government Buyer: - Drug Enforcement Administration (DEA), U.S. Department of Justice - OEMs and Vendors: - Kinetochem LLC (applicant and proposed manufacturer) - Products/Services Requested: - Bulk manufacture of 3,4-Methylenedioxy-N-methylcathinone (drug code 7540, Schedule I) - Intended use: Active Pharmaceutical Ingredient (API) for customers, research, and clinical trials - No other activity authorized for this drug code - Unique/Notable Requirements: - Registration is strictly for manufacturing the specified controlled substance as an API - DEA invites comments or objections from other registered bulk manufacturers and applicants - Focus is on compliance with controlled substance regulations and research/clinical trial support

Description

Kinetochem LLC has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The application is a notice published by the Drug Enforcement Administration under the Justice Department. Registered bulk manufacturers and applicants may submit electronic comments or objections, and file written requests for a hearing on the application by October 26, 2026. The company plans to bulk manufacture the listed controlled substances as Active Pharmaceutical Ingredients for customers and for research and clinical trials.

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