Federal Register #DEA-1740

DEA Notice: Unither Manufacturing LLC Application to Import Methylphenidate for Analytical Testing

This notice concerns Unither Manufacturing LLC's application to the Drug Enforcement Administration (DEA) for registration as an importer of controlled substances. - Government Buyer: - U.S. Department of Justice, Drug Enforcement Administration (DEA) - OEMs and Vendors: - Unither Manufacturing LLC (applicant) - Products/Services Requested: - Methylphenidate (Schedule II controlled substance) - Purpose: Importation solely for updating analytical testing procedures to comply with European Union requirements for exported finished dosage form products - Unique or Notable Requirements: - Importation is strictly limited to analytical testing; no authorization for commercial sale or other activities - No finished dosage forms (FDA-approved or non-approved) are included for commercial sale - No other products, services, or vendors are involved in this notice

Description

Unither Manufacturing LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). The application is for the import of methylphenidate (Schedule II) solely for purposes of updating their analytical testing procedures to meet European Union requirements for their exported finished dosage form product. No other activity for this drug code is authorized for this registration. Comments or objections to the issuance of the proposed registration may be submitted electronically on or before August 17, 2026, and requests for a hearing must also be filed by this date.

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