Federal Register #DEA-1716

DEA Notice: Amneal Pharmaceuticals, LLC Seeks Import Registration for Controlled Substances (Research Use)

This notice from the Drug Enforcement Administration (DEA) announces Amneal Pharmaceuticals, LLC's application to register as an importer of controlled substances for research and development purposes. - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEM/Vendor: - Amneal Pharmaceuticals, LLC - Products/Services Requested: - Authorization to import finished unit formulations of controlled substances - No specific controlled substances, part numbers, or quantities detailed - Unique/Notable Requirements: - Importation is strictly for internal development and research - No authorization for commercial sale or importation of FDA-approved/non-approved finished dosage forms - DEA is soliciting comments or objections from registered bulk manufacturers and applicants - Place of Performance: - Amneal Pharmaceuticals, LLC, Piscataway, New Jersey - Contracting Office: - DEA, Springfield, Virginia

Description

Amneal Pharmaceuticals, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). The company plans to import the listed controlled substance as finished unit formulations for internal development and research purposes only. No other activity for this drug code is authorized for this registration. Registered bulk manufacturers of the affected basic class(es), and applicants, may submit electronic comments or objections to the issuance of the proposed registration by June 22, 2026. Requests for a hearing on the application must also be filed by June 22, 2026.

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