Federal Register #2026-08587

DEA Review of ANI Pharmaceuticals Application to Import Levorphanol and Tapentadol

The Drug Enforcement Administration (DEA) is reviewing an application from ANI Pharmaceuticals Inc. to import specific controlled substances. - Government Buyer: - Drug Enforcement Administration (DEA), under the Justice Department - OEM/Vendor: - ANI Pharmaceuticals Inc. (applicant and importer) - Products Requested: - Levorphanol (Schedule II controlled substance, drug code 9220) - Purpose: For distribution to customers - No specified quantity - Tapentadol (Schedule II controlled substance, drug code 9780) - Purpose: For internal research and reference standards - No specified quantity - Unique/Notable Requirements: - Importation is strictly limited to the purposes stated (distribution for Levorphanol; research/reference for Tapentadol) - No importation of finished dosage forms for commercial sale is permitted - No other activities for these drug codes are authorized under this registration - Only the two substances listed are covered by this application

Description

ANI Pharmaceuticals Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). The application involves the importation of controlled substances such as Levorphanol and Tapentadol, with specific uses outlined for distribution and internal research. Registered bulk manufacturers and applicants may submit electronic comments or objections, or file a written request for a hearing by June 3, 2026. The registration will not authorize the import of FDA-approved or nonapproved finished dosage forms for commercial sale.

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