ANI Pharmaceuticals Applies to Import Levorphanol and Tapentadol
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This notice opens public review of ANI Pharmaceuticals Inc.’s application to import two Schedule II controlled substances: levorphanol and tapentadol. It does not approve the application yet, but gives eligible manufacturers and applicants a chance to object or request a hearing by June 3, 2026. ANI says levorphanol would be imported for distribution to customers, while tapentadol would be imported only in small amounts for internal research and reference standards. The registration would not allow ANI to import finished drug products for commercial sale.
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Key Changes
- DEA is reviewing ANI Pharmaceuticals’ application to register as an importer of levorphanol and tapentadol.
- Eligible registered bulk manufacturers and applicants may comment, object, or request a hearing by June 3, 2026.
- The proposed authorization would limit levorphanol to customer distribution and tapentadol to small quantities for internal research and reference standards.
Obligations
What this law requires
Any registered bulk manufacturer or applicant submitting comments or objections on ANI Pharmaceuticals Inc.’s proposed importer registration must submit them electronically through the Federal eRulemaking Portal at https://www.regulations.gov.
Any eligible person requesting a hearing on ANI Pharmaceuticals Inc.’s importer application must file a written hearing request by the stated deadline and send it to DEA Hearing Clerk/OALJ and DEA Federal Register Representative/DPW at 8701 Morrissette Drive, Springfield, Virginia 22152; the request should also be sent to the DEA Administrator at the same address.
If ANI Pharmaceuticals Inc. is granted the importer registration, levorphanol (drug code 9220, Schedule II) may be imported under that registration only for distribution to customers.
If ANI Pharmaceuticals Inc. is granted the importer registration, tapentadol (drug code 9780, Schedule II) may be imported under that registration only in small quantities for internal research and reference standards purposes.
ANI Pharmaceuticals Inc. may not conduct any activities under the proposed registration for levorphanol or tapentadol other than the activities expressly authorized for those drug codes.