ANI Pharma's Bid to Import Key Controlled Drugs
Published Date: 5/4/2026
Notice
Summary
ANI Pharmaceuticals wants to import certain controlled drugs like Levorphanol and Tapentadol. People who make or use these drugs can share their thoughts or ask for a hearing by June 3, 2026. This move could affect drug availability and regulation, so keep an eye on the deadline to have your say!
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
No Import of Finished Dosage Forms
The notice states that authorization for this import registration will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. Permit approval will be limited to activities consistent with 21 U.S.C. 952(a)(2).
Comment and Hearing Deadline
Registered bulk manufacturers and applicants may submit electronic comments or objections, or file a written request for a hearing, on ANI Pharmaceuticals Inc.'s importer application by June 3, 2026. Comments must be submitted through Regulations.gov or hearing requests sent to the DEA addresses listed in the notice.
Levorphanol Import Authorization Sought
ANI Pharmaceuticals applied to be registered to import Levorphanol (controlled substance code 9220, Schedule II) for distribution to customers. If the registration is granted, this import authorization would cover Levorphanol distribution as described in the application.
Tapentadol Import Limited to Research
ANI applied to import Tapentadol (controlled substance code 9780, Schedule II) only in small quantities for internal research and reference standards purposes. The application states no other activities for this drug code are authorized for this registration.
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Key Dates
Department and Agencies
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Previous / Next Documents
Previous: 2026-08586 — Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals Inc.
ANI Pharmaceuticals wants to make a big batch of a strong medicine called Levorphanol, which is a controlled substance. This affects people in the drug manufacturing and regulation world, and the public can share their thoughts or ask for a hearing by July 6, 2026. If approved, ANI will help develop new medicines, but no other activities with this drug are allowed under this registration.
Next: 2026-08588 — Bulk Manufacturer of Controlled Substances Application: Patheon API Inc.
Patheon API Inc. wants to make large amounts of special research drugs like dimethyltryptamine and psilocybin. This affects researchers and companies involved in clinical trials, with a chance to comment or ask for a hearing by July 6, 2026. No money changes are mentioned, but this move could speed up important medical studies.