2026-08586Notice

ANI Pharma Applies for Levorphanol Bulk Production

Published Date: 5/4/2026

Notice

Summary

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.

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Key Dates

Published Date
Comments Due
5/4/2026
7/6/2026

Department and Agencies

Department
Independent Agency
Agency
Justice Department
Drug Enforcement Administration
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