DEA Notice: ANI Pharmaceuticals Applies to Bulk Manufacture Levorphanol
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 manufacture levorphanol in bulk. Levorphanol is a Schedule II controlled substance, so the company needs DEA registration before it can produce it at scale. The planned activity is limited to bulk manufacturing for development and possible later use in a commercial drug product. Existing registered bulk manufacturers and applicants for the same drug class may submit comments, objections, or hearing requests by July 6, 2026.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- DEA is reviewing ANI Pharmaceuticals Inc.’s application to register as a bulk manufacturer of levorphanol.
- The proposed registration would cover only bulk manufacturing for development and eventual use in a commercial drug product.
- Eligible controlled-substance manufacturers and applicants may submit comments, objections, or hearing requests by July 6, 2026.
Obligations
What this law requires
ANI Pharmaceuticals Inc. must obtain DEA registration as a bulk manufacturer before bulk manufacturing levorphanol, a Schedule II controlled substance, in bulk.
Any comments or objections to the proposed DEA registration must be submitted electronically through the Federal eRulemaking Portal at regulations.gov.
Any written request for a hearing on ANI Pharmaceuticals Inc.’s bulk manufacturer application must be filed by the applicable eligible parties by the stated deadline.
ANI Pharmaceuticals Inc.’s proposed registration for levorphanol, drug code 9220, authorizes only bulk manufacturing for development and eventual use in a commercial drug product; no other activity for this drug code is authorized under this registration.