ANI Pharmaceuticals Inc. Applies to Import Controlled Substances

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ANI Pharmaceuticals Inc. has asked the Drug Enforcement Administration (DEA) to approve its registration as an importer of two controlled substances: Levorphanol and Tapentadol.

Levorphanol has a drug code of 9220 and is listed as a Schedule II substance. ANI Pharmaceuticals plans to import Levorphanol for distribution to customers.

Tapentadol has a drug code of 9780 and is also a Schedule II substance. ANI Pharmaceuticals will only import small amounts of Tapentadol. The Tapentadol is for internal research and making reference standards. No other uses of these drugs are allowed under this registration.

Only bulk manufacturers already registered for these drugs, or new applicants, may send comments or objections about ANI’s application. Comments and objections must be sent electronically through the Federal eRulemaking Portal at https://www.regulations.gov. The deadline is July 2, 2025.

Anyone asking for a hearing about this application must send their written request by July 2, 2025. Requests for hearings must be sent to several DEA addresses in Springfield, Virginia. These addresses include the Hearing Clerk/OALJ, the DEA Federal Register Representative/DPW, and the Administrator.

The DEA says it will approve permit applications only if ANI Pharmaceuticals’ business activity matches what is allowed under U.S. law 21 U.S.C. 952(a)(2). ANI’s authorization will not cover importing FDA-approved or non-approved finished dosage forms for sale.

The notice was signed by Matthew Strait, Deputy Assistant Administrator, and published in the Federal Register on June 2, 2025.

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