Notice2025-10230
Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals Inc.
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 5, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
ANI Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Full Text
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<title>Federal Register, Volume 90 Issue 107 (Thursday, June 5, 2025)</title>
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[Federal Register Volume 90, Number 107 (Thursday, June 5, 2025)]
[Notices]
[Pages 23954-23955]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10230]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1547]
Bulk Manufacturer of Controlled Substances Application: ANI
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: ANI Pharmaceuticals Inc. has applied to be registered as a
bulk manufacturer of basic class(es) of controlled substance(s). Refer
to SUPPLEMENTARY INFORMATION listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants, therefore, may submit electronic comments on, or
objections to the issuance of the proposed registration on or before
August 4, 2025. Such persons may also file a written request for a
hearing on the application on or before August 4, 2025.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
[[Page 23955]]
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on April 21, 2025, ANI Pharmaceuticals Inc., 70 Lake
Drive, East Windsor, New Jersey 08520, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
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Controlled substance Drug code Schedule
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Levorphanol........................... 9220 II
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The company plans to bulk manufacture the listed controlled
substance for development and eventual use in a commercial drug
product. No other activity for this drug code is authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-10230 Filed 6-4-25; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on June 5, 2025.
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