Notice2024-11879
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
May 31, 2024
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 89 Issue 106 (Friday, May 31, 2024)</title>
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[Federal Register Volume 89, Number 106 (Friday, May 31, 2024)]
[Notices]
[Page 47176]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11879]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1365]
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
July 30, 2024. Such persons may also file a written request for a
hearing on the application on or before July 30, 2024.
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on April 9, 2024, 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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Psilocybin........................... 7437 I
Levorphanol.......................... 9220 II
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The company plans to bulk manufacture the listed controlled
substances for the internal use or for sale to its customers. No other
activities for these drug codes are authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-11879 Filed 5-30-24; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on May 31, 2024.
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