Notice2025-23467
Bulk Manufacturer of Controlled Substances Application: Janssen 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
December 19, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Janssen 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 242 (Friday, December 19, 2025)</title>
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[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Notices]
[Page 59583]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23467]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1635]
Bulk Manufacturer of Controlled Substances Application: Janssen
Pharmaceuticals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Janssen 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
February 17, 2026. Such persons may also file a written request for a
hearing on the application on or before February 17, 2026.
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 November 7, 2025, Janssen Pharmaceuticals, Inc., 1440
Olympic Drive, Buildings 1-5 and 7-14, Athens, Georgia 30601-1645,
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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Methylphenidate...................... 1724 II
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The company plans to manufacture the listed controlled substance
for sale to its customers. No other activity for this drug code is
authorized for this registration.
Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2025-23467 Filed 12-18-25; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on December 19, 2025.
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