Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.

Issuing agencies

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 91 Issue 200 (Monday, October 19, 2026)</title>
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[Federal Register Volume 91, Number 200 (Monday, October 19, 2026)]
[Notices]
[Page 66151]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21369]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1788]


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 
December 18, 2026. Such persons may also file a written request for a 
hearing on the application on or before December 18, 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 September 9, 2026, Janssen Pharmaceuticals, Inc., 
1440 Olympic Drive, Buildings 1 and 5 and 8 and 20, 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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                                           Drug
          Controlled substance             code          Schedule
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Methylphenidate........................     1724  II
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    The company plans to manufacture the listed controlled substance 
for the internal use intermediates for sale to its customers. No other 
activity for this drug code is authorized for this registration.

Justin Wood,
Deputy Assistant Administrator.
[FR Doc. 2026-21369 Filed 10-16-26; 8:45 am]
BILLING CODE 4410-09-P


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