Notice2025-21790

Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC

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 3, 2025

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Kinetochem LLC 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 230 (Wednesday, December 3, 2025)</title>
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[Federal Register Volume 90, Number 230 (Wednesday, December 3, 2025)]
[Notices]
[Page 55764]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21790]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1625]


Bulk Manufacturer of Controlled Substances Application: 
Kinetochem LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Kinetochem LLC 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 2, 2026. Such persons may also file a written request for a 
hearing on the application on or before February 2, 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 October 15, 2025, Kinetochem LLC, 96 Market Street, 
Suite 102, Georgetown, Texas 78626-3618, 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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Marihuana..............................    7360  I
Tetrahydrocannabinols..................    7370  I
Psilocybin.............................    7437  I
Psilocyn...............................    7438  I
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    The company plans to bulk manufacture the listed controlled 
substances as Active Pharmaceutical Ingredients to its customers as 
well as for research and clinical trials. In reference to drug codes 
7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans 
to bulk manufacture these drugs as synthetic. No other activities for 
these drug codes are authorized for this registration.

Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2025-21790 Filed 12-2-25; 8:45 am]
BILLING CODE 4410-09-P


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Indexed from Federal Register on December 3, 2025.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.