Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US), LLC, 13782 [2025-05055]
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13782
Federal Register / Vol. 90, No. 57 / Wednesday, March 26, 2025 / Notices
such findings, and may result in the
issuance of an exclusion order or a cease
and desist order or both directed against
the respondent.
By order of the Commission.
Issued: March 21, 2025.
Sharon Bellamy,
Supervisory Hearings and Information
Officer.
[FR Doc. 2025–05116 Filed 3–25–25; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on February 11, 2025,
Pharmaron Manufacturing Services (US)
LLC, 498 Washington Street, Coventry,
Rhode Island 02816, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
[Docket No. DEA–1514]
Importer of Controlled Substances
Application: Pharmaron Manufacturing
Services (US) LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Pharmaron Manufacturing
Services (US) LLC has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTARY INFORMATION
listed below for further drug
information.
SUMMARY:
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 April 25, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 25, 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
https://www.regulations.gov 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 https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
khammond on DSK9W7S144PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:57 Mar 25, 2025
Jkt 265001
Controlled substance
Dimethyltryptamine ..........
Drug
code
Schedule
7435
I
The company plans to import the
above controlled substance for internal
analytical use and to support technology
transfer, further process, and subsequent
production of Active Pharmaceutical
Ingredient for sale to its customers. No
other activity for this drug code is
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–05056 Filed 3–25–25; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1512]
Bulk Manufacturer of Controlled
Substances Application: Pharmaron
Manufacturing Services (US), LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
electronic comments on or objections to
the issuance of the proposed registration
on or before May 27, 2025. Such persons
may also file a written request for a
hearing on the application on or before
May 27, 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
https://www.regulations.gov 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 https://www.regulations.gov. 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 February 11, 2025,
Pharmaron Manufacturing Services
(US), LLC, 498 Washington Street,
Coventry, Rhode Island 02816 applied
to be registered as a bulk manufacturer
of the following basic class(es) of
controlled substance(s):
Controlled substance
Dimethyltryptamine ....
Oxymorphone ............
Noroxymorphone .......
Drug
code
7435
9652
9668
Schedule
I
II
II
The company plans to bulk
manufacture the listed controlled
substances to produce material for
clinical trials. No other activities for
these drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–05055 Filed 3–25–25; 8:45 am]
BILLING CODE P
AGENCY:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Pharmaron Manufacturing
Services (US), 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
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
[Docket No. DEA–1515]
Bulk Manufacturer of Controlled
Substances Application: Sterling
Wisconsin, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
E:\FR\FM\26MRN1.SGM
26MRN1
]]>Agencies
[Federal Register Volume 90, Number 57 (Wednesday, March 26, 2025)]
[Notices]
[Page 13782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05055]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1512]
Bulk Manufacturer of Controlled Substances Application: Pharmaron
Manufacturing Services (US), LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Pharmaron Manufacturing Services (US), 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
May 27, 2025. Such persons may also file a written request for a
hearing on the application on or before May 27, 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 https://www.regulations.gov 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 https://www.regulations.gov. 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 February 11, 2025, Pharmaron Manufacturing Services
(US), LLC, 498 Washington Street, Coventry, Rhode Island 02816 applied
to be registered as a bulk manufacturer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Dimethyltryptamine.................... 7435 I
Oxymorphone........................... 9652 II
Noroxymorphone........................ 9668 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances to produce material for clinical trials. No other activities
for these drug codes are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-05055 Filed 3-25-25; 8:45 am]
BILLING CODE P
