Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc., 11997 [2025-04045]
Download as PDF
<![CDATA[
11997
Federal Register / Vol. 90, No. 48 / Thursday, March 13, 2025 / Notices
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
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on January 17, 2025,
Meridian Medical Technologies, LLC,
2555 Hermelin Drive, Saint Louis,
Missouri 63144, applied to be registered
as an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Schedule
SUPPLEMENTARY INFORMATION listed
below for further drug information.
Morphine ..........................
9300
II
DATES:
The company plans to import the
listed controlled substance for analytical
purposes only. 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. 2025–04043 Filed 3–12–25; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1508]
Bulk Manufacturer of Controlled
Substances Application: Patheon
Pharmaceuticals Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Patheon Pharmaceuticals Inc.
has applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
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 May 12, 2025. Such persons
may also file a written request for a
hearing on the application on or before
May 12, 2025.
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.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 4, 2025,
Patheon Pharmaceuticals Inc., 2110 East
Galbraith Road, Cincinnati, Ohio
45237–1625 applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...............................................................................................................................................
The company plans to manufacture
the above listed controlled substance as
Active Pharmaceutical Ingredient that
will be further synthesized into Food
and Drug Administration-approved
dosage forms. No other activity for this
drug code is authorized for this
registration.
DEPARTMENT OF JUSTICE
Matthew Strait,
Deputy Assistant Administrator.
AGENCY:
khammond on DSK9W7S144PROD with NOTICES
[FR Doc. 2025–04045 Filed 3–12–25; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
16:14 Mar 12, 2025
Drug Enforcement Administration
[Docket No. DEA–1509]
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Fisher Clinical Services, Inc.
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.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
SUMMARY:
Jkt 265001
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
2010
Schedule
I
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 14, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 14, 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
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Notices]
[Page 11997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04045]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1508]
Bulk Manufacturer of Controlled Substances Application: Patheon
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Patheon 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
May 12, 2025. Such persons may also file a written request for a
hearing on the application on or before May 12, 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 4, 2025, Patheon Pharmaceuticals Inc., 2110
East Galbraith Road, Cincinnati, Ohio 45237-1625 applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............. 2010 I
------------------------------------------------------------------------
The company plans to manufacture the above listed controlled
substance as Active Pharmaceutical Ingredient that will be further
synthesized into Food and Drug Administration-approved dosage forms. No
other activity for this drug code is authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-04045 Filed 3-12-25; 8:45 am]
BILLING CODE 4410-09-P
