Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 9732-9733 [2025-02732]
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<![CDATA[
9732
Federal Register / Vol. 90, No. 31 / Tuesday, February 18, 2025 / Notices
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 January 8, 2025,
Scottsdale Research Institute, 12815
North Cave Creek Road, Phoenix,
Arizona 85022, applied to be registered
as a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
Drug
code
Controlled substance
Marihuana Extract .........
Marihuana ......................
Tetrahydrocannabinols ..
I
7350
7360
7370
Schedule
I
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to support clinical trials and
distribution to their customers for
research purposes. No other activities
for these drug codes are authorized for
this registration.
Matthew Strait,
Deputy Assistant Administrator.
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 January 8, 2025,
Scottsdale Research Institute, 12815
North Cave Creek Road, Phoenix,
Arizona 85022, applied to be registered
as a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
ADDRESSES:
Controlled substance
Ibogaine ...........................
3,4Methylenedioxymethamphetamine.
Drug
code
Schedule
7260
7405
I
I
[FR Doc. 2025–02733 Filed 2–14–25; 8:45 am]
The company plans to bulk
manufacture the listed controlled
substances for internal research and
analytical development purposes. No
other activities for these drug codes are
authorized for this registration.
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Matthew Strait,
Deputy Assistant Administrator.
[Docket No. DEA–1499]
Bulk Manufacturer of Controlled
Substances Application: Scottsdale
Research Institute
[FR Doc. 2025–02739 Filed 2–14–25; 8:45 am]
BILLING CODE P
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Drug Enforcement Administration
Scottsdale Research Institute
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 April 21, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 21, 2025.
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
DEPARTMENT OF JUSTICE
VerDate Sep<11>2014
17:15 Feb 14, 2025
Jkt 265001
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 March 20, 2025. Such
persons may also file a written request
for a hearing on the application on or
before March 20, 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
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 December 5, 2024,
Mylan Pharmaceuticals Inc., 2898
Manufacturers Road, Greensboro, North
Carolina 27406–4600, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
DATES:
Controlled substance
[Docket No. DEA–1493]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Pharmaceuticals, 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.
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Remifentanil .....................
Drug
code
Schedule
I 9739 III
The company plans to import the
listed controlled substance in finished
dosage form for commercial distribution
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
E:\FR\FM\18FEN1.SGM
18FEN1
9733
Federal Register / Vol. 90, No. 31 / Tuesday, February 18, 2025 / Notices
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Psilocybin ......................
Psilocyn .........................
Matthew Strait,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[FR Doc. 2025–02738 Filed 2–14–25; 8:45 am]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Inc.
Drug Enforcement
Administration, Justice.
AGENCY:
DEPARTMENT OF JUSTICE
[Docket No. DEA–1496]
Patheon API 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.
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 21, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 21, 2025.
DATES:
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 January 16, 2025,
Patheon API Inc., 6173 East Old Marion
Highway, Florence, South Carolina
29506 applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE P
Drug Enforcement Administration
Notice of application.
17:15 Feb 14, 2025
I
I
I
Matthew Strait,
Deputy Assistant Administrator.
[Docket No. DEA–1498]
VerDate Sep<11>2014
I
7437
7438
Schedule
The company plans to import the
listed controlled substances as reference
standards for research and development
as part of API Manufacturing. No other
activities for these drug codes are
authorized for this registration.
[FR Doc. 2025–02732 Filed 2–14–25; 8:45 am]
ACTION:
Drug
code
Controlled substance
Jkt 265001
Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceuticals, Inc.
Frm 00030
Fmt 4703
Sfmt 4703
Methylphenidate ..............
Hydromorphone ...............
Tapentadol ......................
I
Drug
code
Schedule
1724
9150
9780
II
II
II
I
The company plans to bulk
manufacture the listed controlled
substances for the internal use
intermediates for sale to its customers.
No other activities for these drug codes
are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–02740 Filed 2–14–25; 8:45 am]
BILLING CODE P
Drug Enforcement Administration
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 April 21, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 21, 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
PO 00000
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
SUMMARY:
is notice that on December 4, 2024,
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):
[Docket No. DEA–1492]
Bulk Manufacturer of Controlled
Substances Application: Purisys, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Purisys, 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 April 21, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 21, 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
SUMMARY:
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 90, Number 31 (Tuesday, February 18, 2025)]
[Notices]
[Pages 9732-9733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02732]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1493]
Importer of Controlled Substances Application: Mylan
Pharmaceuticals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Mylan Pharmaceuticals, 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 applicants, therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
March 20, 2025. Such persons may also file a written request for a
hearing on the application on or before March 20, 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 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 December 5, 2024, Mylan Pharmaceuticals Inc., 2898
Manufacturers Road, Greensboro, North Carolina 27406-4600, applied to
be registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Remifentanil............................ 9739 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance in
finished dosage form for commercial distribution 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
[[Page 9733]]
Administration-approved or non-approved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-02732 Filed 2-14-25; 8:45 am]
BILLING CODE 4410-09-P
