Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc., 53922-53923 [2023-17030]
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53922
Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Notices
Controlled substance
Drug code
Piminodine .......................................................................................................................................................................
Racemethorphan .............................................................................................................................................................
Racemorphan ..................................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Bezitramide ......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
Moramide-intermediate ....................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for distribution to its
customers. In reference to dug 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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17036 Filed 8–8–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1241]
Importer of Controlled Substances
Application: Cambrex Charles City
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Cambrex Charles City 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 September 8, 2023. Such
persons may also file a written request
for a hearing on the application on or
before September 8, 2023.
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:19 Aug 08, 2023
Jkt 259001
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 July 3, 2023, Cambrex
Charles City, 1205 11th Street, Charles
City, Iowa 50616–3466, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled
substance
Drug
code
Psilocybin ..............................
4-Anilino-N-phenethyl-4-piperidine (ANPP).
Phenylacetone ......................
Cocoa Leaves .......................
Opium Raw ...........................
Poppy Straw Concentrate .....
Schedule
7437
8333
I
II
8501
9040
9600
9670
II
II
II
II
The company plans to import
psilocybin for formulation development
and clinical trial support for their
customers. The remaining listed
controlled substances will be imported
to support the manufacture into other
controlled substances which will be
distributed to their customers. No other
activities for these drug codes are
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).
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
9730
9732
9733
9737
9739
9740
9743
9780
9800
9801
9802
Schedule
II
II
II
II
II
II
II
II
II
II
II
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17038 Filed 8–8–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1231]
Bulk Manufacturer of Controlled
Substances Application: Cambrex
High Point, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Cambrex High Point, 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 October 10, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 10, 2023.
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\09AUN1.SGM
09AUN1
Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Notices
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 June 14, 2023, Cambrex
High Point, Inc., 4180 Mendenhall Oaks
Parkway, High Point, North Carolina
27265–8017, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
Controlled substance
Oxymorphone ...........
Noroxymorphone ......
Drug
code
Schedule
9652
9668
II
II
The company plans to manufacture
the above listed controlled substances in
bulk for use as internal intermediates
and distribution to its customers. No
other activities for these drug codes are
authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
In
accordance with 21 CFR 1301.34(a), this
is notice that on June 5, 22023 Catalent
Pharma Solutions, LLC, 3031 Red Lion
Road Philadelphia, Pennsylvania 19114,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
[FR Doc. 2023–17030 Filed 8–8–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1226]
Controlled substance
Importer of Controlled Substances
Application: Catalent Pharma
Solutions, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Catalent Pharma Solutions,
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.
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 September 8, 2023. Such
persons may also file a written request
for a hearing on the application on or
before September 8, 2023.
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:19 Aug 08, 2023
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.
Jkt 259001
Lysergic acid
diethylamide.
5-Methoxy-N,Ndimethyltryptamine.
Psilocybin .....................
Psilocyn ........................
Tapentadol ....................
Drug
code
Schedule
7315
I
7431
I
7437
7438
9780
I
I
II
The company plans to import the
listed controlled substances as finished
dosage unit products for clinical trials,
research, and analytical activities. No
other activities for these drug codes are
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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17021 Filed 8–8–23; 8:45 am]
BILLING CODE P
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
53923
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1236]
Importer of Controlled Substances
Application: Galephar Pharmaceutical
Research, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Galephar Pharmaceutical
Research, 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:
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 September 8, 2023. Such
persons may also file a written request
for a hearing on the application on or
before September 8, 2023.
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 June 13, 2023, Galephar
Pharmaceutical Research, Inc., 100 Carr
198 Industrial Park, Juncos, Puerto Rico
00777–383 applied to be registered as an
DATES:
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 88, Number 152 (Wednesday, August 9, 2023)]
[Notices]
[Pages 53922-53923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17030]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1231]
Bulk Manufacturer of Controlled Substances Application: Cambrex
High Point, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Cambrex High Point, 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
October 10, 2023. Such persons may also file a written request for a
hearing on the application on or before October 10, 2023.
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
[[Page 53923]]
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 June 14, 2023, Cambrex High Point, Inc., 4180
Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017, applied
to be registered as a bulk manufacturer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Oxymorphone........................... 9652 II
Noroxymorphone........................ 9668 II
------------------------------------------------------------------------
The company plans to manufacture the above listed controlled
substances in bulk for use as internal intermediates and distribution
to its customers. No other activities for these drug codes are
authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-17030 Filed 8-8-23; 8:45 am]
BILLING CODE P
