Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals, Inc., 19327 [2023-06700]
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19327
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
The company plans to bulk
manufacture the listed controlled
substances for the production of active
pharmaceutical ingredients (API) and
analytical reference standards for sale to
its customers. The company plans to
manufacture the above listed controlled
substances as clinical trial and starting
materials to make compounds for
distribution to its customers. No other
activities for these drug codes are
authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06687 Filed 3–30–23; 8:45 am]
BILLING CODE P
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 February 22, 2023,
PerkinElmer, Inc., 120 East Dedham
Street, Boston, Massachusetts 02118–
2852, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
Lysergic Acid
Diethylamide.
Thebaine .......................
[Docket No. DEA–1167]
Importer of Controlled Substances
Application: PerkinElmer, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PerkinElmer, 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 May 1, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 1, 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
Drug
code
Schedule
7315
I
9333
II
The company plans to import the
listed controlled substances for bulk
manufacturing into radioactive
formulations for sale to its customers for
research purposes. Drug code 9333
(Thebaine) will be used to import the
Thebaine derivative Diprenorphine. 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. 2023–06696 Filed 3–30–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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 30, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 30, 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on March 3, 2023, ANI
Pharmaceuticals, Inc., 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
DATES:
Controlled substance
Psilocybin .....................
Levorphanol ..................
Drug
code
7437
9220
Schedule
I
I
The company plans to bulk
manufacture the listed controlled
substances for the internal use or for
sale to its customers. No other activities
for these drug codes are authorized for
this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06700 Filed 3–30–23; 8:45 am]
[Docket No. DEA–1173]
BILLING CODE P
Bulk Manufacturer of Controlled
Substances Application: ANI
Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Drug Enforcement Administration
ANI 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.
Importer of Controlled Substances
Application: Lyndra Therapeutics
AGENCY:
SUMMARY:
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
[Docket No. DEA–1165]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
E:\FR\FM\31MRN1.SGM
31MRN1
]]>Agencies
[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Page 19327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06700]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1173]
Bulk Manufacturer of Controlled Substances Application: ANI
Pharmaceuticals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: ANI 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 30, 2023. Such persons may also file a written request for a
hearing on the application on or before May 30, 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on March 3, 2023, ANI Pharmaceuticals, Inc., 70 Lake
Drive, East Windsor, New Jersey 08520, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin............................. 7437 I
Levorphanol............................ 9220 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the internal use or for sale to its customers. No other
activities for these drug codes are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-06700 Filed 3-30-23; 8:45 am]
BILLING CODE P
