Bulk Manufacturer of Controlled Substances Application: Benuvia Therapeutics Inc., 10388-10389 [2022-03897]
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10388
Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 15, 2021,
Mylan Inc., 3711 Collins Ferry Road,
Morgantown, West Virginia 26505–
2362, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance
Amphetamine ..................
Methylphenidate ..............
Oxycodone ......................
Hydromorphone ...............
Methadone ......................
Morphine ..........................
Fentanyl ...........................
Drug
code
Schedule
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
The company plans to import finished
dosage forms for analytical testing and
distribution for clinical trials. No other
activity for these drug codes 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 the Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
listed below for further drug
information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before March 28, 2022. Such persons
may also file a written request for a
hearing on the application on or before
March 28, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a hearing
should also 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 10, 2021,
Myonex Inc., 100 Progress Drive,
Horsham, Pennsylvania 19044, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
[FR Doc. 2022–03907 Filed 2–23–22; 8:45 am]
Controlled substance
BILLING CODE P
Amphetamine ..................
Lisdexamfetamine ...........
Methylphenidate ..............
Nabilone ..........................
Oxycodone ......................
Hydromorphone ...............
Hydrocodone ...................
Morphine ..........................
Oxymorphone ..................
Fentanyl ...........................
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–960]
Importer of Controlled Substances
Application: Myonex Inc.
Drug
code
Schedule
1100
1205
1724
7379
9143
9150
9193
9300
9652
9801
II
II
II
II
II
II
II
II
II
II
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–03903 Filed 2–23–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–953]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Therapeutics Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Benuvia Therapeutics Inc.,
has applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplemental Information listed below
for further drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 25, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 25, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on November 16, 2021,
Benuvia Therapeutics Inc., 2700
Oakmont Drive, Round Rock, Texas
78665, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Myonex Inc. has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTAL INFORMATION
SUMMARY:
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.
The company plans to import the
listed controlled substances for clinical
trials, research, and analytical purposes.
No other activity for these drug codes is
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
jspears on DSK121TN23PROD with NOTICES1
Controlled substance
Drug code
Tetrahydrocannabinols ....................................................................................................................................................
3,4-Methylenedioxyamphetamine ....................................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .............................................................................................................................
VerDate Sep<11>2014
16:46 Feb 23, 2022
Jkt 256001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
E:\FR\FM\24FEN1.SGM
24FEN1
7370
7400
7405
7431
7435
7437
7438
7439
Schedule
I
I
I
I
I
I
I
I
10389
Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices
The company plans to bulk
manufacture the listed controlled
substances for the internal use
intermediates or for sale to its
customers. The company plans to
manufacture the above-listed controlled
substances in bulk to produce finished
dosage forms and conduct research to
develop new drug products and for
clinical studies. In reference to drug
code 7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture this
drug as a synthetic. No other activities
for these drug codes are authorized for
this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–03897 Filed 2–23–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Controlled substance
Amphetamine ..................
Methylphenidate ..............
Nabilone ..........................
Hydrocodone ...................
Levorphanol .....................
Thebaine ..........................
Alfentanil ..........................
Remifentanil .....................
Sufentanil .........................
Drug
code
Schedule
1100
1724
7379
9193
9220
9333
9737
9739
9740
II
II
II
II
II
II
II
II
II
The company plans to support its
other manufacturing facilities located in
West Deptford, New Jersey and
Conshohocken, Pennsylvania with
manufacturing and analytical testing. In
reference to drug code 9333 as bulk, the
company plans to manufacture a
Thebaine derivative for distribution to
its customers. No other activities for
these drug codes are authorized for this
registration.
Drug Enforcement Administration
Matthew J. Strait,
Deputy Assistant Administrator.
[Docket No. DEA–956]
[FR Doc. 2022–03901 Filed 2–23–22; 8:45 am]
BILLING CODE P
Bulk Manufacturer of Controlled
Substances Application: Johnson
Matthey Pharmaceutical Materials Inc.
Drug Enforcement Administration
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
[Docket No. DEA–958]
Notice of application.
Johnson Matthey
Pharmaceutical Materials Inc. has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplemental Information listed below
for further drug information.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 25, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 25, 2022.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on November 5, 2021,
Johnson Matthey Pharmaceutical
Materials Inc., 25 Patton Road, Devens,
Massachusetts 01434, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
jspears on DSK121TN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:46 Feb 23, 2022
DEPARTMENT OF JUSTICE
Jkt 256001
Importer of Controlled Substances
Application: Noramco Coventry LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Noramco Coventry LLC has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before March 28, 2022. Such persons
may also file a written request for a
hearing on the application on or before
March 28, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 9990
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 29, 2021,
Noramco Coventry 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):
SUPPLEMENTARY INFORMATION:
Controlled substance
Tetrahydrocannabinols ....
Methylphenidate ..............
Oxycodone ......................
Hydromorphone ...............
Hydrocodone ...................
Morphine ..........................
Opium, raw ......................
Oxymorphone ..................
Poppy Straw Concentrate
Drug
code
Schedule
7370
1724
9143
9150
9193
9300
9600
9652
9670
I
II
II
II
II
II
II
II
II
The company plans to import Opium,
raw (9600), and Poppy Straw
Concentrate (9670) in order to bulk
manufacture-controlled substances in
Active Pharmaceutical Ingredient (API)
form. The company will use the
imported narcotic raw materials in
ancillary activities including process
development and analytical studies.
Noramco does not anticipate
redistributing the imported narcotic raw
materials domestically to other
registered bulk manufacturers. The
company plans to import the other
listed controlled substances for internal
reference standards use only. No other
activity for these drug codes 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 J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–03902 Filed 2–23–22; 8:45 am]
BILLING CODE P
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10388-10389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03897]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-953]
Bulk Manufacturer of Controlled Substances Application: Benuvia
Therapeutics Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Benuvia Therapeutics Inc., has applied to be registered as a
bulk manufacturer of basic class(es) of controlled substance(s). Refer
to Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before April 25, 2022.
Such persons may also file a written request for a hearing on the
application on or before April 25, 2022.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on November 16, 2021, Benuvia Therapeutics Inc., 2700
Oakmont Drive, Round Rock, Texas 78665, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols.............. 7370 I
3,4-Methylenedioxyamphetamine...... 7400 I
3,4-Methylenedioxymethamphetamine.. 7405 I
5-Methoxy-N-N-dimethyltryptamine... 7431 I
Dimethyltryptamine................. 7435 I
Psilocybin......................... 7437 I
Psilocyn........................... 7438 I
5-Methoxy-N,N-diisopropyltryptamine 7439 I
------------------------------------------------------------------------
[[Page 10389]]
The company plans to bulk manufacture the listed controlled
substances for the internal use intermediates or for sale to its
customers. The company plans to manufacture the above-listed controlled
substances in bulk to produce finished dosage forms and conduct
research to develop new drug products and for clinical studies. In
reference to drug code 7370 (Tetrahydrocannabinols), the company plans
to bulk manufacture this drug as a synthetic. No other activities for
these drug codes are authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-03897 Filed 2-23-22; 8:45 am]
BILLING CODE P
