Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials Inc., 10389 [2022-03901]
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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]
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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]
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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]
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E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Page 10389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03901]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-956]
Bulk Manufacturer of Controlled Substances Application: Johnson
Matthey Pharmaceutical Materials Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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.
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 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):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................. 1100 II
Methylphenidate......................... 1724 II
Nabilone................................ 7379 II
Hydrocodone............................. 9193 II
Levorphanol............................. 9220 II
Thebaine................................ 9333 II
Alfentanil.............................. 9737 II
Remifentanil............................ 9739 II
Sufentanil.............................. 9740 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.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-03901 Filed 2-23-22; 8:45 am]
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