Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials Inc., 10389 [2022-03901]

Download as PDF 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]
[Page 10389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03901]


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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.

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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]
BILLING CODE P
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