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Manufacturers Notice of Application - 2020

[Federal Register Volume 85, Number 226 (Monday, November 23, 2020)]
[Notices]
[Page 74765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25764]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-745]

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 January 22, 2021. Such persons may also file a written request for a hearing on the application on or before January 22, 2021.

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 2, 2020, 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):

Controlled Substance Drug 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 activity for these drug codes is authorized for this registration.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2020-25764 Filed 11-20-20; 8:45 am]

BILLING CODE P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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