Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2020

[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15799-15800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05750]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-602]

Bulk Manufacturer of Controlled Substances Application: Navinta LLC

ACTION: Notice of application.


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 May 18, 2020.

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 September 23, 2019, Navinta LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618-1414 registered as a bulk manufacturer of the following basic class(es), of controlled substances:

[[Page 15800]]

Controlled Substance Drug Code Schedule
4-Anilino-N-phenethyl-4-piperidine (ANPP) 8333 II
Levomethorphan 9210 II
Levorphanol 9220 II
Remifentanil 9739 II
Fentanyl 9801 II

The company plans to bulk manufacture API quantities of the listed controlled substances for validation purposes and FDA approval.

Dated: March 5, 2020.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2020-05750 Filed 3-18-20; 8:45 am]

BILLING CODE 4410-09-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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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
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