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

Manufacturers Notice of Application - 2020

[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Page 70190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24465]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-741]

Bulk Manufacturer of Controlled Substances Application: Navinta LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.


SUMMARY: Navinta LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY 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 4, 2021. Such persons may also file a written request for a hearing on the application on or before January 4, 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 September 25, 2020, Navinta LLC 1499 Lower Ferry Road, Ewing, New Jersey 08618-1414, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s):

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 active pharmaceutical ingredients (API) quantities of the listed controlled substances for validation purposes and the Food and Drug Administration's approval. No other activity for these drug codes is authorized for this registration.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2020-24465 Filed 11-3-20; 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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