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Notice

Bulk Manufacturer of Controlled Substances Application: Navinta LLC

This document has a comment period that ends in 44 days. (05/18/2020) Submit a formal comment

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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.

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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:Start Printed Page 15800

Controlled substanceDrug codeSchedule
4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
Levomethorphan9210II
Levorphanol9220II
Remifentanil9739II
Fentanyl9801II

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

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Dated: March 5, 2020.

William T. McDermott,

Assistant Administrator.

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

BILLING CODE 4410-09-P