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Notice

Manufacturer of Controlled Substances; Notice of Registration: Navinta, LLC

Document Details

Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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By Notice dated April 10, 2013, and published in the Federal Register on April 19, 2013, 78 FR 23596, Navinta, LLC., 1499 Lower Ferry Road, Ewing, New Jersey 08618-1414, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:

DrugSchedule
Pentobarbital (2270)II
Remifentanil (9739)II

The company plans initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then to produce commercial size batches for distribution to dosage form manufacturers upon FDA approval.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Navinta, LLC., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Navinta, LLC., to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed.

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Dated: August 15, 2013.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

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[FR Doc. 2013-20757 Filed 8-23-13; 8:45 am]

BILLING CODE 4410-09-P