80 FR 42545 - Manufacturer of Controlled Substances Registration: Navinta LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 137 (July 17, 2015)

Navinta LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Navinta LLC registration as a manufacturer of those controlled substances.

[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Page 42545]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17525]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Navinta LLC

ACTION: Notice of registration.

-----------------------------------------------------------------------

SUMMARY: Navinta LLC applied to be registered as a manufacturer of 
certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Navinta LLC registration as a manufacturer 
of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated February 11, 2015, and 
published in the Federal Register on February 19, 2015, 80 FR 8901, 
Navinta LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618-1414 
applied to be registered as a manufacturer of certain basic classes of 
controlled substances. No comments or objections were submitted for 
this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Navinta LLC to manufacture the 
basic classes of controlled substances is consistent with the public 
interest and with United States obligations under international 
treaties, conventions, or protocols in effect on May 1, 1971. The DEA 
investigated the company's maintenance of effective controls against 
diversion by inspecting and testing the company's physical security 
systems, verifying the company's compliance with state and local laws, 
and reviewing 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:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Pentobarbital (2270).......................  II
Remifentanil (9739)........................  II
------------------------------------------------------------------------

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

    Dated: July 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-17525 Filed 7-16-15; 8:45 am]
 BILLING CODE 4410-09-P