[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Page 4955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01815]



[[Page 4955]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-933]


Bulk Manufacturer of Controlled Substances Application: Navinta 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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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 April 1, 2022. 
Such persons may also file a written request for a hearing on the 
application on or before April 1, 2022.

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 October 18, 2021, Navinta LLC, 1499 Lower Ferry Road, 
Ewing, New Jersey 08618-1414, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                            Drug
          Controlled substance              code          Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine           8333  II
 (ANPP).
Levomethorphan..........................     9210  II
Levorphanol.............................     9220  II
Noroxymorphone..........................     9739  II
Fentanyl................................     9801  II
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    The company plans to bulk manufacture active pharmaceutical 
ingredients (API) quantities of the listed controlled subsances for 
validation purpose and the Food and Drug Adminstration approval. No 
other activities for these drug codes are authorized for this 
registration.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022-01815 Filed 1-28-22; 8:45 am]
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