[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]


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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.

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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 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):

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        Controlled substance            Drug code          Schedule
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4-Anilino-N-phenethyl-4-piperidine             8333  II
 (ANPP).
Levomethorphan.....................            9210  II
Levorphanol........................            9220  II
Remifentanil.......................            9739  II
Fentanyl...........................            9801  II
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    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