Notice2022-01815
Bulk Manufacturer of Controlled Substances Application: Navinta LLC
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 31, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 20 (Monday, January 31, 2022)</title>
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[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Page 4955]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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):
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Drug
Controlled substance code Schedule
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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]
BILLING CODE P
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</html>Indexed from Federal Register on January 31, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.