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)
Drug Enforcement Administration
Federal Register Volume 80, Issue 137 (July 17, 2015)
| Page Range | 42545-42545 | |
| FR Document | 2015-17525 |
[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
![Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices 42545
The company plans to import the Controlled substance Schedule Controlled substance Schedule
FDA approved drug product in finished
dosage form for distribution to its Tapentadol (9780) ........................ II Remifentanil (9739) ...................... II
customers.
Dated: July 10, 2015. The company plans to manufacturer The company plans to initially
bulk active pharmaceutical ingredients manufacture API quantities of the listed
Joseph T. Rannazzisi,
(API) for distribution and product controlled substances for validation
Deputy Assistant Administrator.
development to its customers. purposes and FDA approval, and then
[FR Doc. 2015–17514 Filed 7–16–15; 8:45 am] produce commercial size batches for
Dated: July 10, 2015.
BILLING CODE 4410–09–P distribution to dosage form
Joseph T. Rannazzisi,
manufacturers upon FDA approval.
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE [FR Doc. 2015–17523 Filed 7–16–15; 8:45 am] Dated: July 10, 2015.
BILLING CODE 4410–09–P
Joseph T. Rannazzisi,
Drug Enforcement Administration Deputy Assistant Administrator.
[Docket No. DEA–392] [FR Doc. 2015–17525 Filed 7–16–15; 8:45 am]
DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P
Manufacturer of Controlled
Substances Registration: Mallinckrodt, Drug Enforcement Administration
LLC [Docket No. DEA–392] DEPARTMENT OF JUSTICE
ACTION: Notice of registration. Manufacturer of Controlled Drug Enforcement Administration
SUMMARY: Mallinckrodt, LLC applied to Substances Registration: Navinta LLC [Docket No. DEA–392]
be registered as a manufacturer of
certain basic classes of controlled ACTION: Notice of registration. Importer of Controlled Substances
substances. The Drug Enforcement Registration: Siegfried USA, LLC
SUMMARY: Navinta LLC applied to be
Administration (DEA) grants registered as a manufacturer of certain ACTION: Notice of registration.
Mallinckrodt, LLC registration as a basic classes of controlled substances.
manufacturer of those controlled The Drug Enforcement Administration SUMMARY: Siegfried USA, LLC applied to
substances. (DEA) grants Navinta LLC registration as be registered as an importer of certain
SUPPLEMENTARY INFORMATION: By notice a manufacturer of those controlled basic classes of controlled substances.
dated January 21, 2015, and published substances. The Drug Enforcement Administration
in the Federal Register on January 28, (DEA) grants Siegfried USA, LLC
SUPPLEMENTARY INFORMATION: By notice
2015, 80 FR 4592, Mallinckrodt LLC, registration as an importer of those
dated February 11, 2015, and published
3600 North Second Street, St. Louis, controlled substances.
in the Federal Register on February 19,
Missouri 63147 applied to be registered 2015, 80 FR 8901, Navinta LLC, 1499 SUPPLEMENTARY INFORMATION: By notice
as a manufacturer of certain basic Lower Ferry Road, Ewing, New Jersey dated April 14, 2015, and published in
classes of controlled substances. No 08618–1414 applied to be registered as the Federal Register on April 22, 2015,
comments or objections were submitted a manufacturer of certain basic classes 80 FR 22561, Siegfried USA, LLC, 33
to this notice. of controlled substances. No comments Industrial Park Road, Pennsville, New
The DEA has considered the factors in Jersey 08070 applied to be registered as
or objections were submitted for this
21 U.S.C. 823(a) and determined that an importer of certain basic classes of
notice.
the registration of Mallinckrodt, LLC to controlled substances. Comments and
The DEA has considered the factors in
manufacture the basic classes of requests for hearings on applications to
21 U.S.C. 823(a) and determined that
controlled substances is consistent with import narcotic raw material are not
the registration of Navinta LLC to
the public interest and with United appropriate. 72 FR 3417 (January 25,
manufacture the basic classes of
States obligations under international 2007).
controlled substances is consistent with
treaties, conventions, or protocols in The DEA has considered the factors in
the public interest and with United
effect on May 1, 1971. The DEA 21 U.S.C. 823, 952(a) and 958(a) and
States obligations under international
investigated the company’s maintenance determined that the registration of
treaties, conventions, or protocols in
of effective controls against diversion by Siegfried USA, LLC to import the basic
effect on May 1, 1971. The DEA
inspecting and testing the company’s classes of controlled substances is
investigated the company’s maintenance
physical security systems, verifying the consistent with the public interest and
of effective controls against diversion by
company’s compliance with state and with United States obligations under
inspecting and testing the company’s
local laws, and reviewing the company’s international treaties, conventions, or
physical security systems, verifying the
background and history. protocols in effect on May 1, 1971. The
Therefore, pursuant to 21 U.S.C. company’s compliance with state and
local laws, and reviewing the company’s DEA investigated the company’s
823(a), and in accordance with 21 CFR maintenance of effective controls
1301.33, the above-named company is background and history.
Therefore, pursuant to 21 U.S.C. against diversion by inspecting and
granted registration as a bulk testing the company’s physical security
manufacturer of the following basic 823(a), and in accordance with 21 CFR
systems, verifying the company’s
srobinson on DSK5SPTVN1PROD with NOTICES
classes of controlled substances: 1301.33, the above-named company is
granted registration as a bulk compliance with state and local laws,
manufacturer of the basic classes of and reviewing the company’s
Controlled substance Schedule background and history.
controlled substances listed:
Gamma Hydroxybutyric Acid I Therefore, pursuant to 21 U.S.C.
(2010). Controlled substance Schedule 952(a) and 958(a), and in accordance
Lisdexamfetamine (1205) ............. II with 21 CFR 1301.34, the above-named
Oripavine (9330) ........................... II Pentobarbital (2270) ..................... II company is granted registration as an
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Document Created: 2018-02-23 09:20:56
Document Modified: 2018-02-23 09:20:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of registration. | |
| FR Citation | 80 FR 42545 |
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