Bulk Manufacturer of Controlled Substances Application: Navinta, LLC, 38471 [2015-16441]
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38471
Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization
will not extend to the import of FDA
approved or non-approved finished
dosage forms for commercial sale.
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances:
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers.
In reference to Amphetamine (1100),
the company plans to acquire the listed
controlled substance in bulk from a
domestic source in order to manufacture
other controlled substances in bulk for
distribution to its customers.
[FR Doc. 2015–16448 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Euticals, Inc.
ACTION:
Notice of registration.
Controlled substance
Gamma
Hydroxybutyric
Acid
(2010).
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Phenylacetone (8501) ..................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Oripavine (9330) ...........................
Tapentadol (9780) ........................
Schedule
I
II
II
II
II
II
II
II
II
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–16454 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
Euticals, Inc. applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Euticals, Inc. registration
as a manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated January 9, 2015, and published in
the Federal Register on January 26,
2015, 80 FR 3978, Euticals, Inc., 2460
W. Bennett Street, Springfield, Missouri
65807–1229 applied to be registered as
a manufacturer of certain basic classes
of controlled substances. No comments
or objections were submitted to this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Euticals, Inc. 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
Lhorne on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:37 Jul 02, 2015
Jkt 235001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on
February 4, 2015, Navinta, LLC, 1499
Lower Ferry Road, Ewing, New Jersey
08618–1414 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Fentanyl (9801) ............................
Schedule
II
II
The company plans initially to
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval, then
eventually upon FDA approval to
produce commercial size batches for
distribution to dosage form
manufacturers.
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Navinta, LLC
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–16441 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.33(a) on
or before September 4, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
DATES:
PO 00000
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Mylan Pharmaceuticals,
Inc.
ACTION:
Notice of registration.
Mylan Pharmaceuticals, Inc.
applied to be registered as an importer
of certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Mylan
Pharmaceuticals, Inc. registration as an
importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated March 20, 2015, and published in
the Federal Register on March 27, 2015,
80 FR 16436, Mylan Pharmaceuticals,
Inc., 3711 Collins Ferry Road,
Morgantown, West Virginia 26505
applied to be registered as an importer
SUMMARY:
E:\FR\FM\06JYN1.SGM
06JYN1
]]>Agencies
[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Page 38471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16441]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Navinta,
LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration in accordance with 21 CFR
1301.33(a) on or before September 4, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODXL,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, dispensers, importers, and exporters of
controlled substances (other than final orders in connection with
suspension, denial, or revocation of registration) has been redelegated
to the Deputy Assistant Administrator of the DEA Office of Diversion
Control (``Deputy Assistant Administrator'') pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on
February 4, 2015, Navinta, LLC, 1499 Lower Ferry Road, Ewing, New
Jersey 08618-1414 applied to be registered as a bulk manufacturer of
the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine (ANPP) II
(8333).
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans initially to manufacture API quantities of the
listed controlled substances for validation purposes and FDA approval,
then eventually upon FDA approval to produce commercial size batches
for distribution to dosage form manufacturers.
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16441 Filed 7-2-15; 8:45 am]
BILLING CODE 4410-09-P
