Bulk Manufacturer of Controlled Substances Application: Novitium Pharma LLC, 76108 [2020-26171]
Download as PDF
<![CDATA[
76108
Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices
European customers, meets the
standards established by the European
Pharmacopeia, administered by the
Directorate for the quality of Medicines
(EDQM). In order to ensure that its
product will meet European
specifications, the company seeks to
import morphine supplied by EDQM for
use as reference standards. No other
activity for these drug codes is
authorized for this registration.
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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Levorphanol .....................
Drug
code
Schedule
9220
II
The company plans to bulk
manufacture the above-controlled
substance to support production of the
company’s Food and Drug
Administration approved drug product.
No other activity for this drug code is
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–26171 Filed 11–25–20; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
William T. McDermott,
Assistant Administrator.
[Docket No. DEA–746]
[FR Doc. 2020–26172 Filed 11–25–20; 8:45 am]
Importer of Controlled Substances
Application: Noramco Inc.
BILLING CODE P
Drug Enforcement Administration
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
[Docket No. DEA–743]
SUMMARY:
AGENCY:
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Novitium
Pharma LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Novitium Pharma LLC has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplemental 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 26, 2021. Such
persons may also file a written request
for a hearing on the application on or
before January 26, 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 November 2, 2020,
Novitium Pharma LLC, 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Controlled substance
VerDate Sep<11>2014
19:29 Nov 25, 2020
Jkt 253001
Noramco Inc. has applied to
be registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplemental 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 December 28, 2020. Such
persons may also file a written request
for a hearing on the application on or
before December 28, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on October 23, 2020,
Noramco Inc., 500 Swedes Landing
Road, Wilmington, Delaware, 19801–
PO 00000
Frm 00105
Fmt 4703
Sfmt 4703
4417, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance
Marihuana ........................
Tetrahydrocannabinols ....
Nabilone ..........................
Phenylacetone .................
Opium, Raw .....................
Poppy Straw Concentrate
Tapentadol ......................
Drug
code
Schedule
7360
7370
7379
8501
9600
9670
9780
I
I
II
II
II
II
II
The company plans to import
Phenylacetone (8501), and Poppy Straw
Concentrate (9670) to bulk manufacture
other controlled substances for
distribution to its customers. The
company plans to import an
intermediate form of Tapentadol (9780)
to bulk manufacture Tapentadol for
distribution to its customers. In
reference to drug codes 7360
(Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to import a synthetic cannabidiol
and a synthetic Tetrahydrocannabinol.
No other activity for these drug codes is
authorized for this registration.
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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–26174 Filed 11–25–20; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–742]
Importer of Controlled Substances
Application: Lyndra Therapeutics
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Lyndra Therapeutics has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
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
SUMMARY:
E:\FR\FM\27NON1.SGM
27NON1
]]>Agencies
[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Page 76108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26171]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-743]
Bulk Manufacturer of Controlled Substances Application: Novitium
Pharma LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Novitium Pharma LLC has applied to be registered as a bulk
manufacturer of basic class(es) of controlled substance(s). Refer to
Supplemental 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 26,
2021. Such persons may also file a written request for a hearing on the
application on or before January 26, 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 November 2, 2020, Novitium Pharma LLC, 70 Lake Drive,
East Windsor, New Jersey 08520, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Levorphanol............................. 9220 II
------------------------------------------------------------------------
The company plans to bulk manufacture the above-controlled
substance to support production of the company's Food and Drug
Administration approved drug product. No other activity for this drug
code is authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-26171 Filed 11-25-20; 8:45 am]
BILLING CODE P
