80 FR 45550 - Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 146 (July 30, 2015)

Page Range		45550-45550
FR Document		2015-18695

Apertus Pharmaceuticals applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Apertus Pharmaceuticals registration as a manufacturer of those controlled substances.

Federal Register, Volume 80 Issue 146 (Thursday, July 30, 2015)

[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Page 45550]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18695]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Apertus 
Pharmaceuticals

ACTION: Notice of registration.

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SUMMARY: Apertus Pharmaceuticals applied to be registered as a 
manufacturer of certain basic classes of controlled substances. The 
Drug Enforcement Administration (DEA) grants Apertus Pharmaceuticals 
registration as a manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated March 20, 2015, and 
published in the Federal Register on March 27, 2015, 80 FR 16440, 
Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, Missouri 63011 
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 Apertus Pharmaceuticals 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
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
------------------------------------------------------------------------

    The company plans to divide the synthesized cannabidiol, with a 
portion going for sale as an API in nabiximol. The raw material will be 
used to synthesize dronabinol. Therefore, they anticipate consuming and 
purchasing small quantities of CS for generating data to support the 
Drug Master File with the FDA including validation batches, standards 
and stability studies.
    No other activity for this drug code is authorized for this 
registration.

    Dated: July 23, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-18695 Filed 7-29-15; 8:45 am]
 BILLING CODE P

45550 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Notices

Beirut, LEBANON; Cliintel, Centennial, Global Technology SA, Caba, protocols in effect on May 1, 1971. The
CO; Covalense Technologies Ltd., ARGENTINA; Ufone, Islamabad, DEA investigated the company’s
Hyderabad, INDIA; Cricket Wireless, PAKISTAN; Vodafone India Limited, maintenance of effective controls
San Diego, CA; CTC Ltd., Kyiv, Mumbai, INDIA; and Zain KSA, Riyadh, against diversion by inspecting and
UKRAINE; Enhancesys Innovations SAUDI ARABIA. testing the company’s physical security
LLC, Cupertino, CA; EPAEON LTD, No other changes have been made in systems, verifying the company’s
Nicosia, CYPRUS; E-Plus Mobilfunk either the membership or planned compliance with state and local laws,
GmbH & Co. KG, Duesseldorf, activity of the group research project. and reviewing the company’s
GERMANY; Intel Corporation, Santa Membership in this group research background and history.
Clara, CA; Iskratel, d.o.o., Kranj, project remains open, and The Forum Therefore, pursuant to 21 U.S.C.
SLOVENIA; Laboratory For Telecomm- intends to file additional written 823(a), and in accordance with 21 CFR
Faculty of Elect. Eng. University of notifications disclosing all changes in 1301.33, the above-named company is
Ljubljana, Ljubljana, SLOVENIA; Limtel membership. granted registration as a bulk
Sp. z o.o., Olsztyn, POLAND; Mendix On October 21, 1988, The Forum filed manufacturer of the basic classes of
Inc., Boston, MA; Mirus Teknologia, its original notification pursuant to controlled substances listed:
Osterville, MA; Modern Times Group section 6(a) of the Act. The Department
MTG AB, Stockholm, SWEDEN; of Justice published a notice in the Controlled substance Schedule
Network Rail, Milton Keynes, UNITED Federal Register pursuant to section
Marihuana (7360) ......................... I
KINGDOM; NetYCE, Amsterdam, THE 6(b) of the Act on December 8, 1988 (53 Tetrahydrocannabinols (7370) ..... I
NETHERLANDS; New South Wales FR 49615).
Government Telecommunications The last notification was filed with The company plans to divide the
Authority, Sydney, AUSTRALIA; NII the Department on April 21, 2015. A synthesized cannabidiol, with a portion
Holdings, Inc., Reston, VA; Nordiska notice was published in the Federal going for sale as an API in nabiximol.
Servercentralen AB, Bromma, SWEDEN; Register pursuant to section 6(b) of the The raw material will be used to
Olds Fibre Ltd., Olds, CANADA; Omera Act on May 27, 2015 (80 FR 30268). synthesize dronabinol. Therefore, they
Consulting P/S, Copenhagen, Patricia A. Brink, anticipate consuming and purchasing
DENMARK; Pacific Broadband Director of Civil Enforcement, Antitrust small quantities of CS for generating
Networks Limited, Scoresby, Division. data to support the Drug Master File
AUSTRALIA; Petrobras, Rio de Janeiro, [FR Doc. 2015–18627 Filed 7–29–15; 8:45 am] with the FDA including validation
BRAZIL; Proxwel, Bizerte, TUNISIA; BILLING CODE P
batches, standards and stability studies.
Resolvetel Ltd., Henley-on-Thames, No other activity for this drug code is
UNITED KINGDOM; Selex ES, Rome, authorized for this registration.
ITALY; Singer TC GmbH, Schwedeneck, DEPARTMENT OF JUSTICE Dated: July 23, 2015.
GERMANY; SLA Mobile, Belfast, Joseph T. Rannazzisi,
UNITED KINGDOM; Smart Information Drug Enforcement Administration Deputy Assistant Administrator.
Systems Gmbh, Vienna, AUSTRIA;
[Docket No. DEA–392] [FR Doc. 2015–18695 Filed 7–29–15; 8:45 am]
Systex Corporation, Taipei, TAIWAN;
BILLING CODE P
TELEMAR NORTE LESTE S.A., Rio de Manufacturer of Controlled
Janeiro, BRAZIL; TOA Technologies, Substances Registration: Apertus
Inc., Beachwood, OH; University of Pharmaceuticals DEPARTMENT OF JUSTICE
Stuttgart, Stuttgart, GERMANY;
Univision LLC, Ulaanbaatar, ACTION: Notice of registration. Drug Enforcement Administration
MONGOLIA; VDVL, Rijswijk, THE
NETHERLANDS; Viasat, Inc., Carlsbad, SUMMARY: Apertus Pharmaceuticals [Docket No. DEA–392]
CA; VIP Operator, Skopje, applied to be registered as a
manufacturer of certain basic classes of Manufacturer of Controlled
MACEDONIA; Vodacom (Pty) Ltd.,
controlled substances. The Drug Substances Registration: Cambridge
Midrand, SOUTH AFRICA; WebRadar,
Enforcement Administration (DEA) Isotope Lab
Rio de Janeiro, BRAZIL; wwite p/l,
Eaglemont, AUSTRALIA; Zain Kuwait, grants Apertus Pharmaceuticals ACTION: Notice of registration.
Kuwait City, KUWAIT; Zettics, Seattle, registration as a manufacturer of those
WA; beCloud, Minsk, BELARUS; controlled substances. SUMMARY: Cambridge Isotope Lab
CORRELOR TECHNOLOGIES PTE. SUPPLEMENTARY INFORMATION: By notice applied to be registered as a
LTD., Singapore, SINGAPORE; Innovise dated March 20, 2015, and published in manufacturer of a certain basic class of
ESM Ltd., Slough, UNITED KINGDOM; the Federal Register on March 27, 2015, controlled substance. The Drug
Kwezi Software Solutions, Woodmead, 80 FR 16440, Apertus Pharmaceuticals, Enforcement Administration (DEA)
SOUTH AFRICA; Maksen Consulting, 331 Consort Drive, St. Louis, Missouri grants Cambridge Isotope Lab
S.A., Lisbon, PORTUGAL; Maxis 63011 applied to be registered as a registration as a manufacturer of this
Broadband Sdn Bhd, Kuala Lumpur, manufacturer of certain basic classes of controlled substance.
MALAYSIA; Mediaan/abs bv, Heerlen, controlled substances. No comments or SUPPLEMENTARY INFORMATION: By notice
THE NETHERLANDS; Polish objections were submitted to this notice. dated February 5, 2015, and published
Telephones Foundation, Warszawa, The DEA has considered the factors in in the Federal Register on February 11,
Lhorne on DSK7TPTVN1PROD with NOTICES

POLAND; Portugal Telecom Inovacao, 21 U.S.C. 823(a) and determined that 2015, 80 FR 7635, Cambridge Isotope
SA, Aveiro, PORTUGAL; PT the registration of Apertus Lab, 50 Frontage Road, Andover,
Comunicacoes, Lisbon, PORTUGAL; Pharmaceuticals to manufacture the Massachusetts 01810 applied to be
SAPO (PT Comunicacoes), Lisbon, basic classes of controlled substances is registered as a manufacturer of a certain
PORTUGAL; Softera Oy, Helsinki, consistent with the public interest and basic class of controlled substance. No
FINLAND; Telecom Argentina, S.A., with United States obligations under comments or objections were submitted
Buenos Aires, ARGENTINA; Telefonica international treaties, conventions, or to this notice.

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Document Created: 2018-02-23 09:29:46
Document Modified: 2018-02-23 09:29:46

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 45550

80 FR 45550 - Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 80, Issue 146 (July 30, 2015)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration