Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals, 45550 [2015-18695]

Download as PDF Lhorne on DSK7TPTVN1PROD with NOTICES 45550 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Notices Beirut, LEBANON; Cliintel, Centennial, CO; Covalense Technologies Ltd., Hyderabad, INDIA; Cricket Wireless, San Diego, CA; CTC Ltd., Kyiv, UKRAINE; Enhancesys Innovations LLC, Cupertino, CA; EPAEON LTD, Nicosia, CYPRUS; E-Plus Mobilfunk GmbH & Co. KG, Duesseldorf, GERMANY; Intel Corporation, Santa Clara, CA; Iskratel, d.o.o., Kranj, SLOVENIA; Laboratory For TelecommFaculty of Elect. Eng. 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LTD., Singapore, SINGAPORE; Innovise ESM Ltd., Slough, UNITED KINGDOM; Kwezi Software Solutions, Woodmead, SOUTH AFRICA; Maksen Consulting, S.A., Lisbon, PORTUGAL; Maxis Broadband Sdn Bhd, Kuala Lumpur, MALAYSIA; Mediaan/abs bv, Heerlen, THE NETHERLANDS; Polish Telephones Foundation, Warszawa, POLAND; Portugal Telecom Inovacao, SA, Aveiro, PORTUGAL; PT Comunicacoes, Lisbon, PORTUGAL; SAPO (PT Comunicacoes), Lisbon, PORTUGAL; Softera Oy, Helsinki, FINLAND; Telecom Argentina, S.A., Buenos Aires, ARGENTINA; Telefonica VerDate Sep<11>2014 14:54 Jul 29, 2015 Jkt 235001 Global Technology SA, Caba, ARGENTINA; Ufone, Islamabad, PAKISTAN; Vodafone India Limited, Mumbai, INDIA; and Zain KSA, Riyadh, SAUDI ARABIA. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and The Forum intends to file additional written notifications disclosing all changes in membership. On October 21, 1988, The Forum filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to section 6(b) of the Act on December 8, 1988 (53 FR 49615). The last notification was filed with the Department on April 21, 2015. A notice was published in the Federal Register pursuant to section 6(b) of the Act on May 27, 2015 (80 FR 30268). Patricia A. Brink, Director of Civil Enforcement, Antitrust Division. [FR Doc. 2015–18627 Filed 7–29–15; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE 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 Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Schedule I 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. Drug Enforcement Administration Dated: July 23, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [Docket No. DEA–392] [FR Doc. 2015–18695 Filed 7–29–15; 8:45 am] Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals ACTION: Notice of registration. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration 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 SUMMARY: BILLING CODE P [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Cambridge Isotope Lab ACTION: Notice of registration. Cambridge Isotope Lab applied to be registered as a manufacturer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Cambridge Isotope Lab registration as a manufacturer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated February 5, 2015, and published in the Federal Register on February 11, 2015, 80 FR 7635, Cambridge Isotope Lab, 50 Frontage Road, Andover, Massachusetts 01810 applied to be registered as a manufacturer of a certain basic class of controlled substance. No comments or objections were submitted to this notice. SUMMARY: E:\FR\FM\30JYN1.SGM 30JYN1

Agencies

[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Page 45550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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