2016-18921. Bulk Manufacturer of Controlled Substances Registration

ACTION:

Notice of registration.

SUMMARY:

Registrants listed below have applied for and been granted registration by-the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of controlled substances.

SUPPLEMENTARY INFORMATION:

The companies listed below applied to be registered as manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices.

Company	FR Docket	Published
Noramco, Inc.	81 FR 7587	February 12, 2016.
Cayman Chemical Company	81 FR 9217	February 24, 2016.
Janssen Pharmaceutical, Inc.	81 FR 9219	February 24, 2016.
Insys Therapeutics, Inc.	81 FR 9220	February 24, 2016.
Siemens Healthcare Diagnostics, Inc.	81 FR 15565	March 23, 2016.
Siegfried USA, LLC	81 FR 15567	March 23, 2016.
Patheon Pharmaceuticals, Inc.	81 FR 15571	March 23, 2016.
Navinta, LLC	81 FR 20418	April 7, 2016.
Patheon API Manufacturing, Inc.	81 FR 22122	April 14, 2016.

The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable 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 each of the company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history.

Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed persons.

Dated: August 2, 2016.

Louis J. Milione,

Deputy Assistant Administrator.