2021-04809. Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Patheon Pharmaceuticals Inc 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 May 10, 2021. Such persons may also file a written request for a hearing on the application on or before May 10, 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 February 2, 2021, Patheon Pharmaceuticals Inc, 2110 East Galbraith Road, Cincinnati, Ohio 45237-1625, applied to be registered as a bulk manufacturer of the following basic class of controlled substance:

Controlled substance	Drug code	Schedule
Gamma Hydroxybutyric Acid	2010	I

The company plans to manufacture the above-listed controlled substance as Active Pharmaceutical Ingredient (API) that will be further synthesized into Food and Drug Administration-approved dosage forms. No other activities for this drug code are authorized for this registration.

William T. McDermott,

Assistant Administrator.