Skip to content
LexBuild

Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.

---
identifier: "/us/fr/2020-09556"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc."
title_number: 0
title_name: "Federal Register"
section_number: "2020-09556"
section_name: "Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc."
positive_law: false
currency: "2020-05-05"
last_updated: "2020-05-05"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Justice Department"
document_number: "2020-09556"
document_type: "notice"
publication_date: "2020-05-05"
agencies:
  - "Justice Department"
  - "Drug Enforcement Administration"
fr_citation: "85 FR 26715"
fr_volume: 85
docket_ids:
  - "Docket No. DEA-636"
comments_close_date: "2020-07-06"
fr_action: "Notice of application."
---

#  Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.

**ACTION:**

Notice of application.

**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 July 6, 2020.

**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 21, 2020, Patheon A PI Manufacturing, Inc, 309 Delaware Street, Greenville, South Carolina 29605, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:

| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Gamma Hydroxybutyric Acid | 2010 | I |
| Alpha-methyltryptamine | 7432 | I |
| Thebaine | 9333 | II |
| Noroxymorphone | 9668 | II |

The company plans to bulk manufacture the above-listed controlled substances as an Active Pharmaceutical Ingredient (API) for distribution to its customers. No other activities for these drug codes are authorized for this registration.

William T. McDermott,

Assistant Administrator.