Foreign-Trade Zone (FTZ) 177; Authorization of Limited Production Activity; AstraZeneca Pharmaceuticals LP; (Pharmaceutical Products); Mount Vernon, Indiana

On March 27, 2025, AstraZeneca Pharmaceuticals LP submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 177A, in Mount Vernon, Indiana.

The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (90 FR 14599, April 3, 2025). On November 14, 2025, the applicant was notified of the FTZ Board's decision that the proposed activity has been authorized on a limited basis, subject to the FTZ Act and the Board's regulations, including section 400.14, and subject to a three-year limited authorization as well as a requirement that after two years, AstraZeneca demonstrate to the satisfaction of the FTZ Board that any foreign status API be sourced from trusted, secure providers that manufacture in countries with adequate health and safety regulations that are not in countries of concern. AstraZeneca may submit requests for the FTZ Board to review proposed sources of API, and the FTZ Board should ordinarily review such applications within 90 days of receiving the request.