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Amneal Pharmaceuticals, Inc.

For the period ended Sep 30, 2025. Filed Nov 6, 2025.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 6, 2025

AMRX$21.28+5.7%Stored close · as of Nov 9, 2026

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Item 1A. Risk Factors

Other than set forth below, there have been no material changes to the disclosures presented in our 2024 Annual Report on Form 10-K under Item 1A. Risk Factors.

A U.S. Government Shutdown Could Adversely Impact Our Regulatory, Operational and Financial Performance

We rely heavily on timely interactions with the U.S. Food and Drug Administration, the Drug Enforcement Administration, and other agencies of the U.S. Federal Government for, among other things, new product approvals, procurement quotas for controlled substances, facility inspections, and regulatory guidance. During a government shutdown, delays in these interactions could negatively impact our regulatory, operational and financial performance.

Additionally, our AvKARE segment provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, predominantly focused on the U.S. Department of Defense and the U.S. Department of Veterans Affairs. Interruptions in government contracting and procurement processes, and slower payment cycles to distributors which AvKARE uses to do business with these governmental agencies, could also negatively impact our operational and financial performance.

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