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Generic Firms Want Congress To Build On CARES Act To Prevent Critical Drug Shortages

Executive Summary

The association for manufacturers of generics and biologics calls for public sector investment in priority medicines.

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One in five drug GMP warning letters FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. Year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier and the other a unit of DuPont.

Warning Letters Special Report: What Worried The FDA Most About Pharmaceutical Supply Chains

One in five of the drug GMP warning letters the US FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became a major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. The year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier, and the other a unit of DuPont.

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