Ten Percent of Globally Manufactured APIs Linked to US Drug Shortages

From 2020-2021, more than 10 percent of globally manufactured active pharmaceutical ingredients (API) — 147 compounds — were linked to drug shortages in the US, according to a research letter published in JAMA Network.

Most of these APIs were manufactured in India (35.3 percent), Italy (12 percent), China (10.7 percent) and the US (9.6 percent), Mariana P. Socal, and colleagues wrote. The rest of the short-supply APIs were made in Spain, Germany, Japan, France, Switzerland, and the UK.

It’s important to track which APIs are experiencing supply issues, and where those issues originate, said Socal, of Johns Hopkins University, and her co-authors. “Identifying API manufacturers linked to shortages could guide FDA inspections and help prioritize approvals of new entrants in vulnerable markets,” they wrote.

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