US drug supply at risk from single-country KSM sources: report

Nearly half of the 100 medicines vulnerable to supply disruptions in the U.S. have at least one key starting material (KSM) with a single-source country, creating potential drug shortage risks, according to a new report from the U.S. Pharmacopeia (USP).

While many of the drugs found on this year’s Vulnerable Medicine List (VML) carried over from USP’s previously published report, the new list incorporates data from its Medicine Supply Map adding essential KSM manufacturing data that helps identify where upstream ingredient dependencies create hidden risks for medicines.

USP has previously made the case that the U.S. supply chain for KSMs, the building blocks needed to manufacture active pharmaceutical ingredients (APIs), is at risk due to America’s reliance on countries such as China and India for these critical chemicals.

While multiple API or finished-dose manufacturers may exist, the report notes that this redundancy can be an illusion if they rely on a single upstream KSM source. These risks extend to the API level as well, particularly when multiple manufacturers rely on the same KSM source. In those cases, even if a drug manufacturer sources APIs from several producers, that redundancy becomes effectively meaningless if all of them depend on the same upstream supplier.

“Geographic concentration at the KSM level can create systemic risk that is invisible when analysis stops at the finished-dosage tier,” the report found. Disruption in the region, whether in the form of export restrictions, natural disasters, or regulatory action, will directly impact API development.

Three high-volume essential drugs newly added to the list this year — oseltamivir capsules, famotidine injection, and metoprolol tartrate injection — were identified as being susceptible to hidden geographic concentration risks.

Other key highlights from the report include that 70% of VML listed drugs are not in shortage but are structurally vulnerable. 

“As of February 2026, only 30 of the 100 VML drugs (30%) are in shortage according to FDA. Those 70% of drugs not in shortage are included in the VML because of the lack of resilience in their upstream supply chains, demonstrating the list’s proactive, forward-looking design,” the report noted.

The report also found that 63% of at-risk drugs are injectables, given ongoing production challenges. Meanwhile, oral solid drugs make up the second largest group, comprising 22% of the list. No single therapeutic class was disproportionately affected, with vulnerabilities spanning a wide range of disease categories.

Additionally, using the new data to compile the latest VML, USP also found that nearly three quarters of medicines facing the most critical supply chain vulnerabilities are considered essential medicines as designated by the World Health Organization (WHO) and the FDA.

Structural risks run deeper

While the VML provides a data-driven snapshot of these vulnerabilities, USP has long discussed many of the structural risks underpinning them.

In a recent interview with Pharma Manufacturing’s Off Script podcast, USP CEO Ronald Piervincenzi outlined some of the underlying dynamics that help explain the patterns reflected in the new VML.

Through its broader supply chain analysis, USP found that 41% of key starting materials used to make medicines for the U.S. are sourced exclusively from China. Extending that analysis downstream, the organization determined that roughly 35% of U.S. medicines rely on KSMs that are only produced in China.

“Over a third of U.S. medicines could be cut off in a trade war with China,” said Piervincenzi. “Trading with India wouldn’t help because they would not have those same key starting materials.”

That level of dependency, he noted, represents a significant vulnerability not only from a supply chain standpoint but also from a national security perspective.

“With that many medicines vulnerable, that is a leverage point that could affect the ability for the U.S. to be secure. This is why it’s so critically important that we figure out a way to create more resiliency, not just for shortages, but also from a national security front.”

While reshoring remains a key part of the conversation, Piervincenzi emphasized that simply moving production out of China is not — on its own — a sufficient solution, pointing instead to the need for diversified sourcing strategies and alternative manufacturing approaches.

Last year, Piervincenzi testified before Congress that advanced manufacturing technologies (AMTs) are needed to rebuild America’s domestic production of APIs and KSMs. 

“Enabling economically viable domestic production of prioritized APIs and KSMs is an important element of a comprehensive effort to enhance medicine supply chain resiliency,” Piervincenzi said. “Emerging technologies offer promising avenues for reducing our dependence on overseas supply chains. Incentivizing acceleration of innovative approaches like continuous manufacturing and flow chemistry are key to modernizing, localizing, and stabilizing production.”

AMTs are critical to lowering costs for U.S. facilities to produce higher quality medicines, according to Piervincenzi, who warned that where American manufacturers lag furthest behind other countries is in APIs and “even more so” in KSMs.

Check out Pharma Manufacturing’s two-part interview with Piervincenzi to learn more.