China-Sourced KSMs Leave Vital 40 Exposed, APIIC Warns

Brian Doty, Ph.D., vice president of R&D and programs at the API Innovation Center (APIIC), says domestic sourcing efforts need to focus upstream of active pharmaceutical ingredients (APIs), on the key starting materials (KSMs) used to make them. In an interview with Pharmaceutical Commerce, Doty notes The US makes some APIs, though “not as much as we should.”

In Senate testimony, APIIC chair and founder Anthony Sardella described a study of 40 vital medicines that are clinically essential and often in shortage. Where data were available, it found that 47% of their KSMs come only from China.¹ Doty pointed to a similar figure for APIs: 83 of the top 100 generics prescribed in the U.S. rely on foreign-sourced active ingredients, he says. A Senate Special Committee on Aging cited the same finding in its October 2025 report.²

“Not having a reliable source, one that we can control quantity as well as quality, and even pricing, puts us in a very vulnerable position as a country,” Doty says.

The APIIC advocates for continuous flow chemistry, which Doty says is replacing today’s standard of batch chemistry, making high-quality materials in less time. A conventional plant may use a three-story tank for one step of one process. Continuous flow runs many reaction sequences in a row and needs less space, Doty says.

Because it is smaller, the technology can go into existing facilities, which avoids the cost and time of building new ones. Margins in generics are thin and process costs must stay under control, Doty says, so manufacturers need a strong financial reason to change.

“We have to show up with a good business case, and this is really one of the few ways that we can do that,” he says.

References

1. Sardella A. Statement for the record. U.S. Senate Special Committee on Aging. Prescription for Trouble: Drug Safety, Supply Chains, and the Risk to Aging Americans. October 3, 2025. Accessed November 9, 2026. https://www.aging.senate.gov/download/10/06/2025/testimony_sardella-100325pdf?download=1

2. U.S. Senate Special Committee on Aging. Protecting Seniors’ Access to Essential Medications: Securing the Foreign Generic Pharmaceutical Supply Chain. October 20, 2025. Accessed November 9, 2026. https://www.aging.senate.gov/download/senate-aging-american-drugs-report?download=1