Reshoring APIs and Scaling Continuous Manufacturing for Generic Drug Supply

Generic medicines account for the vast majority of prescriptions in the U.S., yet much of their underlying supply chain remains heavily dependent on foreign-sourced active pharmaceutical ingredients (APIs). As concerns around drug shortages and supply chain resilience intensify, attention is shifting upstream toward how APIs are manufactured, where they are sourced, and what it will take to rebuild domestic production capacity. At the same time, advanced manufacturing approaches like continuous flow are gaining traction as a way to improve efficiency, safety, and cost competitiveness in a traditionally low-margin market.

In this episode of Off Script, we spoke with Brian Doty, vice president of R&D and programs at the API Innovation Center (APIIC), about the structural challenges facing generic drug manufacturing and the role advanced technologies could play in addressing them. The conversation explores why API supply is often the cause of downstream drug shortages, the technical and economic limitations of traditional batch processing, and how continuous manufacturing can reduce process steps, improve control, and enable safer production. Doty also discusses the practical barriers to adoption as well as the growing role of FDA engagement programs and policy incentives in accelerating change.