What Does the Operational Reality of Reshoring Actually Look Like?

Rohit Tripathi, VP of Industry Strategy, Manufacturing & CPG at RELEX, explains that pharmaceutical manufacturing cannot be reshored the way a simple manufacturing or assembly plant can be reshored. He identifies the biggest hurdle as the need for qualified suppliers, validated processes, FDA-ready facilities, trained labor, and reliable distribution, all of which must be established before production can realistically shift domestically.

Tripathi adds that for many products, reshoring also requires transferring technical knowledge and qualifying new sources without compromising quality or availability, which he calls the key part of the challenge. He then turns to what reshoring actually means in practice: if the active pharmaceutical ingredient (API), the key starting points, or the packaging remain offshore, the supply chain is still exposed. Reshoring, in his view, has to be designed with that end-to-end capability in mind, and not just as a label on the last step of production.

Tripathi explains how that same exposure is precisely what shows up in the numbers on U.S. dependency for APIs and raw materials from China and India. He notes that generics and biosimilars represent about 90% of U.S. prescriptions, and that FDA said back in 2025 that more than 70% of generic drugs were manufactured outside the United States, with only 9% of active pharmaceutical ingredients in the U.S., calling this a clearly big exposure to non-U.S. companies and regions. India and China, he says, are certainly two big ones, but he also adds an important layer of nuance: India itself reported that China is about 74% of its API bulk drug and intermediate imports, so there is that dependency as well that is coming in.Tripathi closes by noting that chemical input inflation on all of these regions, as well as these ingredients, should not be forgotten either, since it compounds the exposure already created by where the supply chain's key inputs actually originate.