China and India together account for 90% of new active pharmaceutical ingredient drug master files submitted for U.S. medicines in 2025, as the U.S. share continues to shrink, according to a Sept. 11 analysis from U.S. Pharmacopeia’s Medicine Supply Map.
Here are five things to know:
- China now holds 21% of all active API drug master files tied to U.S. medicines, up from 18% in 2024 and 13% in 2021, the largest single-year gain the country has recorded.
- India remains the largest single holder of active API drug master files at 49%, though its share of new filings has fallen sharply from a 2021 peak of 62%.
- The U.S. share of active API drug master files dropped to 6% in 2025, down from 10% in 2021, and the country accounted for just 3% of new filings, continuing what USP called “a continued erosion rather than a recent, short-term shift.” A separate USP volume-based analysis found China’s share of U.S. prescription API volume rose to 10% in 2025, up from 8% the year before.
- The findings come amid a federal push to reduce reliance on overseas API sources. A 100% tariff on certain patented drugs and associated pharmaceutical ingredients took effect July 31 for certain large manufacturers, with other companies following Sept. 29. Companies with qualifying most-favored-nation pricing and onshoring agreements can receive a zero tariff rate through January 2029.
- Those agreements also include commitments to expand domestic pharmaceutical manufacturing. The nine companies that signed agreements Aug. 31 committed to invest at least $19.6 billion collectively in U.S. manufacturing, with several agreeing to contribute API to the government’s Strategic Active Pharmaceutical Ingredients Reserve. Separately, HHS has invested in domestic pharmaceutical manufacturing capacity under the Defense Production Act, and companies such as Mark Cuban’s Cost Plus Drugs have begun manufacturing generics domestically. USP said the continued concentration of API manufacturing remains “a structural vulnerability within the U.S. pharmaceutical supply chain.”
