Is Outsourcing FDA Approved Quality to the Third World Possible?
Sep 16, 2025
Key Takeaways from Two Studies Reviewing Changing Drug Manufacturing.
Roughly 85% of the active pharmaceutical ingredients (APIs) consumed in the United States are produced overseas, with India, China, and Italy standing out as the leading sources. Only around 15% of APIs originate from domestic facilities. In other words, the U.S. generic drug supply chain relies heavily on these foreign suppliers, particularly for both APIs and generic medications.
Between 2010 and 2020, India’s share of U.S. generic drug production rose from about 20% to 50%, while the portion manufactured within the United States declined from approximately 50% to 35%.
By contrast, the production of finished pharmaceuticals shows a different pattern: brand-name drugs and biologics are still concentrated in the United States and Western Europe, with about 80% of brand drugs and nearly 90% of biologics manufactured in those regions as of 2020.
References:
https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2022.01120
https://journals.sagepub.com/doi/10.1177/10600280211069540
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