The distribution of foreign API manufacturer drug master files (DMFs) submitted to the U.S. Food and Drug Administration changed dramatically over the past two decades. The share of domestic DMFs submitted to the FDA dropped from 15 to four percent, while, on the other hand, the share of India and China increased around threefold and sixfold, respectively.
Distribution of foreign API manufacturer drug
master files submitted to the U.S. FDA in 2000 and 2021, by country of manufacture
Characteristic
2000
2021
India
20%
62%
China
4%
23%
U.S.
15%
4%
Europe
49%
7%
Other
13%
4%
0%10%20%30%40%50%60%70%
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US Senate (Committee on Homeland Security & Governmental Affairs). (March 31, 2023). Distribution of foreign API manufacturer drug
master files submitted to the U.S. FDA in 2000 and 2021, by country of manufacture [Graph]. In Statista. Retrieved May 10, 2025, from https://www.statista.com/statistics/1497929/foreign-api-manufacturer-dmfs-submitted-to-us-fda/
US Senate (Committee on Homeland Security & Governmental Affairs). "Distribution of foreign API manufacturer drug
master files submitted to the U.S. FDA in 2000 and 2021, by country of manufacture." Chart. March 31, 2023. Statista. Accessed May 10, 2025. https://www.statista.com/statistics/1497929/foreign-api-manufacturer-dmfs-submitted-to-us-fda/
US Senate (Committee on Homeland Security & Governmental Affairs). (2023). Distribution of foreign API manufacturer drug
master files submitted to the U.S. FDA in 2000 and 2021, by country of manufacture. Statista. Statista Inc.. Accessed: May 10, 2025. https://www.statista.com/statistics/1497929/foreign-api-manufacturer-dmfs-submitted-to-us-fda/
US Senate (Committee on Homeland Security & Governmental Affairs). "Distribution of Foreign Api Manufacturer Drug
Master Files Submitted to The U.S. Fda in 2000 and 2021, by Country of Manufacture." Statista, Statista Inc., 31 Mar 2023, https://www.statista.com/statistics/1497929/foreign-api-manufacturer-dmfs-submitted-to-us-fda/
US Senate (Committee on Homeland Security & Governmental Affairs), Distribution of foreign API manufacturer drug
master files submitted to the U.S. FDA in 2000 and 2021, by country of manufacture Statista, https://www.statista.com/statistics/1497929/foreign-api-manufacturer-dmfs-submitted-to-us-fda/ (last visited May 10, 2025)
Distribution of foreign API manufacturer drug
master files submitted to the U.S. FDA in 2000 and 2021, by country of manufacture [Graph], US Senate (Committee on Homeland Security & Governmental Affairs), March 31, 2023. [Online]. Available: https://www.statista.com/statistics/1497929/foreign-api-manufacturer-dmfs-submitted-to-us-fda/
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