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Distribution of foreign API manufacturer drug master files submitted to the U.S. FDA in 2000 and 2021, by country of manufacture
Foreign API manufacturer drug master files submitted to FDA 2000 vs. 2021
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.
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Starter Account
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$199 USD
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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 ÌÇÐÄÆƽâ°æ. Retrieved July 25, 2026, from /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. ÌÇÐÄÆƽâ°æ. Accessed July 25, 2026. /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. ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 25, 2026. /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." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 31 Mar 2023, /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 ÌÇÐÄÆƽâ°æ, /statistics/1497929/foreign-api-manufacturer-dmfs-submitted-to-us-fda/ (last visited July 25, 2026)
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: /statistics/1497929/foreign-api-manufacturer-dmfs-submitted-to-us-fda/
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