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The United States, while not leading in the overall production volume, remains a critical player in high-value APIs, particularly those that involve complex synthesis or advanced biotechnological processes. The U.S. regulatory environment, spearheaded by the Food and Drug Administration (FDA), imposes stringent guidelines on manufacturing practices. As a result, U.S.-produced APIs often carry premium pricing, reflecting their quality and reliability. The U.S. also invests heavily in research and innovation, focusing on the development of novel drugs and advanced therapeutics, which further drives API innovation.
active pharmaceutical ingredient production by country
