Companies in India, China, and Europe continue to play an outsized role in manufacturing active pharmaceutical ingredients (API) used in products destined for the US market in terms of locations cited in API drug master files (DMFs) filed with the US Food and Drug Administration (FDA).
 
According to the US Pharmacopeia’s (USP) Medicine Supply Map, only 4% of the active API DMFs filed with FDA in 2023 cited US manufacturing facilities; 50% were held by India, followed by China at 32%, the EU at 10% and other countries at 4%. DMFs are submitted to FDA by companies supplying drug ingredients to another company and are confidential and stripped of proprietary information. USP notes that not all drug products are made with APIs referencing DMFs, and that the proportion of DMFs is not necessarily indicative of total output by a country or region.
 
Instead, USP said the geographical analysis of DMFs can shed light on global manufacturing trends. When looking at total active DMFs, India remains in the lead globally, with 48%, followed by the EU with 17%, China with 16%, and the US with 9%...[USP]