Single Source
446 medicines that Brussels, Washington or Geneva list as critical or essential. For each active ingredient we counted the companies that hold an active US Drug Master File or a valid EU Certificate of Suitability. The list starts with the thinnest: that is where one failed inspection can take out the supply.
| Molecule | Used for | US DMF | EU CEP | Total | Status | EU CEP countries | Lists |
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Who holds these files? Names, sites and contacts of every holder are in the API-FDF database.
Open API-FDFHow we count
Companies, not documents
We count companies, not documents. A qualified source is a company that holds an active Type II Drug Master File on FDA's list (third quarter 2026) or a valid Certificate of Suitability in the EDQM database (checked 14 November 2026). Files for intermediates and finished products are left out.
Three official lists
The molecules come from three lists: the EU Union list of critical medicines (version 2.1, November 2026), FDA's essential medicines list under Executive Order 13944, and the WHO Model List of Essential Medicines (24th list, 2025). Vaccines, blood products, antibodies, insulins and simple salts are not counted.
A file is not a shipment
An active file shows that a company can supply the US or EU market. It does not prove that it ships today. Zero means no open file in either registry: the ingredient may still be made in-house by the brand owner or under another route, such as WHO prequalification.
Hidden by default
Brand-only molecules, where few makers are expected while the patent runs, and a few commodity substances sold mostly outside these files are marked and hidden by default.