Research reports
Each report is a dated snapshot with its base population, method and limitations stated. Where a dataset is published, the rows and query behind the headline are on the open data page. Revisions are logged on corrections.
More than 1 in 4 APIs have only one current documented source
Of 2,295 APIs with a current US DMF or EU CEP holder, 610 have exactly one and 40% have two or fewer.
Who holds EU Certificates of Suitability?
China has the most CEP holders, India the most valid certificates; together 59% of valid CEPs. 92% are Chemical (monograph) certificates.
Where FDA-registered API manufacturing sites are
India, China and the US hold 65% of FDA-registered API sites; about 1 in 4 could be matched to an EU/UK GMP certificate issued in the last three years.
A Drug Master File isn't a clean bill of health
About 1 in 8 active US Type II DMF holders has a linked FDA enforcement action.
The API patent cliff 2026–2029
92 ingredients whose last listed US product patent expires within three years; 19 have no current DMF or CEP on record.
FDA Warning Letters to drug manufacturers, 2008–2026
732 Warning Letters attributed to directory companies; three in four went to firms in the US or India.