Datasets behind our research
Every PharmaTek report headline can be reproduced from a frozen, versioned file published here, with the query, population, method, limitations and licence. Releases are never overwritten; a new edition gets a new file.
FDA-registered API manufacturing sites by country (all countries)
For every country with at least one FDA-registered establishment listing API manufacture: the number of such sites and of all FDA-registered drug establishments. Recount behind the API manufacturing geography report.
Valid EU Certificates of Suitability by holder country
Holders of a valid CEP and the number of valid CEPs they hold, by the holder country recorded by EDQM. Recount behind the EU CEP supplier geography report.
Active Type II DMF holders and FDA enforcement, by company country
Companies holding an active US Type II DMF, and how many have a linked FDA Form 483, Warning Letter or recall, by the company's recorded country. Recount behind the DMF enforcement report.
FDA drug Warning Letters attributed to directory companies, by year and country
FDA drug Warning Letters, 2008–2026, that PharmaTek attributed to a company in its directory, counted by year issued and by the country in the FDA record.
API product-patent expiries to 2031 with current DMF/CEP sources
Active ingredients whose latest Orange Book-listed product patent expires within five years, with the number of organisations holding a current DMF or CEP for each. Recount behind the patent-cliff report.
Cross-register match precision benchmark
1,001 reviewed links between regulatory records and PharmaTek organisation and site profiles (DMF holders, CEP holders, GMP documents, FDA enforcement events and FDA sites), before and after the 23 October 2026 link repair, plus one link for every distinct non-exact DMF holder and enforcement name. Each link is judged as the same legal entity or site, a related entity in the same group, wrong, or unclear.
FDA-registered pharmaceutical manufacturing sites by country
For each country with at least five published sites: FDA-registered drug establishments, those registered for API manufacture, distinct operators, and published sites matched to current EU/UK GMP certificates or EU non-compliance statements.
Current documented sources per active pharmaceutical ingredient
For every API with at least one current documented source, the number of distinct organisations holding an active US FDA Type II Drug Master File or a valid EU Certificate of Suitability.
How records are read and matched: methodology. Found a problem? Corrections.