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.
Revision 2026-10-23.6, published 23 Oct 2026, 15:20 UTC · SHA-256 31c73e50736b15a93616880efa8bb7919f98a267368f14eea859118a1c015aca
- Population
- Active pharmaceutical ingredients with a PharmaTek profile and at least one current documented source on 23 Oct 2026. Inactive (historical) DMFs and model-inferred links are excluded.
- Method
- Calculated by the same code the API pages, A–Z lists and homepage use (lib/evidence-model.js). Supplier rows are grouped into one organisation per legal entity: by linked company, then an unlinked name joins an organisation with the same name once legal forms are removed, a compatible legal form and a compatible country (FARMAK AS joins Farmak, A.s.). An organisation is current with an active Type II DMF or a valid CEP; a certificate counts only when its latest revision is Valid. Valid CEP holders that match no counted organisation are further organisations, one per holder entity. Parent and sister companies are not merged.
- Limitations
- Covers US DMF and EU CEP records only. Manufacturers that supply under an EU ASMF without a CEP, or only domestic markets, do not appear, and a filing is not proof of current supply, so a count describes documented sources, not market concentration or output shares. Substances with no current record are outside the population. A CEP holder is not necessarily the manufacturer. Where a DMF and a CEP are held by sister companies, the group counts twice. Revisions 2026-10-23.1 to .5 were published at /data/api-documented-source-concentration-2026-10-23.csv, which was overwritten as the counting rule was corrected; each is kept below with its hash.
- Licence
- PharmaTek's derived counts are released under CC BY 4.0 (credit “PharmaTek Intelligence”). Underlying DMF records are US public domain; CEP-derived counts carry the EDQM credit below.
Columns
| Column | Meaning |
|---|---|
| api_name | Substance name as held in PharmaTek |
| slug | Profile path: /directory/api/{slug} |
| cas_number | CAS Registry Number where known |
| current_documented_sources | Distinct organisations with an active US Type II DMF or a valid CEP for the substance |
| with_active_us_dmf | Of those, organisations with an active US Type II DMF |
| with_eu_cep | Of those, organisations holding a valid CEP |
| organisations | The counted organisations, by the name shown on the profile (from revision 2026-10-23.6) |
How this revision was built
The file is generated by code, not by a hand-written query: the build script reads the inputs below and counts organisations with the same module the API pages use, so the release and the live pages apply one rule. Both the code as run and its frozen inputs are published, so the file can be rebuilt byte for byte:
- build-release.mjs, evidence-model.js and entity-guard.js (the code as run)
- Frozen inputs (gzipped JSON of the API, DMF/CEP supplier and certificate rows, fetched 23 Oct 2026, 15:19 UTC)
node build-release.mjs --dataset api-documented-source-concentration --revision 2026-10-23.6 --from-inputs 2026-10-23.6.inputs.json.gz
# expected SHA-256 31c73e50736b15a93616880efa8bb7919f98a267368f14eea859118a1c015acaRevisions
Every published revision stays downloadable. Cite the revision you used; a later revision supersedes it but does not replace it.
| Revision | Published | Rows | SHA-256 |
|---|---|---|---|
| 2026-10-23.6current | 23 Oct 2026, 15:20 UTC | 2,295 | 31c73e50736b15a9… |
| 2026-10-23.5 | 23 Oct 2026, 12:23 UTC | 2,295 | f51cf790a82e6de9… |
| 2026-10-23.4 | 23 Oct 2026, 12:06 UTC | 2,295 | fdf5d3fe6e0d087f… |
| 2026-10-23.3 | 23 Oct 2026, 11:40 UTC | 2,295 | 6ef44ded23f8dbbd… |
| 2026-10-23.2 | 23 Oct 2026, 09:13 UTC | 2,295 | 084f8307ed335419… |
| 2026-10-23.1 | 23 Oct 2026, 02:58 UTC | 2,295 | b081f4c89e6abb88… |
| 2026-10-22.1 | 23 Oct 2026, 01:05 UTC | 2,223 | b159ba23d84118b4… |
Earlier revisions were published at a dated path that was overwritten when a correction was made; they are restored here from version control, timed by the change that published each one.
Sources
Certification Online Database. European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, (2026), URL: https://extranet.edqm.eu/publications/recherches_CEP.shtml. Accessed 19 October 2026. Reproduced with permission; the EDQM and the Council of Europe accept no liability for any consequence arising from its use.