More than 1 in 4 APIs have only one current documented source
Sourcing teams plan around a second source. Across 2,295 active pharmaceutical ingredients with at least one current documented source — an organisation holding an active US Type II DMF or an EU Certificate of Suitability — 27% have exactly one, and40% have two or fewer. The documented cushion is often thinner than assumed.
Data as of 23 October 2026 · Sources: FDA List of Drug Master Files & EDQM CEP database · Analysis by PharmaTek Intelligence
Reviewed by Dr Sanaz Baheran, PhD in pharmaceutical science, co-founder of PharmaTek
Key findings
More than a quarter have one documented source
Of the 2,295 APIs with a current documented source, 610 — 27% — have exactly one organisation holding an active US DMF or an EU CEP. For those substances the US and EU registers show no second documented holder. Other manufacturers may exist outside these registers, so this is not a finding of sole supply, and a filing does not show current production.
Two in five have a second source at most
Add the 318 substances with two and 40% of these APIs have two or fewer current documented sources. A record shows a regulatory filing, not available capacity or a qualified supplier, so a usable second source still has to be qualified before it is needed.
At the other end, a few APIs are deeply commoditised
795 APIs have six or more current documented sources, up to 72 for rivaroxaban. Documentation is not spread evenly: it is thinnest in the tail, which is where mapping candidates ahead of time pays off most.
Current documented sources per API
Distribution of the 2,295 APIs by number of distinct organisations holding an active US DMF or an EU CEP. Download the rows from the dataset page.
Highlighted: single-source (rose) and dual-source (amber) — the concentration-risk tail.
What this means for sourcing teams
The headline is a caution against an assumption. “There is always a second source” is true for the commoditised middle of the market and false for a large, specific slice of it. For 27% of these APIs, no second organisation holds a current US DMF or EU CEP. That does not mean no second manufacturer exists, but it does mean a buyer cannot find one in the two registers most buyers check first.
The practical response is to know your source count before a disruption, not during one. A substance with one documented source needs a deliberate strategy — a qualified backup, inventory buffer, or a plan to develop a new source — with the lead time that qualification actually takes. Our guide to single vs dual sourcing covers when a second source earns its cost, and the API supplier qualification checklist covers how long standing up a new one really takes.
Concentration also compounds with geography. As our CEP supplier geography and API manufacturing geography reports show, documented sources cluster in a few countries — so a “second source” that sits in the same cluster as the first hedges less than the count suggests.
Every API profile on PharmaTek separates current records from historical ones and links each holder to its regulatory record. Explore the API directory.
Methodology & sources
- Base: 2,295 active pharmaceutical ingredients with at least one current documented source as of 23 October 2026: a distinct organisation holding an active US FDA Type II Drug Master File or an EU Certificate of Suitability linked to the substance. Inactive (historical) DMFs are excluded.
- “Sources” counts distinct organisations (legal entities), not certificates: one holding several DMFs or CEPs for a substance counts once, and spellings of one entity's name in different registers are merged. Sister companies in one group count separately. The same code counts the API pages and the dataset (revision 2026-10-23.6).
- Coverage can err both ways. A substance may have manufacturers outside these two registers, so a single documented source is not a finding of sole supply; and a filing does not show that anything is being made today. The counts describe documented sources, not market concentration or output shares, and substances with no current record are outside the population. The FDA does not approve or certify DMFs. Model-inferred links are excluded.
- A record is a regulatory filing, not a quality verdict or proof of current availability. Revised 23 October 2026: valid CEP holders without a linked company profile are now counted (22 October edition: 2,223 APIs; 28.6% single). Revised 22 October 2026: the September edition (2,910 APIs; 30% single) counted inactive DMFs and described DMF holders as certified. See corrections.
Cite this report: PharmaTek Intelligence, “More Than 1 in 4 APIs Have Only One Current Documented Source,” edition of 23 October 2026. https://pharmatek.co.uk/reports/single-source-api-risk
This report describes documented-source concentration in aggregate and makes no judgement about any individual substance or company. It reflects current documented sources (active DMFs and valid CEPs) at a point in time; always confirm current supply options against primary sources before a sourcing decision.
See how many current documented sources your API has
Search any substance for its current US DMF and EU CEP holders, their recorded countries, and their FDA compliance history — the concentration question, answered before you need it.
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