1 in 3 APIs has only one certified source
Sourcing teams plan around a second source. Across 2,910 active pharmaceutical ingredients for which we can evidence a certified supplier — a company holding a US Type II DMF or a valid EU Certificate of Suitability — 30% have exactly one, and nearly half have two or fewer. The cushion is often thinner than assumed.
Data as of September 2026 · Sources: FDA List of Drug Master Files & EDQM CEP database · Analysis by PharmaTek Intelligence
Key findings
Single-source is the norm for a large slice of the catalogue
Of the 2,910 APIs with an evidenced certified supplier, 872 — 30% — have exactly one. For those substances there is no certified fallback on record: a compliance action, a plant closure, or a geopolitical shock at that single supplier has no ready alternative in the US or EU certification systems.
Nearly half have a second source at most
Add the 368 dual-source substances and 45% of these APIs have two or fewer certified sources. Dual-sourcing is a real improvement over single, but two suppliers in the same industrial cluster — often the same country — is a thinner hedge than it looks. The realistic second source has to be qualified before it is needed, not assumed to exist.
At the other end, a few APIs are deeply commoditised
961 APIs have six or more certified sources, and the most competitive run to 59 — the generic molecules where a buyer can compare and switch freely. Risk is not spread evenly: it concentrates in the thin-source tail, which is exactly where mapping your sources ahead of time pays off most.
Certified sources per API
Distribution of the 2,910 APIs by number of distinct certified suppliers (US DMF or EU CEP holders).
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 30% of the APIs we can certify-source, the second supplier is not thin — it is absent from the US and EU certification systems entirely. That is the difference between a supply plan and a supply hope.
The practical response is to know your source count before a disruption, not during one. A substance with one certified 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, certified 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.
PharmaTek maps every certified source to its substance and its FDA compliance record, so “how many certified suppliers does this API have, and where are they” is a filter rather than a research project. Explore the API directory.
Methodology & sources
- Base: 2,910 active pharmaceutical ingredients for which PharmaTek can evidence at least one certified supplier as of September 2026. A certified supplier is a distinct company holding an active US FDA Type II Drug Master File or a valid EU Certificate of Suitability linked to the substance.
- “Sources” counts distinct supplier companies, not certificates — a company holding several DMFs or CEPs for one substance counts once.
- The measure is deliberately conservative. A substance may have manufacturers that are not certified in these two systems, so a single certified source is a floor on concentration risk — evidence of thin certified supply, not a claim of sole global manufacture. It excludes model-inferred links.
- Certification is a supply credential, not a quality verdict; source count should be read alongside each supplier's inspection record.
Cite this report: PharmaTek Intelligence, “1 in 3 APIs Has Only One Certified Source,” September 2026. https://pharmatek.co.uk/reports/single-source-api-risk
This report describes certified-supply concentration in aggregate and makes no judgement about any individual substance or company. It reflects certified sources on record at a point in time; always confirm current supply options against primary sources before a sourcing decision.
See how many certified sources your API has
Search any substance for its certified US DMF and EU CEP suppliers, their countries, and their FDA compliance history — the concentration question, answered before you need it.
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