Where the World's APIs Are Actually Made: 2,385 FDA-Registered Sites
Every company that manufactures a drug ingredient for the US market must register that site with the FDA. We analysed all 9,821 registered establishments and isolated the 2,385whose registered operations include active pharmaceutical ingredient manufacture. The result is a map of where the world's medicines really begin — and it is far more concentrated than most supply-chain conversations assume.
Data as of August 2026 · Source: U.S. FDA drug establishment register · Analysis by PharmaTek Intelligence
Key findings
India has more FDA-registered API plants than the United States
India accounts for 540 API-manufacturing sites against 508 in the US and 493 in China. The gap is narrow, but the direction surprises people who assume domestic capacity still leads. Together these three countries hold 65% of every API site registered with the FDA.
The long tail is thinner than the headlines suggest
After the top three, no country reaches 100 sites. Italy (90), Germany (87) and Japan (83) lead the rest, and 45 of the 57 countries with any API capacity have fewer than 25 sites each. Diversifying away from Asia means competing for a genuinely small pool of alternatives.
Only about 1 in 5 API sites also holds a current EU or UK GMP certificate
Of the 2,385 FDA-registered API sites, 486 carry a matching GMP certificate in the EU (EudraGMDP) or UK (MHRA) registers. US registration and European GMP certification are different things — a supplier qualified for one market is not automatically qualified for the other.
API manufacturing sites by country
Top 12 of 57 countries, by number of FDA-registered establishments whose operations include API manufacture.
Highlighted: India (largest) and China. Remaining countries each hold fewer than 36 sites.
What this means for sourcing teams
Concentration is the headline, but the actionable finding is the second one. When a supply shock hits a single region — an import alert, a plant closure, a geopolitical disruption — the realistic alternatives are not spread evenly across 57 countries. They cluster in the same three places, and the fourth-largest source of API capacity anywhere in the world has 90 sites.
That makes knowing your second source before you need it a materially different exercise from assuming one exists. A dual-source strategy that names two suppliers in the same industrial cluster is single-sourcing with extra paperwork.
The GMP finding matters just as much for qualification. An FDA establishment registration confirms a site is registered to manufacture for the US market. It says nothing about European approval, and our cross-reference against the EU and UK certificate registers found that roughly four in five FDA-registered API sites have no matching current GMP certificate in either. If you are sourcing for an EU filing, that is the gap to check first — alongside the site's Drug Master File coverage and its FDA Form 483 history.
PharmaTek maps every site in this analysis to its parent company, its regulatory filings and its inspection record, so these questions are answerable in one place rather than across four registers in three jurisdictions. See the supplier directory.
Methodology & sources
- Dataset: the complete FDA Drug Establishments Current Registration Site (DECRS) register, 9,821 establishments as of August 2026. We counted the 2,385whose registered business operations include “API MANUFACTURE”. Country is the registered site address, not the parent company's headquarters — so a US-headquartered firm's plant in Hyderabad counts as India.
- A site registers with the FDA if it manufactures for the US market, so this measures US-facing API capacity. Plants serving only other markets are out of scope, and the true global count is higher — particularly in China, where much capacity supplies domestic and non-US markets.
- GMP cross-reference: 486 of the API sites match a current certificate of GMP compliance in EudraGMDP (EU) or MHRA-GMDP (UK), matched on site name. Name matching is conservative, so this is a floor rather than a ceiling.
- Counting sites is not the same as counting volume or capacity. A single large plant can out-produce a dozen small ones; this analysis measures the number of registered establishments, which is what the public record supports.
Cite this report: PharmaTek Intelligence, “Where the World's APIs Are Actually Made: 2,385 FDA-Registered Sites,” August 2026. https://pharmatek.co.uk/reports/api-manufacturing-geography
Registration is not endorsement. Appearing in the FDA register means a site has registered its operations; it is not a quality rating, and this report makes no judgement about any individual company.
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