Where FDA-Registered API Manufacturing Sites Are: 2,412 Sites in 57 Countries
Every company that manufactures a drug ingredient for the US market must register that site with the FDA. We analysed all 10,013 registered establishments and isolated the 2,412 whose registered operations include active pharmaceutical ingredient manufacture. The result is a map of where sites registered to make APIs for the US market are. It counts registered sites, not output or capacity, and plants that never supply the US are not in it.
Data as of 23 October 2026 · Source: U.S. FDA drug establishment register · Analysis by PharmaTek Intelligence
Reviewed by Dr Sanaz Baheran, PhD in pharmaceutical science, co-founder of PharmaTek
Key findings
India has the most FDA-registered API sites; China and the US are level
India has 551 sites registered for API manufacture, against 508 in China and 507 in the US. Together these three countries hold 65% of the API sites registered with the FDA. These are counts of registered establishments; they say nothing about how much each site makes.
Outside the top three, registered API sites are few
After the top three, no country reaches 100 sites. Italy (90), Germany (85) and Japan (84) lead the rest, and 44 of the 57 countries with any registered API site have fewer than 25 each. For a buyer looking for a US-registered site outside India, China and the US, the registered options are limited; whether a given site makes a given substance needs checking substance by substance.
About 1 in 4 API sites could be matched to a recent EU or UK GMP certificate
Of the 2,412 FDA-registered API sites, 586 (24%) could be matched by site address (street plus city or postcode) to a GMP certificate in the EU (EudraGMDP) or UK (MHRA) registers issued within the last three years, the EMA's default review window after an inspection (not an official expiry date). Unmatched does not mean uncertified: addresses are written differently between registers. What it does show is that US registration and European GMP evidence are separate checks.
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
Registered sites are not spread evenly. When a disruption hits one region (an import alert, a plant closure, a geopolitical event), the US-registered API sites in other countries are a short list: the fourth-largest country has 90. Site counts do not tell you which of them make your substance, at what scale, or whether they would take new business.
That makes identifying a second source before you need it a different exercise from assuming one exists. For a specific substance, start from its documented sources (an active DMF or a valid CEP) and check where those organisations' sites are; two suppliers in the same region share the same regional risks.
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 GMP status. Our address-based cross-reference matched about one in four FDA-registered API sites to an EU or UK GMP certificate issued in the last three years; the rest could not be matched, which is not the same as having none. If you are sourcing for an EU filing, ask for the certificate early, alongside the site's Drug Master File coverage and its FDA Form 483 history.
Each site in this analysis carries its registered operations and any matched GMP certificates in PharmaTek; see the methodology for how sites are matched. For the certificate-holder view of the same supply base — who holds EU Certificates of Suitability — see our EU CEP supplier geography report.
Reproduce this report
This is the 23 October 2026 edition. The August 2026 edition counted 2,385 API sites (India 540, US 508, China 493) and matched 486 to a GMP certificate by site name; this edition matches by site address, after the 23 October link repair. Data, query and limitations
Methodology & sources
- Dataset: the complete FDA Drug Establishments Current Registration Site (DECRS) register, 10,013 establishments with an FEI in 83 countries as of 23 October 2026; 9,938 of them are in the 57 countries that have at least one API site (the rows of the dataset) and 75 in 26 countries with none. We counted the 2,412 whose 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 counts US-registered API sites, not global capacity. Plants serving only other markets are out of scope, and the global number of API plants is higher, particularly in China, where many plants supply domestic and non-US markets.
- GMP cross-reference: 586 of the API sites match a certificate of GMP compliance in EudraGMDP (EU) or MHRA-GMDP (UK) issued within the last three years (the EMA default review window, not an expiry date), matched on the site's street and its city or postcode. Address matching misses sites written differently in the two registers and can, rarely, pick the wrong building (59 of 60 sampled matches were correct; see the measured match quality), so the figure can be off in both directions. An unmatched site is not an uncertified site.
- 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 FDA-Registered API Manufacturing Sites Are: 2,412 Sites in 57 Countries,” 23 October 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.
Look up registered API sites by country
Each country page lists its FDA-registered API sites with their registered operations, matched GMP documents and registrant companies.
Manufacturing countries