Dataset · revision 2026-10-23.2
FDA-registered pharmaceutical manufacturing sites by country
For each country with at least five published sites: FDA-registered drug establishments, those registered for API manufacture, distinct operators, and published sites matched to current EU/UK GMP certificates or EU non-compliance statements.
Revision 2026-10-23.2, published 23 Oct 2026, 12:33 UTC · SHA-256 7980408e8dea29ea26abe6460edc9f2cb66b8763266735fb64917f6984de3110
- Population
- Drug establishments in the FDA Drug Establishments Current Registration Site with an FEI, grouped by registered site country. Only sites registered to supply the US market are included.
- Method
- Country is parsed from the registered address (with ISO-3 handling for names that contain commas, e.g. Korea, South). A GMP document is matched to a site when its EudraGMDP/MHRA address names the site's street and its city or postcode (rule applied in the 23 Oct 2026 link repair; this file was re-released after it). The three-year window is the EMA guideline default after inspection, not an official expiry.
- Limitations
- US-facing sites only, so national totals understate global capacity, especially where manufacturing serves domestic markets. Address matching misses sites whose address is written differently in the two registers: an unmatched site is not an uncertified site. Site counts are not production volume.
- Licence
- PharmaTek's derived counts are released under CC BY 4.0 (credit “PharmaTek Intelligence”). FDA records are US public domain; GMP matches derive from EudraGMDP and MHRA registers with attribution.
Columns
| Column | Meaning |
|---|---|
| country | Country of the registered site address (not the operator's headquarters) |
| fda_registered_sites | Establishments with an FEI in the FDA current registration list |
| api_manufacture_sites | Of those, establishments whose registered operations include API MANUFACTURE |
| distinct_operators | Distinct operating companies resolved for those establishments |
| published_sites | Sites with a public PharmaTek page: API manufacture registered, or a GMP document matched |
| published_sites_with_current_eu_uk_gmp | Published sites matched to an EU or UK GMP certificate inspected within three years |
| published_sites_with_eu_non_compliance | Published sites with an EU GMP non-compliance statement on record |
Query used for this release
with pub as (
select f.id, f.country, f.parent_company_id,
'API MANUFACTURE' = any(f.operations) as api,
exists (select 1 from core2.gmp_certificates g where g.facility_id = f.id) as any_gmp,
exists (select 1 from core2.gmp_certificates g where g.facility_id = f.id
and g.doc_type = 'GMPC' and g.expiry_derived >= date '2026-10-23') as cur_gmp,
exists (select 1 from core2.gmp_certificates g where g.facility_id = f.id
and g.doc_type = 'non_compliance') as nc
from core2.facilities f
where f.fei is not null and f.facility_name is not null and f.country is not null
)
select country,
count(*) as fda_registered_sites,
count(*) filter (where api) as api_manufacture_sites,
count(distinct parent_company_id) as distinct_operators,
count(*) filter (where api or any_gmp) as published_sites,
count(*) filter (where (api or any_gmp) and cur_gmp) as published_sites_with_current_eu_uk_gmp,
count(*) filter (where (api or any_gmp) and nc) as published_sites_with_eu_non_compliance
from pub
group by country
having count(*) filter (where api or any_gmp) >= 5
order by api_manufacture_sites desc, fda_registered_sites desc;Revisions
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 |
|---|---|---|---|
| 2026-10-23.2current | 23 Oct 2026, 12:33 UTC | 36 | 7980408e8dea29ea… |
| 2026-10-23.1 | 23 Oct 2026, 01:19 UTC | 37 | 6e9ba9cffb1822a3… |
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
Cite as: PharmaTek Intelligence, “FDA-registered pharmaceutical manufacturing sites by country”, revision 2026-10-23.2 (SHA-256 7980408e8dea), https://pharmatek.co.uk/data/manufacturing-sites-by-country. See the methodology and corrections.