Dataset · revision 2026-10-23.2
Active Type II DMF holders and FDA enforcement, by company country
Companies holding an active US Type II DMF, and how many have a linked FDA Form 483, Warning Letter or recall, by the company's recorded country. Recount behind the DMF enforcement report.
Revision 2026-10-23.2, published 23 Oct 2026, 12:23 UTC · SHA-256 f0a513edfb3306ee409044c6f60e135363aab1124966780ae69e0b80ecb19ef6
- Population
- Companies linked to an active Type II DMF in the FDA DMF list on 23 Oct 2026 (1,776 companies; 216 with linked enforcement), counted after the same-day repair of stored links.
- Method
- DMFs and enforcement events are linked to companies by exact organisation name. Counts are distinct companies.
- Limitations
- Depends on name links. Before the 23 Oct repair our review found 97.5% of DMF links and 92% of enforcement links pointed to the right legal entity; fresh samples after it found 60 of 60 for each (see methodology for the confidence bounds). Country is the company's recorded country, not the site's. The August 2026 edition counted 1,802 holders and 221 with enforcement.
- Licence
- Derived counts under CC BY 4.0 (credit “PharmaTek Intelligence”); FDA records are US public domain.
Columns
| Column | Meaning |
|---|---|
| company_hq_country | Country recorded for the company profile (often headquarters); a few malformed values were normalised (South to South Korea, USA to United States) |
| active_type_ii_dmf_holders | Companies linked to at least one active Type II DMF |
| holders_with_fda_enforcement | Of those, companies with at least one linked Form 483, Warning Letter or recall |
Query used for this release
with h as (
select distinct company_id from core2.drug_master_files
where dmf_type = 'II' and status = 'Active' and company_id is not null
), ev as (
select distinct r.company_id from core2.regulatory_events r join h using (company_id)
where r.event_type in ('483', 'warning_letter', 'recall')
)
select coalesce(nullif(c.country_hq, ''), 'Not recorded') as company_hq_country,
count(*) as active_type_ii_dmf_holders,
count(ev.company_id) as holders_with_fda_enforcement
from h join core2.companies c on c.id = h.company_id
left join ev on ev.company_id = h.company_id
group by 1 order by 2 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, 12:23 UTC | 48 | f0a513edfb3306ee… |
| 2026-10-23.1 | 23 Oct 2026, 02:35 UTC | 47 | b455c1bcafff63fc… |
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.
Cite as: PharmaTek Intelligence, “Active Type II DMF holders and FDA enforcement, by company country”, revision 2026-10-23.2 (SHA-256 f0a513edfb33), https://pharmatek.co.uk/data/dmf-holders-enforcement-by-country. See the methodology and corrections.