Danipharm A/S
Denmark Updated 9 July 2026
Danipharm A/S is an API manufacturer based in Denmark. It holds one active US drug master file. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 1 October 2020 as VAI.
1
registered plants
1 with an FDA FEI number
0
filings
across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
- 1 October 2020 VAI US FDA
- 4 March 2015 VAI US FDA
- 8 July 2011 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Denmark, Denmark | 3002806781 |
What they file, and where
| Molecule | Regulators | Docs |
| Lactulose | SFDA (Saudi Arabia), US FDA | 2 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| EMA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 1 October 2020.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates