Suppliers / Danipharm A/S

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
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
EU GMP
1 of 1 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