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

Lactulose API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Danipharm A/S

Does Danipharm A/S hold a US DMF or a CEP?
Danipharm A/S holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Danipharm A/S FDA-registered?
One site operated by Danipharm A/S carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Danipharm A/S's last inspection go?
The most recent inspection on record closed on 1 October 2020 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Danipharm A/S manufacture?
1 registered site is on record, in Denmark (Denmark). Every site is listed on this page with the register it came from.
What does Danipharm A/S make?
1 molecule is on record against Danipharm A/S, including Lactulose. Each links through to that molecule's full manufacturer list.
Which regulators recognise Danipharm A/S's GMP?
Current GMP certificates are on record from EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 1 October 2020.

Comparable suppliers

Fresenius Kabi shares 1 molecule Inalco Sas Di Giovanni Cipolletti And C shares 1 molecule Lactose (India) shares 1 molecule Abbott Healthcare Products shares 1 molecule Baolingbao Biology shares 1 molecule

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates