Suppliers / Dompe Farmaceutici S P A

Dompe Farmaceutici S P A

Italy 2 duplicate records merged Updated 9 July 2026

Dompe Farmaceutici S P A is a finished-dose manufacturer based in Italy. It appears in 283 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and INFARMED (PT). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 20 September 2022 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
283
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 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

  • 20 September 2022 VAI US FDA
  • 30 January 2020 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
L'AQUILA (AQ), United Arab Emirates Not on file
L'AQUILA, Italy Not on file
Italy, Italy 3004216297

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 225 None
EMA 40 2
INFARMED (PT) 8 None
AEMPS (ES) 5 None
MPA (SE) 3 None
FAMHP (BE) 1 None

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Open risk flags

  • The most recent inspection outcome was VAI, on 20 September 2022.

Sources on this page

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