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

Questions about Dompe Farmaceutici S P A

Does Dompe Farmaceutici S P A hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Dompe Farmaceutici S P A. It does have 283 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Dompe Farmaceutici S P A FDA-registered?
One site operated by Dompe Farmaceutici S P A 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 Dompe Farmaceutici S P A's last inspection go?
The most recent inspection on record closed on 20 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Dompe Farmaceutici S P A manufacture?
3 registered sites are on record, in United Arab Emirates and Italy (L'aquila (aq), L'aquila and Italy). Every site is listed on this page with the register it came from.
Which regulators recognise Dompe Farmaceutici S P A'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 20 September 2022.

Comparable suppliers

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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