Suppliers / Farmila-Thea Farmaceutici

Farmila-Thea Farmaceutici

Italy Updated 9 July 2026

Farmila-Thea Farmaceutici is a finished-dose manufacturer based in Italy. It appears in 5 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE) and UZPHARM (UZ). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 27 January 2023 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
5
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 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

  • 27 January 2023 VAI US FDA

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

Registered plants

Site FDA FEI
Settimo Milanese (MI), United Arab Emirates Not on file
SETTIMO MILANESE, Italy Not on file
Settimo Milanese, Italy Not on file
Italy, Italy 3004438462

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 4 None
UZPHARM (UZ) 1 None
EMA None 1

Questions about Farmila-Thea Farmaceutici

Does Farmila-Thea Farmaceutici hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Farmila-Thea Farmaceutici. It does have 5 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Farmila-Thea Farmaceutici FDA-registered?
One site operated by Farmila-Thea Farmaceutici 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 Farmila-Thea Farmaceutici's last inspection go?
The most recent inspection on record closed on 27 January 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Farmila-Thea Farmaceutici manufacture?
4 registered sites are on record, in United Arab Emirates and Italy (Settimo Milanese (mi), Settimo Milanese and Settimo Milanese among others). Every site is listed on this page with the register it came from.
Which regulators recognise Farmila-Thea Farmaceutici'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 27 January 2023.

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Sources on this page

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