Suppliers / Fidia Farmaceutici

Fidia Farmaceutici

Italy Updated 9 July 2026

Fidia Farmaceutici is an API and finished-dose manufacturer based in Italy. It holds 7 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with AIFA (IT), EMA and AEMPS (ES). Its GMP standing is certified by EMA, ANVISA (Brazil) and EAEU_EEC. Its most recent recorded inspection, by US FDA, closed on 2 July 2009 as VAI.

0
active US DMFs
7
valid CEPs
11
registered plants 1 with an FDA FEI number
267
filings across 19 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

  • 2 July 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Abano Terme (Padua), United Arab Emirates Not on file
Padova, United Arab Emirates Not on file
20037, United Arab Emirates Not on file
ABANO TERME, Italy Not on file
- DIVISIONE SOLMAG Abano Terme, Italy Not on file
NOTO, Italy Not on file

5 further sites are on record.

What they file, and where

Molecule Regulators Docs
Sodium Hyaluronate EDQM 7
Tretinoin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Apixaban finished dose Brimonidine finished dose Clavulanic Acid finished dose Clomifene finished dose Cyproterone finished dose Dorzolamide finished dose Ezetimibe finished dose Flunarizine finished dose Hyaluronic Acid finished dose Isotretinoin finished dose Methylprednisolone finished dose Silver Sulfadiazine finished dose
Show 4 more molecule pages
Travoprost finished dose Tretinoin API Triamcinolone finished dose Triamcinolone Acetonide finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 153 None
EMA 39 3
AEMPS (ES) 19 None
EDE (AE) 14 None
DPM (TN) 10 None
SFDA (Saudi Arabia) 6 None
ANVISA (Brazil) None 3
EAEU_EEC None 1

Questions about Fidia Farmaceutici

Does Fidia Farmaceutici hold a US DMF or a CEP?
Fidia Farmaceutici holds 7 valid CEPs. 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 Fidia Farmaceutici FDA-registered?
One site operated by Fidia 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 Fidia Farmaceutici's last inspection go?
The most recent inspection on record closed on 2 July 2009 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Fidia Farmaceutici manufacture?
11 registered sites are on record, in United Arab Emirates and Italy (Abano Terme (padua), Padova and 20037 among others). Every site is listed on this page with the register it came from.
What does Fidia Farmaceutici make?
2 molecules are on record against Fidia Farmaceutici, including Sodium Hyaluronate and Tretinoin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fidia Farmaceutici's GMP?
Current GMP certificates are on record from EMA, ANVISA (Brazil) and EEC (Eurasian Economic Union). 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 2 July 2009.

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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