Suppliers / Guna

Guna

Italy 93 employees Updated 9 July 2026

Guna is a finished-dose manufacturer based in Italy. It appears in 80 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), INVIMA (CO) and EDE (AE). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 16 May 2014 as OAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
80
filings across 3 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

  • 16 May 2014 OAI US FDA

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

Registered plants

Site FDA FEI
Milano, United Arab Emirates Not on file
MILANO, Italy Not on file
Milan, Italy Not on file
Italy, Italy 3004443273

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 60 None
INVIMA (CO) 19 None
EDE (AE) 1 None
EMA None 1

Questions about Guna

Does Guna hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Guna. It does have 80 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Guna FDA-registered?
One site operated by Guna 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 Guna's last inspection go?
The most recent inspection on record closed on 16 May 2014 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 1 inspection is on file, of which 1 closed as OAI.
Where does Guna manufacture?
4 registered sites are on record, in United Arab Emirates and Italy (Milano, Milano and Milan among others). Every site is listed on this page with the register it came from.
Which regulators recognise Guna'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 OAI, on 16 May 2014.

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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