Suppliers / Combino Pharm Malta

Combino Pharm Malta

Malta 2 duplicate records merged Updated 9 July 2026

Combino Pharm Malta is a finished-dose manufacturer based in Malta. It appears in 22 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with INFARMED (PT), ARCSA (EC) and MPA (SE). Its GMP standing is certified by EAEU_EEC and EMA. Its most recent recorded inspection, by US FDA, closed on 10 March 2022 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
22
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

  • 10 March 2022 VAI US FDA
  • 17 July 2019 VAI US FDA

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

Registered plants

Site FDA FEI
BIRZEBBUGIA, Malta Not on file
Malta, Malta 3009883315
Birzebbuga, Malta Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
INFARMED (PT) 11 None
ARCSA (EC) 3 None
MPA (SE) 2 None
UZPHARM (UZ) 2 None
MINSA (CR) 2 None
AEMPS (ES) 1 None
EAEU_EEC None 1
EMA None 1

Questions about Combino Pharm Malta

Does Combino Pharm Malta hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Combino Pharm Malta. It does have 22 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Combino Pharm Malta FDA-registered?
One site operated by Combino Pharm Malta 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 Combino Pharm Malta's last inspection go?
The most recent inspection on record closed on 10 March 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Combino Pharm Malta manufacture?
3 registered sites are on record, in Malta (Birzebbugia, Malta and Birzebbuga). Every site is listed on this page with the register it came from.
Which regulators recognise Combino Pharm Malta's GMP?
Current GMP certificates are on record from EEC (Eurasian Economic Union) and 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 10 March 2022.

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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