KELIX bio Malta
Malta 70 employees Updated 9 July 2026
KELIX bio Malta is a finished-dose manufacturer based in Malta. It appears in 18 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA and EDE (AE). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 16 December 2022 as VAI.
3
registered plants
1 with an FDA FEI number
18
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
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 December 2022 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Birzebbuga BBG3000, United Arab Emirates | Not on file |
| Birzebbuga, Malta | Not on file |
| Malta, Malta | 3013541978 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| EMA | 11 | 1 |
| EDE (AE) | 7 | None |
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Open risk flags
- The most recent inspection outcome was VAI, on 16 December 2022.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates