Eli Lilly Italia
Italy Updated 9 July 2026
Eli Lilly Italia is a finished-dose manufacturer based in Italy. It appears in 7 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and MEDSAFE (NZ). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 24 May 2023 as NAI.
3
registered plants
2 with an FDA FEI number
7
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 24 May 2023 NAI US FDA
- 4 April 2023 VAI US FDA
- 15 March 2022 NAI US FDA
- 17 January 2020 VAI US FDA
- 23 February 2018 NAI US FDA
- 17 June 2016 NAI US FDA
- 10 November 2011 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Ireland, Ireland | 3002806888 |
| SESTO FIORENTINO, Italy | Not on file |
| Italy, Italy | 3002806895 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 6 | 1 |
| MEDSAFE (NZ) | 1 | None |
| ANVISA (Brazil) | None | 1 |
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Open risk flags
- 1 active litigation matter is on record.
- The most recent inspection outcome was NAI, on 24 May 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates