Suppliers / Eli Lilly Italia

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 ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 24 May 2023 as NAI.

0
active US DMFs
0
valid CEPs
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
Plants
2 of 2 confirmed
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

Questions about Eli Lilly Italia

Does Eli Lilly Italia hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Eli Lilly Italia. It does have 7 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Eli Lilly Italia FDA-registered?
2 sites operated by Eli Lilly Italia carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Eli Lilly Italia's last inspection go?
The most recent inspection on record closed on 24 May 2023 as NAI (No Action Indicated: nothing objectionable was found). 7 inspections are on file.
Where does Eli Lilly Italia manufacture?
3 registered sites are on record, in Ireland and Italy (Ireland, Sesto Fiorentino and Italy). Every site is listed on this page with the register it came from.
Which regulators recognise Eli Lilly Italia's GMP?
Current GMP certificates are on record from ANVISA (Brazil) and US FDA. 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was NAI, on 24 May 2023.

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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