Suppliers / Eli Lilly And

Eli Lilly And

United States LLY Updated 9 July 2026

Eli Lilly And is an API and finished-dose manufacturer based in United States. It holds 3 valid CEPs across a filed portfolio of 4 molecules. Its filings concentrate with Health Canada, AIFA (IT) and FAMHP (BE). Its GMP standing is certified by EMA, MFDS (Korea) and ZLG (DE), among 9 authorities. Its most recent recorded inspection, by US FDA, closed on 30 January 2026 as VAI.

0
active US DMFs
3
valid CEPs
12
registered plants 1 with an FDA FEI number
3,751
filings across 40 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 8 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

  • 30 January 2026 VAI US FDA
  • 9 January 2026 NAI US FDA
  • 20 May 2025 VAI US FDA
  • 27 March 2025 VAI US FDA
  • 15 January 2025 NAI US FDA
  • 14 February 2024 NAI US FDA
  • 15 September 2023 VAI US FDA
  • 24 May 2023 NAI US FDA

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

Registered plants

Site FDA FEI
Indianapolis, United Arab Emirates Not on file
Sesto Fiorentino, United Arab Emirates Not on file
Fegersheim, United Arab Emirates Not on file
Alcobendas, United Arab Emirates Not on file
Brussels, Belgium Not on file
Vernier, Switzerland Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Azaperone For Veterinary Use EDQM 1
Enilconazole For Veterinary Use EDQM 1
Gemcitabine EDQM 1
Olanzapine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Abemaciclib finished dose Atomoxetine finished dose Baricitinib finished dose Cefaclor finished dose Cefalotin finished dose Cefazolin finished dose Cefuroxime finished dose Cephalexin finished dose Dobutamine finished dose Duloxetine finished dose Erythromycin finished dose Estradiol finished dose
Show 21 more molecule pages
Fluoxetine finished dose Fosfomycin finished dose Gemcitabine API Heparin finished dose Imatinib finished dose Lasmiditan finished dose Nizatidine finished dose Nortriptyline finished dose Orforglipron finished dose Pemetrexed finished dose Pitavastatin finished dose Prasugrel finished dose Raloxifene finished dose Tadalafil finished dose Teriparatide finished dose Testosterone finished dose Tirzepatide finished dose Triptorelin finished dose Vancomycin finished dose Vincristine finished dose Olanzapine API

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 469 None
AIFA (IT) 423 None
FAMHP (BE) 369 None
EMA 341 10
INFARMED (PT) 215 None
DIGEMAPS (DO) 199 None
MFDS (Korea) None 6
ZLG (DE) None 6
ANSM (FR) None 5
NAFDAC (NG) None 5
US FDA None 4
ANVISA (Brazil) None 4
COFEPRIS (MX) None 2
EDA (EG) None 1

Scale

Year Revenue Exports Destinations
2025 $65.2B Not reported Not reported
2024 $45.0B Not reported Not reported
2023 $34.1B Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Eli Lilly And

Does Eli Lilly And hold a US DMF or a CEP?
Eli Lilly And holds 3 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Eli Lilly And FDA-registered?
One site operated by Eli Lilly And 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 Eli Lilly And's last inspection go?
The most recent inspection on record closed on 30 January 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Eli Lilly And manufacture?
12 registered sites are on record, in United Arab Emirates, Belgium, Switzerland and China (Indianapolis, Sesto Fiorentino and Fegersheim among others). Every site is listed on this page with the register it came from.
What does Eli Lilly And make?
4 molecules are on record against Eli Lilly And, including Azaperone For Veterinary Use, Enilconazole For Veterinary Use, Gemcitabine and Olanzapine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Eli Lilly And's GMP?
Current GMP certificates are on record from EMA, MFDS (Korea), ZLG (DE), ANSM (FR), NAFDAC (NG) and 4 more. 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

  • One recent serious compliance event is on record.
  • The most recent inspection outcome was VAI, on 30 January 2026.

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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
Company filings
Revenue as reported