Suppliers / Elanco US

Elanco US

United States 17 employees Updated 9 July 2026

Elanco US is a finished-dose manufacturer based in United States. It appears in 425 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with DKMA (DK), Health Canada and MPA (SE). Its GMP standing is certified by ANSM (FR) and EMA. Its most recent recorded inspection, by US FDA, closed on 14 June 2018 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
425
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 14 June 2018 VAI US FDA
  • 25 June 2015 VAI US FDA
  • 9 May 2013 VAI US FDA
  • 15 December 2011 NAI US FDA
  • 8 May 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Basel, Switzerland Not on file
France, France Not on file
Huningue, France Not on file
United Kingdom, United Kingdom 3003701830
Riyadh, Saudi Arabia Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
DKMA (DK) 131 None
Health Canada 129 None
MPA (SE) 106 None
NPRA (MY) 31 None
EMA 22 1
URPL (PL) 5 None
ANSM (FR) None 3

Scale

Year Revenue Exports Destinations
2024 $243.4M Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Elanco US

Does Elanco US hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Elanco US. It does have 425 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Elanco US FDA-registered?
One site operated by Elanco US 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 Elanco US's last inspection go?
The most recent inspection on record closed on 14 June 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Elanco US manufacture?
5 registered sites are on record, in Switzerland, France, United Kingdom and Saudi Arabia (Basel, France and Huningue among others). Every site is listed on this page with the register it came from.
Which regulators recognise Elanco US's GMP?
Current GMP certificates are on record from ANSM (FR) 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 14 June 2018.

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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
Company filings
Revenue as reported