Suppliers / Guerbet

Guerbet

France Updated 9 July 2026

Guerbet is a finished-dose manufacturer based in France. It appears in 544 regulatory filings across 23 regulators, without an active US DMF or CEP on file. Its filings concentrate with FAMHP (BE), AIFA (IT) and EMA. Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 21 January 2021 as VAI.

0
active US DMFs
0
valid CEPs
7
registered plants 1 with an FDA FEI number
544
filings across 23 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 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

  • 21 January 2021 VAI US FDA

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

Registered plants

Site FDA FEI
Aulnay-sous-bois, United Arab Emirates Not on file
Aulnay-Sous-Bois, United Arab Emirates Not on file
Zürich, Switzerland Not on file
AULNAY-SOUS-BOIS, France Not on file
France, France 3002807063
Aulnay Sous Bois, France Not on file

1 further sites are on record.

What they file, and where

Molecule Regulators Docs
Iobitridol SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Gadoteric Acid finished dose Iodixanol finished dose Iohexol finished dose Iopamidol finished dose Iopromide finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
FAMHP (BE) 113 None
AIFA (IT) 99 None
EMA 81 1
SWISSMEDIC (CH) 68 None
ANSM (FR) 21 17
MPA (SE) 21 None
ANVISA (Brazil) None 3
MFDS (Korea) None 2

Scale

Year Revenue Exports Destinations
2024 $910.3M 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 We do not publish the identity of any buyer.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 Guerbet

Does Guerbet hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Guerbet. It does have 544 filings with 23 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Guerbet FDA-registered?
One site operated by Guerbet 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 Guerbet's last inspection go?
The most recent inspection on record closed on 21 January 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Guerbet manufacture?
7 registered sites are on record, in United Arab Emirates, Switzerland and France (Aulnay-sous-bois, Aulnay-sous-bois and Zürich among others). Every site is listed on this page with the register it came from.
What does Guerbet make?
1 molecule is on record against Guerbet, including Iobitridol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Guerbet's GMP?
Current GMP certificates are on record from ANSM (FR), ANVISA (Brazil), MFDS (Korea) 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 21 January 2021.

Comparable suppliers

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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