Suppliers / Bracco Imaging

Bracco Imaging

Italy 232 employees Updated 9 July 2026

Bracco Imaging is an API and finished-dose manufacturer based in Italy. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with AIFA (IT), FAMHP (BE) and NMPA (CN). Its GMP standing is certified by EMA, MFDS (Korea) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 24 March 2023 as VAI.

1
active US DMFs
1
valid CEPs
7
registered plants 2 with an FDA FEI number
344
filings across 14 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
4 of 4 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

  • 24 March 2023 VAI US FDA
  • 28 October 2022 VAI US FDA
  • 15 December 2017 VAI US FDA
  • 6 May 2016 NAI US FDA

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

Registered plants

Site FDA FEI
Milano, United Arab Emirates Not on file
Milano, Italy Not on file
COLLERETTO GIACOSA, Italy Not on file
CERIANO LAGHETTO, Italy Not on file
COLLERETTO GIACOSA (TO), Italy Not on file
Italy, Italy 3005604782

1 further sites are on record.

What they file, and where

Molecule Regulators Docs
Iopamidol US FDA 1
Levothyroxine Sodium EDQM 1

Also appears on these molecule pages

Iodixanol finished dose Iohexol finished dose Iopamidol API Iopromide finished dose Levothyroxine API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 106 None
FAMHP (BE) 57 None
NMPA (CN) 43 None
EMA 33 2
Health Canada 26 None
DKMA (DK) 22 None
MFDS (Korea) None 2
ANVISA (Brazil) None 1

Questions about Bracco Imaging

Does Bracco Imaging hold a US DMF or a CEP?
Bracco Imaging holds 1 active US drug master file and 1 valid CEP. 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 Bracco Imaging FDA-registered?
2 sites operated by Bracco Imaging 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 Bracco Imaging's last inspection go?
The most recent inspection on record closed on 24 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Bracco Imaging manufacture?
7 registered sites are on record, in United Arab Emirates and Italy (Milano, Colleretto Giacosa and Ceriano Laghetto among others). Every site is listed on this page with the register it came from.
What does Bracco Imaging make?
2 molecules are on record against Bracco Imaging, including Iopamidol and Levothyroxine Sodium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bracco Imaging's GMP?
Current GMP certificates are on record from EMA, MFDS (Korea) and ANVISA (Brazil). 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 24 March 2023.

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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