Suppliers / Icrom

Icrom

Italy 107 employees 2 duplicate records merged Updated 9 July 2026

Icrom is a contract manufacturer based in Italy. It holds 11 active US drug master files and 10 valid CEPs across a filed portfolio of 13 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 28 February 2025 as VAI.

11
active US DMFs
10
valid CEPs
2
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 February 2025 VAI US FDA
  • 26 July 2019 VAI US FDA
  • 5 December 2014 VAI US FDA
  • 24 September 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Concorezzo, Italy Not on file
Italy, Italy 3007410503

What they file, and where

Molecule Regulators Docs
Amisulpride EDQM, US FDA 3
Fluorescein EDQM, US FDA 3
Minoxidil EDQM, SFDA (Saudi Arabia), US FDA 3
Methylene Blue EDQM, US FDA 2
Metoclopramide EDQM, US FDA 2
Risperidone EDQM, US FDA 2
Bepotastine US FDA 1
Brinzolamide US FDA 1
Diacerein EDQM 1
Epinastine US FDA 1
Show all 13 molecules on file
Indocyanine Green US FDA 1
Sulpiride EDQM 1
Tiapride EDQM 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 28 February 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates