Suppliers / ICE

ICE

Italy Updated 9 July 2026

ICE is an API manufacturer based in Italy. It holds 3 active US drug master files and 10 valid CEPs across a filed portfolio of 6 molecules. Its filings concentrate with AIFA (IT) and RCETH (BY). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 2 December 2022 as VAI.

3
active US DMFs
10
valid CEPs
6
registered plants 1 with an FDA FEI number
198
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 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

  • 2 December 2022 VAI US FDA
  • 8 November 2018 VAI US FDA
  • 7 February 2014 NAI US FDA
  • 16 December 2010 NAI US FDA

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

Registered plants

Site FDA FEI
REGGIO NELL'EMILIA, Italy Not on file
BASALUZZO, Italy Not on file
Reggio Emilia, Italy Not on file
Basaluzzo, Alessandria, Italy Not on file
Italy, Italy 3003744137
Ivrea, Italy Not on file

What they file, and where

Molecule Regulators Docs
Ursodeoxycholic Acid EDQM, SFDA (Saudi Arabia), US FDA 7
Chenodeoxycholic Acid EDQM, US FDA 2
Cholic Acid EDQM 2
Deoxycholic Acid EDQM 1
Deoxycholic Acid And Its Derivatives EDQM 1
Tauroursodeoxycholic Acid US FDA 1

Also appears on these molecule pages

Cholic Acid API Ursodeoxycholic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 197 None
RCETH (BY) 1 None
EMA None 1

Questions about ICE

Does ICE hold a US DMF or a CEP?
ICE holds 3 active US drug master files and 10 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 ICE FDA-registered?
One site operated by ICE 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 ICE's last inspection go?
The most recent inspection on record closed on 2 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does ICE manufacture?
6 registered sites are on record, in Italy (Reggio Nell'emilia, Basaluzzo and Reggio Emilia among others). Every site is listed on this page with the register it came from.
What does ICE make?
6 molecules are on record against ICE, including Ursodeoxycholic Acid, Chenodeoxycholic Acid, Cholic Acid and Deoxycholic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise ICE's GMP?
Current GMP certificates are on record from 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 2 December 2022.

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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