Suppliers / Bioindustria Laboratorio Italiano Medicinali

Bioindustria Laboratorio Italiano Medicinali

Italy 71 employees Updated 9 July 2026

Bioindustria Laboratorio Italiano Medicinali is an API manufacturer based in Italy. It holds 4 active US drug master files and 2 valid CEPs across a filed portfolio of 5 molecules. Its filings concentrate with AIFA (IT), ANPP (DZ) and UZPHARM (UZ). Its most recent recorded inspection, by US FDA, closed on 24 February 2023 as VAI.

4
active US DMFs
2
valid CEPs
5
registered plants 2 with an FDA FEI number
306
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 24 February 2023 VAI US FDA
  • 1 April 2022 VAI US FDA
  • 21 June 2018 VAI US FDA
  • 15 June 2018 NAI US FDA
  • 10 March 2015 VAI US FDA
  • 18 September 2014 NAI US FDA
  • 25 June 2013 VAI US FDA
  • 7 April 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Novi Ligure, United Arab Emirates Not on file
FRESONARA, Italy Not on file
Novi Ligure, Italy Not on file
Italy, Italy 3002717526
Italy, Italy 3002806499

What they file, and where

Molecule Regulators Docs
Prazosin EDQM, US FDA 2
Hyaluronidase EDQM 1
Indapamide US FDA 1
Terazosin US FDA 1
Torasemide US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 291 None
ANPP (DZ) 4 None
UZPHARM (UZ) 4 None
NPRA (MY) 3 None
EDE (AE) 3 None
NCELS (KZ) 1 None

Comparing suppliers?

Choose your molecules and target markets. Bioindustria Laboratorio Italiano Medicinali comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 24 February 2023.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability