Suppliers / Bioindustria Laboratorio Italiano Medicinali

Bioindustria Laboratorio Italiano Medicinali

Italy 71 employees Updated 9 July 2026

Bioindustria Laboratorio Italiano Medicinali is an API and finished-dose 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

Amiodarone finished dose Indapamide API Methylene Blue finished dose Prazosin API Terazosin API Torasemide API Tranexamic Acid finished dose

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

Questions about Bioindustria Laboratorio Italiano Medicinali

Does Bioindustria Laboratorio Italiano Medicinali hold a US DMF or a CEP?
Bioindustria Laboratorio Italiano Medicinali holds 4 active US drug master files and 2 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 Bioindustria Laboratorio Italiano Medicinali FDA-registered?
2 sites operated by Bioindustria Laboratorio Italiano Medicinali 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 Bioindustria Laboratorio Italiano Medicinali's last inspection go?
The most recent inspection on record closed on 24 February 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Bioindustria Laboratorio Italiano Medicinali manufacture?
5 registered sites are on record, in United Arab Emirates and Italy (Novi Ligure, Fresonara and Italy among others). Every site is listed on this page with the register it came from.
What does Bioindustria Laboratorio Italiano Medicinali make?
5 molecules are on record against Bioindustria Laboratorio Italiano Medicinali, including Prazosin, Hyaluronidase, Indapamide and Terazosin. Each links through to that molecule's full manufacturer list.
Where does Bioindustria Laboratorio Italiano Medicinali file?
Filings are on record with AIFA (IT), ANPP (DZ), UZPHARM (UZ), NPRA (MY) and 2 other regulators, 306 in total.

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 February 2023.

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Sources on this page

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