Suppliers / ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI

ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI

Italy Updated 9 July 2026

ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI is an API and finished-dose manufacturer based in Italy. It holds 3 active US drug master files and 2 valid CEPs across a filed portfolio of 4 molecules. Its filings concentrate with AIFA (IT) and FAMHP (BE). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 21 November 2024 as VAI.

3
active US DMFs
2
valid CEPs
3
registered plants 1 with an FDA FEI number
60
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 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

  • 21 November 2024 VAI US FDA
  • 19 September 2023 VAI US FDA
  • 21 February 2020 VAI US FDA
  • 17 July 2018 VAI US FDA
  • 4 July 2017 OAI US FDA
  • 3 March 2015 VAI US FDA
  • 5 October 2012 VAI US FDA
  • 30 October 2009 VAI US FDA

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

Registered plants

Site FDA FEI
APRILIA (LT), Italy Not on file
Italy, Italy 3002807242
Aprilia, Italy Not on file

What they file, and where

Molecule Regulators Docs
Piperacillin Sodium EDQM 2
Ampicillin US FDA 1
Oxacillin US FDA 1
Sulbactam US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 57 None
FAMHP (BE) 3 None
EMA None 5
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 21 November 2024.

Sources on this page

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