Suppliers / Istituto Biochimico Italiano Giovanni Lorenzini

Istituto Biochimico Italiano Giovanni Lorenzini

Italy Updated 9 July 2026

ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI is an API 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

Ampicillin API Oxacillin API Piperacillin API Sulbactam API

Filings and GMP by regulator

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

Questions about Istituto Biochimico Italiano Giovanni Lorenzini

Does Istituto Biochimico Italiano Giovanni Lorenzini hold a US DMF or a CEP?
Istituto Biochimico Italiano Giovanni Lorenzini holds 3 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 Istituto Biochimico Italiano Giovanni Lorenzini FDA-registered?
One site operated by Istituto Biochimico Italiano Giovanni Lorenzini 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 Istituto Biochimico Italiano Giovanni Lorenzini's last inspection go?
The most recent inspection on record closed on 21 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Istituto Biochimico Italiano Giovanni Lorenzini manufacture?
3 registered sites are on record, in Italy (Aprilia (lt), Italy and Aprilia). Every site is listed on this page with the register it came from.
What does Istituto Biochimico Italiano Giovanni Lorenzini make?
4 molecules are on record against Istituto Biochimico Italiano Giovanni Lorenzini, including Piperacillin Sodium, Ampicillin, Oxacillin and Sulbactam. Each links through to that molecule's full manufacturer list.
Which regulators recognise Istituto Biochimico Italiano Giovanni Lorenzini's GMP?
Current GMP certificates are on record from EMA and US FDA. 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.

Comparing suppliers?

Choose your molecules and target markets. Istituto Biochimico Italiano Giovanni Lorenzini 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 21 November 2024.

Comparable suppliers

Apitoria Pharma shares 4 molecules Acs Dobfar shares 3 molecules Inner Mongolia Changsheng Pharmaceutical shares 3 molecules Imexpharm shares 3 molecules Fresenius Kabi shares 2 molecules

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