IBI Lorenzini

Aprilia, Latina, Italy
Hybrid — also manufactures internal programs
Sterile Injectables Lyophilization Biologics Oral Solid Dose Topicals Clinical Trial Manufacturing
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP ✓ HC GMP (8)

Quick Facts: IBI Lorenzini

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Aprilia, Latina, Italy
Website
Modalities
Sterile Injectables, Lyophilization, Biologics, Oral Solid Dose, Topicals, Clinical Trial Manufacturing
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About IBI Lorenzini

IBI Lorenzini makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Sterile Injectables, Lyophilization, Biologics, Oral Solid Dose, Topicals, Clinical Trial Manufacturing. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.ibi-lorenzini.it/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

IBI Lorenzini FDA Inspection History

2024-11
2023-09
NAI VAI OAI
Date Site Type Observations Classification
2024-11-21
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
Aprilia Company-level
Bioresearch Monitoring Yes Voluntary Action Indicated (VAI)
2023-09-19
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
Aprilia Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

IBI Lorenzini FDA 483 Findings 1 observations · 2024-11-21 → 2024-11-21 ?

By subsystem

  • Other 1 (100.0%)

By severity

  • 2 — Minor: 1
  • Repeat observations: 0

Most severe findings

  • Minor (2) Other 2024-11-21 21 CFR 314.81(b)(2)
    Timely submission

    "An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application."

Hiring Activity Beta

Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source: public careers pages · Checked Oct 30, 2026

Frequently Asked Questions About IBI Lorenzini

How many FDA inspections does IBI Lorenzini have on record?
CDMO Signal tracks 2 FDA inspections for IBI Lorenzini, sourced from the FDA inspection database. See the full inspection history above.
Has IBI Lorenzini received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for IBI Lorenzini.
Does IBI Lorenzini have a CDMO Signal Score?
Not yet. IBI Lorenzini is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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