Indena
Milan, Italy
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (1)
✓ EMA GMP (15)
○ MHRA GMP
✓ HC GMP (5)
Quick Facts: Indena
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Milan, Italy
- Website
- https://www.indena.com/
- Modalities
- Small Molecule API, High-Potency APIs, Microbial Fermentation
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Indena
Indena makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, High-Potency APIs, Microbial Fermentation. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.indena.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Indena FDA Inspection History
2021-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2021-11-26 |
Indena S.p.A.
Settala
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Indena EMA GMP Compliance 15 certificates
2025-10
2024-10
2023-10
2023-10
2023-07
2023-07
2023-07
2022-01
2022-01
2021-11
2018-11
2018-05
2018-02
2016-11
2016-11
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 25MPP060HFR01 | Indena | France | 2025-10-23 | COMPLIANT |
| IT/3/H/2025 | Indena S.p.A. | Italy | 2024-10-17 | COMPLIANT |
| IT-API/28/H/2025 | Indena S.p.A. | Italy | 2023-10-20 | COMPLIANT |
| IT-API/37/H/2024 | Indena S.p.A. | Italy | 2023-10-20 | COMPLIANT |
| IT-API/105/H/2025 | Indena S.p.A. | Italy | 2023-07-13 | COMPLIANT |
| IT-API/124/H/2024 | Indena S.p.A. | Italy | 2023-07-13 | COMPLIANT |
| IT-API/33/H/2025 | Indena S.p.A. | Italy | 2023-07-13 | COMPLIANT |
| 22MPP002HFR01 | Indena | France | 2022-01-13 | COMPLIANT |
| 22MPP002HFR02 | Indena | France | 2022-01-13 | COMPLIANT |
| IT-API/125/H/2022 | Indena S.p.A. | Italy | 2021-11-26 | COMPLIANT |
| NBF/52/2020/V | INDENA S.p.A. | Italy | 2018-11-27 | COMPLIANT |
| IT-API/220/H/2020 | INDENA S.P.A. | Italy | 2018-05-10 | COMPLIANT |
| 18MPP015HFR02 | INDENA SAS | France | 2018-02-15 | COMPLIANT |
| IT-API/178/H/2019 | INDENA S.P.A. | Italy | 2016-11-24 | COMPLIANT |
| IT-API/231/H/2018 | INDENA S.P.A. | Italy | 2016-11-24 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
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
Company Signals 1 articles
Company announcements, not verified evidence. They do not change any score.
Indena to showcase its integrated European platform for HPAPIs and complex molecules at CPHI Milan 2026 - Manufacturing Chemist
Indena to showcase its integrated European platform for HPAPIs and complex molecules at CPHI Milan 2026 Manufacturing Chemist
Frequently Asked Questions About Indena
How many FDA inspections does Indena have on record?
CDMO Signal tracks 1 FDA inspection for Indena, sourced from the FDA inspection database. See the full inspection history above.
Has Indena received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Indena.
Does Indena hold EMA or MHRA GMP certificates?
CDMO Signal tracks 15 EMA GMP certificates for Indena.
Does Indena have a CDMO Signal Score?
Not yet. Indena is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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