Kaneka
Takasago, Hyogo, Japan
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (4)
○ MHRA GMP
✓ HC GMP (1)
Quick Facts: Kaneka
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Takasago, Hyogo, Japan
- Website
- https://www.fcd.kaneka.co.jp/en/
- Modalities
- Small Molecule API, Intermediates
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Kaneka
Kaneka makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, Intermediates. 1 manufacturing site registered with the U.S. FDA. Website: https://www.fcd.kaneka.co.jp/en/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Kaneka FDA Inspection History
2024-02
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2024-02-26 |
Kaneka Eurogentec SA
Seraing
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Kaneka EMA GMP Compliance 4 certificates
2025-03
2024-02
2024-02
2024-02
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| BE/GMP/2025/009 | Kaneka Eurogentec | Belgium | 2025-03-13 | COMPLIANT |
| BE/GMP/2024/009 | Kaneka EurogentecAlternative Name:Kaneka Eurogentec S.A. | Belgium | 2024-02-26 | COMPLIANT |
| BE/GMP/2024/008 | Kaneka EurogentecAlternative Name:Kaneka Eurogentec S.A. | Belgium | 2024-02-26 | COMPLIANT |
| BE/GMP/2024/010 | Kaneka EurogentecAlternative Name:Kaneka Eurogentec S.A. | Belgium | 2024-02-26 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
Frequently Asked Questions About Kaneka
How many FDA inspections does Kaneka have on record?
CDMO Signal tracks 1 FDA inspection for Kaneka, sourced from the FDA inspection database. See the full inspection history above.
Has Kaneka received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Kaneka.
Does Kaneka hold EMA or MHRA GMP certificates?
CDMO Signal tracks 4 EMA GMP certificates for Kaneka.
Does Kaneka have a CDMO Signal Score?
Not yet. Kaneka is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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