Kaneka Eurogentec

Seraing, BE
No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07
80.3
Signal Score
○ FDA Inspections ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (4) ○ MHRA GMP

Quick Facts: Kaneka Eurogentec

Signal Score
80.3/100 (as of 2026-09-07)
Quality Compliance
100.0/100
Headquarters
Seraing, BE
Modalities
mRNA, Plasmid, Oligonucleotide
Active Programs
Data pending
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

About Kaneka Eurogentec

European mRNA/pDNA CDMO with GMP capabilities.

Signal Score & Pillar Breakdown

Scores are being republished. Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance 100.0
FDA InspectionsNo US records on file
EMA GMP Certificates4 on record
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs — no verified data
Sponsors— no verified data
ModalitiesmRNA, Plasmid, Oligonucleotide
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 68.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity 58.0
Profile-based capacity assessment

Kaneka Eurogentec 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 07, 2026

Frequently Asked Questions About Kaneka Eurogentec

Does Kaneka Eurogentec hold EMA or MHRA GMP certificates?
CDMO Signal tracks 4 EMA GMP certificates for Kaneka Eurogentec.
What is Kaneka Eurogentec's CDMO Signal Score?
Kaneka Eurogentec has a Signal Score of 80/100, based on quality, operations, financial stability, and capacity data.
Evaluating Kaneka Eurogentec for a manufacturing program?
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