Wacker Biotech
Jena, DE · Amsterdam, NL · San Diego, CA
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-02
81.6
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (13)
○ MHRA GMP
Quick Facts: Wacker Biotech
- Signal Score
- 81.6/100 (as of 2026-04-02)
- Quality Compliance
- 100.0/100 — No FDA inspection records found for this manufacturer
- Headquarters
- Jena, DE · Amsterdam, NL · San Diego, CA
- Modalities
- mRNA, Plasmid, Biologics
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
Signal Score & Pillar Breakdown
Quality Compliance
100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
EMA GMP Certificates13 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesmRNA, Plasmid, Biologics
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
68.0
Parent company: Wacker Chemie AG (WCH.DE)
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Wacker Chemie AG (WCH.DE)
Financial assessment: 68.0/100
Capacity
63.0
3 manufacturing sites
Sites: Jena, Germany, Amsterdam, Netherlands, San Diego, CA
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
3 manufacturing sites
EMA GMP Compliance 13 certificates
2025-11
2025-11
2025-11
2025-11
2025-11
2025-11
2025-06
2025-01
2025-01
2025-01
2024-09
2024-09
2024-09
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_SN_01_GMP_2025_0064 | Wacker Chemie AG | Germany | 2025-11-04 | COMPLIANT |
| DE_SN_01_GMP_2025_0066 | Wacker Chemie AG | Germany | 2025-11-04 | COMPLIANT |
| DE_SN_01_GMP_2025_0063 | Wacker Chemie AG | Germany | 2025-11-04 | COMPLIANT |
| DE_SN_01_GMP_2025_0062 | Wacker Chemie AG | Germany | 2025-11-04 | COMPLIANT |
| DE_SN_01_GMP_2025_0067 | Wacker Chemie AG | Germany | 2025-11-04 | COMPLIANT |
| DE_SN_01_GMP_2025_0065 | Wacker Chemie AG | Germany | 2025-11-04 | COMPLIANT |
| DE_TH_01H_GMP_2025_0038 | Wacker Biotech GmbH | Germany | 2025-06-05 | COMPLIANT |
| NL/API 25/2054513 | Wacker Biotech B.V. | Netherlands | 2025-01-16 | COMPLIANT |
| NL/H 25/2054513B2 | Wacker Biotech B.V. | Netherlands | 2025-01-16 | COMPLIANT |
| NL/H 25/2054513 | Wacker Biotech B.V. | Netherlands | 2025-01-16 | COMPLIANT |
| DE_ST_01_GMP_2025_0017 | Wacker Biotech GmbH | Germany | 2024-09-18 | COMPLIANT |
| DE_ST_01_GMP_2025_0018 | Wacker Biotech GmbH | Germany | 2024-09-18 | COMPLIANT |
| DE_ST_01_GMP_2025_0019 | Wacker Biotech GmbH | Germany | 2024-09-18 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Apr 05, 2026
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