GH Genhelix (mAbxience)
Spain
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 (3)
○ MHRA GMP
✓ HC GMP (4)
Quick Facts: GH Genhelix (mAbxience)
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Spain
- Website
- https://mabxience.com/
- Modalities
- Biologics
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About GH Genhelix (mAbxience)
GH Genhelix (mAbxience) makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Biologics. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://mabxience.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
GH Genhelix (mAbxience) FDA Inspection History
2022-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2022-10-26 |
GH Genhelix S.A.
Leon
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Nov 01, 2026
GH Genhelix (mAbxience) EMA GMP Compliance 3 certificates
2025-09
2025-09
2022-10
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 2468/25 | Gh Genhelix S.A. | Spain | 2025-09-25 | COMPLIANT |
| 6532/25 | Gh Genhelix S.A. | Spain | 2025-09-25 | COMPLIANT |
| 6532/22 | Gh Genhelix S.A. | Spain | 2022-10-26 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Nov 01, 2026
Japan-accredited overseas site (PMDA)
biologics · 1 site
- Leon, Spain · GH Genhelix S.A. — biologics · valid to Sep 23, 2030
PMDA accreditation of a foreign manufacturing site is recognition within Japan's regulatory system, not an inspection outcome. PMDA's list covers only manufacturing sites outside Japan, so a company's plants in Japan are not on it. Source: PMDA, list of accredited/registered foreign manufacturers (as of Oct 16, 2026), Public Data License 1.0 (terms)
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 31, 2026
Frequently Asked Questions About GH Genhelix (mAbxience)
How many FDA inspections does GH Genhelix (mAbxience) have on record?
CDMO Signal tracks 1 FDA inspection for GH Genhelix (mAbxience), sourced from the FDA inspection database. See the full inspection history above.
Has GH Genhelix (mAbxience) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for GH Genhelix (mAbxience).
Does GH Genhelix (mAbxience) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 3 EMA GMP certificates for GH Genhelix (mAbxience).
Does GH Genhelix (mAbxience) have a CDMO Signal Score?
Not yet. GH Genhelix (mAbxience) is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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