Biomay AG
Vienna, Austria
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
76.3
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (11)
○ MHRA GMP
Quick Facts: Biomay AG
- Signal Score
- 76.3/100 (as of 2026-09-07)
- Quality Compliance
- 98.9/100
- Headquarters
- Vienna, Austria
- Modalities
- Plasmid
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Biomay AG
Pure-play CDMO.
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
98.9
FDA InspectionsNo US records on file
EMA GMP Certificates11 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesPlasmid
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
60.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
53.0
Profile-based capacity assessment
Attribution not established
(2)
These records are excluded from this company’s established evidence
because their attribution is unresolved. This describes an evidence-linking
limitation, not an assessment of the underlying regulatory findings.
| Source | Establishment named by the regulator | Location | Identifier |
|---|---|---|---|
| FDA inspection | Biomat USA, Inc | Zanesville, Ohio | FDA/FEI=3024595229 |
| FDA inspection | Biomat USA Inc | Killeen, Texas | FDA/FEI=3022477122 |
Source records retained verbatim · attribution not established
Biomay AG EMA GMP Compliance 11 certificates
2026-02
2025-10
2024-03
2024-03
2024-03
2024-03
2024-03
2023-11
2023-10
2022-03
2022-03
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 481719-104874335 | Biomay AG | Austria | 2026-02-19 | COMPLIANT |
| 484219-103674986 | Biomay AG | Austria | 2025-10-16 | COMPLIANT |
| 481719-104568656 | Biomay AG | Austria | 2024-03-13 | COMPLIANT |
| 481719-103425951 | Biomay AG | Austria | 2024-03-13 | COMPLIANT |
| 481719-102752478 | Biomay AG | Austria | 2024-03-13 | COMPLIANT |
| 481719-104874230 | Biomay AG | Austria | 2024-03-13 | COMPLIANT |
| 481719-102570085 | Biomay AG | Austria | 2024-03-13 | COMPLIANT |
| 484219-101573243 | Biomay AG | Austria | 2023-11-23 | COMPLIANT |
| 481719-101983357 | Biomay AG | Austria | 2023-10-11 | COMPLIANT |
| 484219-100395448 | Biomay AG | Austria | 2022-03-17 | COMPLIANT |
| 484219-102096252 | Biomay AG | Austria | 2022-03-17 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 06, 2026
Frequently Asked Questions About Biomay AG
Does Biomay AG hold EMA or MHRA GMP certificates?
CDMO Signal tracks 11 EMA GMP certificates for Biomay AG.
What is Biomay AG's CDMO Signal Score?
Biomay AG has a Signal Score of 76/100, based on quality, operations, financial stability, and capacity data.
Evaluating Biomay AG for a manufacturing program?
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