Biomay AG
Vienna, Austria
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
73.3
Signal Score
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (11)
○ MHRA GMP
Quick Facts: Biomay AG
- Signal Score
- 73.3/100 (as of 2026-04-29)
- Quality Compliance
- 92.6/100
- Headquarters
- Vienna, Austria
- Modalities
- Plasmid
- 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
About Biomay AG
Pure-play CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
92.6
FDA Inspections2 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-12-09)
EMA GMP Certificates11 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesPlasmid
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
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity
53.0
1 manufacturing site: Vienna, AT
Modalities: Plasmid
Capacity assessment: 53.0/100
Sites: Vienna, AT
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
1 manufacturing site: Vienna, AT
Modalities: Plasmid
Capacity assessment: 53.0/100
Biomay AG FDA Inspection History
2025-12
2025-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-12-09 | Zanesville, Ohio | Blood and Blood Products | Yes | Voluntary Action Indicated (VAI) |
| 2025-11-06 | Killeen, Texas | Blood and Blood Products | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Jul 04, 2026
Biomay AG FDA 483 Findings 5 observations · 2025-11-06 → 2025-12-09 ?
By subsystem
By severity
- 3 — Moderate: 2
- 2 — Minor: 3
- Repeat observations: 0
Most severe findings
-
Following manufacturer's instructions
"Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer."
-
Thorough investigations
"Failure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy."
-
Separation
"Failure to ensure that where the method of separation of the plasma intended for injectable products involves a system in which an airway must be inserted into the plasma container, the airway is sterile."
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 Jul 04, 2026
Frequently Asked Questions About Biomay AG
How many FDA inspections does Biomay AG have on record?
CDMO Signal tracks 2 FDA inspections for Biomay AG, sourced from the FDA inspection database. See the full inspection history above.
Has Biomay AG received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for 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 73/100, based on quality, operations, financial stability, and capacity data.
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