Fresenius Kabi
Bad Homburg, Germany
Program data pending ClinicalTrials.gov matching
78.1
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (7)
○ EMA GMP
○ MHRA GMP
Quick Facts: Fresenius Kabi
- Signal Score
- 78.1/100
- Quality Compliance
- 98.8/100
- Headquarters
- Bad Homburg, Germany
- Modalities
- Biologics (Sterile Injectables), Monoclonal Antibody, Biosimilars, Small Molecule API, HPAPI / Oncology Injectables, mRNA, Cell Therapy (equipment/processing platform), Sterile Fill-Finish, Compounding (outsourcing facility)
- 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 Fresenius Kabi
Auto-created by AI matchmaker. Data verification pending.
Signal Score & Pillar Breakdown
Quality Compliance
98.8
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-01-24)
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesBiologics (Sterile Injectables), Monoclonal Antibody, Biosimilars, Small Molecule API, HPAPI / Oncology Injectables, mRNA, Cell Therapy (equipment/processing platform), Sterile Fill-Finish, Compounding (outsourcing facility)
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
60.0
Broad modality coverage (9 modalities)
Source: SEC EDGAR, press monitoring, company profiles
Profile-based capacity assessment
Recent Press7 articles
Broad modality coverage (9 modalities)
Fresenius Kabi FDA Inspection History
2025-01
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-01-24 | Uppsala | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Sep 01, 2026
Recent News 7 articles
Fresenius Kabi & TQ Therapeutics join forces to accelerate cell & gene therapy manufacturing - Indian Pharma Post
Fresenius Kabi, TQ Therapeutics Announce Cell Therapy Technology Agreement - Business Wire
Faster to the bedside: Collaboration in cell therapy of Fresenius Kabi and TQ Therapeutics - European Biotechnology Magazine
Fresenius debuts European consortium to pursue bedside CAR-T production - Fierce Pharma
Cellular Origins, Fresenius Kabi Tout Automation Milestone in Scaling CGT Manufacturing - Contract Pharma
Fresenius Kabi and Cellular Origins link for CGT manufacture - Pharmaceutical Technology
Milestone Reached in Cell and Gene Therapy Robotic Automation and Manufacturing Collaboration - Genetic Engineering and Biotechnology News
Frequently Asked Questions About Fresenius Kabi
How many FDA inspections does Fresenius Kabi have on record?
CDMO Signal tracks 1 FDA inspection for Fresenius Kabi, sourced from the FDA inspection database. See the full inspection history above.
Has Fresenius Kabi received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Fresenius Kabi.
What is Fresenius Kabi's CDMO Signal Score?
Fresenius Kabi has a Signal Score of 78/100, based on quality, operations, financial stability, and capacity data.
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