Rentschler Biopharma
Laupheim, Germany
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
77.9
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (4)
✓ EMA GMP (2)
○ MHRA GMP
Quick Facts: Rentschler Biopharma
- Signal Score
- 77.9/100 (as of 2026-09-07)
- Quality Compliance
- 99.6/100
- Headquarters
- Laupheim, Germany
- Website
- https://rentschler-biopharma.com
- Modalities
- Monoclonal Antibody, Recombinant Protein
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Rentschler Biopharma
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
99.6
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-01-17)
EMA GMP Certificates2 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesMonoclonal Antibody, Recombinant Protein
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
58.0
Profile-based capacity assessment
Recent Press4 articles
Rentschler Biopharma FDA Inspection History
2025-01
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-01-17 |
Rentschler Biopharma Inc.
Milford, Massachusetts
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 07, 2026
Rentschler Biopharma EMA GMP Compliance 2 certificates
2026-02
2023-05
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_BW_01_GMP_2026_0092 | Rentschler Biopharma SE | Germany | 2026-02-05 | COMPLIANT |
| DE_BW_01_GMP_2025_0209 | Rentschler Biopharma SE | Germany | 2023-05-05 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 07, 2026
Recent News 4 articles
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion - Manufacturing Digital Magazine
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion Manufacturing Digital Magazine
Rentschler Biopharma Advances Milford Site Expansion - Contract Pharma
Rentschler Biopharma Advances Milford Site Expansion Contract Pharma
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion - GlobeNewswire
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion GlobeNewswire
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion - GlobeNewswire
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion GlobeNewswire
Frequently Asked Questions About Rentschler Biopharma
How many FDA inspections does Rentschler Biopharma have on record?
CDMO Signal tracks 1 FDA inspection for Rentschler Biopharma, sourced from the FDA inspection database. See the full inspection history above.
Has Rentschler Biopharma received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Rentschler Biopharma.
Does Rentschler Biopharma hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 EMA GMP certificates for Rentschler Biopharma.
What is Rentschler Biopharma's CDMO Signal Score?
Rentschler Biopharma has a Signal Score of 78/100, based on quality, operations, financial stability, and capacity data.
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