Rommelag CDMO
Germany
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (4)
○ MHRA GMP
✓ HC GMP (3)
Quick Facts: Rommelag CDMO
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Germany
- Website
- https://www.rommelag.com/de/
- Modalities
- Sterile Fill-Finish
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Rommelag CDMO
Rommelag CDMO is a contract development and manufacturing organization (CDMO). Capabilities: Sterile Fill-Finish. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.rommelag.com/de/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Rommelag CDMO FDA Inspection History
2025-03
2022-04
2022-02
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-03-20 |
Rommelag CDMO GmbH
Sulzbach-Laufen
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-04-05 |
Rommelag CDMO GmbH
Sulzbach-Laufen
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-02-11 |
Rommelag CDMO Switzerland AG
Zell Lu
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Rommelag CDMO EMA GMP Compliance 4 certificates
2025-03
2025-03
2024-07
2024-07
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_BW_01_GMP_2025_0027 | Rommelag CDMO GmbH | Germany | 2025-03-20 | COMPLIANT |
| DE_BW_01_GMP_2025_0078 | Rommelag CDMO GmbH | Germany | 2025-03-20 | COMPLIANT |
| DE_BW_01_GMP_2025_0083 | Rommelag CDMO GmbH | Germany | 2024-07-04 | COMPLIANT |
| DE_BW_01_GMP_2025_0084 | Rommelag CDMO GmbH | Germany | 2024-07-04 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
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 30, 2026
Frequently Asked Questions About Rommelag CDMO
How many FDA inspections does Rommelag CDMO have on record?
CDMO Signal tracks 3 FDA inspections for Rommelag CDMO, sourced from the FDA inspection database. See the full inspection history above.
Has Rommelag CDMO received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Rommelag CDMO.
Does Rommelag CDMO hold EMA or MHRA GMP certificates?
CDMO Signal tracks 4 EMA GMP certificates for Rommelag CDMO.
Does Rommelag CDMO have a CDMO Signal Score?
Not yet. Rommelag CDMO is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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