IDT Biologika
Germany
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
✓ Press (4)
✓ EMA GMP (2)
○ MHRA GMP
✓ HC GMP (7)
Quick Facts: IDT Biologika
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Germany
- Website
- https://idt-biologika.de/
- Modalities
- Biologics, Cell & Gene Therapy, Sterile Fill-Finish
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About IDT Biologika
IDT Biologika is a contract development and manufacturing organization (CDMO). Capabilities: Biologics, Cell & Gene Therapy, Sterile Fill-Finish. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://idt-biologika.de/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
IDT Biologika FDA Inspection History
2023-09
2023-08
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2023-09-08 |
IDT Biologika GmbH
Dessau-Rosslau
Company-level
|
Vaccines and Allergenic Products | Yes | Voluntary Action Indicated (VAI) |
| 2023-08-25 |
IDT Biologika GmbH
Dessau-Rosslau
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
IDT Biologika FDA 483 Findings 5 observations · 2023-09-08 → 2023-09-08 ?
By subsystem
By severity
- 5 — Critical: 1
- 4 — Serious: 1
- 3 — Moderate: 1
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Backup data not assured as exact and complete
"Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems."
-
Environmental Monitoring System
"Aseptic processing areas are deficient regarding the system for monitoring environmental conditions."
-
Suitability of testing methods verified
"The suitability of all testing methods is not verified under actual conditions of use."
IDT Biologika EMA GMP Compliance 2 certificates
2024-09
2024-09
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_ST_01_GMP_2025_0004 | IDT Biologika GmbH | Germany | 2024-09-04 | COMPLIANT |
| DE_ST_01_GMP_2025_0005 | IDT Biologika GmbH | Germany | 2024-09-04 | 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
Company Signals 4 articles
Company announcements, not verified evidence. They do not change any score.
IDT Biologika Accelerates Global CDMO Expansion Manufacturing capabilities highlighted through consecutive participation in WVC, CPHI and BIO-Europe 2025 - PR Newswire
Takeda taps Biological E to ramp up Qdenga manufacturing capacity on quest to make 100M doses a year - Fierce Pharma
From the experts: How to successfully implement Annex 1 regulations - Pharmaceutical Technology
SK Bioscience begins 'globalization' push, paying $244M for majority stake in contract manufacturer IDT Biologika - Fierce Pharma
Frequently Asked Questions About IDT Biologika
How many FDA inspections does IDT Biologika have on record?
CDMO Signal tracks 2 FDA inspections for IDT Biologika, sourced from the FDA inspection database. See the full inspection history above.
Has IDT Biologika received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for IDT Biologika.
Does IDT Biologika hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 EMA GMP certificates for IDT Biologika.
Does IDT Biologika have a CDMO Signal Score?
Not yet. IDT Biologika is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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