Laboratoire Unither
France
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (4)
✓ MHRA GMP (1)
✓ HC GMP (15)
Quick Facts: Laboratoire Unither
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- France
- Website
- https://www.unither-pharma.com/
- Modalities
- Sterile Fill-Finish, Semi-solids & Liquids, Oral Solid Dose
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Laboratoire Unither
Laboratoire Unither is a contract development and manufacturing organization (CDMO). Capabilities: Sterile Fill-Finish, Semi-solids & Liquids, Oral Solid Dose. 3 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.unither-pharma.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Laboratoire Unither FDA Inspection History
2021-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2021-10-22 |
Laboratoire Unither
Coutances
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Laboratoire Unither EMA GMP Compliance 4 certificates
2023-12
2023-12
2023-12
2023-12
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 2024_HPF_FR_044 | Laboratoire Unither | France | 2023-12-15 | COMPLIANT |
| 2024_HPF_FR_045 | Laboratoire Unither | France | 2023-12-15 | COMPLIANT |
| 2024_HPF_FR_098 | Laboratoire Unither | France | 2023-12-15 | COMPLIANT |
| 2024_HPF_FR_099 | Laboratoire Unither | France | 2023-12-15 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
Laboratoire Unither MHRA GMP Compliance 1 certificates
2015-12
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 45897 Insp GMP 45897/39893-0005[H] | UNITHER MANUFACTURING LLC | 14623 | 2015-12-14 | COMPLIANT |
Source: MHRA GMDP Database · 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 Laboratoire Unither
How many FDA inspections does Laboratoire Unither have on record?
CDMO Signal tracks 1 FDA inspection for Laboratoire Unither, sourced from the FDA inspection database. See the full inspection history above.
Has Laboratoire Unither received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Laboratoire Unither.
Does Laboratoire Unither hold EMA or MHRA GMP certificates?
CDMO Signal tracks 4 EMA and 1 MHRA GMP certificates for Laboratoire Unither.
Does Laboratoire Unither have a CDMO Signal Score?
Not yet. Laboratoire Unither is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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