Minakem
France (Beuvry-la-Foret and Dunkerque); Belgium (Mont-Saint-Guibert)
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (12)
○ MHRA GMP
✓ HC GMP (8)
Quick Facts: Minakem
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- France (Beuvry-la-Foret and Dunkerque); Belgium (Mont-Saint-Guibert)
- Website
- https://minakem.com/
- Modalities
- Small Molecule API
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Minakem
Minakem is a contract development and manufacturing organization (CDMO). Capabilities: Small Molecule API. 3 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://minakem.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Minakem FDA Inspection History
2023-04
2022-03
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2023-04-19 |
Minakem High Potent, S.A.
Corbais
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-03-11 |
Minakem Beuvry Production SAS
Beuvry-La-Foret
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Nov 01, 2026
Minakem EMA GMP Compliance 12 certificates
2026-02
2025-07
2023-04
2022-03
2022-03
2022-03
2022-03
2021-05
2021-05
2018-01
2018-01
2017-03
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 26MPP006HVFR01 | Minakem Beuvry Production | France | 2026-02-12 | COMPLIANT |
| 25MPP042HVFR01 | Minakem Dunkerque Production | France | 2025-07-11 | COMPLIANT |
| BE/GMP/2023/029 | Minakem High Potent | Belgium | 2023-04-19 | COMPLIANT |
| 22MPP020HFR01 | Minakem Beuvry Production | France | 2022-03-11 | COMPLIANT |
| 22MPP020HFR02 | Minakem Beuvry Production | France | 2022-03-11 | COMPLIANT |
| 22MPP020VFR01 | Minakem Beuvry Production | France | 2022-03-11 | COMPLIANT |
| 22MPP020VFR02 | Minakem Beuvry Production | France | 2022-03-11 | COMPLIANT |
| 21MPP040HFR01 | MINAKEM DUNKERQUE PRODUCTION | France | 2021-05-21 | COMPLIANT |
| 21MPP040HFR02 | Minakem Dunkerque Production | France | 2021-05-21 | COMPLIANT |
| 18MPP008HFR02 | MINAKEM BEUVRY PRODUCTION | France | 2018-01-25 | COMPLIANT |
| 18MPP008VFR02 | MINAKEM BEUVRY PRODUCTION | France | 2018-01-25 | COMPLIANT |
| 17MPP017HFR02 | MINAKEM DUNKERQUE PRODUCTION | France | 2017-03-09 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Nov 01, 2026
Japan-accredited overseas site (PMDA)
general (non-sterile) · 3 sites
- Mont-Saint-Guibert, Belgium · Minakem High Potent — general (non-sterile) · valid to Jan 21, 2031
- Beuvry-la-foret, France · Minakem Beuvry Production — general (non-sterile) · valid to Jun 10, 2028
- Dunkerque, France · Minakem Dunkerque Production — general (non-sterile) · valid to Sep 16, 2029
PMDA accreditation of a foreign manufacturing site is recognition within Japan's regulatory system, not an inspection outcome. PMDA's list covers only manufacturing sites outside Japan, so a company's plants in Japan are not on it. Source: PMDA, list of accredited/registered foreign manufacturers (as of Oct 16, 2026), Public Data License 1.0 (terms)
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 31, 2026
Frequently Asked Questions About Minakem
How many FDA inspections does Minakem have on record?
CDMO Signal tracks 2 FDA inspections for Minakem, sourced from the FDA inspection database. See the full inspection history above.
Has Minakem received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Minakem.
Does Minakem hold EMA or MHRA GMP certificates?
CDMO Signal tracks 12 EMA GMP certificates for Minakem.
Does Minakem have a CDMO Signal Score?
Not yet. Minakem is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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