CARBOGEN AMCIS
Bubendorf, Switzerland
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (8)
○ Clinical Trials
○ SEC Filings
✓ Press (1)
✓ EMA GMP (5)
○ MHRA GMP
✓ HC GMP (26)
Quick Facts: CARBOGEN AMCIS
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Bubendorf, Switzerland
- Website
- https://www.carbogen-amcis.com/
- Modalities
- Small Molecule API, ADC / Bioconjugation, Sterile Fill-Finish
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About CARBOGEN AMCIS
CARBOGEN AMCIS makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, ADC / Bioconjugation, Sterile Fill-Finish. 4 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.carbogen-amcis.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
CARBOGEN AMCIS FDA Inspection History
2025-11
2025-11
2025-06
2024-06
2024-06
2024-03
2022-12
2022-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-14 |
Carbogen Amcis AG
Bubendorf
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2025-11-14 |
Carbogen Amcis AG
Hunzenschwil
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2025-06-12 |
Dishman Carbogen Amcis Limited
Ahmedabad
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-06-26 |
Carbogen AMCIS AG
Aarau
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-06-21 |
Carbogen Amcis AG
Hunzenschwil
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-03-07 |
Dishman Carbogen Amcis Limited
Ahmedabad
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-12-16 |
Carbogen Amcis AG
Bubendorf
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-11-09 |
Carbogen Amcis B.V.
Veenendaal
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
CARBOGEN AMCIS EMA GMP Compliance 5 certificates
2025-06
2025-06
2025-04
2025-01
2025-01
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 2025_HPF_FR_072 | Carbogen Amcis S.A.S. | France | 2025-06-19 | COMPLIANT |
| 2025_HPF_FR_073 | Carbogen Amcis S.A.S. | France | 2025-06-19 | COMPLIANT |
| NL/API 25/2056597 | Carbogen Amcis B.V. | Netherlands | 2025-04-09 | COMPLIANT |
| 2025_HPF_FR_033 | Carbogen Amcis S.A.S. | France | 2025-01-24 | COMPLIANT |
| 2025_HPF_FR_034 | Carbogen Amcis S.A.S. | France | 2025-01-24 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
EMA Non-Compliance Statements 1
CH20-0177 — DISHMAN CARBOGEN AMCIS LIMITED, India
Issued: 2020-04-20
Issued: 2020-04-20
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 1 articles
Company announcements, not verified evidence. They do not change any score.
CARBOGEN AMCIS announces successful first FDA pre-approval inspection at its Vionnaz site - Manufacturing Chemist
CARBOGEN AMCIS announces successful first FDA pre-approval inspection at its Vionnaz site Manufacturing Chemist
Frequently Asked Questions About CARBOGEN AMCIS
How many FDA inspections does CARBOGEN AMCIS have on record?
CDMO Signal tracks 8 FDA inspections for CARBOGEN AMCIS, sourced from the FDA inspection database. See the full inspection history above.
Has CARBOGEN AMCIS received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for CARBOGEN AMCIS.
Does CARBOGEN AMCIS hold EMA or MHRA GMP certificates?
CDMO Signal tracks 5 EMA GMP certificates for CARBOGEN AMCIS.
Does CARBOGEN AMCIS have a CDMO Signal Score?
Not yet. CARBOGEN AMCIS is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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