Corden Pharma
Plankstadt, DE · Caponago, IT · Boulder, CO
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
82.1
Signal Score
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
✓ Press (1)
✓ EMA GMP (8)
○ MHRA GMP
Quick Facts: Corden Pharma
- Signal Score
- 82.1/100 (as of 2026-04-29)
- Quality Compliance
- 98.7/100
- Headquarters
- Plankstadt, DE · Caponago, IT · Boulder, CO
- Modalities
- mRNA, Oligonucleotide, Biologics
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Corden Pharma
Manufactured lipids for BioNTech COVID vaccine.
Signal Score & Pillar Breakdown
Quality Compliance
98.7
FDA Inspections2 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-11-14)
EMA GMP Certificates8 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesmRNA, Oligonucleotide, Biologics
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
68.0
Parent company: ICIG
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: ICIG
Financial assessment: 68.0/100
Capacity
67.0
3 manufacturing sites
Facility expansion news detected
Sites: Plankstadt, Germany, Caponago, Italy, Boulder, CO
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
Recent Press1 articles
3 manufacturing sites
Facility expansion news detected
FDA Inspection History
2025-11
2025-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-14 | Boulder, Colorado | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-10-23 | Fairfield, New Jersey | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved May 20, 2026
FDA 483 Findings 3 observations · 2025-08-15 → 2025-10-23 ?
By subsystem
By severity
- 2 — Minor: 3
- Repeat observations: 0
Most severe findings
-
Written procedures not established/followed
"Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product."
-
Verification activity - appropriate
"You did not conduct an appropriate supplier verification activity."
-
Verification activity frequency
"You did not determine the frequency of conducting the verification activities to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection."
EMA GMP Compliance 8 certificates
2025-10
2025-10
2025-05
2025-03
2025-03
2025-03
2025-03
2025-03
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_BW_01_GMP_2025_0261 | Corden Pharma GmbH | Germany | 2025-10-15 | COMPLIANT |
| DE_BW_01_GMP_2025_0260 | Corden Pharma GmbH | Germany | 2025-10-15 | COMPLIANT |
| 2025_HPF_FR_090 | Corden Pharma Chenove | France | 2025-05-15 | COMPLIANT |
| IT/80/H/2025 | Corden Pharma S.p.A. | Italy | 2025-03-28 | COMPLIANT |
| F022/S1/MH/001/2026 | Corden Pharma Lisbon S.A. | Portugal | 2025-03-21 | COMPLIANT |
| F022/S2/MH/001/2026 | Corden Pharma Lisbon S.A. | Portugal | 2025-03-21 | COMPLIANT |
| F022/S2/ME/001/2026 | Corden Pharma Lisbon S.A. | Portugal | 2025-03-21 | COMPLIANT |
| F022/S1/ME/001/2026 | Corden Pharma Lisbon S.A. | Portugal | 2025-03-21 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved May 20, 2026
Recent News 1 articles
CordenPharma Colorado Partners with BioMed Realty on Peptide Development Lab Expansion - CHEManager
CordenPharma Colorado Partners with BioMed Realty on Peptide Development Lab Expansion CHEManager.
Represent this organization? Contact us to verify or update this profile.
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