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
Sponsorsno 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

  • Other 1 (33.3%)
  • Equipment & Facilities 1 (33.3%)
  • Documentation & Records 1 (33.3%)

By severity

  • 2 — Minor: 3
  • Repeat observations: 0

Most severe findings

  • Minor (2) Equipment & Facilities 2025-10-23 21 CFR 211.67(b)
    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."

  • Minor (2) Other 2025-08-15 21 CFR 1.506(d)(1)(ii)
    Verification activity - appropriate

    "You did not conduct an appropriate supplier verification activity."

  • Minor (2) Documentation & Records 2025-08-15 21 CFR 1.506(d)(1)(i)
    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

facility_expansion 2026-03-19
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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