Corden Pharma (Colorado site / formerly AmbioPharm combined)
Boulder, CO
Program data pending ClinicalTrials.gov matching
76.7
Signal Score
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
✓ Press (3)
✓ EMA GMP (9)
○ MHRA GMP
Quick Facts: Corden Pharma (Colorado site / formerly AmbioPharm combined)
- Signal Score
- 76.7/100
- Quality Compliance
- 98.7/100
- Headquarters
- Boulder, CO
- Modalities
- Peptide API (SPPS), GLP-1 Peptide API, HPAPI Peptide
- 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 (Colorado site / formerly AmbioPharm combined)
Auto-created by AI matchmaker. Data verification pending.
Signal Score & Pillar Breakdown
Quality Compliance
98.7
FDA Inspections2 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-11-14)
EMA GMP Certificates9 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesPeptide API (SPPS), GLP-1 Peptide API, HPAPI Peptide
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
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity
55.0
Manufacturing site information being gathered
Modalities: Peptide API (SPPS), GLP-1 Peptide API, HPAPI Peptide
Capacity assessment: 55.0/100
Source: SEC EDGAR, press monitoring, company profiles
Profile-based capacity assessment
Recent Press3 articles
Manufacturing site information being gathered
Modalities: Peptide API (SPPS), GLP-1 Peptide API, HPAPI Peptide
Capacity assessment: 55.0/100
Corden Pharma (Colorado site / formerly AmbioPharm combined) 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 Jul 16, 2026
Corden Pharma (Colorado site / formerly AmbioPharm combined) 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."
Corden Pharma (Colorado site / formerly AmbioPharm combined) EMA GMP Compliance 9 certificates
2025-10
2025-10
2025-05
2025-03
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 |
| IT/121/H/2026 | 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 Jul 16, 2026
Recent News 3 articles
CordenPharma Acquires AmbioPharm to Expand Global Peptide API Capacity - PR Newswire
GLP-1 manufacturer CordenPharma strikes deal for peptide CDMO, lining up new production sites in US and China - Fierce Pharma
CordenPharma Colorado Partners with BioMed Realty on Peptide Development Lab Expansion - CHEManager
CordenPharma Colorado Partners with BioMed Realty on Peptide Development Lab Expansion CHEManager.
Frequently Asked Questions About Corden Pharma (Colorado site / formerly AmbioPharm combined)
How many FDA inspections does Corden Pharma (Colorado site / formerly AmbioPharm combined) have on record?
CDMO Signal tracks 2 FDA inspections for Corden Pharma (Colorado site / formerly AmbioPharm combined), sourced from the FDA inspection database. See the full inspection history above.
Has Corden Pharma (Colorado site / formerly AmbioPharm combined) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Corden Pharma (Colorado site / formerly AmbioPharm combined).
Does Corden Pharma (Colorado site / formerly AmbioPharm combined) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 9 EMA GMP certificates for Corden Pharma (Colorado site / formerly AmbioPharm combined).
What is Corden Pharma (Colorado site / formerly AmbioPharm combined)'s CDMO Signal Score?
Corden Pharma (Colorado site / formerly AmbioPharm combined) has a Signal Score of 77/100, based on quality, operations, financial stability, and capacity data.
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