Kindeva Drug Delivery

Woodbury, MN
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-02
76.0
Signal Score
✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ✓ MHRA GMP (3)

Quick Facts: Kindeva Drug Delivery

Signal Score
76.0/100 (as of 2026-04-02)
Quality Compliance
98.2/100
Headquarters
Woodbury, MN
Modalities
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

Signal Score & Pillar Breakdown

Quality Compliance 98.2
FDA Inspections2 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-11-13)
MHRA GMP Certificates3 on record
Operations
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs no verified data
Sponsorsno verified data
ModalitiesBiologics
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 53.0
1 manufacturing site: Woodbury, MN
Modalities: Biologics
Capacity assessment: 53.0/100
Sites: Woodbury, MN
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
1 manufacturing site: Woodbury, MN
Modalities: Biologics
Capacity assessment: 53.0/100

FDA Inspection History

2025-11
2025-03
NAI VAI OAI
Date Site Type Observations Classification
2025-11-13 Northridge, California Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
2025-03-14 Loughborough Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Apr 05, 2026

MHRA GMP Compliance 3 certificates

2025-03
2025-03
2019-12
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK MIA(IMP) 52811 Insp GMP/IMP 52811/17386-0042[I] KINDEVA DRUG DELIVERY LIMITED LOUGHBOROUGH LE11 5SF 2025-03-11 COMPLIANT
UK MIA 52811 Insp GMP/IMP 52811/17386-0042[H] KINDEVA DRUG DELIVERY LIMITED LOUGHBOROUGH LE11 5SF 2025-03-11 COMPLIANT
UK MIA 45438 Insp GMP 45438/17386-0030[H] KINDEVA DRUG DELIVERY LIMITED LOUGHBOROUGH LE11 5SF 2019-12-16 COMPLIANT
Source: MHRA GMDP Database · Retrieved Apr 05, 2026
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