FUJIFILM Diosynth Biotechnologies
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-02
83.5
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (10)
✓ MHRA GMP (6)
Quick Facts: FUJIFILM Diosynth Biotechnologies
- Signal Score
- 83.5/100 (as of 2026-04-02)
- Quality Compliance
- 100.0/100 — No FDA inspection records found for this manufacturer
- Headquarters
- Research Triangle, NC · Holly Springs, NC · Hillerod, DK
- Modalities
- AAV, mRNA/LNP, 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
100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
EMA GMP Certificates10 on record
MHRA GMP Certificates6 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, mRNA/LNP, 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
75.0
Strong parent backing: FUJIFILM Holdings (Japan)
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Strong parent backing: FUJIFILM Holdings (Japan)
Capacity
63.0
3 manufacturing sites
Sites: Research Triangle Park, NC, Hillerød, Denmark, Holly Springs, NC
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
Status
3 manufacturing sites
EMA GMP Compliance 10 certificates
2025-06
2025-06
2025-02
2025-02
2025-02
2025-01
2025-01
2025-01
2024-06
2024-06
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DK API-H 10001266 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2025-06-12 | COMPLIANT |
| DK H 10001269 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2025-06-12 | COMPLIANT |
| DK API-H 10001234 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2025-02-04 | COMPLIANT |
| DK H 10001235 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2025-02-04 | COMPLIANT |
| DK IMP 10001236 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2025-02-04 | COMPLIANT |
| DK H 10001233 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2025-01-21 | COMPLIANT |
| DK API-H 10001232 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2025-01-21 | COMPLIANT |
| DK IMP 10001237 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2025-01-21 | COMPLIANT |
| DK IMP 10000995 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2024-06-19 | COMPLIANT |
| DK H 10000994 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2024-06-19 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Apr 05, 2026
MHRA GMP Compliance 6 certificates
2025-03
2025-03
2025-03
2025-03
2025-03
2025-03
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK MIA 18480 Insp GMP 18480/37423709-0003[H] | FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED | REDCAR TS10 4RF | 2025-03-24 | COMPLIANT |
| UK MIA(IMP) 18480 Insp IMP 18480/37423707-0002[I] | FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED | DARLINGTON DL1 1HG | 2025-03-24 | COMPLIANT |
| UK MIA(IMP) 18480 Insp IMP 18480/37423709-0004[I] | FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED | REDCAR TS10 4RF | 2025-03-24 | COMPLIANT |
| UK MIA(IMP) 18480 Insp IMP 18480/37423705-0002[I] | FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED | DARLINGTON DL1 1GL | 2025-03-24 | COMPLIANT |
| UK MIA(IMP) 18480 Insp GMP/IMP 18480/10934-0018[I] | FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED | BILLINGHAM TS23 1LH | 2025-03-18 | COMPLIANT |
| UK MIA 18480 Insp GMP/IMP 18480/10934-0018[H] | FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED | BILLINGHAM TS23 1LH | 2025-03-18 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Apr 05, 2026
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