FUJIFILM Diosynth Biotechnologies
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
84.8
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (17)
✓ MHRA GMP (6)
Quick Facts: FUJIFILM Diosynth Biotechnologies
- Signal Score
- 84.8/100 (as of 2026-04-29)
- 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, mRNA
- 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 FUJIFILM Diosynth Biotechnologies
$2B Holly Springs mega-site.
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 Certificates17 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, mRNA
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
68.0
3 manufacturing sites
Broad modality coverage (4 modalities)
Sites: Research Triangle Park, NC, Hillerød, Denmark, Holly Springs, NC
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
Status
3 manufacturing sites
Broad modality coverage (4 modalities)
FUJIFILM Diosynth Biotechnologies EMA GMP Compliance 17 certificates
2026-05
2026-05
2026-05
2026-03
2026-03
2026-02
2026-02
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 H 10001511 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2026-05-21 | COMPLIANT |
| DK IMP 10001512 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2026-05-21 | COMPLIANT |
| DK API-H 10001510 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2026-05-21 | COMPLIANT |
| DK H 10001414 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2026-03-04 | COMPLIANT |
| DK IMP 10001415 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2026-03-04 | COMPLIANT |
| DK H 10001468 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2026-02-06 | COMPLIANT |
| DK IMP 10001469 | FUJIFILM Diosynth Biotechnologies Denmark ApS | Denmark | 2026-02-06 | COMPLIANT |
| 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 Aug 22, 2026
FUJIFILM Diosynth Biotechnologies 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 Aug 22, 2026
Frequently Asked Questions About FUJIFILM Diosynth Biotechnologies
Does FUJIFILM Diosynth Biotechnologies hold EMA or MHRA GMP certificates?
CDMO Signal tracks 17 EMA and 6 MHRA GMP certificates for FUJIFILM Diosynth Biotechnologies.
What is FUJIFILM Diosynth Biotechnologies's CDMO Signal Score?
FUJIFILM Diosynth Biotechnologies has a Signal Score of 85/100, based on quality, operations, financial stability, and capacity data.
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