FUJIFILM Diosynth Biotechnologies

Research Triangle, NC · Holly Springs, NC · Hillerod, DK
AAV mRNA/LNP Biologics mRNA
No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07
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 2026-09-07)
Quality Compliance
100.0/100
Headquarters
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
Modalities
AAV, mRNA/LNP, Biologics, mRNA
Active Programs
Data pending
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

Scores are being republished. Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance 100.0
FDA InspectionsNo US records on file
EMA GMP Certificates17 on record
MHRA GMP Certificates6 on record
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs — no verified data
Sponsors— no verified data
ModalitiesAAV, mRNA/LNP, Biologics, mRNA
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 75.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity 68.0
Capacity status: Expanding
StatusExpanding

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 Oct 07, 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 Oct 07, 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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