Takeda

Boston, MA · Zurich, CH
Hybrid — also manufactures internal programs
AAV Cell Therapy
100 confirmed programs · 27 sponsors · Last scored 2026-04-29
80.9
Signal Score
✓ FDA Inspections (3) ✓ Clinical Trials (100) ○ SEC Filings ✓ Press (7) ✓ EMA GMP (18) ○ MHRA GMP

Quick Facts: Takeda

Signal Score
80.9/100 (as of 2026-04-29)
Quality Compliance
96.8/100
Headquarters
Boston, MA · Zurich, CH
Modalities
AAV, Cell Therapy
Active Programs
100 confirmed from ClinicalTrials.gov across 27 sponsors
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

About Takeda

Hybrid developer + CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 96.8
FDA Inspections3 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-11-12)
EMA GMP Certificates18 on record
Operations 89.6
100 active programs across 27 sponsors
Modalities: Cell Therapy, AAV
66 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
100 active programs across 27 sponsors · Modalities: Cell Therapy, AAV · 66 programs in advanced phases (Phase 2/3)
Programs 100
Sponsors27
ModalitiesAAV, Cell Therapy
100 active programs across 27 sponsors
Modalities: Cell Therapy, AAV
66 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07422480 A Study to Compare Elritercept With Epoetin Alfa to Treat... PHASE3 Recruiting
NCT07224100 Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib... PHASE2 Recruiting
NCT07624838 Real-life Experience of Brentuximab Vedotin Plus CHP as... NA Recruiting
NCT06980480 A Study of Gammagard Liquid (Immune Globulin Infusion, 10%)... PHASE3 Recruiting
NCT07217301 IBI363 vs Docetaxel in Patients With Advanced Squamous Lung... PHASE3 Recruiting
NCT07205718 A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors PHASE1/PHASE2 Recruiting
NCT06377228 A Study of TAK-007 in Adults With Refractory Lupus Nephritis... PHASE1 Withdrawn
NCT06588868 Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma NA Recruiting
NCT06677892 A Study of Maribavir in Adults With Post-transplant... NA Recruiting
NCT06615921 A Study of Maribavir in Adults With Post-transplant... NA Completed
View all 100 programs →
Source: ClinicalTrials.gov · Retrieved Jul 04, 2026
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 63.0
2 manufacturing sites
Sites: Boston, MA, Zurich, CH
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
Recent Press7 articles
2 manufacturing sites

Takeda FDA Inspection History

2025-11
2025-09
2024-10
NAI VAI OAI
Date Site Type Observations Classification
2025-11-12 Singen (Hohentwiel) Drug Quality Assurance No Voluntary Action Indicated (VAI)
2025-09-26 Hauppauge, New York Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
2024-10-16 Cambridge, Massachusetts Bioresearch Monitoring No No Action Indicated (NAI)
Source: FDA Data Dashboard · Retrieved Jul 04, 2026

Takeda FDA 483 Findings 1 observations · 2025-09-26 → 2025-09-26 ?

By subsystem

  • Documentation & Records 1 (100.0%)

By severity

  • 2 — Minor: 1
  • Repeat observations: 0

Most severe findings

  • Minor (2) Documentation & Records 2025-09-26 21 CFR 211.22(d)
    Procedures not in writing, fully followed

    "The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed."

About this data →

Takeda EMA GMP Compliance 18 certificates

2026-03
2026-03
2026-03
2026-03
2026-03
2026-02
2026-02
2025-12
2025-12
2025-11
2025-11
2025-07
2025-07
2025-07
2025-07
2025-07
2025-02
2025-02
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
483038-105130824 Takeda Manufacturing Austria AG Austria 2026-03-20 COMPLIANT
483039-104783268 Takeda Manufacturing Austria AG Austria 2026-03-20 COMPLIANT
483039-104916748 Takeda Manufacturing Austria AG Austria 2026-03-20 COMPLIANT
483039-105522770 Takeda Manufacturing Austria AG Austria 2026-03-20 COMPLIANT
IT-API/68/H/2026 Takeda Manufacturing Italia S.p.A. Italy 2026-03-13 COMPLIANT
480001-104799057 Takeda Manufacturing Austria AG Austria 2026-02-26 COMPLIANT
CRN00GXFQ/M12976 Takeda Pharmaceuticals International AG Ireland Branch Ireland 2026-02-11 COMPLIANT
CRN00GT94_M00807/00001 Takeda Ireland Limited Ireland 2025-12-12 COMPLIANT
CRN00GT94_ IMP00002/00001 Takeda Ireland Limited Ireland 2025-12-12 COMPLIANT
DE_BB_01_GMP_2025_0046 Takeda GmbH Germany 2025-11-28 COMPLIANT
DE_BW_01_GMP_2026_0012 Takeda GmbH Germany 2025-11-12 COMPLIANT
36209/M00807/00002 Takeda Ireland Limited Ireland 2025-07-11 COMPLIANT
36209/ASR11355/00001 Takeda Ireland Limited Ireland 2025-07-11 COMPLIANT
483038-104067091 Takeda Manufacturing Austria AG Austria 2025-07-04 COMPLIANT
483034-103627593 Takeda Manufacturing Austria AG Austria 2025-07-04 COMPLIANT
483039-103639089 Takeda Manufacturing Austria AG Austria 2025-07-04 COMPLIANT
IT-API/20/H/2025 Takeda Manufacturing Italia S.p.A. Italy 2025-02-14 COMPLIANT
484005-103627759 Takeda Austria GmbH Austria 2025-02-14 COMPLIANT
Source: EMA EudraGMDP · Retrieved Jul 04, 2026

Clinical Activity 100 studies

NCT07422480 A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults... PHASE3 Recruiting NCT07224100 Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the... PHASE2 Recruiting NCT07624838 Real-life Experience of Brentuximab Vedotin Plus CHP as First-line Treatment... NA Recruiting NCT06980480 A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent... PHASE3 Recruiting NCT07217301 IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After... PHASE3 Recruiting NCT07205718 A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors PHASE1/PHASE2 Recruiting NCT06377228 A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) or... PHASE1 Withdrawn NCT06588868 Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma NA Recruiting NCT06677892 A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV)... NA Recruiting NCT06615921 A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection NA Completed NCT05952804 IVIG for Infection Prevention After CAR-T-Cell Therapy PHASE2 Recruiting NCT05718297 Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion... PHASE2 Withdrawn NCT05748197 A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia PHASE1 Recruiting NCT05886478 A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With... NA Completed NCT05737849 A Study to Learn About the Tests Looking for a Gene Mutation in Adults With... NA Withdrawn NCT05721950 A Study to Learn About Brigatinib Treatment Information Available in Chinese... NA Active Not Recruiting NCT05319353 A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and... PHASE3 Recruiting NCT05886491 A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia PHASE1/PHASE2 Terminated NCT05571137 A Study on Cytomegalovirus (CMV) Infection Outcomes Among Hematopoietic Stem... NA Completed NCT05735327 A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small... NA Active Not Recruiting
+ 80 more studies
Source: ClinicalTrials.gov · Retrieved Jul 04, 2026

Recent News 7 articles

general 2026-05-05
Second life for a gene therapy; Takeda passes Phase 2/3 test; UK cancer biotech's $83M raise - Endpoints News
Second life for a gene therapy; Takeda passes Phase 2/3 test; UK cancer biotech's $83M raise  Endpoints News
Source →
general 2026-04-26
Takeda walks away from cell therapy in priority U-turn - MSN
Takeda walks away from cell therapy in priority U-turn  MSN
Source →
general 2026-04-25
Takeda walks away from cell therapy in priority U-turn - MSN
Takeda walks away from cell therapy in priority U-turn  MSN
Source →
general 2026-04-25
Takeda walks away from cell therapy in priority U-turn - MSN
Takeda walks away from cell therapy in priority U-turn  MSN
Source →
general 2026-04-10
Fierce Pharma Asia—Takeda-Denali split-up; Merck, Zhifei's revised deal; Shionogi's made-in-US plan - Fierce Pharma
Fierce Pharma Asia—Takeda-Denali split-up; Merck, Zhifei's revised deal; Shionogi's made-in-US plan  Fierce Pharma
Source →
general 2026-03-18
Sandoz expands biosim collab with Samsung Bioepis, sets sights on Takeda's Entyvio - Fierce Pharma
Sandoz expands biosim collab with Samsung Bioepis, sets sights on Takeda's Entyvio  Fierce Pharma
Source →
general 2026-02-26
A rare approach to a rare disease: Infant botulism | Takeda Stories - Takeda Pharmaceuticals
A rare approach to a rare disease: Infant botulism | Takeda Stories  Takeda Pharmaceuticals
Source →

Frequently Asked Questions About Takeda

How many FDA inspections does Takeda have on record?
CDMO Signal tracks 3 FDA inspections for Takeda, sourced from the FDA inspection database. See the full inspection history above.
Has Takeda received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Takeda.
Does Takeda hold EMA or MHRA GMP certificates?
CDMO Signal tracks 18 EMA GMP certificates for Takeda.
How many clinical programs is Takeda linked to?
Takeda is associated with 100 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Takeda's CDMO Signal Score?
Takeda has a Signal Score of 81/100, based on quality, operations, financial stability, and capacity data.
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