Takeda
Boston, MA · Zurich, CH
Hybrid — also manufactures internal programs
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
81.9
Signal Score
✓ FDA Inspections (3)
✓ Clinical Trials (100)
○ SEC Filings
✓ Press (7)
✓ EMA GMP (18)
○ MHRA GMP
Quick Facts: Takeda
- Signal Score
- 81.9/100 (as of 2026-09-07)
- Quality Compliance
- 99.6/100
- Headquarters
- Boston, MA · Zurich, CH
- Modalities
- AAV, Cell Therapy
- Active Programs
- Data pending
- 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
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
99.6
FDA Inspections3 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2026-04-10)
EMA GMP Certificates18 on record
Operations
89.6
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, Cell Therapy
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
NCT07205718
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
PHASE1/PHASE2
Recruiting
View all 100 programs →
Source: ClinicalTrials.gov · Retrieved Oct 07, 2026
Financial Stability
60.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
63.0
Profile-based capacity assessment
Recent Press7 articles
Takeda FDA Inspection History
2026-04
2025-11
2024-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-04-10 |
Takeda Pharmaceuticals, Inc.
Cambridge, Massachusetts
Facility-linked
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2025-11-12 |
Takeda GmbH
Singen (Hohentwiel)
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-10-16 |
TAKEDA PHARMACEUTICALS INC
Cambridge, Massachusetts
Facility-linked
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Oct 07, 2026
Attribution not established
(1)
These records are excluded from this company’s established evidence
because their attribution is unresolved. This describes an evidence-linking
limitation, not an assessment of the underlying regulatory findings.
| Source | Establishment named by the regulator | Location | Identifier |
|---|---|---|---|
| FDA inspection | A&Z Pharmaceutical Inc | Hauppauge, New York | FDA/FEI=1000521505 |
Source records retained verbatim · attribution not established
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 Oct 07, 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
Active Not 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 Oct 07, 2026
Recent News 7 articles
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
Takeda walks away from cell therapy in priority U-turn - MSN
Takeda walks away from cell therapy in priority U-turn MSN
Takeda walks away from cell therapy in priority U-turn - MSN
Takeda walks away from cell therapy in priority U-turn MSN
Takeda walks away from cell therapy in priority U-turn - MSN
Takeda walks away from cell therapy in priority U-turn MSN
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
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
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
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 82/100, based on quality, operations, financial stability, and capacity data.
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