Pfizer CentreOne

Kalamazoo, MI · McPherson, KS
Biologics mRNA
363 confirmed programs · 115 sponsors · Last scored 2026-04-02
91.5
Signal Score
✓ FDA Inspections (4) ✓ Clinical Trials (363) ✓ SEC Filings (13) ○ Press ✓ EMA GMP (12) ✓ MHRA GMP (3)

Quick Facts: Pfizer CentreOne

Signal Score
91.5/100 (as of 2026-04-02)
Quality Compliance
100.0/100
Headquarters
Kalamazoo, MI · McPherson, KS
Modalities
Biologics, mRNA
Active Programs
363 confirmed from ClinicalTrials.gov across 115 sponsors
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
FDA Inspections4 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-12-16)
EMA GMP Certificates12 on record
MHRA GMP Certificates3 on record
Operations 93.8
363 active programs across 115 sponsors
Modalities: mRNA, Biologics
210 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
363 active programs across 115 sponsors · Modalities: mRNA, Biologics · 210 programs in advanced phases (Phase 2/3)
Programs 363
Sponsors115
ModalitiesBiologics, mRNA
363 active programs across 115 sponsors
Modalities: mRNA, Biologics
210 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT06507904 A Study to Learn How Different Preparations of Osivelotor... PHASE1 Not Yet Recruiting
NCT07476287 Symbiotic-Lung-14: A Study to Learn About the Study Medicine... PHASE2 Not Yet Recruiting
NCT07489066 Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone... PHASE2 Not Yet Recruiting
NCT07227415 A Study to Learn About the Medicine Called PF-08634404 Dosed... PHASE1/PHASE2 Recruiting
NCT07222566 A Study to Learn About the Study Medicine Called PF-08634404... PHASE3 Recruiting
NCT07226999 A Study to Learn About the Study Medicine Called PF-08634404... PHASE2/PHASE3 Recruiting
NCT07261371 A Study to Compare Blood Levels of Different Dosage... PHASE1 Recruiting
NCT07123090 A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic... PHASE2 Recruiting
NCT06974786 Frontline T-cell Engager vs Autologous Stem Cell Transplant... PHASE2 Recruiting
NCT06758401 This is a Study to Learn About How the Combination of the... PHASE3 Recruiting
View all 363 programs →
Source: ClinicalTrials.gov · Retrieved Apr 05, 2026
Financial Stability 89.0
Publicly traded — financial transparency
Moderate industry presence in SEC filings (22 mentions)
Major facility investment disclosed in SEC filings
Source: SEC EDGAR, press monitoring
13 SEC filings with industry mentions on record
SEC Filings13 with industry mentions
Publicly traded — financial transparency
Moderate industry presence in SEC filings (22 mentions)
Major facility investment disclosed in SEC filings
Capacity 76.0
2 manufacturing sites
7 facility investment mentions in SEC filings
Sites: Kalamazoo, MI, McPherson, KS
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
2 manufacturing sites
7 facility investment mentions in SEC filings

FDA Inspection History

2025-12
2025-10
2025-08
2025-06
NAI VAI OAI
Date Site Type Observations Classification
2025-12-16 Pleasant Prairie, Wisconsin Drug Quality Assurance No No Action Indicated (NAI)
2025-10-24 Groton, Connecticut Bioresearch Monitoring No Voluntary Action Indicated (VAI)
2025-08-22 San Diego, California Bioresearch Monitoring No No Action Indicated (NAI)
2025-06-18 Parsippany, New Jersey Bioresearch Monitoring No No Action Indicated (NAI)
Source: FDA Data Dashboard · Retrieved Apr 05, 2026

EMA GMP Compliance 12 certificates

2025-11
2025-11
2025-11
2025-08
2025-08
2025-07
2025-04
2024-10
2024-10
2022-09
2022-09
2022-09
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
CRN00GTL9-ASR11421/00001 Pfizer Ireland Pharmaceuticals Unlimited CompanyAlternative Name:Pfizer Ireland Pharmaceuticals Ireland 2025-11-21 COMPLIANT
CRN00GTL9-M1063/00001 Pfizer Ireland Pharmaceuticals Unlimited CompanyAlternative Name:Pfizer Ireland Pharmaceuticals Ireland 2025-11-21 COMPLIANT
CRN00GTL9-IMP070/00001 Pfizer Ireland Pharmaceuticals Unlimited Company Ireland 2025-11-21 COMPLIANT
36270/M11173/00001 Pfizer Ireland Pharmaceuticals Unlimited CompanyAlternative Name:Pfizer Ireland Pharmaceuticals Ireland 2025-08-07 COMPLIANT
36270/IMP11510/00001 Pfizer Ireland Pharmaceuticals Unlimited CompanyAlternative Name:Pfizer Ireland Pharmaceuticals Ireland 2025-08-07 COMPLIANT
DE_BW_01_GMP_2025_0205 Pfizer Manufacturing Deutschland GmbH Germany 2025-07-02 COMPLIANT
35854/IMP 13426/00001 Pfizer Ireland Pharmaceuticals Unlimited Company Ireland 2025-04-16 COMPLIANT
35284/ASR11424/1B Pfizer Ireland Pharmaceuticals Unlimited Company Ireland 2024-10-25 COMPLIANT
35320/IMP11510-00002 Pfizer Ireland Pharmaceuticals Unlimited Company Ireland 2024-10-08 COMPLIANT
33578-IMP070/00001 Pfizer Ireland Pharmaceuticals Ireland 2022-09-23 COMPLIANT
CRN00GWFF-M1063/00001 Pfizer Ireland Pharmaceuticals Unlimited CompanyAlternative Name:Pfizer Ireland Pharmaceuticals Ireland 2022-09-23 COMPLIANT
33578-ASR11421/00001 Pfizer Ireland Pharmaceuticals Ireland 2022-09-23 COMPLIANT
Source: EMA EudraGMDP · Retrieved Apr 05, 2026

MHRA GMP Compliance 3 certificates

2021-12
2016-05
2016-05
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK MIA(IMP) 57 Insp IMP 57/16600-0035[I] PFIZER LIMITED SANDWICH CT13 9NJ 2021-12-07 COMPLIANT
UK GMP 6268 Insp GMP 6579/604899-0010 [H] PFIZER INCORPORATED 49001 2016-05-16 COMPLIANT
UK GMP 6268 Insp GMP 6579/604899-0010 [V] PFIZER INCORPORATED 49001 2016-05-16 COMPLIANT
Source: MHRA GMDP Database · Retrieved Apr 05, 2026

Clinical Activity 363 studies

NCT06507904 A Study to Learn How Different Preparations of Osivelotor Taste and Enter... PHASE1 Not Yet Recruiting NCT07476287 Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called... PHASE2 Not Yet Recruiting NCT07489066 Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in... PHASE2 Not Yet Recruiting NCT07227415 A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in... PHASE1/PHASE2 Recruiting NCT07222566 A Study to Learn About the Study Medicine Called PF-08634404 in Combination... PHASE3 Recruiting NCT07226999 A Study to Learn About the Study Medicine Called PF-08634404 in Combination... PHASE2/PHASE3 Recruiting NCT07261371 A Study to Compare Blood Levels of Different Dosage Formulations of the... PHASE1 Recruiting NCT07123090 A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma PHASE2 Recruiting NCT06974786 Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and... PHASE2 Recruiting NCT06758401 This is a Study to Learn About How the Combination of the Study Medicines... PHASE3 Recruiting NCT06918002 Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus... PHASE3 Recruiting NCT06987734 Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for... PHASE2 Recruiting NCT06634836 Patient Interview Study to Explore the Impact of Gene Therapy in Hemophilia A & B NA Withdrawn NCT06218069 Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor PHASE2/PHASE3 Not Yet Recruiting NCT06799026 A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma... PHASE1 Recruiting NCT06533748 Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute... PHASE2 Recruiting NCT06483100 Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance PHASE2 Recruiting NCT06704724 A Study to Learn About the Study Medicine PF-07985045 When Given Alone or... PHASE1 Active Not Recruiting NCT06075615 A Study to Learn About Dacomitnib in Patients With Non-small Cell Lung... NA Withdrawn NCT06546553 A Study to Learn About How Different Amounts of the Study Medicine... PHASE1 Terminated
+ 343 more studies
Source: ClinicalTrials.gov · Retrieved Apr 05, 2026

Financial Intelligence

10-K 2026-02-26 5 keyword mentions
"For 2023, the total adjustments of $246 million included charges of (i) $474 million for certain legal matters, primarily representing certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer, and to a lesser extent, legal obligations related to pre-acquisition matters and (ii) $127 million mostly related to our equity-method accounting pro-rata share of intangible asset amortization and impairments, costs of separating from GSK and restructur"
"Divestitures Divestiture of Early-Stage Rare Disease Gene Therapy Portfolio– –On September 19, 2023, we completed an agreement with Alexion, under which Alexion purchased and licensed the assets of our early-stage rare disease gene therapy portfolio."
"2023 included, among other things, (i) dividend income of $ 265 million from our investment in ViiV and $ 211 million from our investment in Nimbus resulting from Takeda’s acquisition of Nimbus’s oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor program subsidiary and (ii) a $ 222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion."
View on SEC EDGAR →
8-K 2026-02-03 0 keyword mentions
View on SEC EDGAR →
8-K 2025-12-16 0 keyword mentions
View on SEC EDGAR →
8-K 2025-11-21 0 keyword mentions
View on SEC EDGAR →
8-K 2025-11-13 0 keyword mentions
View on SEC EDGAR →
10-Q 2025-11-04 1 keyword mentions
"(h) PC1 includes revenues from our contract manufacturing and our active pharmaceutical ingredient sales operation, as well as revenues related to our manufacturing and supply agreements with legacy Pfizer businesses/partnerships."
View on SEC EDGAR →
8-K 2025-11-04 0 keyword mentions
View on SEC EDGAR →
10-Q 2025-08-05 1 keyword mentions
"(g) PC1 includes revenues from our contract manufacturing and our active pharmaceutical ingredient sales operation, as well as revenues related to our manufacturing and supply agreements with legacy Pfizer businesses/partnerships."
View on SEC EDGAR →
10-Q 2025-05-05 1 keyword mentions
"(f) PC1 includes revenues from our contract manufacturing and our active pharmaceutical ingredient sales operation, as well as revenues related to our manufacturing and supply agreements with legacy Pfizer businesses/partnerships."
View on SEC EDGAR →
10-K 2025-02-27 6 keyword mentions
"For 2023, the total adjustments of $246 million included charges of (i) $474 million for certain legal matters, primarily representing certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer, and to a lesser extent, legal obligations related to pre-acquisition matters and (ii) $127 million mostly related to our equity-method accounting pro-rata share of intangible asset amortization and impairments, costs of separating from GSK and restructur"
"Divestitures Divestiture of Early-Stage Rare Disease Gene Therapy Portfolio– –On September 19, 2023, we completed an agreement with Alexion, under which Alexion purchased and licensed the assets of our early-stage rare disease gene therapy portfolio."
"and Subsidiary Companies associated with PC1, related to finite-lived licensing agreements, and reflected updated contract manufacturing forecasts reflecting changes to market dynamics."
View on SEC EDGAR →
10-Q 2024-11-04 4 keyword mentions
"The third quarter and first nine months of 2023 included, among other things, a $ 222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion."
"(i) PC1 includes revenues from our contract manufacturing and our active pharmaceutical ingredient sales operation, as well as revenues related to our manufacturing and supply agreements with legacy Pfizer businesses/partnerships."
"For the third quarter of 2023, the total Other (income)/deductions––net adjustment of $85 million primarily included a $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion, partially offset by charges of $71 million for certain legal matters, representing legal obligations related to pre-acquisition matters and certain product liability expenses related to products discontinued and/or divested by Pfizer."
View on SEC EDGAR →
10-Q 2024-08-05 3 keyword mentions
"(g) PC1 includes revenues from our contract manufacturing and our active pharmaceutical ingredient sales operation, as well as revenues related to our manufacturing and supply agreements with legacy Pfizer businesses/partnerships."
"CIFFREO, a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with DMD did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo."
View on SEC EDGAR →
10-Q 2024-05-08 1 keyword mentions
"(g) PC1 includes revenues from our contract manufacturing and our active pharmaceutical ingredient sales operation, as well as revenues related to our manufacturing and supply agreements with legacy Pfizer businesses/partnerships."
View on SEC EDGAR →
Source: SEC EDGAR · Retrieved Apr 05, 2026
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