Pfizer CentreOne
Kalamazoo, MI · McPherson, KS
365 confirmed programs
· 115 sponsors
· Last scored 2026-04-29
91.5
Signal Score
✓ FDA Inspections (4)
✓ Clinical Trials (365)
✓ SEC Filings (14)
○ Press
✓ EMA GMP (13)
✓ MHRA GMP (3)
Quick Facts: Pfizer CentreOne
- Signal Score
- 91.5/100 (as of 2026-04-29)
- Quality Compliance
- 100.0/100
- Headquarters
- Kalamazoo, MI · McPherson, KS
- Modalities
- Biologics, mRNA
- Active Programs
- 365 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
About Pfizer CentreOne
Pfizer's contract manufacturing arm.
Signal Score & Pillar Breakdown
Quality Compliance
100.0
FDA Inspections4 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-12-16)
EMA GMP Certificates13 on record
MHRA GMP Certificates3 on record
Operations
93.8
365 active programs across 115 sponsors
Modalities: Biologics, mRNA
211 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
365 active programs across 115 sponsors · Modalities: Biologics, mRNA · 211 programs in advanced phases (Phase 2/3)
Programs
365
Sponsors115
ModalitiesBiologics, mRNA
365 active programs across 115 sponsors
Modalities: Biologics, mRNA
211 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07489066
Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone...
PHASE2
Not Yet Recruiting
NCT07226999
Symbiotic-Lung-04: A Study to Learn About the Study Medicine...
PHASE2/PHASE3
Recruiting
View all 365 programs →
Source: ClinicalTrials.gov · Retrieved May 20, 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
14 SEC filings with industry mentions on record
SEC Filings14 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 May 20, 2026
EMA GMP Compliance 13 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
2021-07
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 |
| AUR23-20/ASR11424 | Pfizer Ireland Pharmaceuticals | Ireland | 2021-07-16 | NON-COMPLIANT |
Source: EMA EudraGMDP · Retrieved May 20, 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 May 20, 2026
Clinical Activity 365 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
Recruiting
NCT07567352
A Study to Learn About Patients With Non-Small Cell Lung Cancer (NSCLC) Who...
NA
Active Not Recruiting
NCT07556549
A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment...
NA
Active Not Recruiting
NCT07489066
Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in...
PHASE2
Not Yet Recruiting
NCT07227415
Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404...
PHASE1/PHASE2
Recruiting
NCT07222566
Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called...
PHASE3
Recruiting
NCT07226999
Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called...
PHASE2/PHASE3
Recruiting
NCT07261371
A Study to Compare Blood Levels of Different Dosage Formulations of the...
PHASE1
Completed
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
+ 345 more studies
Source: ClinicalTrials.gov · Retrieved May 20, 2026
Financial Intelligence
"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."
"(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."
"(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."
"(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."
"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."
"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."
"(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."
"(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."
Source: SEC EDGAR · Retrieved May 20, 2026
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