Pfizer CentreOne
Kalamazoo, MI · McPherson, KS
366 confirmed programs
· 115 sponsors
· Last scored 2026-04-29
91.5
Signal Score
✓ FDA Inspections (4)
✓ Clinical Trials (366)
✓ SEC Filings (14)
○ Press
✓ EMA GMP (15)
✓ 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
- 366 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 Certificates15 on record
MHRA GMP Certificates3 on record
Operations
93.8
366 active programs across 115 sponsors
Modalities: mRNA, Biologics
211 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
366 active programs across 115 sponsors · Modalities: mRNA, Biologics · 211 programs in advanced phases (Phase 2/3)
Programs
366
Sponsors115
ModalitiesBiologics, mRNA
366 active programs across 115 sponsors
Modalities: mRNA, Biologics
211 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07663630
A Study to Learn About the Study Medicine Called Ponsegromab...
PHASE1
Not Yet Recruiting
NCT07226999
Symbiotic-Lung-04: A Study to Learn About the Study Medicine...
PHASE2/PHASE3
Recruiting
View all 366 programs →
Source: ClinicalTrials.gov · Retrieved Jul 04, 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
Pfizer CentreOne 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 Jul 04, 2026
Pfizer CentreOne EMA GMP Compliance 15 certificates
2026-03
2026-03
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 |
|---|---|---|---|---|
| CRN00GZYJ/M11173/00001 | Pfizer Ireland Pharmaceuticals Unlimited CompanyAlternative Name:Pfizer Ireland Pharmaceuticals | Ireland | 2026-03-27 | COMPLIANT |
| CRN00GZYJ/IMP11510/00001 | Pfizer Ireland Pharmaceuticals Unlimited CompanyAlternative Name:Pfizer Ireland Pharmaceuticals | Ireland | 2026-03-27 | COMPLIANT |
| 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 Jul 04, 2026
Pfizer CentreOne 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 Jul 04, 2026
Clinical Activity 366 studies
NCT06507904
A Study to Learn How Different Preparations of Osivelotor Taste and Enter...
PHASE1
Not Yet Recruiting
NCT07663630
A Study to Learn About the Study Medicine Called Ponsegromab in Adults With...
PHASE1
Not Yet Recruiting
NCT07489066
Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in...
PHASE2
Recruiting
NCT07556549
A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment...
NA
Active Not 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
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
+ 346 more studies
Source: ClinicalTrials.gov · Retrieved Jul 04, 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 Jul 04, 2026
Frequently Asked Questions About Pfizer CentreOne
How many FDA inspections does Pfizer CentreOne have on record?
CDMO Signal tracks 4 FDA inspections for Pfizer CentreOne, sourced from the FDA inspection database. See the full inspection history above.
Has Pfizer CentreOne received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Pfizer CentreOne.
Does Pfizer CentreOne hold EMA or MHRA GMP certificates?
CDMO Signal tracks 15 EMA and 3 MHRA GMP certificates for Pfizer CentreOne.
How many clinical programs is Pfizer CentreOne linked to?
Pfizer CentreOne is associated with 366 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Pfizer CentreOne's CDMO Signal Score?
Pfizer CentreOne has a Signal Score of 92/100, based on quality, operations, financial stability, and capacity data.
Evaluating Pfizer CentreOne for a manufacturing program?
Use the free AI matchmaker to compare Pfizer CentreOne against other CDMOs by FDA, EMA, and clinical-trial data — no login required.
Find & compare CDMOs →
Represent this organization? Contact us to verify or update this profile.
See all CDMOs in:
Similar CDMOs
Corden Pharma
Plankstadt, DE · Caponago, IT · Boulder, CO
Signal Score: 82.5
mRNA, Oligonucleotide, Biologics
Merck KGaA / MilliporeSigma (CDMO)
Darmstadt, DE · St. Louis, MO
Signal Score: 81.8
mRNA, Biologics, Cell Therapy
Evonik Health Care
Birmingham, AL · Vancouver, BC
Signal Score: 81.5
mRNA, Biologics
Curia (RNA/Advanced)
Albany, NY · Albuquerque, NM
Signal Score: 79.4
mRNA, Oligonucleotide, Biologics
ProBio
Taipei, TW
Signal Score: 78.1
mRNA, Biologics