Catalent
Bagsværd, Denmark (operating under Novo Holdings)
10 partnership announcements in press monitoring
· Last scored 2026-09-07
73.1
Signal Score
✓ FDA Inspections (12)
○ Clinical Trials
○ SEC Filings
✓ Press (20)
✓ EMA GMP (21)
✓ MHRA GMP (16)
Quick Facts: Catalent
- Signal Score
- 73.1/100 (as of 2026-09-07)
- Quality Compliance
- 74.9/100
- Headquarters
- Bagsværd, Denmark (operating under Novo Holdings)
- Website
- https://catalent.com
- Modalities
- Monoclonal Antibody, Recombinant Protein, ADC, AAV, mRNA, Plasmid DNA, Fill-Finish
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Catalent
Acquired by Novo Holdings for $16.5B.
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
74.9
FDA Inspections12 on record
Warning Letters2
Last InspectionVoluntary Action Indicated (VAI) (2026-05-22)
EMA GMP Certificates21 on record
MHRA GMP Certificates16 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer. 10 partnership announcements found in press monitoring.
Programs
— no verified data
Sponsors— no verified data
ModalitiesMonoclonal Antibody, Recombinant Protein, ADC, AAV, mRNA, Plasmid DNA, Fill-Finish
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Partnership Announcements (from press monitoring)
Financial Stability
75.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
68.0
Profile-based capacity assessment
Recent Press20 articles
Catalent FDA Inspection History
2026-05
2026-04
2025-12
2025-10
2025-07
2025-06
2025-06
2025-04
2025-04
2024-11
2024-10
2026-01
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-05-22 |
Catalent Pharma Solutions LLC
Morrisville, North Carolina
Facility-linked
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2026-04-24 |
Catalent Indiana, LLC
Bloomington, Indiana
Facility-linked
|
Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 2025-12-17 |
Catalent Pharma Solutions, LLC
Philadelphia, Pennsylvania
Company-level
|
Human Cellular, Tissue, and Gene Therapies | No | No Action Indicated (NAI) |
| 2025-10-24 |
Catalent Greenville Inc
Greenville, North Carolina
Facility-linked
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-07-14 |
Catalent Indiana, LLC
Bloomington, Indiana
Facility-linked
|
Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 2025-06-09 |
Catalent Micron Technologies, Inc.
Malvern, Pennsylvania
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2025-06-05 |
Catalent Pharma Solutions, LLC
Philadelphia, Pennsylvania
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-04-22 |
Catalent Pharma Solutions, LLC
Winchester, Kentucky
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-04-09 |
Catalent Maryland, Inc.
Baltimore, Maryland
Facility-linked
|
Human Cellular, Tissue, and Gene Therapies | Yes | Voluntary Action Indicated (VAI) |
| 2024-11-15 |
Catalent Maryland Inc
Harmans, Maryland
Facility-linked
|
Human Cellular, Tissue, and Gene Therapies | No | No Action Indicated (NAI) |
| 2024-10-10 |
Catalent Pharma Solutions Limited
Swindon
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2026-01-30 |
Catalent Pharma Solutions, LLC
Saint Petersburg, Florida
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
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 | Avista Pharma Solutions, Inc. | Agawam, Massachusetts | FDA/FEI=1220785 |
Source records retained verbatim · attribution not established
Catalent FDA 483 Findings 4 observations · 2025-10-24 → 2026-05-22 ?
By subsystem
By severity
- 3 — Moderate: 2
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Written program not followed
"The written stability testing program is not followed."
-
Microbiological testing
"Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing."
-
Written procedures not established/followed
"Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product."
Catalent EMA GMP Compliance 21 certificates
2026-05
2026-05
2026-04
2026-01
2026-01
2025-09
2024-05
2024-05
2024-04
2024-04
2024-03
2024-03
2024-03
2024-03
2024-03
2024-02
2024-02
2024-02
2020-01
2020-01
2020-01
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_BW_01_GMP_2026_0170 | Catalent Germany Schorndorf GmbH | Germany | 2026-05-22 | COMPLIANT |
| DE_BW_01_GMP_2026_0171 | Catalent Germany Schorndorf GmbH | Germany | 2026-05-22 | COMPLIANT |
| IT/110/H/2026 | Catalent Anagni S.r.l. | Italy | 2026-04-15 | COMPLIANT |
| 2026_HPF_FR_061 | Catalent France Limoges S.A.S. | France | 2026-01-16 | COMPLIANT |
| 2026_HPF_FR_060 | Catalent France Limoges S.A.S. | France | 2026-01-16 | COMPLIANT |
| DE_NW_03_GMP_2026_0037 | Catalent Duesseldorf GmbH | Germany | 2025-09-11 | COMPLIANT |
| BE/GMP/2024/061 | Catalent Gosselies | Belgium | 2024-05-27 | COMPLIANT |
| BE/GMP/2024/060 | Catalent Gosselies | Belgium | 2024-05-27 | COMPLIANT |
| DE_BW_01_GMP_2024_0147 | Catalent Germany Schorndorf GmbH | Germany | 2024-04-12 | COMPLIANT |
| DE_BW_01_GMP_2024_0177 | Catalent Germany Schorndorf GmbH | Germany | 2024-04-12 | COMPLIANT |
| IT/104/H/2024 | Catalent Italy S.p.A. | Italy | 2024-03-22 | COMPLIANT |
| IT/98/H/2026 | Catalent Italy S.p.A. | Italy | 2024-03-22 | COMPLIANT |
| IT/103/H/2026 | Catalent Italy S.p.A. | Italy | 2024-03-22 | COMPLIANT |
| BE/GMP/2024/022 | Catalent Gosselies PS | Belgium | 2024-03-15 | COMPLIANT |
| BE/GMP/2024/021 | Catalent Gosselies PS | Belgium | 2024-03-15 | COMPLIANT |
| IT/234/H/2024 | Catalent Anagni S.r.l. | Italy | 2024-02-23 | COMPLIANT |
| DE_BW_01_GMP_2024_0042 | Catalent Germany Eberbach GmbH | Germany | 2024-02-02 | COMPLIANT |
| DE_BW_01_GMP_2024_0040 | Catalent Germany Eberbach GmbH | Germany | 2024-02-02 | COMPLIANT |
| BE/GMP/2020/003 | Catalent Belgium SA | Belgium | 2020-01-20 | COMPLIANT |
| BE/GMP/2020/007 | Catalent Belgium SA | Belgium | 2020-01-20 | COMPLIANT |
| BE/GMP/2020/013 | Catalent Belgium SA | Belgium | 2020-01-20 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 07, 2026
Catalent MHRA GMP Compliance 16 certificates
2025-06
2025-06
2025-06
2024-10
2023-06
2022-06
2022-06
2021-03
2017-03
2017-03
2016-10
2015-10
2013-09
2013-02
2011-03
2009-02
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK MIA 5451 Insp GMP/IMP 5451/16389-0023[H] | CATALENT MICRON TECHNOLOGIES LIMITED | DARTFORD DA2 6QY | 2025-06-26 | COMPLIANT |
| UK MIA(IMP) 5451 Insp GMP/IMP 5451/16389-0023[I] | CATALENT MICRON TECHNOLOGIES LIMITED | DARTFORD DA2 6QY | 2025-06-26 | COMPLIANT |
| UK API 5451 Insp GMP/IMP 5451/16389-0023 | CATALENT MICRON TECHNOLOGIES LIMITED | DARTFORD DA2 6QY | 2025-06-26 | COMPLIANT |
| UK MIA 14023 Insp GMP 14023/4574-0024[H] | CATALENT UK SWINDON ZYDIS LIMITED | SWINDON SN5 8RU | 2024-10-09 | COMPLIANT |
| UK MIA(IMP) 14023 Insp GMP/IMP 14023/4574-0022[I] | CATALENT UK SWINDON ZYDIS LIMITED | SWINDON SN5 8RU | 2023-06-13 | COMPLIANT |
| UK MIA 5451 Insp GMP/IMP 5451/16389-0021[H] | CATALENT MICRON TECHNOLOGIES LIMITED | DARTFORD DA2 6QY | 2022-06-21 | COMPLIANT |
| UK ManA 5451 Insp GMP 5451/16389-0022[V] | CATALENT MICRON TECHNOLOGIES LIMITED | DARTFORD DA2 6QY | 2022-06-21 | COMPLIANT |
| UK MIA 32496 Insp GMP 5451/16389-0019[H] | CATALENT MICRON TECHNOLOGIES LIMITED | DARTFORD DA2 6QY | 2021-03-29 | COMPLIANT |
| UK GMP 20656 Insp GMP 33168/460035-0005[H] | CATALENT PHARMA SOLUTIONS LLC | 33716 | 2017-03-27 | COMPLIANT |
| UK GMP 20657 Insp GMP 20657/873857-0004[H] | CATALENT PHARMA SOLUTIONS LLC | 40391 | 2017-03-13 | COMPLIANT |
| UK GMP 20656 Insp GMP 20656/430174-0010[H] | CATALENT PHARMA SOLUTIONS LLC | NEW JERSEY 08873 | 2016-10-17 | COMPLIANT |
| UK GMP 20656 Insp GMP 20656/430168-0005[H] | CATALENT PHARMA SOLUTIONS INCORPORATED | 19114 | 2015-10-05 | COMPLIANT |
| UK GMP 20656 Insp GMP/IMP 20656/430174-0009 [V] | CATALENT PHARMA SOLUTIONS LLC | NEW JERSEY 08873 | 2013-09-17 | COMPLIANT |
| UK GMP 20657 Insp GMP 27385/113084-0005[H] | CATALENT PHARMA SOLUTIONS | 64137 | 2013-02-25 | COMPLIANT |
| UK API 18653 Insp GMP 18653/2970147-0002 | CATALENT MICRON TECHNOLOGIES INCORPORATED | 19355 | 2011-03-28 | COMPLIANT |
| UK GMP 33624 Insp GMP 33624/542366-0001[H] | CATALENT PHARMA SOLUTIONS | PR-00791 | 2009-02-13 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Oct 07, 2026
Recent News 20 articles
Cartherics and Catalent Expand Commercial License Agreement - BioInformant
Cartherics and Catalent Expand Commercial License Agreement BioInformant
Cartherics and Catalent announce enhanced partnership - Lab + Life Scientist
Cartherics and Catalent announce enhanced partnership Lab + Life Scientist
Catalent Inc stock (US1488061029): Why Google Discover changes matter more now - AD HOC NEWS
Catalent Inc stock (US1488061029): Why Google Discover changes matter more now AD HOC NEWS
Catalent Inc stock (US1488061029): Why Google Discover changes matter more now - AD HOC NEWS
Catalent Inc stock (US1488061029): Why Google Discover changes matter more now AD HOC NEWS
Catalent Inc stock (US1488061029): Why Google Discover changes matter more now - AD HOC NEWS
Catalent Inc stock (US1488061029): Why Google Discover changes matter more now AD HOC NEWS
Cartherics and Catalent deepen partnership to accelerate next generation cell therapies - Biotech Dispatch
Cartherics and Catalent deepen partnership to accelerate next generation cell therapies Biotech Dispatch
Cartherics and Catalent expand commercial license agreement - Med-Tech Insights
Cartherics and Catalent expand commercial license agreement Med-Tech Insights
Australia's Cartherics expands agreement with Catalent to focus on cancer and endometriosis treatment - BioSpectrum Asia
Australia's Cartherics expands agreement with Catalent to focus on cancer and endometriosis treatment BioSpectrum Asia
Cartherics deepens Catalent alliance to scale CAR-NK manufacturing - The Pharma Letter
Cartherics deepens Catalent alliance to scale CAR-NK manufacturing The Pharma Letter
Cartherics and Catalent Expand Commercial License Agreement - BioSpace
Cartherics and Catalent Expand Commercial License Agreement BioSpace
Cartherics and Catalent deepen partnership to accelerate next generation cell therapies - PharmaDispatch
Cartherics and Catalent deepen partnership to accelerate next generation cell therapies PharmaDispatch
Cartherics deepens Catalent alliance to scale CAR-NK manufacturing - The Pharma Letter
Cartherics deepens Catalent alliance to scale CAR-NK manufacturing The Pharma Letter
Cartherics and Catalent Expand Commercial License Agreement - Business Wire
Cartherics and Catalent Expand Commercial License Agreement Business Wire
Cartherics, Catalent Expand Partnership - Contract Pharma
Cartherics, Catalent Expand Partnership Contract Pharma
Cartherics and Catalent Expand Commercial License Agreement - PharmiWeb.com
Cartherics and Catalent Expand Commercial License Agreement PharmiWeb.com
Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPSC-Derived Cell Therapies in Ocular and Retinal Diseases - BioInformant
Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPSC-Derived Cell Therapies in Ocular and Retinal Diseases BioInformant
Layoffs at Novo’s Ex-Catalent Site Despite Signs of Turnaround, Continued Investment - BioSpace
Layoffs at Novo’s Ex-Catalent Site Despite Signs of Turnaround, Continued Investment BioSpace
List of 13 Acquisitions by Catalent (Apr 2026) - Tracxn
List of 13 Acquisitions by Catalent (Apr 2026) Tracxn
Catalent Inc stock faces uncertainty after 2023 Novo Nordisk acquisition amid evolving pharma servic - AD HOC NEWS
Catalent Inc stock faces uncertainty after 2023 Novo Nordisk acquisition amid evolving pharma servic AD HOC NEWS
Catalent Inc stock delisted after 2023 Novo Nordisk acquisition faces ongoing integration uncertaint - AD HOC NEWS
Catalent Inc stock delisted after 2023 Novo Nordisk acquisition faces ongoing integration uncertaint AD HOC NEWS
Frequently Asked Questions About Catalent
How many FDA inspections does Catalent have on record?
CDMO Signal tracks 12 FDA inspections for Catalent, sourced from the FDA inspection database. See the full inspection history above.
Has Catalent received an FDA warning letter?
Yes — CDMO Signal has 2 FDA warning letters on record for Catalent.
Does Catalent hold EMA or MHRA GMP certificates?
CDMO Signal tracks 21 EMA and 16 MHRA GMP certificates for Catalent.
What is Catalent's CDMO Signal Score?
Catalent has a Signal Score of 73/100, based on quality, operations, financial stability, and capacity data.
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