Catalent
Somerset, NJ (Now Novo Holdings)
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-02
81.0
Signal Score
✓ FDA Inspections (9)
○ Clinical Trials
○ SEC Filings
✓ Press (19)
✓ EMA GMP (13)
✓ MHRA GMP (16)
Quick Facts: Catalent
- Signal Score
- 81.0/100 (as of 2026-04-02)
- Quality Compliance
- 89.0/100 — OAI classification at Bloomington (2025-07-14) — CRITICAL
- Headquarters
- Somerset, NJ (Now Novo Holdings)
- Modalities
- AAV, CAR-T, Lentiviral, Plasmid DNA
- Active Programs
- No ClinicalTrials.gov matches confirmed — 8 partnership announcements in press
- 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
89.0
OAI classification at Bloomington (2025-07-14) — CRITICAL
Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
Source: FDA Data Dashboard
OAI classification at Bloomington (2025-07-14) — CRITICAL · Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
FDA Inspections9 on record
Warning Letters1
Last InspectionNo Action Indicated (NAI) (2025-12-17)
EMA GMP Certificates13 on record
MHRA GMP Certificates16 on record
OAI classification at Bloomington (2025-07-14) — CRITICAL
Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer. 8 partnership announcements found in press monitoring.
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, CAR-T, Lentiviral, Plasmid DNA
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
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
Strong parent backing: Novo Holdings (acquired Feb 2024, $16.5B)
M&A activity detected (1 articles)
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Strong parent backing: Novo Holdings (acquired Feb 2024, $16.5B)
M&A activity detected (1 articles)
Capacity
73.0
3 manufacturing sites
Broad modality coverage (4 modalities)
Strong partnership activity (8 articles)
Sites: Harmans, MD, Gosselies, Belgium, Limoges, France
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
Recent Press19 articles
3 manufacturing sites
Broad modality coverage (4 modalities)
Strong partnership activity (8 articles)
FDA Inspection History
2025-12
2025-10
2025-07
2025-06
2025-06
2025-04
2025-04
2024-11
2024-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-12-17 | Philadelphia, Pennsylvania | Human Cellular, Tissue, and Gene Therapies | No | No Action Indicated (NAI) |
| 2025-10-24 | Greenville, North Carolina | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-07-14 | Bloomington, Indiana | Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 2025-06-09 | Malvern, Pennsylvania | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2025-06-05 | Philadelphia, Pennsylvania | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-04-22 | Winchester, Kentucky | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-04-09 | Baltimore, Maryland | Human Cellular, Tissue, and Gene Therapies | Yes | Voluntary Action Indicated (VAI) |
| 2024-11-15 | Harmans, Maryland | Human Cellular, Tissue, and Gene Therapies | No | No Action Indicated (NAI) |
| 2024-10-10 | Swindon | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Apr 05, 2026
EMA GMP Compliance 13 certificates
2024-05
2024-05
2024-04
2024-04
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 |
|---|---|---|---|---|
| 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 |
| 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 Apr 05, 2026
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 Apr 05, 2026
Recent News 19 articles
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
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
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
GelMEDIX partners with Catalent to advance vision-restoring cell therapies - Indian Pharma Post
GelMEDIX partners with Catalent to advance vision-restoring cell therapies Indian Pharma Post
GelMEDIX, Catalent Partner to Advance iPSC-Derived Cell Therapies - Contract Pharma
GelMEDIX, Catalent Partner to Advance iPSC-Derived Cell Therapies Contract Pharma
Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPS - PharmiWeb.com
Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPS pharmiweb.com
Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPSC-Derived Cell Therapies in Ocular and Retinal Diseases - BioSpace
Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPSC-Derived Cell Therapies in Ocular and Retinal Diseases BioSpace
Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPSC-Derived Cell Therapies in Ocular and Retinal Diseases - Yahoo Finance
Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPSC-Derived Cell Therapies in Ocular and Retinal Diseases Yahoo Finance
Incyte’s Lung Cancer Expansion Bid Thwarted by Issues at Novo’s Catalent-Acquired Site - BioSpace
Incyte’s Lung Cancer Expansion Bid Thwarted by Issues at Novo’s Catalent-Acquired Site BioSpace
Another Round of Catalent Layoffs Hits Maryland — Over 500 Workers Impacted in the Past Year - BioBuzz
Another Round of Catalent Layoffs Hits Maryland — Over 500 Workers Impacted in the Past Year BioBuzz
Layoff Tracker: BMS, Catalent Further Whittle Workforces - BioSpace
Layoff Tracker: Takeda Restructuring Will Affect Workforce, Could Include Layoffs BioSpace
Catalent cuts staff by 96 in another round of layoffs in Maryland - Fierce Pharma
Catalent cuts staff by 96 in another round of layoffs in Maryland Fierce Pharma
Fill Finish Manufacturing Market Analysis Report 2026-2035: A $21+ Billion Market by 2030 with Johnson & Johnson, AbbVie, Thermo Fisher Scientific, BD & Co, Baxter, Lonza, and Catalent Leading - Yahoo Finance
Fill Finish Manufacturing Market Analysis Report 2026-2035: A $21+ Billion Market by 2030 with Johnson & Johnson, AbbVie, Thermo Fisher Scientific, BD & Co, Baxter, Lonza, and Catalent Leading Yahoo Finance
Korea's S.Biomedics announces partnership with Catalent to develop and manufacture TED‑A9 - BioSpectrum Asia
Korea's S.Biomedics announces partnership with Catalent to develop and manufacture TED‑A9 BioSpectrum Asia
Korea's S.Biomedics announces partnership with Catalent to develop and manufacture TED‑A9 - BioSpectrum Asia
Korea's S.Biomedics announces partnership with Catalent to develop and manufacture TED‑A9 BioSpectrum Asia
Catalent and S.Biomedics Announce Partnership to Develop and Manufacture TED‑A9 - BioSpace
Catalent and S.Biomedics Announce Partnership to Develop and Manufacture TED‑A9 BioSpace
Catalent and S.Biomedics Announce Partnership to Develop and Manufacture TED‑A9 - Yahoo Finance
Catalent and S.Biomedics Announce Partnership to Develop and Manufacture TED‑A9 Yahoo Finance
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