Catalent (Novo Holdings)

Harmans, MD · Gosselies, BE
Monoclonal Antibody Recombinant Protein ADC AAV mRNA Plasmid DNA Fill-Finish
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
50.6
Signal Score
✓ FDA Inspections (11) ○ Clinical Trials ○ SEC Filings ✓ Press (20) ✓ EMA GMP (16) ✓ MHRA GMP (16)

Quick Facts: Catalent (Novo Holdings)

Signal Score
50.6/100 (as of 2026-04-29)
Quality Compliance
26.7/100 — OAI classification at Bloomington (2025-07-14) — CRITICAL
Headquarters
Harmans, MD · Gosselies, BE
Website
Modalities
Monoclonal Antibody, Recombinant Protein, ADC, AAV, mRNA, Plasmid DNA, Fill-Finish
Active Programs
No ClinicalTrials.gov matches confirmed — 10 partnership announcements in press
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

About Catalent (Novo Holdings)

Pure-play CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 26.7
OAI classification at Bloomington (2025-07-14) — CRITICAL
Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
Source: FDA Data Dashboard
OAI classification at Bloomington (2025-07-14) — CRITICAL · Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated · Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
FDA Inspections11 on record
Warning Letters2
Last InspectionVoluntary Action Indicated (VAI) (2026-01-30)
EMA GMP Certificates16 on record
MHRA GMP Certificates16 on record
OAI classification at Bloomington (2025-07-14) — CRITICAL
Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
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
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.
Financial Stability 75.0
Strong parent backing: Novo Holdings
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Strong parent backing: Novo Holdings
Capacity 68.0
2 manufacturing sites
Broad modality coverage (7 modalities)
Sites: Harmans, MD, Gosselies, BE
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
StatusAvailable
2 manufacturing sites
Broad modality coverage (7 modalities)
Sites: Harmans, MD, Gosselies, BE
Recent Press20 articles
2 manufacturing sites
Broad modality coverage (7 modalities)

Catalent (Novo Holdings) FDA Inspection History

2026-01
2025-12
2025-10
2025-07
2025-07
2025-06
2025-06
2025-04
2025-04
2024-11
2024-10
NAI VAI OAI
Date Site Type Observations Classification
2026-01-30 Saint Petersburg, Florida Drug Quality Assurance No Voluntary Action Indicated (VAI)
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)
2025-07-25 Agawam, Massachusetts 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 Jul 04, 2026

Catalent (Novo Holdings) FDA 483 Findings 8 observations · 2025-07-25 → 2025-10-24 ?

By subsystem

  • Other 2 (25.0%)
  • Laboratory Controls 2 (25.0%)
  • Equipment & Facilities 1 (12.5%)
  • Documentation & Records 1 (12.5%)
  • Data Integrity 1 (12.5%)
  • CAPA 1 (12.5%)

By severity

  • 5 — Critical: 1
  • 3 — Moderate: 3
  • 2 — Minor: 4
  • Repeat observations: 0

Most severe findings

  • Critical (5) Data Integrity 2025-07-25 21 CFR 211.68(b)
    Computer control of master formula records

    "Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel."

  • Moderate (3) Laboratory Controls 2025-10-24 21 CFR 211.166(a)
    Written program not followed

    "The written stability testing program is not followed."

  • Moderate (3) Laboratory Controls 2025-10-24 21 CFR 211.165(b)
    Microbiological testing

    "Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing."

About this data →

Catalent (Novo Holdings) EMA GMP Compliance 16 certificates

2026-04
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
IT/110/H/2026 Catalent Anagni S.r.l. Italy 2026-04-15 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 Jul 04, 2026

Catalent (Novo Holdings) 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 Jul 04, 2026

Recent News 20 articles

partnership 2026-04-30
Cartherics and Catalent Expand Commercial License Agreement - BioInformant
Cartherics and Catalent Expand Commercial License Agreement  BioInformant
Source →
partnership 2026-04-23
Cartherics and Catalent announce enhanced partnership - Lab + Life Scientist
Cartherics and Catalent announce enhanced partnership  Lab + Life Scientist
Source →
general 2026-04-19
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
Source →
general 2026-04-19
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
Source →
general 2026-04-19
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
Source →
partnership 2026-04-14
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
Source →
partnership 2026-04-13
Cartherics and Catalent expand commercial license agreement - Med-Tech Insights
Cartherics and Catalent expand commercial license agreement  Med-Tech Insights
Source →
general 2026-04-11
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
Source →
general 2026-04-10
Cartherics deepens Catalent alliance to scale CAR-NK manufacturing - The Pharma Letter
Cartherics deepens Catalent alliance to scale CAR-NK manufacturing  The Pharma Letter
Source →
partnership 2026-04-10
Cartherics and Catalent Expand Commercial License Agreement - BioSpace
Cartherics and Catalent Expand Commercial License Agreement  BioSpace
Source →
partnership 2026-04-10
Cartherics and Catalent deepen partnership to accelerate next generation cell therapies - PharmaDispatch
Cartherics and Catalent deepen partnership to accelerate next generation cell therapies  PharmaDispatch
Source →
general 2026-04-10
Cartherics deepens Catalent alliance to scale CAR-NK manufacturing - The Pharma Letter
Cartherics deepens Catalent alliance to scale CAR-NK manufacturing  The Pharma Letter
Source →
partnership 2026-04-09
Cartherics and Catalent Expand Commercial License Agreement - Business Wire
Cartherics and Catalent Expand Commercial License Agreement  Business Wire
Source →
partnership 2026-04-09
Cartherics, Catalent Expand Partnership - Contract Pharma
Cartherics, Catalent Expand Partnership  Contract Pharma
Source →
partnership 2026-04-09
Cartherics and Catalent Expand Commercial License Agreement - PharmiWeb.com
Cartherics and Catalent Expand Commercial License Agreement  PharmiWeb.com
Source →
partnership 2026-04-01
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
Source →
general 2026-04-01
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
Source →
general 2026-04-01
List of 13 Acquisitions by Catalent (Apr 2026) - Tracxn
List of 13 Acquisitions by Catalent (Apr 2026)  Tracxn
Source →
general 2026-03-25
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
Source →
general 2026-03-25
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
Source →

Frequently Asked Questions About Catalent (Novo Holdings)

How many FDA inspections does Catalent (Novo Holdings) have on record?
CDMO Signal tracks 11 FDA inspections for Catalent (Novo Holdings), sourced from the FDA inspection database. See the full inspection history above.
Has Catalent (Novo Holdings) received an FDA warning letter?
Yes — CDMO Signal has 2 FDA warning letters on record for Catalent (Novo Holdings).
Does Catalent (Novo Holdings) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 16 EMA and 16 MHRA GMP certificates for Catalent (Novo Holdings).
What is Catalent (Novo Holdings)'s CDMO Signal Score?
Catalent (Novo Holdings) has a Signal Score of 51/100, based on quality, operations, financial stability, and capacity data.
Evaluating Catalent (Novo Holdings) for a manufacturing program?
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