Catalent (Novo Holdings)
Harmans, MD · Gosselies, BE
Program data pending ClinicalTrials.gov matching
· Last scored 2026-03-15
80.2
Signal Score
✓ FDA Inspections (7)
○ Clinical Trials
○ SEC Filings
✓ Press (15)
Quick Facts: Catalent (Novo Holdings)
- Signal Score
- 80.2/100 (as of 2026-03-15)
- Quality Compliance
- 80.0/100 — Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
- Headquarters
- Harmans, MD · Gosselies, BE
- Modalities
- AAV, CAR-T, Lentiviral, Plasmid
- Active CGT Programs
- No ClinicalTrials.gov matches confirmed — 7 partnership announcements in press
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CGT manufacturing intelligence platform
Signal Score & Pillar Breakdown
Quality Compliance
80.0
Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
Source: FDA Data Dashboard
Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
FDA Inspections7 on record
Warning Letters1
Last InspectionNo Action Indicated (NAI) (2025-12-17)
Warning Letter: CGMP/Finished Pharmaceuticals/Adulterated
Operations
94.5
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Source: ClinicalTrials.gov
No clinical trial matches found for this manufacturer · Operational score requires ClinicalTrials.gov data
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, CAR-T, Lentiviral, Plasmid
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
Source: SEC EDGAR, press monitoring
Subsidiary of Novo Holdings
SEC FilingsParent: Novo Holdings
Strong parent backing: Novo Holdings
Capacity
68.0
2 CGT manufacturing sites
Broad modality coverage (4 modalities)
Sites: Harmans, MD, Gosselies, BE
Source: SEC EDGAR, press monitoring, company profiles
2 CGT manufacturing sites
StatusAvailable
2 CGT manufacturing sites
Broad modality coverage (4 modalities)
Sites: Harmans, MD, Gosselies, BE
Recent Press15 articles
2 CGT manufacturing sites
Broad modality coverage (4 modalities)
FDA Inspection History
2025-12
2025-07
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) |
| 2025-07-14 | Bloomington, Indiana | Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 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 Mar 20, 2026
Recent News 15 articles
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
Novo's troubled Indiana plant claims another victim as FDA rejects Incyte's lung cancer application - Fierce Pharma
Novo's troubled Indiana plant claims another victim as FDA rejects Incyte's lung cancer application Fierce Pharma
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: Vistagen, Evotec, Reckitt Benckiser Downsize, Collectively Affecting Hundreds 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
Drug manufacturer cuts 96 jobs in third round of layoffs - The Business Journals
Drug manufacturer cuts 96 jobs in third round of layoffs The Business Journals
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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