Novartis
Basel, Switzerland
415 confirmed programs
· 117 sponsors
· Last scored 2026-04-29
80.1
Signal Score
✓ FDA Inspections (14)
✓ Clinical Trials (136)
✓ SEC Filings (30)
✓ Press (20)
✓ EMA GMP (36)
✓ MHRA GMP (3)
Quick Facts: Novartis
- Signal Score
- 80.1/100 (as of 2026-04-29)
- Quality Compliance
- 66.9/100 — OAI classification at Lincoln (2024-07-29) — CRITICAL
- Headquarters
- Basel, Switzerland
- Modalities
- CAR-T, Gene Therapy
- Active Programs
- 415 confirmed from ClinicalTrials.gov across 117 sponsors
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Novartis
Kymriah manufacturer.
Signal Score & Pillar Breakdown
Quality Compliance
66.9
OAI classification at Lincoln (2024-07-29) — CRITICAL
OAI classification at Selaqui (2025-09-16) — CRITICAL
Source: FDA Data Dashboard
OAI classification at Lincoln (2024-07-29) — CRITICAL · OAI classification at Selaqui (2025-09-16) — CRITICAL
FDA Inspections14 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-11-21)
EMA GMP Certificates36 on record
MHRA GMP Certificates3 on record
OAI classification at Lincoln (2024-07-29) — CRITICAL
OAI classification at Selaqui (2025-09-16) — CRITICAL
Operations
94.8
415 active programs across 117 sponsors
Modalities: CAR-T, Gene Therapy
277 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
415 active programs across 117 sponsors · Modalities: CAR-T, Gene Therapy · 277 programs in advanced phases (Phase 2/3)
Programs
415
Sponsors117
ModalitiesCAR-T, Gene Therapy
415 active programs across 117 sponsors
Modalities: CAR-T, Gene Therapy
277 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07443137
CAR-T ceLL for Eradication of Active Residual Disease in LBCL...
PHASE1
Not Yet Recruiting
NCT05469828
Crizanlizumab Improves Tissue Oxygen Supply Demand Matching...
PHASE1/PHASE2
Not Yet Recruiting
NCT06456138
Trametinib Plus Anlotinib Combined With Tislelizumab in...
PHASE1/PHASE2
Not Yet Recruiting
NCT06430671
Peptide-coupled Red Blood Cells for the Treatment of Multiple...
PHASE1
Active Not Recruiting
View all 136 programs →
Source: ClinicalTrials.gov · Retrieved May 20, 2026
Financial Stability
78.0
Publicly traded — financial transparency
Strong industry presence in SEC filings (67 mentions)
Multiple manufacturing risk factors in SEC filings
Source: SEC EDGAR, press monitoring
30 SEC filings with industry mentions on record
SEC Filings30 with industry mentions
Publicly traded — financial transparency
Strong industry presence in SEC filings (67 mentions)
Multiple manufacturing risk factors in SEC filings
Capacity
87.0
3 manufacturing sites
8 facility investment mentions in SEC filings
Active facility expansion (26 articles)
Regulatory milestones (2 articles)
Sites: Morris Plains, NJ, Stein, Switzerland, Les Ulis, France
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
Recent Press20 articles
3 manufacturing sites
8 facility investment mentions in SEC filings
Active facility expansion (26 articles)
Regulatory milestones (2 articles)
FDA Inspection History
2025-11
2025-10
2025-10
2025-09
2025-09
2025-09
2025-06
2025-03
2024-11
2024-08
2024-08
2024-07
2024-07
2024-06
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-21 | Monmouth Junction, New Jersey | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-10-24 | Fairfield, New Jersey | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-10-03 | Piscataway, New Jersey | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-09-26 | Indianapolis, Indiana | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-09-16 | Selaqui | Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 2025-09-11 | Georgetown, Indiana | Bioresearch Monitoring | Yes | Voluntary Action Indicated (VAI) |
| 2025-06-25 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2025-03-03 | East Hanover, New Jersey | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-11-19 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-08-29 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-08-08 | Morris Plains, New Jersey | Human Cellular, Tissue, and Gene Therapies | Yes | Voluntary Action Indicated (VAI) |
| 2024-07-29 | Lincoln, Rhode Island | Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
| 2024-07-12 | Ahmedabad | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-06-27 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved May 20, 2026
FDA 483 Findings 12 observations · 2025-08-07 → 2025-11-21 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 11
- Repeat observations: 0
Most severe findings
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed."
-
Equipment Design, Size and Location
"Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use."
-
Procedures not in writing, fully followed
"The responsibilities and procedures applicable to the quality control unit are not in writing."
EMA GMP Compliance 36 certificates
2026-02
2026-02
2026-02
2025-12
2025-12
2025-12
2025-12
2025-12
2025-11
2025-11
2025-11
2025-10
2025-10
2025-10
2025-10
2025-10
2025-04
2025-04
2025-03
2025-03
2025-03
2024-11
2024-07
2024-07
2024-07
2024-07
2023-12
2023-12
2023-12
2023-12
2023-12
2023-12
2023-12
2023-12
2023-12
2023-12
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 483918-104880329 | Sandoz GmbH | Austria | 2026-02-12 | COMPLIANT |
| 483917-104880304 | Sandoz GmbH | Austria | 2026-02-11 | COMPLIANT |
| DE_BY_05_GMP_2026_0054 | Novartis Pharma GmbH | Germany | 2026-02-10 | COMPLIANT |
| 450-8/2026-2 | Novartis Pharmaceutical Manufacturing LLCAlternative Name:Novartis farmacevtska proizvodnja d.o.o. | Slovenia | 2025-12-19 | COMPLIANT |
| 401-27/2025-8 | Novartis Pharmaceutical Manufacturing LLCAlternative Name:Novartis farmacevtska proizvodnja d.o.o. | Slovenia | 2025-12-09 | COMPLIANT |
| 484326-105148947 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2025-12-05 | COMPLIANT |
| 484326-103675833 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2025-12-05 | COMPLIANT |
| 484296-103675257 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2025-12-04 | COMPLIANT |
| 481921-104823957 | Sandoz GmbH | Austria | 2025-11-27 | COMPLIANT |
| BE/GMP/2025/157 | Novartis PharmaAlternative Name:Novartis Pharma N.V. | Belgium | 2025-11-24 | COMPLIANT |
| BE/GMP/2025/156 | Novartis PharmaAlternative Name:Novartis Pharma N.V. | Belgium | 2025-11-24 | COMPLIANT |
| 484600-104544504 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2025-10-20 | COMPLIANT |
| DE_BY_05_GMP_2026_0024 | Novartis Pharma GmbH | Germany | 2025-10-14 | COMPLIANT |
| 484295-104642509 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2025-10-10 | COMPLIANT |
| 484295-103675105 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2025-10-10 | COMPLIANT |
| 484295-104295901 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2025-10-10 | COMPLIANT |
| 480012-103600843 | Sandoz GmbH | Austria | 2025-04-04 | COMPLIANT |
| 480012-104850659 | Sandoz GmbH | Austria | 2025-04-04 | COMPLIANT |
| 481921-103633811 | Sandoz GmbH | Austria | 2025-03-14 | COMPLIANT |
| 481921-104620227 | Sandoz GmbH | Austria | 2025-03-14 | COMPLIANT |
| 481921-104432587 | Sandoz GmbH | Austria | 2025-03-14 | COMPLIANT |
| 484496-103501763 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2024-11-04 | COMPLIANT |
| 482900-102570338 | Sandoz GmbH | Austria | 2024-07-04 | COMPLIANT |
| 482875-104851118 | Sandoz GmbH | Austria | 2024-07-04 | COMPLIANT |
| 482878-102570316 | Sandoz GmbH | Austria | 2024-07-04 | COMPLIANT |
| 482875-102481557 | Sandoz GmbH | Austria | 2024-07-04 | COMPLIANT |
| 484295-102362426 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
| 484295-104659277 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
| 484295-103890257 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
| 484295-104484889 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
| 484295-102504807 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
| 484295-104299099 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
| 484295-104466717 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
| 484295-104090448 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
| 484295-102485983 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
| 484295-102771143 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2023-12-14 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved May 20, 2026
MHRA GMP Compliance 3 certificates
2021-03
2019-03
2013-04
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK MIA 4416 Insp GMP/GDP 4416/19135216-0003[H] | SANDOZ LIMITED | CAMBERLEY GU15 3YL | 2021-03-08 | COMPLIANT |
| UK MIA 4416 Insp GMP 4416/1803065-0009[H] | SANDOZ LIMITED | CAMBERLEY GU16 7SR | 2019-03-01 | COMPLIANT |
| UK GMP 4647 Insp GMP 4647/1766568-0003[H] | NOVARTIS | 94070-06256 | 2013-04-22 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved May 20, 2026
Clinical Activity 136 studies
NCT07443137
CAR-T ceLL for Eradication of Active Residual Disease in LBCL (CLEAR-1 Study)
PHASE1
Not Yet Recruiting
NCT07493408
Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST...
PHASE2
Not Yet Recruiting
NCT07250087
Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse...
PHASE1
Recruiting
NCT06964958
177LuPSMA in Renal Cell Carcinoma
PHASE2
Active Not Recruiting
NCT05469828
Crizanlizumab Improves Tissue Oxygen Supply Demand Matching in Patients With...
PHASE1/PHASE2
Not Yet Recruiting
NCT06456138
Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC
PHASE1/PHASE2
Not Yet Recruiting
NCT06430671
Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis
PHASE1
Active Not Recruiting
NCT06395402
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
PHASE2
Recruiting
NCT05567055
Central Nervous System Efficacy of Capmatinib in NSCLC With Brain Metastases...
PHASE2
Withdrawn
NCT05714891
Neoadjuvant Platform Trial in Non-Small Cell Lung Cancer
PHASE2
Active Not Recruiting
NCT06662825
Real World Patient Characteristics and Treatment Patterns From Crizanlizumab...
NA
Completed
NCT06662825
Real World Patient Characteristics and Treatment Patterns From Crizanlizumab...
NA
Completed
NCT05472220
Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and...
PHASE1
Withdrawn
NCT06271369
Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.
NA
Completed
NCT05435846
Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell...
PHASE1
Terminated
NCT04894370
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With...
PHASE2
Recruiting
NCT05479448
Predictive Factors for Treatment Response in Patients With Newly-diagnosed...
NA
Recruiting
NCT05199961
Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With...
NA
Terminated
NCT04890236
Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With...
EARLY_PHASE1
Completed
NCT02645149
Molecular Profiling and Matched Targeted Therapy for Patients With...
PHASE2
Completed
+ 116 more studies
Source: ClinicalTrials.gov · Retrieved May 20, 2026
Financial Intelligence
"We face a challenge to attract and retain top talent in several areas, including biology, immunology, chemistry, clinical development, drug manufacturing, data, digital and IT, including AI, oncology, and advanced therapy platforms (i.e., gene and cell therapy, radioligand therapy, and xRNA)."
"In addition, we manufacture and sell a number of sterile products, biologic products, and products that involve advanced therapy platforms, such as gene and cell therapy, radioligand therapy, and xRNA, or require a supply of highly specialized raw materials, such as cell lines, tissue samples, bacteria, viral strains, and radioisotopes."
"The T315I mutation causes resistance to most available TKI therapies, and, as a result, patients with this mutation would otherwise have limited treatment options
•
Zolgensma
(onasemnogene abeparvovec)/
Itvisma
(onasemnogene abeparvovec-brve) is a one-time gene therapy designed to address the genetic root cause of spinal muscular atrophy (SMA) by replacing the function of the missing or nonworking SMN1 gene."
"“The SMA disease landscape has dramatically changed over the last
six years, when the first gene therapy was approved."
"Novartis has an exclusive, worldwide license with Nationwide Children's Hospital to both the intravenous
and intrathecal delivery of adeno-associated virus 9 (AAV9) gene replacement therapy for the treatment of all types of SMA; an exclusive,
worldwide license from REGENXBIO for any recombinant AAV vector in its intellectual property portfolio for the
in vivo
gene replacement
therapy treatment of SMA in humans; an exclusive, worldwide licensing agreement with Généthon for
in vivo
delivery
of AAV"
"We face a challenge to attract and retain top talent in several areas, including biology, immunology, chemistry, clinical development, drug manufacturing, data, digital and IT, oncology, and advanced therapy platforms (i.e., gene and cell therapy, radioligand therapy and xRNA) and to maintain and strengthen our employer reputation."
"In addition, we manufacture and sell a number of sterile products, biologic products and products that involve advanced therapy platforms, such as gene and cell therapy, radioligand therapy, and xRNA, all of which are particularly complex and involve highly specialized manufacturing technologies."
"In addition, we manufacture and sell a number of sterile products, biologic products, and products that involve advanced therapy platforms, such as gene and cell therapy, radioligand therapy, and xRNA, all of which are particularly complex and involve highly specialized manufacturing technologies."
"OAV101 IT is the first investigational
gene therapy to provide clinical benefit in treatment-naïve patients with SMA aged two
and older with a positive risk benefit profile"
"7
The results from the
Phase III STEER study add to the clinical data and emerging real-world evidence for the use
of one-time gene therapy to treat SMA."
"About
OAV101 IT
Intrathecal onasemnogene abeparvovec (OAV101 IT) is an investigational,
one-time gene therapy for patients with spinal muscular atrophy (SMA)."
Source: SEC EDGAR · Retrieved May 20, 2026
Recent News 20 articles
Novartis Plans Closure Of Wehr Manufacturing Site By 2028 - RTTNews
Novartis Plans Closure Of Wehr Manufacturing Site By 2028 RTTNews
Novartis to close German manufacturing site, cutting 220 jobs - Fierce Pharma
Novartis to close German manufacturing site, cutting 220 jobs Fierce Pharma
Novartis to site seventh new facility in North Carolina - European Pharmaceutical Review
Novartis to site seventh new facility in North Carolina European Pharmaceutical Review
Biopharma bites: FDA withholds vaccine data, plus staffing cuts for Novartis, Gilead - FirstWord Pharma
Biopharma bites: FDA withholds vaccine data, plus staffing cuts for Novartis, Gilead FirstWord Pharma
Novartis to Add New Facility in Morrisville, NC - Contract Pharma
Novartis to Add New Facility in Morrisville, NC Contract Pharma
Novartis taps North Carolina as new manufacturing hub location - MSN
Novartis taps North Carolina as new manufacturing hub location MSN
Novartis unveils North Carolina API plant as final piece of $23B US expansion - BioSpace
Novartis unveils North Carolina API plant as final piece of $23B US expansion BioSpace
Novartis rounds out $23B US investment push with plans for North Carolina API plant - Fierce Pharma
Novartis rounds out $23B US investment push with plans for North Carolina API plant Fierce Pharma
Novartis to build Morrisville pharma facility as part of $23 billion push - CBS 17
Novartis to build Morrisville pharma facility as part of $23 billion push CBS 17
Novartis finalizes US manufacturing and R&D expansion plan with seventh new facility - GlobeNewswire
Novartis finalizes US manufacturing and R&D expansion plan with seventh new facility GlobeNewswire
Novartis unveils North Carolina factory as final new build in $23B US expansion - Endpoints News
Novartis unveils North Carolina factory as final new build in $23B US expansion Endpoints News
Novartis announces new API manufacturing facility in North Carolina - StreetInsider
Novartis announces new API manufacturing facility in North Carolina StreetInsider
Novartis finalizes US manufacturing and R&D expansion plan with seventh new facility - marketscreener.com
Novartis finalizes US manufacturing and R&D expansion plan with seventh new facility marketscreener.com
Novartis to open new drug manufacturing facility in Morrisville, North Carolina - ABC11 Raleigh-Durham
Novartis finalizes new drug manufacturing facility in Morrisville, North Carolina ABC11 Raleigh-Durham
Novartis finalizes US manufacturing and R&D expansion plan - The Pharma Letter
Novartis finalizes US manufacturing and R&D expansion plan The Pharma Letter
Novartis (NVS) Expands Manufacturing with New Facility in North Carolina - GuruFocus
Novartis (NVS) Expands Manufacturing with New Facility in North Carolina GuruFocus
Novartis to build Morrisville pharma facility as part of $23 billion push - CBS 17
Novartis to build Morrisville pharma facility as part of $23 billion push CBS 17
Manufacturing Insights: Novartis’ Next Move - DCAT Value Chain Insights
Manufacturing Insights: Novartis’ Next Move DCAT Value Chain Insights
Novartis to open API manufacturing facility in Morrisville - BioProcess International
Novartis to open API manufacturing facility in Morrisville BioProcess International
Novartis Finalizes US Expansion with Seventh Facility to Strengthen End-to-End Drug Manufacturing - BioPharm International
Novartis Finalizes US Expansion with Seventh Facility to Strengthen End-to-End Drug Manufacturing BioPharm International
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