Novartis Contract Manufacturing
Morris Plains, NJ · Stein, CH
Hybrid — also manufactures internal programs
414 confirmed programs
· 117 sponsors
· Last scored 2026-04-02
81.5
Signal Score
✓ FDA Inspections (8)
✓ Clinical Trials (278)
✓ SEC Filings (29)
✓ Press (20)
✓ EMA GMP (29)
✓ MHRA GMP (3)
Quick Facts: Novartis Contract Manufacturing
- Signal Score
- 81.5/100 (as of 2026-04-02)
- Quality Compliance
- 97.8/100 — OAI classification at Selaqui (2025-09-16) — CRITICAL
- Headquarters
- Morris Plains, NJ · Stein, CH
- Modalities
- CAR-T
- Active Programs
- 414 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
Signal Score & Pillar Breakdown
Quality Compliance
97.8
OAI classification at Selaqui (2025-09-16) — CRITICAL
Source: FDA Data Dashboard
OAI classification at Selaqui (2025-09-16) — CRITICAL
FDA Inspections8 on record
Warning Letters0
Last InspectionOfficial Action Indicated (OAI) (2025-09-16)
EMA GMP Certificates29 on record
MHRA GMP Certificates3 on record
OAI classification at Selaqui (2025-09-16) — CRITICAL
Operations
94.8
414 active programs across 117 sponsors
Modalities: CAR-T
276 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
414 active programs across 117 sponsors · Modalities: CAR-T · 276 programs in advanced phases (Phase 2/3)
Programs
414
Sponsors117
ModalitiesCAR-T
414 active programs across 117 sponsors
Modalities: CAR-T
276 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07421167
A Study to Assess the Tolerability of Ianalumab (VAY736) With...
PHASE2
Not Yet Recruiting
NCT07468071
Rollover Study for Participants Who Have Been Treated With...
PHASE1/PHASE2
Not Yet Recruiting
View all 278 programs →
Source: ClinicalTrials.gov · Retrieved Apr 05, 2026
Financial Stability
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
29 SEC filings with industry mentions on record
SEC Filings29 with industry mentions
Private company
Financial assessment: 60.0/100
Capacity
58.0
2 manufacturing sites
Sites: Morris Plains, NJ, Stein, CH
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
StatusConstrained
2 manufacturing sites
Sites: Morris Plains, NJ, Stein, CH
Recent Press20 articles
2 manufacturing sites
FDA Inspection History
2025-09
2025-06
2025-03
2024-11
2024-08
2024-08
2024-07
2024-06
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-16 | Selaqui | Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 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) |
| 2024-07-12 | 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 Apr 05, 2026
EMA GMP Compliance 29 certificates
2025-12
2025-12
2025-12
2025-12
2025-12
2025-11
2025-11
2025-11
2025-10
2025-10
2025-10
2025-10
2025-04
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
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 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 |
| 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 |
Source: EMA EudraGMDP · Retrieved Apr 05, 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 Apr 05, 2026
Clinical Activity 278 studies
NCT07448610
ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy...
PHASE4
Not Yet Recruiting
NCT07421167
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's...
PHASE2
Not Yet Recruiting
NCT07468071
Rollover Study for Participants Who Have Been Treated With and Are...
PHASE1/PHASE2
Not Yet Recruiting
NCT07039422
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and...
PHASE2
Recruiting
NCT07378969
A Non-Interventional Study PASS to Characterize Secondary Malignancies of...
NA
Not Yet Recruiting
NCT07006727
Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing...
PHASE1
Recruiting
NCT06855277
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants...
PHASE3
Recruiting
NCT07048197
A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of...
PHASE1/PHASE2
Recruiting
NCT07029555
An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis
PHASE1
Recruiting
NCT06910813
DFT383 in Pediatric Participants With Nephropathic Cystinosis
PHASE1/PHASE2
Recruiting
NCT06711887
Phase III Extension Study of Efficacy and Safety of Ianalumab With or...
PHASE3
Recruiting
NCT06704269
Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in...
PHASE1/PHASE2
Recruiting
NCT06868290
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe...
PHASE2
Recruiting
NCT06617793
An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of...
PHASE1/PHASE2
Recruiting
NCT06665256
Phase 2 Study of Rapcabtagene Autoleucel in Myositis
PHASE2
Recruiting
NCT06675864
Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease...
PHASE1/PHASE2
Recruiting
NCT06439082
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg)...
PHASE3
Recruiting
NCT06562192
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast...
PHASE1
Recruiting
NCT06470048
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse...
PHASE2
Recruiting
NCT06376253
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
PHASE1
Terminated
+ 258 more studies
Source: ClinicalTrials.gov · Retrieved Apr 05, 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 Apr 05, 2026
Recent News 20 articles
Novartis charts major expansion plan - China Daily
Novartis charts major expansion plan China Daily
Novartis Pledges $480M To Expand China Presence, Following Eli Lilly and AstraZeneca - BioSpace
Novartis Pledges $480M To Expand China Presence, Following Eli Lilly and AstraZeneca BioSpace
Novartis doubles down on China with $480 million investment - The Pharma Letter
Novartis doubles down on China with $480 million investment The Pharma Letter
Novartis announces further China investment - China Daily
Novartis announces further China investment China Daily
Novartis to Invest Over USD460 Million to Boost Drug Production in Beijing, R&D in Shanghai - Yicai Global
Novartis to Invest Over USD460 Million to Boost Drug Production in Beijing, R&D in Shanghai Yicai Global
Novartis joins Lilly, AZ in China expansion with $480M commitment to boost manufacturing, R&D - Fierce Pharma
Novartis joins Lilly, AZ in China expansion with $480M commitment to boost manufacturing, R&D Fierce Pharma
Novartis joins peers in committing cash to China - FirstWord Pharma
Novartis joins peers in committing cash to China FirstWord Pharma
Novartis to boost multidimensional investments - China Daily
Novartis to boost multidimensional investments China Daily
Novartis to build radioligand therapy site in Texas to expand US manufacturing - MSN
Novartis to build radioligand therapy site in Texas to expand US manufacturing MSN
Novartis CEO says expanded US production limits tariff risk - MSN
Novartis CEO says expanded US production limits tariff risk MSN
Novartis taps North Carolina as new manufacturing hub location - MSN
Novartis taps North Carolina as new manufacturing hub location MSN
Human Gene Therapy Market Set to Boom Through 2033 | Novartis • Gilead Sciences • Spark Therapeutics - openPR.com
Human Gene Therapy Market Set to Boom Through 2033 | Novartis • Gilead Sciences • Spark Therapeutics openPR.com
Novartis, Nucor partner US Forged Rings and others expand domestic investments - Manufacturing Dive
Novartis, Nucor partner US Forged Rings and others expand domestic investments Manufacturing Dive
Novartis, Nucor partner US Forged Rings and others expand domestic investments - Yahoo Finance
Novartis, Nucor partner US Forged Rings and others expand domestic investments Yahoo Finance
Novartis to Build New Radioligand Therapy Site in Denton, Texas - Contract Pharma
Novartis to Build New Radioligand Therapy Site in Denton, Texas Contract Pharma
Novartis Gains 0.59% on Gene Therapy Expansion and Digital Health Push as Trading Volume Ranks 365th - Bitget
Novartis Gains 0.59% on Gene Therapy Expansion and Digital Health Push as Trading Volume Ranks 365th Bitget
Novartis Gains 0.59% on Gene Therapy Expansion and Digital Health Push as Trading Volume Ranks 365th - Bitget
Novartis Gains 0.59% on Gene Therapy Expansion and Digital Health Push as Trading Volume Ranks 365th Bitget
AI in Pharma Manufacturing Market Research 2026-2040: Pfizer, Moderna, Novartis, Merck, and Sanofi are Integrating AI Into Their Operations As the Sector Evolves Towards Pharma 4.0 - Yahoo Finance UK
AI in Pharma Manufacturing Market Research 2026-2040: Pfizer, Moderna, Novartis, Merck, and Sanofi are Integrating AI Into Their Operations As the Sector Evolves Towards Pharma 4.0 Yahoo Finance UK
Novartis plans radioligand therapy manufacturing site in Texas - DOTmed
Novartis plans radioligand therapy manufacturing site in Texas DOTmed
AI in Pharma Manufacturing Market Research 2026-2040: Pfizer, Moderna, Novartis, Merck, and Sanofi are Integrating AI Into Their Operations As the Sector Evolves Towards Pharma 4.0 - Yahoo Finance
AI in Pharma Manufacturing Market Research 2026-2040: Pfizer, Moderna, Novartis, Merck, and Sanofi are Integrating AI Into Their Operations As the Sector Evolves Towards Pharma 4.0 Yahoo Finance
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