Novartis Contract Manufacturing
Morris Plains, NJ · Stein, CH
Hybrid — also manufactures internal programs
419 confirmed programs
· 118 sponsors
· Last scored 2026-04-29
71.2
Signal Score
✓ FDA Inspections (14)
✓ Clinical Trials (282)
✓ SEC Filings (30)
✓ Press (20)
✓ EMA GMP (47)
✓ MHRA GMP (3)
Quick Facts: Novartis Contract Manufacturing
- Signal Score
- 71.2/100 (as of 2026-04-29)
- Quality Compliance
- 68.4/100 — OAI classification at Lincoln (2024-07-29) — CRITICAL
- Headquarters
- Morris Plains, NJ · Stein, CH
- Modalities
- CAR-T
- Active Programs
- 419 confirmed from ClinicalTrials.gov across 118 sponsors
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Novartis Contract Manufacturing
Hybrid developer + CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
68.4
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 Certificates47 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
419 active programs across 118 sponsors
Modalities: CAR-T
279 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
419 active programs across 118 sponsors · Modalities: CAR-T · 279 programs in advanced phases (Phase 2/3)
Programs
419
Sponsors118
ModalitiesCAR-T
419 active programs across 118 sponsors
Modalities: CAR-T
279 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07621809
Two Arm, Double-blind, Phase III Study Assessing Efficacy and...
PHASE3
Not Yet Recruiting
View all 282 programs →
Source: ClinicalTrials.gov · Retrieved Jul 04, 2026
Financial Stability
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
30 SEC filings with industry mentions on record
SEC Filings30 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
Novartis Contract Manufacturing 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 Jul 04, 2026
Novartis Contract Manufacturing 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."
Novartis Contract Manufacturing EMA GMP Compliance 47 certificates
2026-03
2026-03
2026-02
2026-02
2026-02
2026-01
2025-12
2025-12
2025-12
2025-12
2025-12
2025-12
2025-12
2025-12
2025-12
2025-11
2025-11
2025-11
2025-11
2025-11
2025-10
2025-10
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 |
|---|---|---|---|---|
| BE/GMP/2026/031 | Novartis ManufacturingAlternative Name:Novartis Manufacturing N.V. | Belgium | 2026-03-18 | COMPLIANT |
| 484341-105007650 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2026-03-17 | COMPLIANT |
| 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 |
| IT/90/H/2026 | Novartis Farma S.p.A. | Italy | 2026-01-16 | COMPLIANT |
| 450-8/2026-2 | Novartis Pharmaceutical Manufacturing LLCAlternative Name:Novartis farmacevtska proizvodnja d.o.o. | Slovenia | 2025-12-19 | COMPLIANT |
| 450-15/2026-2 | Novartis Pharmaceutical Manufacturing LLCAlternative Name:Novartis farmacevtska proizvodnja d.o.o. | Slovenia | 2025-12-19 | COMPLIANT |
| 450-16/2026-2 | 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 |
| 450-15/2026-1 | Novartis Pharmaceutical Manufacturing LLCAlternative Name:Novartis farmacevtska proizvodnja d.o.o. | Slovenia | 2025-12-09 | COMPLIANT |
| 450-16/2026-1 | 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 |
| BE/GMP/2025/206 | Novartis PharmaAlternative Name:Novartis Pharma N.V. | Belgium | 2025-11-24 | COMPLIANT |
| BE/GMP/2025/207 | Novartis PharmaAlternative Name:Novartis Pharma N.V. | Belgium | 2025-11-24 | COMPLIANT |
| 484600-104544504 | Novartis Pharmaceutical Manufacturing GmbH | Austria | 2025-10-20 | COMPLIANT |
| 484600-105471718 | 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 |
| 484295-105471003 | 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 Jul 04, 2026
Novartis Contract Manufacturing 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 Jul 04, 2026
Clinical Activity 282 studies
NCT07621809
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of...
PHASE3
Not Yet Recruiting
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
Recruiting
NCT07039422
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and...
PHASE2
Recruiting
NCT07564401
A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
PHASE1/PHASE2
Recruiting
NCT07660055
Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
PHASE1
Recruiting
NCT07468071
Rollover Study for Participants Who Have Been Treated With and Are...
PHASE1/PHASE2
Recruiting
NCT07378969
A Non-Interventional Study PASS to Characterize Secondary Malignancies of...
NA
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
Active Not 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
+ 262 more studies
Source: ClinicalTrials.gov · Retrieved Jul 04, 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 Jul 04, 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
Frequently Asked Questions About Novartis Contract Manufacturing
How many FDA inspections does Novartis Contract Manufacturing have on record?
CDMO Signal tracks 14 FDA inspections for Novartis Contract Manufacturing, sourced from the FDA inspection database. See the full inspection history above.
Has Novartis Contract Manufacturing received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Novartis Contract Manufacturing.
Does Novartis Contract Manufacturing hold EMA or MHRA GMP certificates?
CDMO Signal tracks 47 EMA and 3 MHRA GMP certificates for Novartis Contract Manufacturing.
How many clinical programs is Novartis Contract Manufacturing linked to?
Novartis Contract Manufacturing is associated with 282 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Novartis Contract Manufacturing's CDMO Signal Score?
Novartis Contract Manufacturing has a Signal Score of 71/100, based on quality, operations, financial stability, and capacity data.
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