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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9906
Submission : 1992-10-09
Status : Active
Type : II
Registration Number : 227MF10097
Registrant's Address : Lichtstrasse 35, CH-4056 Basel, Switzerland
Initial Date of Registration : 2015-04-09
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23902
Submission : 2010-07-02
Status : Active
Type : II
Certificate Number : CEP 2016-290 - Rev 03
Issue Date : 2024-10-16
Type : Chemical
Substance Number : 2423
Status : Valid
Registrant Name : Novartis Korea Ltd.
Registration Date : 2011-12-09
Registration Number : 20111209-135-H-172-28
Manufacturer Name : Novartis Grimsby Ltd.
Manufacturer Address : Moody Lane, Pyewipe, Grimsby_N.E. Lincolnshire/DN31 2SR/England
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2008-122 - Rev 02
Issue Date : 2023-12-14
Type : Chemical
Substance Number : 1491
Status : Valid
NDC Package Code : 0078-1476
Start Marketing Date : 2007-06-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9643
Submission : 1992-04-15
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23901
Submission : 2010-06-30
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6895
Submission : 1987-03-26
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2019-149 - Rev 00
Issue Date : 2020-09-03
Type : Chemical
Substance Number : 2334
Status : Valid
Registrant Name : Novartis Korea Ltd.
Registration Date : 2021-07-27
Registration Number : 20210727-209-J-1080
Manufacturer Name : Novartis Pharma Schweizerhalle AG@Novartis Pharma Stein AG
Manufacturer Address : Rothausstrasse, 4133, Pratteln, Switzerland@Schaffhauserstrasse, 4332 Stein, Switzerland
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31705
Submission : 2017-05-02
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16772
Submission : 2003-08-19
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27059
Submission : 2013-06-07
Status : Active
Type : II
Registrant Name : G-Therapeutics Korea Co., Ltd.
Registration Date : 2011-02-15
Registration Number : 20110215-49-A-244-16
Manufacturer Name : Novartis Ringaskiddy Limited
Manufacturer Address : Ringaskiddy, Co. Cork
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4583
Submission : 1982-06-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6910
Submission : 1987-03-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7810
Submission : 1988-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23901
Submission : 2010-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3527
Submission : 1979-05-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9643
Submission : 1992-04-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31705
Submission : 2017-05-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31023
Submission : 2016-09-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16772
Submission : 2003-08-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9709
Submission : 1992-06-04
Status : Inactive
Type : II
CEP/COS
Novartis Pharmaceuticals Corporation
Certificate Numbers : CEP 2008-122 - Rev 02
Status : Valid
Issue Date : 2023-12-14
Type : Chemical
Substance Number : 1491
Certificate Numbers : R0-CEP 2000-300 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2005-03-04
Type : TSE
Substance Number :
CEP/COS
Novartis Pharmaceuticals Corporation
Certificate Numbers : R0-CEP 2019-149 - Rev 00
Status : Valid
Issue Date : 2020-09-03
Type : Chemical
Substance Number : 2334
CEP/COS
Novartis Pharmaceuticals Corporation
Certificate Numbers : CEP 2016-290 - Rev 03
Status : Valid
Issue Date : 2024-10-16
Type : Chemical
Substance Number : 2423
Details:
Through the acquisition, Novartis will levarage Regulus pipeline, which includes RGLS8429 (farabursen), a potential next-gen oligonucleotide targeting miR-17 for the treatment of ADPKD.
Lead Product(s): Farabursen
Therapeutic Area: Genetic Disease Brand Name: RGLS8429
Study Phase: Phase IProduct Type: Oligonucleotide
Recipient: Regulus Therapeutics
Deal Size: $1,700.0 million Upfront Cash: $800.0 million
Deal Type: Acquisition April 30, 2025
Lead Product(s) : Farabursen
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Recipient : Regulus Therapeutics
Deal Size : $1,700.0 million
Deal Type : Acquisition
Novartis Acquires Regulus and Farabursen for ADPKD Treatment
Details : Through the acquisition, Novartis will levarage Regulus pipeline, which includes RGLS8429 (farabursen), a potential next-gen oligonucleotide targeting miR-17 for the treatment of ADPKD.
Product Name : RGLS8429
Product Type : Oligonucleotide
Upfront Cash : $800.0 million
April 30, 2025
Details:
The partnership aims to distribute Novartis' Vanrafia (atrasentan HCl) through CareMed. It is indicated for the treatment of proteinuria in adults with primary immunoglobulin A nephropathy.
Lead Product(s): Atrasentan
Therapeutic Area: Nephrology Brand Name: Vanrafia
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: CareMed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 07, 2025
Lead Product(s) : Atrasentan
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : CareMed
Deal Size : Undisclosed
Deal Type : Partnership
CareMed Chosen As Specialty Pharmacy Partner For VANRAFIA
Details : The partnership aims to distribute Novartis' Vanrafia (atrasentan HCl) through CareMed. It is indicated for the treatment of proteinuria in adults with primary immunoglobulin A nephropathy.
Product Name : Vanrafia
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
April 07, 2025
Details:
Through the acquisition, Novartis will strengthen its cardiovascular portfolio with Anthos' MAA868 (abelacimab), a potential monoclonal antibody for the treatment of atrial fibrillation.
Lead Product(s): Abelacimab
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: MAA868
Study Phase: Phase IIIProduct Type: Antibody
Recipient: Anthos Therapeutics
Deal Size: $3,075.0 million Upfront Cash: $925.0 million
Deal Type: Acquisition April 03, 2025
Lead Product(s) : Abelacimab
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Recipient : Anthos Therapeutics
Deal Size : $3,075.0 million
Deal Type : Acquisition
Novartis has Completed the Acquisition of Anthos
Details : Through the acquisition, Novartis will strengthen its cardiovascular portfolio with Anthos' MAA868 (abelacimab), a potential monoclonal antibody for the treatment of atrial fibrillation.
Product Name : MAA868
Product Type : Antibody
Upfront Cash : $925.0 million
April 03, 2025
Details:
Vanrafia (atrasentan HCl) is an investigational oral endothelin A receptor antagonist (ERA), which is approved for IgAN and early-stage development for other rare kidney diseases.
Lead Product(s): Atrasentan
Therapeutic Area: Nephrology Brand Name: Vanrafia
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 02, 2025
Lead Product(s) : Atrasentan
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Gets FDA Approval for Vanrafia® to Reduce Proteinuria in IgAN
Details : Vanrafia (atrasentan HCl) is an investigational oral endothelin A receptor antagonist (ERA), which is approved for IgAN and early-stage development for other rare kidney diseases.
Product Name : Vanrafia
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 02, 2025
Details:
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen, which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
Lead Product(s): 177Lu-vipivotide Tetraxetan,68Ga-PSMA-11
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: Approved FDFProduct Type: Radiolabelled Compounds
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 28, 2025
Lead Product(s) : 177Lu-vipivotide Tetraxetan,68Ga-PSMA-11
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Novartis' Pluvicto for PSMA+ mCRPC Before Chemotherapy
Details : Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen, which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
Product Name : Pluvicto
Product Type : Radiolabelled Compounds
Upfront Cash : Inapplicable
March 28, 2025
Details:
Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway. It is now approved by FDA for the treatment of patients withC3 glomerulopathy.
Lead Product(s): Iptacopan HCl
Therapeutic Area: Nephrology Brand Name: Fabhalta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 20, 2025
Lead Product(s) : Iptacopan HCl
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis’ Fabhalta® FDA Approved for C3 Glomerulopathy (C3G) Treatment
Details : Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway. It is now approved by FDA for the treatment of patients withC3 glomerulopathy.
Product Name : Fabhalta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 20, 2025
Details:
Zolgensma (onasemnogene abeparvovec) is USFDA approved, one time gne therapy that acts as SMN1 gene stimulant. It is indicated for the treatment of spinal muscular atrophy.
Lead Product(s): Onasemnogene Abeparvovec
Therapeutic Area: Genetic Disease Brand Name: Zolgensma
Study Phase: Phase IIIProduct Type: Cell and Gene therapy
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 19, 2025
Lead Product(s) : Onasemnogene Abeparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Phase III Data Shows Efficacy of Onasemnogene Abeparvovec in SMA
Details : Zolgensma (onasemnogene abeparvovec) is USFDA approved, one time gne therapy that acts as SMN1 gene stimulant. It is indicated for the treatment of spinal muscular atrophy.
Product Name : Zolgensma
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
March 19, 2025
Details:
Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway. It is being evaluated for the treatment of patients withC3 glomerulopathy.
Lead Product(s): Iptacopan HCl
Therapeutic Area: Nephrology Brand Name: Fabhalta
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 28, 2025
Lead Product(s) : Iptacopan HCl
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis oral Fabhalta® (iptacopan) Receives Positive CHMP Opinion
Details : Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway. It is being evaluated for the treatment of patients withC3 glomerulopathy.
Product Name : Fabhalta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 28, 2025
Details:
Through the acquisition, Novartis will strengthen its cardiovascular portfolio with Anthos' MAA868 (abelacimab), a potential monoclonal antibody for the treatment of atrial fibrillation.
Lead Product(s): Abelacimab
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: MAA868
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Novartis Pharmaceuticals Corporation
Deal Size: $3,075.0 million Upfront Cash: $925.0 million
Deal Type: Acquisition February 11, 2025
Lead Product(s) : Abelacimab
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : $3,075.0 million
Deal Type : Acquisition
Novartis to Acquire Anthos Therapeutics for USD 925 Million Upfront
Details : Through the acquisition, Novartis will strengthen its cardiovascular portfolio with Anthos' MAA868 (abelacimab), a potential monoclonal antibody for the treatment of atrial fibrillation.
Product Name : MAA868
Product Type : Antibody
Upfront Cash : $925.0 million
February 11, 2025
Details:
Zolgensma (onasemnogene abeparvovec) is USFDA approved, one time gne therapy that acts as SMN1 gene stimulant. It is indicated for the treatment of spinal muscular atrophy.
Lead Product(s): Onasemnogene Abeparvovec
Therapeutic Area: Genetic Disease Brand Name: Zolgensma
Study Phase: Phase IIIProduct Type: Cell and Gene therapy
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 30, 2024
Lead Product(s) : Onasemnogene Abeparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Phase III Study of Onasemnogene Abeparvovec Meets Primary Endpoint in SMA
Details : Zolgensma (onasemnogene abeparvovec) is USFDA approved, one time gne therapy that acts as SMN1 gene stimulant. It is indicated for the treatment of spinal muscular atrophy.
Product Name : Zolgensma
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
December 30, 2024
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Novartis Pharmaceuticals Corporation
Dosage Form : TABLET;ORAL
Brand Name : TAVIST ALLERGY/SINUS/HEAD...
Dosage Strength : 500MG;EQ 0.25MG BASE;3...
Packaging :
Approval Date : 2001-03-01
Application Number : 21082
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Novartis Pharmaceuticals Corporation
Dosage Form : FOR SOLUTION;OPHTHALMIC
Brand Name : MIOCHOL
Dosage Strength : 20MG/VIAL **Federal Re...
Packaging :
Approval Date : 1982-01-01
Application Number : 16211
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Novartis Pharmaceuticals Corporation
Dosage Form : TABLET;ORAL
Brand Name : ACYLANID
Dosage Strength : 0.1MG
Packaging :
Approval Date : 1982-01-01
Application Number : 9436
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Novartis Pharmaceuticals Corporation
Dosage Form : Film-Coated Tablets
Brand Name : Myfortic
Dosage Strength : 360mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Novartis Pharmaceuticals Corporation
Dosage Form : Film-Coated Tablets
Brand Name : Myfortic
Dosage Strength : 180mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Novartis Pharmaceuticals Corporation
Dosage Form : Inf Conc
Brand Name : Zometa
Dosage Strength : 4mg/5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : DISCN
Registration Country : USA
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Novartis Pharmaceuticals Corporation
Dosage Form : TABLET;ORAL
Brand Name : TEKAMLO
Dosage Strength : EQ 150MG BASE;EQ 5MG B...
Packaging :
Approval Date : 2010-08-26
Application Number : 22545
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Novartis Pharmaceuticals Corporation
Dosage Form : TABLET;ORAL
Brand Name : TEKAMLO
Dosage Strength : EQ 300MG BASE;EQ 5MG B...
Packaging :
Approval Date : 2010-08-26
Application Number : 22545
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Novartis Pharmaceuticals Corporation
Dosage Form : TABLET;ORAL
Brand Name : TEKAMLO
Dosage Strength : EQ 150MG BASE;EQ 10MG ...
Packaging :
Approval Date : 2010-08-26
Application Number : 22545
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Novartis Pharmaceuticals Corporation
Dosage Form : TABLET;ORAL
Brand Name : TEKAMLO
Dosage Strength : EQ 300MG BASE;EQ 10MG ...
Packaging :
Approval Date : 2010-08-26
Application Number : 22545
Regulatory Info : DISCN
Registration Country : USA
Excipients
Inspections and registrations
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Novartis Pharmaceuticals Corporation is a supplier offers 71 products (APIs, Excipients or Intermediates).
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