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1. 1038915-73-9
2. Mk-4827 Tosylate
3. Mk-4827 (tosylate)
4. Mk-4827-tosylate
5. Niraparib (tosylate)
6. Mk 4827 Tosylate
7. Niraparib (mk-4827) Tosylate
8. (s)-2-(4-(piperidin-3-yl)phenyl)-2h-indazole-7-carboxamide 4-methylbenzenesulfonate
9. 75ke12ay9u
10. Mk-4827(niraparib) Tosylate
11. 2h-indazole-7-carboxamide, 2-(4-(3s)-3-piperidinylphenyl)-, 4-methylbenzenesulfonate (1:1)
12. Unii-75ke12ay9u
13. Niraparib Tosylate Monohyrate
14. Niraparib(mk-4827) Tosylate
15. Schembl20522624
16. Dtxsid801026487
17. Hy-10619b
18. Mfcd28167748
19. S7625
20. Ccg-269634
21. Niraparib Tosylate [orange Book]
22. Ac-30383
23. As-56981
24. A11848
25. A909268
26. Q27266392
27. (3s)-3-[4-[7-(aminocarbonyl)-2h-indazol-2-yl]phenyl]piperidine Tosylate
28. (s)-2-(4-(piperidin-3-yl)phenyl)-2h-indazole-7-carboxamide 4-?methylbenzenesulfona?te
29. 4-methylbenzenesulfonic Acid;2-[4-[(3s)-piperidin-3-yl]phenyl]indazole-7-carboxamide
30. 2-{4-[(3s)-piperidin-3-yl]phenyl}-2h-indazole-7-carboxamide; 4-methylbenzene-1-sulfonic Acid
Molecular Weight | 492.6 g/mol |
---|---|
Molecular Formula | C26H28N4O4S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 4 |
Exact Mass | 492.18312656 g/mol |
Monoisotopic Mass | 492.18312656 g/mol |
Topological Polar Surface Area | 136 Ų |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 655 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41455
Submission : 2025-03-27
Status : Active
Type : II
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41529
Submission : 2025-03-17
Status : Active
Type : II
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Details:
Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Ovarian Neoplasms.
Lead Product(s): Niraparib Tosylate,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 09, 2025
Lead Product(s) : Niraparib Tosylate,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Ovarian Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 09, 2025
Details:
IMNN-001 is a Cell and Gene Therapy drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Ovarian Epithelial.
Lead Product(s): IMNN-001,Paclitaxel,Carboplatin,Olaparib,Niraparib Tosylate
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Cell & Gene Therapy
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 07, 2025
Lead Product(s) : IMNN-001,Paclitaxel,Carboplatin,Olaparib,Niraparib Tosylate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : IMNN-001 is a Cell and Gene Therapy drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Ovarian Epithelial.
Product Name : Undisclosed
Product Type : Cell & Gene Therapy
Upfront Cash : Inapplicable
April 07, 2025
Details:
Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Ovarian Neoplasms.
Lead Product(s): Niraparib Tosylate,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 21, 2025
Lead Product(s) : Niraparib Tosylate,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Ovarian Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 21, 2025
Details:
ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.
Lead Product(s): Azenosertib,Niraparib Tosylate
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 09, 2025
Lead Product(s) : Azenosertib,Niraparib Tosylate
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Zentalis Announces Fast Track Designation for Azenosertib and Upcoming Data Event
Details : ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 09, 2025
Details:
Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.
Lead Product(s): Niraparib Tosylate,Ipilimumab
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Lustgarten Foundation | GSK | Bristol Myers Squibb
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 24, 2024
Lead Product(s) : Niraparib Tosylate,Ipilimumab
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Lustgarten Foundation | GSK | Bristol Myers Squibb
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 24, 2024
Details:
Jemperli (dostarlimab, targets PD-1) in combination with Zejula (niraparib, targets PARP) is being evaluated as a first line treatment in phase 3 ciical trials of ovarian cancer.
Lead Product(s): Dostarlimab,Niraparib Tosylate
Therapeutic Area: Oncology Brand Name: Jemperli
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 20, 2024
Lead Product(s) : Dostarlimab,Niraparib Tosylate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
GSK Announces FIRST Trial Met Primary Endpoint in Advanced Ovarian Cancer
Details : Jemperli (dostarlimab, targets PD-1) in combination with Zejula (niraparib, targets PARP) is being evaluated as a first line treatment in phase 3 ciical trials of ovarian cancer.
Product Name : Jemperli
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
December 20, 2024
Details:
ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.
Lead Product(s): Azenosertib,Niraparib Tosylate
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 16, 2024
Lead Product(s) : Azenosertib,Niraparib Tosylate
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Zentalis Pharmaceuticals Reports FDA Lifts Partial Clinical Hold on Azenosertib Studies
Details : ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 16, 2024
Details:
Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Prostatic Neoplasms.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Johnson & Johnson Innovative Medicine
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 30, 2024
Lead Product(s) : Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Johnson & Johnson Innovative Medicine
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Prostatic Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 30, 2024
Details:
Akeega (niraparib, abiraterone acetate) is a tablet works by inhibiting approved for BRCA-mutated mCRPC in adults. The FDA has approved FoundationOne Liquid CDx as its companion diagnostic.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Brand Name: Akeega
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: JANSSEN BIOTECH
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 01, 2024
Lead Product(s) : Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : JANSSEN BIOTECH
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves FoundationOne®Liquid CDx as Companion Diagnostic for AKEEGA®
Details : Akeega (niraparib, abiraterone acetate) is a tablet works by inhibiting approved for BRCA-mutated mCRPC in adults. The FDA has approved FoundationOne Liquid CDx as its companion diagnostic.
Product Name : Akeega
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
July 01, 2024
Details:
ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.
Lead Product(s): Azenosertib,Niraparib Tosylate
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 18, 2024
Lead Product(s) : Azenosertib,Niraparib Tosylate
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Zentalis Pharmaceuticals Provides Update on Azenosertib Clinical Development Program
Details : ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 18, 2024
3-(Methoxy carbonyl)-2-nitrobenzoic acid
CAS Number : 138229-59-1
End Use API : Niraparib Tosylate
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
tert-butyl (3S)-3-(4-amino phenyl) piperidine-1-ca...
CAS Number : 1171197-20-8
End Use API : Niraparib Tosylate
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
(S)-3-(4-Bromophenyl)piperidine
CAS Number : 1335523-82-4
End Use API : Niraparib Tosylate
About The Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing ...
(S)-3-(4-bromophenyl)piperidine hydrochloride
CAS Number : 2141967-71-5
End Use API : Niraparib Tosylate
About The Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing ...
RLD : Yes
TE Code :
Brand Name : ZEJULA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2017-03-27
Application Number : 208447
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZEJULA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2023-04-26
Application Number : 214876
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZEJULA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Approval Date : 2023-04-26
Application Number : 214876
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZEJULA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 300MG BASE
Approval Date : 2023-04-26
Application Number : 214876
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Norway
Brand Name : Zejula
Dosage Form : Tablet, film-coated
Dosage Strength : 100 mg
Packaging : Blisterpakning 56item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Zejula
Dosage Form : Tablet, film-coated
Dosage Strength : 100 mg
Packaging : Blisterpakning 84item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Zejula capsules
Dosage Form : Capsule
Dosage Strength : 100mg
Packaging :
Approval Date : 03/10/2018
Application Number : 66763
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Zejula
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 20/01/2023
Application Number : 68652
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Niraparib Tosylate Monohydrate
Brand Name : Zejula
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date : 2024-04-12
Application Number : 1171235006
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Niraparib Tosylate Monohydrate
Brand Name : Zejula
Dosage Form : Hard Capsule
Dosage Strength : 100MG
Packaging :
Approval Date : 2018-03-08
Application Number : 1171235001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Allowed
Registration Country : Switzerland
Niraparib; Abiraterone Acetate
Brand Name : Akeega mg
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg;500mg
Packaging :
Approval Date : 18/04/2024
Application Number : 68977
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Niraparib; Abiraterone Acetate
Brand Name : Akeega mg
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg;500mg
Packaging :
Approval Date : 18/04/2024
Application Number : 68977
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Abiraterone Acetate; Niraparib Tosylate Monohydrate
Brand Name : Akeega
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG; 500 MG
Packaging :
Approval Date : 2023-04-27
Application Number : 1231722002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Abiraterone Acetate; Niraparib Tosylate Monohydrate
Brand Name : Akeega
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG; 500 MG
Packaging :
Approval Date : 2023-04-27
Application Number : 1231722001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : AKEEGA 50 mg /500 mg
Dosage Form : FCT
Dosage Strength : 50mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : AKEEGA 100 mg /500 mg
Dosage Form : FCT
Dosage Strength : 100mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Tablet
Grade : Oral
Excipients by Applications
Global Sales Information
Company : Janssen Biotech
Niraparib/Abiraterone
Drug Cost (USD) : 566,563
Year : 2023
Prescribers : 16
Prescriptions : 31
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Glaxosmithkline
Niraparib Tosylate
Drug Cost (USD) : 161,500,239
Year : 2023
Prescribers : 1886
Prescriptions : 10023
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Glaxosmithkline
Niraparib Tosylate
Drug Cost (USD) : 154,728,383
Year : 2022
Prescribers : 2211
Prescriptions : 11360
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Glaxosmithkline
Niraparib Tosylate
Drug Cost (USD) : 152,013,598
Year : 2021
Prescribers : 2662
Prescriptions : 11565
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Tesaro, Inc.
Niraparib Tosylate
Drug Cost (USD) : 364,669
Year : 2021
Prescribers : 15
Prescriptions : 41
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Tesaro, Inc.
Niraparib Tosylate
Drug Cost (USD) : 140,466,403
Year : 2020
Prescribers : 2766
Prescriptions : 10681
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Tesaro, Inc.
Niraparib Tosylate
Drug Cost (USD) : 95,099,948
Year : 2019
Prescribers : 1773
Prescriptions : 7528
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Tesaro, Inc.
Niraparib Tosylate
Drug Cost (USD) : 68,458,312
Year : 2018
Prescribers : 1451
Prescriptions : 5736
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GlaxoSmithKline (Ireland) Limited
Dosage Form : Tablet, film-coated
Dosage Strength : 100 mg
Price Per Pack (Euro) : 3,186.91
Published in :
Country : Norway
RX/OTC/DISCN :
GlaxoSmithKline (Ireland) Limited
Dosage Form : Tablet, film-coated
Dosage Strength : 100 mg
Price Per Pack (Euro) : 4,780.36
Published in :
Country : Norway
RX/OTC/DISCN :
Main Therapeutic Indication : Oncology
Currency : USD
2020 Revenue in Millions : 470
2019 Revenue in Millions : 317
Growth (%) : 48
Main Therapeutic Indication : Oncology
Currency : USD
2021 Revenue in Millions : 535
2020 Revenue in Millions : 464
Growth (%) : 17
Main Therapeutic Indication : Oncology
Currency : USD
2022 Revenue in Millions : 571
2021 Revenue in Millions : 535
Growth (%) : 7
Main Therapeutic Indication : Oncology
Currency : USD
2023 Revenue in Millions : 564
2022 Revenue in Millions : 571
Growth (%) : 13
Main Therapeutic Indication : Oncology
Currency : USD
2022 Revenue in Millions : 93
2021 Revenue in Millions : 68
Growth (%) : 37
Main Therapeutic Indication : Oncology
Currency : USD
2023 Revenue in Millions : 97
2022 Revenue in Millions : 93
Growth (%) : 18
Main Therapeutic Indication : Oncology
Currency : USD
2024 Revenue in Millions : 738
2023 Revenue in Millions : 564
Growth (%) : 31
Main Therapeutic Indication : Oncology
Currency : USD
2024 Revenue in Millions : 96
2023 Revenue in Millions : 96
Growth (%) : 0
Main Therapeutic Indication : Oncology
Currency : USD
2019 Revenue in Millions : 284
2018 Revenue in Millions : 0
Growth (%) : N/A
Market Place
Reply
29 Sep 2022
Reply
16 Feb 2022
Patents & EXCLUSIVITIES
Patent Expiration Date : 2031-03-27
US Patent Number : 8071623
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 214876
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-03-27
Patent Expiration Date : 2038-03-27
US Patent Number : 11673877
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 208447
Patent Use Code : U-3646
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-03-27
Patent Expiration Date : 2027-08-12
US Patent Number : 8071579
Drug Substance Claim :
Drug Product Claim :
Application Number : 214876
Patent Use Code : U-2655
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-08-12
Patent Expiration Date : 2027-08-12
US Patent Number : 8143241
Drug Substance Claim :
Drug Product Claim :
Application Number : 208447
Patent Use Code : U-2655
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-08-12
Patent Expiration Date : 2038-03-27
US Patent Number : 11091459
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 214876
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-03-27
Patent Expiration Date : 2027-08-12
US Patent Number : 8071579
Drug Substance Claim :
Drug Product Claim :
Application Number : 208447
Patent Use Code : U-2655
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-08-12
Patent Expiration Date : 2038-03-27
US Patent Number : 11091459
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 214876
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-03-27
Patent Expiration Date : 2031-03-27
US Patent Number : 8071623
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 214876
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-03-27
Patent Expiration Date : 2038-03-27
US Patent Number : 11673877
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 214876
Patent Use Code : U-3646
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-03-27
Patent Expiration Date : 2027-08-12
US Patent Number : 8071579
Drug Substance Claim :
Drug Product Claim :
Application Number : 214876
Patent Use Code : U-2655
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-08-12
Exclusivity Code : ODE-277
Exclusivity Expiration Date : 2026-10-23
Application Number : 208447
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-295
Exclusivity Expiration Date : 2027-04-29
Application Number : 208447
Product Number : 1
Exclusivity Details :
Patent Expiration Date : 2027-04-02
Date Granted : 2016-02-23
Brand Name : ZEJULA
Patent Number : 2647545
Filing Date : 2007-04-02
Strength per Unit : 100 mg
Dosage Form : CAPSULE
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2027-04-02
Date Granted : 2016-02-23
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2028-01-08
Date Granted : 2012-07-17
Brand Name : ZEJULA
Patent Number : 2674436
Filing Date : 2008-01-08
Strength per Unit : 100 mg
Dosage Form : CAPSULE
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2028-01-08
Date Granted : 2012-07-17
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2029-01-08
Date Granted : 2016-03-08
Brand Name : ZEJULA
Patent Number : 2711491
Filing Date : 2009-01-08
Strength per Unit : 100 mg
Dosage Form : CAPSULE
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2029-01-08
Date Granted : 2016-03-08
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2037-06-29
Date Granted : 2023-08-15
Brand Name : ZEJULA
Patent Number : 3029671
Filing Date : 2017-06-29
Strength per Unit : 100 mg
Dosage Form : CAPSULE
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2037-06-29
Date Granted : 2023-08-15
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2027-04-02
Date Granted : 2016-02-23
Brand Name : ZEJULA
Patent Number : 2647545
Filing Date : 2007-04-02
Strength per Unit : 100mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2027-04-02
Date Granted : 2016-02-23
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2028-01-08
Date Granted : 2012-07-17
Brand Name : ZEJULA
Patent Number : 2674436
Filing Date : 2008-01-08
Strength per Unit : 100mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2028-01-08
Date Granted : 2012-07-17
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2029-01-08
Date Granted : 2016-03-08
Brand Name : ZEJULA
Patent Number : 2711491
Filing Date : 2009-01-08
Strength per Unit : 100mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2029-01-08
Date Granted : 2016-03-08
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2037-06-29
Date Granted : 2023-08-15
Brand Name : ZEJULA
Patent Number : 3029671
Filing Date : 2017-06-29
Strength per Unit : 100mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2037-06-29
Date Granted : 2023-08-15
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2027-04-02
Date Granted : 2016-02-23
NIRAPARIB TOSYLATE, ABIRATERONE ACETATE
Brand Name : AKEEGA
Patent Number : 2647545
Filing Date : 2007-04-02
Strength per Unit : 50mg / 500mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2027-04-02
Date Granted : 2016-02-23
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2028-01-08
Date Granted : 2012-07-17
NIRAPARIB TOSYLATE, ABIRATERONE ACETATE
Brand Name : AKEEGA
Patent Number : 2674436
Filing Date : 2008-01-08
Strength per Unit : 50mg / 500mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2028-01-08
Date Granted : 2012-07-17
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ABOUT THIS PAGE
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PharmaCompass offers a list of Niraparib Tosylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Niraparib Tosylate manufacturer or Niraparib Tosylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Niraparib Tosylate manufacturer or Niraparib Tosylate supplier.
PharmaCompass also assists you with knowing the Niraparib Tosylate API Price utilized in the formulation of products. Niraparib Tosylate API Price is not always fixed or binding as the Niraparib Tosylate Price is obtained through a variety of data sources. The Niraparib Tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Niraparib Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niraparib Tosylate, including repackagers and relabelers. The FDA regulates Niraparib Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niraparib Tosylate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Niraparib Tosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niraparib Tosylate supplier is an individual or a company that provides Niraparib Tosylate active pharmaceutical ingredient (API) or Niraparib Tosylate finished formulations upon request. The Niraparib Tosylate suppliers may include Niraparib Tosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Niraparib Tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Niraparib Tosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Niraparib Tosylate active pharmaceutical ingredient (API) in detail. Different forms of Niraparib Tosylate DMFs exist exist since differing nations have different regulations, such as Niraparib Tosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Niraparib Tosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Niraparib Tosylate USDMF includes data on Niraparib Tosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Niraparib Tosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Niraparib Tosylate suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Niraparib Tosylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Niraparib Tosylate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Niraparib Tosylate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Niraparib Tosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Niraparib Tosylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Niraparib Tosylate suppliers with NDC on PharmaCompass.
Niraparib Tosylate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Niraparib Tosylate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Niraparib Tosylate GMP manufacturer or Niraparib Tosylate GMP API supplier for your needs.
A Niraparib Tosylate CoA (Certificate of Analysis) is a formal document that attests to Niraparib Tosylate's compliance with Niraparib Tosylate specifications and serves as a tool for batch-level quality control.
Niraparib Tosylate CoA mostly includes findings from lab analyses of a specific batch. For each Niraparib Tosylate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Niraparib Tosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Niraparib Tosylate EP), Niraparib Tosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Niraparib Tosylate USP).