Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
Annual Reports
NA
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. 1859053-21-6
2. Rucaparib (camsylate)
3. Rucaparib (monocamsylate)
4. Pf-1367338-bw
5. C0-338
6. [(1s,4r)-7,7-dimethyl-2-oxo-1-bicyclo[2.2.1]heptanyl]methanesulfonic Acid;6-fluoro-2-[4-(methylaminomethyl)phenyl]-3,10-diazatricyclo[6.4.1.04,13]trideca-1,4,6,8(13)-tetraen-9-one
7. Co-338
8. 41ax9sj8ko
9. Rucaparib Camsylate [usan]
10. Bicyclo(2.2.1)heptane-1-methanesulfonic Acid, 7,7-dimethyl-2-oxo-, (1s,4r)-, Compd. With 8-fluoro-1,3,4,5-tetrahydro-2-(4-((methylamino)methyl)phenyl)-6h-pyrrolo(4,3,2-ef)(2)benzazepin-6-one (1:1)
11. Bicyclo[2.2.1]heptane-1-methanesulfonic Acid, 7,7-dimethyl-2-oxo-, (1s,4r)-, Compd. With 8-fluoro-1,3,4,5-tetrahydro-2-[4-[(methylamino)methyl]phenyl]-6h-pyrrolo[4,3,2-ef][2]benzazepin-6-one (1:1)
12. Rucaparib(camsylate)
13. Ag14699 Camsylate
14. Rucaparib Camphosulfonate
15. Rucaparib Camphorsulfonate
16. Chembl3833368
17. Rucaparib Camsylate [mi]
18. Schembl22817574
19. Amy9250
20. Chebi:134692
21. Dtxsid301027866
22. 8-fluoro-2-(4-((methylamino)methyl)phenyl)-1,3,4,5-tetrahydro-6h-pyrrolo(4,3,2-ef)(2)benzazepin-6-one (7,7-dimethyl-2-oxobicyclo(2.2.1)heptan-1-yl)methanesulfonate (1:1)
23. Bcp18101
24. Ex-a3053
25. Rucaparib Camsylate [who-dd]
26. S5195
27. Cs-6939
28. Rucaparib Camsylate [orange Book]
29. Ac-30110
30. Hy-102003
31. A902311
32. Q27258428
33. ((1s,4r)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl)methanesulfonic Acid - 8-fluoro-2-(4-((methylamino)methyl)phenyl)-1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one (1:1)
34. [4-(8-fluoro-6-oxo-3,4,5,6-tetrahydro-1h-azepino[5,4,3-cd]indol-2-yl)phenyl]-n-methylmethanaminium [(1s,4r)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonate
35. 8-fluoro-5-(4-((methylamino)methyl)phenyl)-2,3,4,6-tetrahydro-1h-azepino[5,4,3-cd]indol-1-one ((1s,4r)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl)methanesulfonate
1. 283173-50-2
2. Rubraca
3. Rucaparib
4. 8237f3u7eh
Molecular Weight | 555.7 g/mol |
---|---|
Molecular Formula | C29H34FN3O5S |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 5 |
Exact Mass | 555.22032053 g/mol |
Monoisotopic Mass | 555.22032053 g/mol |
Topological Polar Surface Area | 137 Ų |
Heavy Atom Count | 39 |
Formal Charge | 0 |
Complexity | 869 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 1 | |
---|---|
Drug Name | RUBRACA |
Active Ingredient | RUCAPARIB CAMSYLATE |
Company | CLOVIS ONCOLOGY INC (Application Number: N209115. Patents: 6495541, 7351701, 7531530, 8071579, 8143241, 8754072, 8859562, 9045487, 9861638) |
Treatment of fallopian tube cancer , Treatment of ovarian cancer , Treatment of primary peritoneal cancer , Treatment of prostate malignant neoplasms
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35585
Submission : 2021-01-30
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0109
Start Marketing Date : 2021-01-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34419
Submission : 2019-12-26
Status : Active
Type : II
NDC Package Code : 66499-0064
Start Marketing Date : 2018-08-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-0340
Address of the Firm :
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-340n
Address of the Firm :
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
Details:
Under the terms of the Agreement, Tolmar will be responsible for U.S. marketing and sales activities to promote Rubraca (rucaparib) for BRCA-mutated Ovarian Cancer.
Lead Product(s): Rucaparib Camsylate,Inapplicable
Therapeutic Area: Oncology Brand Name: Rubraca
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Tolmar
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 24, 2024
Lead Product(s) : Rucaparib Camsylate,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Tolmar
Deal Size : Undisclosed
Deal Type : Agreement
pharma& Group Promotes Rubraca® For Metastatic Prostate Cancer in U.S.
Details : Under the terms of the Agreement, Tolmar will be responsible for U.S. marketing and sales activities to promote Rubraca (rucaparib) for BRCA-mutated Ovarian Cancer.
Product Name : Rubraca
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
September 24, 2024
Details:
Rubraca (rucaparib) is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents.
Lead Product(s): Rucaparib Camsylate,Nivolumab
Therapeutic Area: Oncology Brand Name: Rubraca
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 09, 2022
Lead Product(s) : Rucaparib Camsylate,Nivolumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Clovis Oncology’s Rubraca® (Rucaparib) as First-Line Maintenance Treatment Improves Progression...
Details : Rubraca (rucaparib) is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer ...
Product Name : Rubraca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 09, 2022
Details:
Rubraca(Rucaparib) is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents.
Lead Product(s): Rucaparib Camsylate,Inapplicable
Therapeutic Area: Oncology Brand Name: Rubraca
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 27, 2022
Lead Product(s) : Rucaparib Camsylate,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Clovis Oncology Presents Data from TRITON3 Phase 3 Trial of Rubraca® (rucaparib) at the 29th Annu...
Details : Rubraca(Rucaparib) is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer a...
Product Name : Rubraca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 27, 2022
Details:
The ATHENA-MONO trial met its primary endpoint, showing Rubraca (rucaparib) monotherapy versus placebo improved progression-free survival (PFS) by investigator assessment in both populations in the primary efficacy analyses: HRD-positive and all patients randomized.
Lead Product(s): Rucaparib Camsylate,Nivolumab
Therapeutic Area: Oncology Brand Name: Rubraca
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 13, 2022
Lead Product(s) : Rucaparib Camsylate,Nivolumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Clovis Oncology Submits Applications for Rubraca® Label Expansion in the US and European Union as...
Details : The ATHENA-MONO trial met its primary endpoint, showing Rubraca (rucaparib) monotherapy versus placebo improved progression-free survival (PFS) by investigator assessment in both populations in the primary efficacy analyses: HRD-positive and all patients...
Product Name : Rubraca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 13, 2022
Details:
The ATHENA-MONO trial met its primary endpoint, showing Rubraca (rucaparib) monotherapy versus placebo improved progression-free survival (PFS) by investigator assessment in both populations in the primary efficacy analyses: HRD-positive and all patients randomized (ITT).
Lead Product(s): Rucaparib Camsylate,Nivolumab
Therapeutic Area: Oncology Brand Name: Rubraca
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 06, 2022
Lead Product(s) : Rucaparib Camsylate,Nivolumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Clovis Oncology’s Rubraca® (Rucaparib) as First-Line Maintenance Treatment Significantly Improv...
Details : The ATHENA-MONO trial met its primary endpoint, showing Rubraca (rucaparib) monotherapy versus placebo improved progression-free survival (PFS) by investigator assessment in both populations in the primary efficacy analyses: HRD-positive and all patients...
Product Name : Rubraca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 06, 2022
Details:
Rucaparib, an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents.
Lead Product(s): Rucaparib Camsylate,Nivolumab
Therapeutic Area: Oncology Brand Name: Rubraca
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 28, 2022
Lead Product(s) : Rucaparib Camsylate,Nivolumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Clovis Oncology Highlights Rubraca® (Rucaparib) and FAP-2286 Data to be Presented at 2022 ASCO An...
Details : Rucaparib, an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents.
Product Name : Rubraca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 28, 2022
Details:
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents.
Lead Product(s): Rucaparib Camsylate,Nivolumab
Therapeutic Area: Oncology Brand Name: Rubraca
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2022
Lead Product(s) : Rucaparib Camsylate,Nivolumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Clovis Oncology’s Rubraca® (Rucaparib) Significantly Improves Progression-Free Survival in Firs...
Details : Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents.
Product Name : Rubraca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 31, 2022
Details:
Survivorship of women with advanced ovarian cancer has improved, primarily the result of 2 key agents, bevacizumab and Poly (ADP-ribose) polymerase inhibitors. In ATHENA trial, demonstrate the efficacy and safety of a third agent Rubraca (rucaparib) for primary treatment.
Lead Product(s): Rucaparib Camsylate,Nivolumab
Therapeutic Area: Oncology Brand Name: Rubraca
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 06, 2022
Lead Product(s) : Rucaparib Camsylate,Nivolumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Survivorship of women with advanced ovarian cancer has improved, primarily the result of 2 key agents, bevacizumab and Poly (ADP-ribose) polymerase inhibitors. In ATHENA trial, demonstrate the efficacy and safety of a third agent Rubraca (rucaparib) for ...
Product Name : Rubraca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 06, 2022
Details:
Rucaparib is an oral, small-molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2, and 3. BDPARIB is first affordable generic in the India available in the form of a tablet, with the cost of therapy less expensive than any existing drugs in the market.
Lead Product(s): Rucaparib Camsylate,Inapplicable
Therapeutic Area: Oncology Brand Name: Bdparib
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 27, 2021
Lead Product(s) : Rucaparib Camsylate,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Rucaparib is an oral, small-molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2, and 3. BDPARIB is first affordable generic in the India available in the form of a tablet, with the cost of therapy less expensive than any existing drugs in the m...
Product Name : Bdparib
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 27, 2021
Details:
Undisclosed
Lead Product(s): Rucaparib Camsylate,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 21, 2020
Lead Product(s) : Rucaparib Camsylate,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 21, 2020
Related Excipient Companies
Excipients by Applications
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
24
PharmaCompass offers a list of Rucaparib Camsylate 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 Rucaparib Camsylate manufacturer or Rucaparib Camsylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rucaparib Camsylate manufacturer or Rucaparib Camsylate supplier.
PharmaCompass also assists you with knowing the Rucaparib Camsylate API Price utilized in the formulation of products. Rucaparib Camsylate API Price is not always fixed or binding as the Rucaparib Camsylate Price is obtained through a variety of data sources. The Rucaparib Camsylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rucaparib Camsylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rucaparib Camsylate, including repackagers and relabelers. The FDA regulates Rucaparib Camsylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rucaparib Camsylate 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 Rucaparib Camsylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rucaparib Camsylate supplier is an individual or a company that provides Rucaparib Camsylate active pharmaceutical ingredient (API) or Rucaparib Camsylate finished formulations upon request. The Rucaparib Camsylate suppliers may include Rucaparib Camsylate API manufacturers, exporters, distributors and traders.
click here to find a list of Rucaparib Camsylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rucaparib Camsylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Rucaparib Camsylate active pharmaceutical ingredient (API) in detail. Different forms of Rucaparib Camsylate DMFs exist exist since differing nations have different regulations, such as Rucaparib Camsylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rucaparib Camsylate DMF submitted to regulatory agencies in the US is known as a USDMF. Rucaparib Camsylate USDMF includes data on Rucaparib Camsylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rucaparib Camsylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rucaparib Camsylate suppliers with USDMF on PharmaCompass.
A Rucaparib Camsylate written confirmation (Rucaparib Camsylate WC) is an official document issued by a regulatory agency to a Rucaparib Camsylate manufacturer, verifying that the manufacturing facility of a Rucaparib Camsylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rucaparib Camsylate APIs or Rucaparib Camsylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Rucaparib Camsylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Rucaparib Camsylate suppliers with Written Confirmation (WC) 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 Rucaparib Camsylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rucaparib Camsylate 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 Rucaparib Camsylate 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 Rucaparib Camsylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rucaparib Camsylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rucaparib Camsylate suppliers with NDC on PharmaCompass.
Rucaparib Camsylate 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 Rucaparib Camsylate 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 Rucaparib Camsylate GMP manufacturer or Rucaparib Camsylate GMP API supplier for your needs.
A Rucaparib Camsylate CoA (Certificate of Analysis) is a formal document that attests to Rucaparib Camsylate's compliance with Rucaparib Camsylate specifications and serves as a tool for batch-level quality control.
Rucaparib Camsylate CoA mostly includes findings from lab analyses of a specific batch. For each Rucaparib Camsylate 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.
Rucaparib Camsylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Rucaparib Camsylate EP), Rucaparib Camsylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rucaparib Camsylate USP).