Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
Canada
0
Listed Dossiers
0
EDQM
0
USP
0
JP
0
Others
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
US Medicaid
NA
1. 1195768-06-9
2. Dabrafenib (mesylate)
3. Gsk 2118436b
4. Dabrafenib Mesilate
5. Dabrafenib Mesylate [usan]
6. Unii-b6dc89i63e
7. Gsk-2118436 Mesylate
8. Gsk-2118436b
9. Methane Sulfonate Salt
10. Gsk2118436b
11. Gsk2118436 Mesylate
12. B6dc89i63e
13. Chebi:75048
14. Gsk-2118436b Mesylate
15. N-(3-(5-(2-aminopyrimidin-4-yl)-2-(tert-butyl)thiazol-4-yl)-2-fluorophenyl)-2,6-difluorobenzenesulfonamide Methanesulfonate
16. Gsk2118436b, Methane Sulfonate Salt
17. Gsk-2118436 Methanesulfonate Salt
18. Gsk-2118436b Methanesulfonate Salt
19. Gsk2118436 Mesylate;gsk 2118436b
20. Dabrafenib Mesilate (jan)
21. Dabrafenib Mesylate (gsk-2118436)
22. Dabrafenib Mesylate (usan)
23. Dabrafenib Mesilate [jan]
24. Taflinar
25. N-[3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide;methanesulfonic Acid
26. Dabrafenib Methanesulfonate
27. Tafinlar (tn)
28. Gsk2118436 Methane Sulfonate Salt
29. Dabrafenib Monomesylate
30. Gsk 2118436 Mesylate
31. Schembl1127269
32. Chembl2105729
33. Dabrafenib Mesylate [mi]
34. Dtxsid70152500
35. Amy30045
36. Bcp04738
37. Ex-a1559
38. Dabrafenib Mesilate [who-dd]
39. Hy-14660a
40. Mfcd20922872
41. S5069
42. Akos025396661
43. Ccg-270246
44. Cs-1641
45. Dabrafenib Mesylate [orange Book]
46. Ac-31302
47. As-17010
48. Ft-0696677
49. D10104
50. A903491
51. Sr-01000941590
52. Sr-01000941590-1
53. Q27145089
54. Gsk2118436 Ms Salt, Dabrafenib Ms Salt, Gsk2118436a Ms Salt
55. Benzenesulfonamide, N-(3-(5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-4-thiazolyl)- 2-fluorophenyl)-2,6-difluoro-, Methanesulfonate (1:1)
56. Benzenesulfonamide, N-[3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluoro-, Methanesulfonate (1:1)
57. Dabrafenib Mesylaten-[3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide, Methanesulfonic Acid; Dabrafenib Mesylate
58. N-(3-(5-(2-aminopyrimidin-4-yl)-2-(1,1-dimethylethyl)thiazol-4-yl)-2-fluorophenyl)-2,6- Difluorobenzenesulfonamide Monomethanesulfonate
59. N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide Methanesulfonate
60. N-{3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide Methanesulfonate
1. 1195765-45-7
2. Dabrafenib
Molecular Weight | 615.7 g/mol |
---|---|
Molecular Formula | C24H24F3N5O5S3 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 14 |
Rotatable Bond Count | 6 |
Exact Mass | 615.08916689 g/mol |
Monoisotopic Mass | 615.08916689 g/mol |
Topological Polar Surface Area | 210 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 910 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
* Melanoma:
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4. 4 and 5. 1).
* Adjuvant treatment of melanoma:
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
* Non-small cell lung cancer (NSCLC):
Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Treatment of melanoma, Treatment of solid malignant tumours (excluding melanoma)
L01EC02
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
2,6-Difluorobenzenesulfonyl chloride
CAS Number : 60230-36-6
End Use API : Dabrafenib Mesylate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
Methyl 3-amino-2-fluorobenzoate
CAS Number : 1195768-18-3
End Use API : Dabrafenib Mesylate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
CAS Number : 13036-57-2
End Use API : Dabrafenib Mesylate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
CAS Number : 630-22-8
End Use API : Dabrafenib Mesylate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
N-{3-[5-(2-chloro-4-pyrimidinyl)-2-(1,1-diethyleth...
CAS Number : 1195768-23-0
End Use API : Dabrafenib Mesylate
About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...
N-{3-[(2-chloro-4-pyrimidinyl)acetyl]-2-fluorophen...
CAS Number : 1195768-20-7
End Use API : Dabrafenib Mesylate
About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...
Methyl 3-((2,6-difluorophenyl)sulfonamido)-2-fluor...
CAS Number : 1195768-19-4
End Use API : Dabrafenib Mesylate
About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...
Methyl 3-amino-2-fluorobenzoate
CAS Number : 1195768-18-3
End Use API : Dabrafenib Mesylate
About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...
CAS Number : 630-22-8
End Use API : Dabrafenib Mesylate
About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...
2-chloro-4-methylpyrimidine
CAS Number : 13036-57-2
End Use API : Dabrafenib Mesylate
About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Adsorbent, Moisture Protection, Stabilization of API
Pharmacopoeia Ref : USP-NF, JP, EP
Technical Specs : Also Available as FUJISIL-F
Ingredient(s) : Silicon Dioxide
Grade : Not Available
Category : API Stability Enhancers, Coating Systems & Additives, Controlled & Modified Release, Direct Compression, Granulation, Rheology Modifiers, Vegetarian Capsules
Application : API Stability Enhancers, Coating Systems & Additives, Controlled & Modified Release, Direct Compression, Granulation, Rheology Modifiers, Vegetarian Capsules
Excipient Details : Controlled Release, Direct Compression,Wet Granulation,Tablet Coating, Liquid Solutions and Suspensions
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Capsule
Grade : Oral and Inhalation
Category : API Stability Enhancers, Vegetarian Capsules
Application : API Stability Enhancers, Vegetarian Capsules
Pharmacopoeia Ref : Certified Vegan, Non-GMO, Vege...
Technical Specs : "Water content – less than 9%, can be customized; Size # 00el -...
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Capsule
Grade : Oral
Category : API Stability Enhancers, Taste Masking, Vegetarian Capsules
Application : API Stability Enhancers, Taste Masking, Vegetarian Capsules
Pharmacopoeia Ref : Certified Vegan, Non-GMO, Vege...
Technical Specs : Size # 0-1
Ingredient(s) : Hydroxypropyl Methyl Cellulose
16 Mar 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217514
03 Jan 2023
// BUSINESSWIRE
30 Nov 2022
// BUSINESSWIRE
07 Jun 2022
// L. Burger REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-drug-combo-shows-promise-childhood-brain-cancer-2022-06-06/
20 Sep 2020
// PRESS RELEASE
https://www.novartis.com/news/media-releases/novartis-reports-late-breaking-data-from-phase-iii-combi-i-trial-spartalizumab-pdr001-tafinlar-and-mekinist-advanced-melanoma
17 Sep 2020
// PHARMA FILE
http://www.pharmafile.com/news/559508/novartis-tafinlarmekinist-combo-improves-five-year-relapse-free-survival-new-phase-3-dat
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
A Dabrafenib Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabrafenib Mesylate, including repackagers and relabelers. The FDA regulates Dabrafenib Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabrafenib Mesylate 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 Dabrafenib Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dabrafenib Mesylate supplier is an individual or a company that provides Dabrafenib Mesylate active pharmaceutical ingredient (API) or Dabrafenib Mesylate finished formulations upon request. The Dabrafenib Mesylate suppliers may include Dabrafenib Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Dabrafenib Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dabrafenib Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dabrafenib Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Dabrafenib Mesylate DMFs exist exist since differing nations have different regulations, such as Dabrafenib Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dabrafenib Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Dabrafenib Mesylate USDMF includes data on Dabrafenib Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dabrafenib Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dabrafenib Mesylate suppliers with USDMF on PharmaCompass.
A Dabrafenib Mesylate written confirmation (Dabrafenib Mesylate WC) is an official document issued by a regulatory agency to a Dabrafenib Mesylate manufacturer, verifying that the manufacturing facility of a Dabrafenib Mesylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dabrafenib Mesylate APIs or Dabrafenib Mesylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Dabrafenib Mesylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Dabrafenib Mesylate 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 Dabrafenib Mesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dabrafenib Mesylate 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 Dabrafenib Mesylate 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 Dabrafenib Mesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dabrafenib Mesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dabrafenib Mesylate suppliers with NDC on PharmaCompass.
Dabrafenib Mesylate 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 Dabrafenib Mesylate 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 Dabrafenib Mesylate GMP manufacturer or Dabrafenib Mesylate GMP API supplier for your needs.
A Dabrafenib Mesylate CoA (Certificate of Analysis) is a formal document that attests to Dabrafenib Mesylate's compliance with Dabrafenib Mesylate specifications and serves as a tool for batch-level quality control.
Dabrafenib Mesylate CoA mostly includes findings from lab analyses of a specific batch. For each Dabrafenib Mesylate 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.
Dabrafenib Mesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dabrafenib Mesylate EP), Dabrafenib Mesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dabrafenib Mesylate USP).
LOOKING FOR A SUPPLIER?