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Also known as: 1195768-06-9, Dabrafenib (mesylate), Gsk 2118436b, Dabrafenib mesilate, Dabrafenib mesylate [usan], Unii-b6dc89i63e
Molecular Formula
C24H24F3N5O5S3
Molecular Weight
615.7  g/mol
InChI Key
YKGMKSIHIVVYKY-UHFFFAOYSA-N
FDA UNII
B6DC89I63E

Dabrafenib Mesylate
Dabrafenib Mesylate is the mesylate salt form of dabrafenib, an orally bioavailable inhibitor of B-raf (BRAF) protein with potential antineoplastic activity. Dabrafenib selectively binds to and inhibits the activity of B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. B-raf belongs to the raf/mil family of serine/threonine protein kinases and plays a role in regulating the MAP kinase/ERKs signaling pathway, which may be constitutively activated due to BRAF gene mutations.
1 2D Structure

Dabrafenib Mesylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide;methanesulfonic acid
2.1.2 InChI
InChI=1S/C23H20F3N5O2S2.CH4O3S/c1-23(2,3)21-30-18(19(34-21)16-10-11-28-22(27)29-16)12-6-4-9-15(17(12)26)31-35(32,33)20-13(24)7-5-8-14(20)25;1-5(2,3)4/h4-11,31H,1-3H3,(H2,27,28,29);1H3,(H,2,3,4)
2.1.3 InChI Key
YKGMKSIHIVVYKY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)(C)C1=NC(=C(S1)C2=NC(=NC=C2)N)C3=C(C(=CC=C3)NS(=O)(=O)C4=C(C=CC=C4F)F)F.CS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
B6DC89I63E
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

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

2.3.2 Other Synonyms

1. 1195765-45-7

2. Dabrafenib

2.4 Create Date
2009-12-22
3 Chemical and Physical Properties
Molecular Weight 615.7 g/mol
Molecular Formula C24H24F3N5O5S3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count14
Rotatable Bond Count6
Exact Mass615.08916689 g/mol
Monoisotopic Mass615.08916689 g/mol
Topological Polar Surface Area210 Ų
Heavy Atom Count40
Formal Charge0
Complexity910
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

* 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)


5 Pharmacology and Biochemistry
5.1 ATC Code

L01EC02


API Reference Price

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31-Jul-2023
15-Nov-2024
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INTERMEDIATES SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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...

Jinan Tantu Chemicals

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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...

Jinan Tantu Chemicals

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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...

Jinan Tantu Chemicals

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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...

Jinan Tantu Chemicals

05

PharmaVenue
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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...

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06

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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...

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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...

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08

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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...

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09

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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...

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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...

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217514

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https://www.businesswire.com/news/home/20230103005222/en

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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

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ABOUT THIS PAGE

Dabrafenib Mesylate Manufacturers

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.

Dabrafenib Mesylate Suppliers

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.

Dabrafenib Mesylate USDMF

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.

Dabrafenib Mesylate WC

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.

Dabrafenib Mesylate NDC

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).

Finished drug products

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.

Unfinished drugs

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.

Compounded drug products

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.

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Dabrafenib Mesylate GMP

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.

Dabrafenib Mesylate CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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