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CAPSULE;ORAL - EQ 75MG BASE

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1 SPI Pharma, 3 DKSH, 1 Faran Shimi Pharmaceutical, 6 Gangwal Healthcare, 1 ACG Worldwide, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 Corel Pharma Chem, 2 DFE Pharma, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem

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68 US Patents, 28 US Exclusivities, 2 Health Canada Patents

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68 US Patents
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Synopsis

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Chemistry

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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 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 Formula	C₂₄H₂₄F₃N₅O₅S₃
Molecular Weight	615.7 g/mol
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 Å²
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

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 SUPPLIERS

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USDMF

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EU WC

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MSN Laboratories

India

Pharma Manufacturing 2024

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NDC API

01

MSN Laboratories Private Limited

India

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Sterling Pharma Solutions Limited

United Kingdom

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Listed Suppliers

01

Fermion Oy

Finland

CPhI India 2024

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Dabrafenib

About the Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & F...

Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & Formulations. API portfolio consists of >30 generic APIs & >10 NCEs & 2 mfg. sites as well as R&D facilities are all located in Finland. Fermion has invested & expanded capabilities in the production of HPAPIs. Drug product CMO services include hormonal & non-hormonal semi-solids, cytotoxic oral solids & packaging. We have 3 mfg. sites & one packaging center for drug products at Orion.

02

Jinan Tantu Chemicals

China

American Pharma Summit

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

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China

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Dabrafenib

About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...

Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.

03

Sichuan Elixir Pharmaceuticals

China

American Pharma Summit

Not Confirmed

Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..

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China

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Dabrafenib Mesylate

About the Company : Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ...

Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ANDA, 505b(2) and P-IV challenges. Exploring macromolecular APIs, we focus on Glycans & polypeptides. Expertise in XDC drugs drives innovative research & payload production. With a global registration platform & international cGMP system, we offer API CMO/CDMO services worldwide. Our strategy combines FDF and APIs. Our labs meet GMP standards with a stable R&D team, over 10 years of experience, we've delivered 20+ successful projects.

04

Alembic Pharmaceuticals Limited

India

China

American Pharma Summit

Not Confirmed

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API Reference Price

[{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701714600,"product":"PHARMA INGREDIENTS - DABRAFENIB MESYLATE(FORM-I) IN-HOUSE","address":"30, AROHI VILLA, S.P. RING ROAD, BOPAL,","city":"AHMEDABAD","supplier":"GREENCROSS EXPORT PRIVATE ","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"TO THE ORDER -- +-","customerCountry":"RUSSIA","quantity":"0.38","actualQuantity":"0.38","unit":"KGS","unitRateFc":"90000","totalValueFC":"33576.3","currency":"USD","unitRateINR":7355263.1578947371,"date":"05-Dec-2023","totalValueINR":"2795000","totalValueInUsd":"33576.3","indian_port":"Ahmedabad Air","hs_no":"29335920","bill_no":"5811376","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"30, AROHI VILLA, S.P. RING ROAD, BOPAL,, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702319400,"product":"DABRAFENIB MESYLATE(FORM-I)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"WORLD MEDICINE ILAC SAN. VE.TIC.LTD","customerCountry":"TURKEY","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"80000","totalValueFC":"696.8","currency":"USD","unitRateINR":5800000,"date":"12-Dec-2023","totalValueINR":"58000","totalValueInUsd":"696.8","indian_port":"Hyderabad Air","hs_no":"29335920","bill_no":"5984779","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702578600,"product":"DABRAFENIB MESYLATE (FORM-I)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"AMEDART LLC","customerCountry":"RUSSIA","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"250000","totalValueFC":"4516.9","currency":"USD","unitRateINR":18800000,"date":"15-Dec-2023","totalValueINR":"376000","totalValueInUsd":"4516.9","indian_port":"Hyderabad Air","hs_no":"29335920","bill_no":"6074440","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""}]

Number of Transactions

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Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - CAPSULE;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 202806

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USFDA APPLICATION NUMBER - 202806

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ABOUT THIS PAGE

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

13 API Suppliers

1 USDMF

1 EU WC

2 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

INTERMEDIATES

15 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

18 FDF Dossiers

5 FDA Orange Book

5 Europe

6 Australia

2 South Africa

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 50MG BASE

CAPSULE;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

3 DKSH

1 Faran Shimi Pharmaceutical

6 Gangwal Healthcare

1 ACG Worldwide

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

10 Corel Pharma Chem

2 DFE Pharma

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

15 Kerry

3 Kima Chemical

6 Lonza Capsugel

8 Microlex e.U

1 Novo Excipients

1 Pharmatrans-Sanaq

1 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

9 Roquette

6 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

8 Sigachi Industries

2 The Dow Chemical Company

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives

23 Fillers, Diluents & Binders

20 Controlled & Modified Release

14 Direct Compression

12 Thickeners and Stabilizers

11 Lubricants & Glidants

8 Co-Processed Excipients

7 Film Formers & Plasticizers

7 Granulation

6 Disintegrants & Superdisintegrants

5 Empty Capsules

4 Vegetarian Capsules

4 Taste Masking

4 API Stability Enhancers

4 Coloring Agents

4 Emulsifying Agents

3 Chewable & Orodispersible Aids

2 Rheology Modifiers

1 Solubilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow

44 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 Finished Drug Prices

10 Annual Reports

MARKET PLACE

3 APIs