Dabrafenib Mesylate | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Dabrafenib Mesylate
Europe

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Dabrafenib Mesylate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 1 USDMF, 1 EU WC, 1 KDMF, 4 NDC API, 16 Listed Suppliers, $ API Reference Price

19 API Suppliers
1 USDMF
1 EU WC
1 KDMF
4 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

63 Drugs in Development

63 Drugs in Development

INTERMEDIATES

22 Intermediate Suppliers

22 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

38 FDF Dossiers, 5 FDA Orange Book, 11 Europe, 3 Canada, 17 Australia, 2 South Africa

38 FDF Dossiers
5 FDA Orange Book
11 Europe
3 Canada
17 Australia
2 South Africa

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 50MG BASE, CAPSULE;ORAL - EQ 75MG BASE

CAPSULE;ORAL - EQ 50MG BASE
CAPSULE;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 5 DKSH, 2 Gangwal Healthcare, 1 ACG Worldwide, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 Corel Pharma Chem, 2 DFE Pharma, 6 Gangwal Chemicals, 4 Ideal Cures, 10 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 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 Silverline Chemicals, 2 The Dow Chemical Company, 2 Vasa Pharmachem

1 SPI Pharma
5 DKSH
2 Gangwal Healthcare
1 ACG Worldwide
4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
10 Corel Pharma Chem
2 DFE Pharma
6 Gangwal Chemicals
4 Ideal Cures
10 Kerry
1 Keval Exports
3 Kima Chemical
6 Lonza Capsugel
8 Microlex e.U
2 Nitika Pharmaceutical Specialities
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 Silverline Chemicals
2 The Dow Chemical Company
2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives, 22 Fillers, Diluents & Binders, 14 Controlled & Modified Release, 12 Thickeners and Stabilizers, 10 Lubricants & Glidants, 9 Direct Compression, 7 Co-Processed Excipients, 7 Granulation, 6 Film Formers & Plasticizers, 5 Empty Capsules, 5 Disintegrants & Superdisintegrants, 4 Coloring Agents, 4 Rheology Modifiers, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 Taste Masking, 4 API Stability Enhancers, 1 Solubilizers

39 Coating Systems & Additives
22 Fillers, Diluents & Binders
14 Controlled & Modified Release
12 Thickeners and Stabilizers
10 Lubricants & Glidants
9 Direct Compression
7 Co-Processed Excipients
7 Granulation
6 Film Formers & Plasticizers
5 Empty Capsules
5 Disintegrants & Superdisintegrants
4 Coloring Agents
4 Rheology Modifiers
4 Emulsifying Agents
4 Chewable & Orodispersible Aids
4 Vegetarian Capsules
4 Taste Masking
4 API Stability Enhancers
1 Solubilizers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 44 News #PharmaBuzz

1 Data Compilation #PharmaFlow
44 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 11 Annual Reports

1 US Medicaid Prescriptions
11 Annual Reports

MARKET PLACE

5 APIs, 1 FDF Dossiers

5 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

68 US Patents, 24 US Exclusivities, 9 Health Canada Patents

68 US Patents
24 US Exclusivities
9 Health Canada Patents

$ API Ref.Price (USD/KG) : 35,696 Xls

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filter Applicant Reset all filters

11 All

01 7Novartis Europharm Limited

02 4Novartis Europharm Limited (1)

filter Active Ingredients Reset all filters

11 All

01 3Dabrafenib

02 3Dabrafenib Mesylate

03 5Dabrafenib mesilate

filter Dosage Form Reset all filters

11 All

01 6Capsule

02 3Dispersible Tablet

03 2Hard Capsule

filter Country Reset all filters

11 All

01 3Estonia

02 5Norway

03 3Spain

filter Brand Name Reset all filters

11 All

01 3Finlee

02 8Tafinlar

Dabrafenib Mesylate

List of Suppliers

Product Main Page

01

Novartis Europharm Limited

Cosmoprof

Not Confirmed

Novartis Europharm Limited

Cosmoprof

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dabrafenib Mesylate

Brand Name : Tafinlar

Dosage Form : Hard Capsule

Dosage Strength : 50MG

Packaging :

Approval Date : 2014-02-26

Application Number : 113865001

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Novartis Europharm Limited

IPPE

Not Confirmed

Novartis Europharm Limited

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dabrafenib Mesylate

Brand Name : Tafinlar

Dosage Form : Hard Capsule

Dosage Strength : 75MG

Packaging :

Approval Date : 2013-09-30

Application Number : 113865003

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Novartis Europharm Limited

IPPE

Not Confirmed

Novartis Europharm Limited

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dabrafenib Mesylate

Brand Name : Finlee

Dosage Form : Dispersible Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 2024-04-12

Application Number : 1231767001

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Novartis Europharm Limited

IPPE

Not Confirmed

Novartis Europharm Limited

IPPE

Not Confirmed

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Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Dabrafenib mesilate

Brand Name : Finlee

Dosage Form : Dispersible Tablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Novartis Europharm Limited (1)

IPPE

Not Confirmed

Novartis Europharm Limited (1)

IPPE

Not Confirmed

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Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Dabrafenib mesilate

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Novartis Europharm Limited (1)

IPPE

Not Confirmed

Novartis Europharm Limited (1)

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Dabrafenib mesilate

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Novartis Europharm Limited (1)

IPPE

Not Confirmed

Novartis Europharm Limited (1)

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Dabrafenib mesilate

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Novartis Europharm Limited (1)

IPPE

Not Confirmed

Novartis Europharm Limited (1)

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Dabrafenib mesilate

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Novartis Europharm Limited

IPPE

Not Confirmed

Novartis Europharm Limited

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Prescription

Registration Country : Estonia

Brand Name : Finlee

Dosage Form : Dispersible Tablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Novartis Europharm Limited

IPPE

Not Confirmed

Novartis Europharm Limited

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Prescription

Registration Country : Estonia

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.