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Approved Marketing Authorisations (MA) containing Dabrafenib Mesylate in Europe. Original Data : EMA Website

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Product

Dabrafenib Mesylate
Dabrafenib (Mesylate)
Europe

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Dabrafenib Mesylate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

12 API Suppliers, 1 USDMF, 1 EU WC, 2 NDC API, 11 Listed Suppliers, $ API Reference Price

12 API Suppliers
1 USDMF
1 EU WC
2 NDC API
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

15 API Suppliers

15 API Suppliers

FINISHED DOSAGE FORMULATIONS

18 FDF Dossiers, 5 FDA Orange Book, 5 Europe, 6 Australia, 2 South Africa

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

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

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 3 DKSH, 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

1 SPI Pharma
3 DKSH
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

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

3 DATA COMPILATION #PharmaFlow
44 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 Finished Drug Prices, 10 Annual Reports

5 Finished Drug Prices
10 Annual Reports

MARKET PLACE

3 APIs, 1 FDF Dossiers

3 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

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

68 US Patents
28 US Exclusivities
2 Health Canada Patents

$ API Ref.Price (USD/KG) : 78,477 Xls

Filters

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filter Applicant Reset all filters

5 All

01 1Novartis Europharm Limited

02 4Novartis Pharma Schweiz AG

filter Active Ingredients Reset all filters

5 All

01 1Dabrafenibmesilat

02 4Dabrafenibum

filter Dosage Form Reset all filters

5 All

01 1Dispergerbar tablett

02 4Kaps

filter Country Reset all filters

5 All

01 1Norway

02 4Switzerland

filter Brand Name Reset all filters

5 All

01 1Finley

02 4Tafinlar

FDF Dossiers
FDA Orange Book
Europe
Australia
South Africa

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01

Novartis Europharm Limited

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Novartis Europharm Limited

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Regulatory Info :

Registration Country : Norway

Dabrafenibmesilat

Brand Name : Finley

Dosage Form : Dispergerbar tablett

Dosage Strength : 10 mg

Packaging : Boks 2 210item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

Novartis Pharma Schweiz AG

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Regulatory Info :

Registration Country : Switzerland

Dabrafenibum

Brand Name : Tafinlar

Dosage Form : Kaps

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

Novartis Pharma Schweiz AG

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Novartis Pharma Schweiz AG

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Regulatory Info :

Registration Country : Switzerland

Dabrafenibum

Brand Name : Tafinlar

Dosage Form : Kaps

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

Novartis Pharma Schweiz AG

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Novartis Pharma Schweiz AG

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Regulatory Info :

Registration Country : Switzerland

Dabrafenibum

Brand Name : Tafinlar

Dosage Form : Kaps

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

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05

Novartis Pharma Schweiz AG

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Novartis Pharma Schweiz AG

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Regulatory Info :

Registration Country : Switzerland

Dabrafenibum

Brand Name : Tafinlar

Dosage Form : Kaps

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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