Trametinib | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Trametinib
Europe

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Trametinib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 6 USDMF, 2 EU WC, 1 KDMF, 7 NDC API, 15 Listed Suppliers, $ API Reference Price

22 API Suppliers
6 USDMF
2 EU WC
1 KDMF
7 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

65 Drugs in Development

65 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

47 FDF Dossiers, 8 FDA Orange Book, 20 Europe, 3 Canada, 14 Australia, 2 South Africa

47 FDF Dossiers
8 FDA Orange Book
20 Europe
3 Canada
14 Australia
2 South Africa

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.5MG, TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG

TABLET;ORAL - EQ 0.5MG
TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 14 SPI Pharma, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Esteem Industries, 1 Finar, 9 Gangwal Chemicals, 1 Gloria Interchem, 4 Ideal Cures, 2 Ingredion Pharma Solutions, 11 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 13 Roquette, 12 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives, 39 Fillers, Diluents & Binders, 21 Direct Compression, 19 Controlled & Modified Release, 18 Disintegrants & Superdisintegrants, 17 Thickeners and Stabilizers, 16 Granulation, 16 Solubilizers, 15 Chewable & Orodispersible Aids, 15 Taste Masking, 12 Lubricants & Glidants, 12 Topical, 10 Parenteral, 10 Co-Processed Excipients, 8 Film Formers & Plasticizers, 6 Emulsifying Agents, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers, 2 Coloring Agents

39 Coating Systems & Additives
39 Fillers, Diluents & Binders
21 Direct Compression
19 Controlled & Modified Release
18 Disintegrants & Superdisintegrants
17 Thickeners and Stabilizers
16 Granulation
16 Solubilizers
15 Chewable & Orodispersible Aids
15 Taste Masking
12 Lubricants & Glidants
12 Topical
10 Parenteral
10 Co-Processed Excipients
8 Film Formers & Plasticizers
6 Emulsifying Agents
5 Empty Capsules
5 API Stability Enhancers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 Rheology Modifiers
2 Coloring Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 49 News #PharmaBuzz

2 Data Compilation #PharmaFlow
49 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 12 Annual Reports

1 US Medicaid Prescriptions
12 Annual Reports

MARKET PLACE

3 APIs

3 APIs

PATENTS & EXCLUSIVITIES

87 US Patents, 34 US Exclusivities, 10 Health Canada Patents

87 US Patents
34 US Exclusivities
10 Health Canada Patents

$ API Ref.Price (USD/KG) : 484,564 Xls

Filters

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filter Applicant Reset all filters

20 All

01 14Novartis Europharm Limited

02 2Novartis Europharm Limited (1)

03 1Novartis Europharm Ltd

04 3Novartis Pharma Schweiz Ag

filter Active Ingredients Reset all filters

20 All

01 8Trametinib

02 8Trametinib Dimethyl Sulfoxide

03 1Trametinibdimetylsulfoksid

04 3Tramway

filter Dosage Form Reset all filters

20 All

01 12Film Coated Tablet

02 2Film-Coated Tablet

03 6Powder For Oral Solution

filter Country Reset all filters

20 All

01 3Denmark

02 3Estonia

03 3Norway

04 4Spain

05 4Sweden

06 3Switzerland

filter Brand Name Reset all filters

20 All

01 15Mekinist

02 1Specxtras

03 4Spexotras

Polpharma Trametinib

List of Suppliers

Product Main Page

01

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

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Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Trametinibdimetylsulfoksid

Brand Name : Spexotras

Dosage Form : Powder For Oral Solution

Dosage Strength : 0.05mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

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Digital Content

Regulatory Info : Prescription

Registration Country : Estonia

Brand Name : Spexotras

Dosage Form : Powder For Oral Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

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Digital Content

Regulatory Info : Prescription

Registration Country : Estonia

Brand Name : Mekinist

Dosage Form : Film-Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

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Digital Content

Regulatory Info : Prescription

Registration Country : Estonia

Brand Name : Mekinist

Dosage Form : Film-Coated Tablet

Dosage Strength : 2mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Trametinib Dimethyl Sulfoxide

Brand Name : Spexotras

Dosage Form : Powder For Oral Solution

Dosage Strength : 0.05MG

Packaging :

Approval Date : 10-04-2024

Application Number : 1231781001

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Brand Name : Mekinist

Dosage Form : Film Coated Tablet

Dosage Strength : 2MG

Packaging :

Approval Date : 03-03-2025

Application Number : 114931006IP

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

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

Brand Name : Mekinist

Dosage Form : Film Coated Tablet

Dosage Strength : 2MG

Packaging :

Approval Date : 24-09-2015

Application Number : 114931006

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Brand Name : Mekinist

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5MG

Packaging :

Approval Date : 24-09-2015

Application Number : 114931002

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

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 : Prescription

Registration Country : Denmark

Trametinib Dimethyl Sulfoxide

Brand Name : Spexotras

Dosage Form : Powder For Oral Solution

Dosage Strength : 0.05mg/ml

Packaging :

Approval Date : 05-01-2024

Application Number : 28106836522

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Novartis Europharm Limited

International Sweetener Colloquium

Not Confirmed

Novartis Europharm Limited

International Sweetener Colloquium

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 : Denmark

Trametinib Dimethyl Sulfoxide

Brand Name : Mekinist

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 30-06-2014

Application Number : 28105247413

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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