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Trametinib Dimethyl Sulfoxide
Europe

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Trametinib Dimethyl Sulfoxide

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 6 USDMF, 2 EU WC, 1 KDMF, 8 NDC API, 15 Listed Suppliers, $ API Reference Price

23 API Suppliers
6 USDMF
2 EU WC
1 KDMF
8 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

171 Drugs in Development

171 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

37 FDF Dossiers, 8 FDA Orange Book, 12 Europe, 3 Canada, 12 Australia, 2 South Africa

37 FDF Dossiers
8 FDA Orange Book
12 Europe
3 Canada
12 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TABLET;ORAL - EQ 0.5MG, TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG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TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 5 DKSH, 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, 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

41 Coating Systems & Additives, 39 Fillers, Diluents & Binders, 21 Direct Compression, 19 Thickeners and Stabilizers, 19 Controlled & Modified Release, 18 Disintegrants & Superdisintegrants, 16 Granulation, 16 Solubilizers, 15 Taste Masking, 15 Chewable & Orodispersible Aids, 12 Topical, 12 Lubricants & Glidants, 10 Parenteral, 10 Co-Processed Excipients, 8 Film Formers & Plasticizers, 7 Emulsifying Agents, 6 Rheology Modifiers, 5 API Stability Enhancers, 5 Empty Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Vegetarian Capsules

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

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 49 News #PharmaBuzz

3 Data Compilation #PharmaFlow
49 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 1 Regulatory FDF Prices, 12 Annual Reports

1 US Medicaid Prescriptions
1 Regulatory FDF Prices
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) : 517,927 Xls

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filter Applicant Reset all filters

12 All

01 8Novartis Europharm Limited

02 1Novartis Europharm Ltd

03 3Novartis Pharma Schweiz Ag

filter Active Ingredients Reset all filters

12 All

01 3Trametinib

02 6Trametinib Dimethyl Sulfoxide

03 3Tramway

filter Dosage Form Reset all filters

12 All

01 8Film Coated Tablet

02 3Powder For Oral Solution

03 1Powder for oral solution, solution

filter Country Reset all filters

12 All

01 1Norway

02 4Spain

03 4Sweden

04 3Switzerland

filter Brand Name Reset all filters

12 All

01 9Mekinist

02 1Specxtras

03 2Spexotras

Polpharma Trametinib

List of Suppliers

Product Main Page

01

Novartis Europharm Limited

PREP

Not Confirmed

Novartis Europharm Limited

PREP

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Digital Content

Regulatory Info :

Registration Country : Norway

Trametinib Dimethyl Sulfoxide

Brand Name : Spexotras

Dosage Form : Powder for oral solution, solution

Dosage Strength : 0.05 mg/ml

Packaging : Bottle 1item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

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02

Novartis Europharm Limited

PREP

Not Confirmed

Novartis Europharm Limited

PREP

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Trametinib Dimethyl Sulfoxide

Brand Name : Mekinist

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 30/06/2014

Application Number : 20130212000025

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

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Corporate PDF

03

Novartis Europharm Limited

PREP

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Novartis Europharm Limited

PREP

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Trametinib Dimethyl Sulfoxide

Brand Name : Mekinist

Dosage Form : Film Coated Tablet

Dosage Strength : 2mg

Packaging :

Approval Date : 30/06/2014

Application Number : 20130212000056

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Novartis Europharm Limited

PREP

Not Confirmed

Novartis Europharm Limited

PREP

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Trametinib Dimethyl Sulfoxide

Brand Name : Specxtras

Dosage Form : Powder For Oral Solution

Dosage Strength : 0.05mg/ml

Packaging :

Approval Date : 05/01/2024

Application Number : 20220912000040

Regulatory Info : Approved

Registration Country : Sweden

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Digital Content

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05

Novartis Europharm Ltd

PREP

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Novartis Europharm Ltd

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Trametinib Dimethyl Sulfoxide

Brand Name : Mekinist

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 30/06/2014

Application Number : 20130212000049

Regulatory Info : Deregistered

Registration Country : Sweden

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06

Novartis Pharma Schweiz Ag

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Novartis Pharma Schweiz Ag

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Regulatory Info : Allowed

Registration Country : Switzerland

Brand Name : Mekinist

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 22/02/2016

Application Number : 65883

Regulatory Info : Allowed

Registration Country : Switzerland

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07

Novartis Pharma Schweiz Ag

PREP

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Novartis Pharma Schweiz Ag

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Regulatory Info : Allowed

Registration Country : Switzerland

Brand Name : Mekinist

Dosage Form : Film Coated Tablet

Dosage Strength : 2mg

Packaging :

Approval Date : 22/02/2016

Application Number : 65883

Regulatory Info : Allowed

Registration Country : Switzerland

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Product Web Link

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08

Novartis Pharma Schweiz Ag

PREP

Not Confirmed

Novartis Pharma Schweiz Ag

PREP

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Digital Content

Regulatory Info : Allowed

Registration Country : Switzerland

Brand Name : Mekinist

Dosage Form : Powder For Oral Solution

Dosage Strength : 4.7mg

Packaging :

Approval Date : 05/09/2023

Application Number : 69134

Regulatory Info : Allowed

Registration Country : Switzerland

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Product Web Link

Digital Content

Corporate PDF

09

Novartis Europharm Limited

PREP

Not Confirmed

Novartis Europharm Limited

PREP

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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 : 2024-04-10

Application Number : 1231781001

Regulatory Info : Authorized

Registration Country : Spain

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Product Web Link

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10

Novartis Europharm Limited

PREP

Not Confirmed

Novartis Europharm Limited

PREP

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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 : 2025-03-03

Application Number : 114931006IP

Regulatory Info : Authorized

Registration Country : Spain

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