Trametinib | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Trametinib
FDA Orange Book

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

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Trametinib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 6 USDMF, 1 EU WC, 8 NDC API, 14 Listed Suppliers, $ API Reference Price

22 API Suppliers
6 USDMF
1 EU WC
8 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

20 Drugs in Development

20 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

24 FDF Dossiers, 8 FDA Orange Book, 5 Europe, 3 Canada, 6 Australia, 2 South Africa

24 FDF Dossiers
8 FDA Orange Book
5 Europe
3 Canada
6 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TABLET;ORAL - EQ 0.5MG, TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG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TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Nanjing Bold Chemical, 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, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 38 Fillers, Diluents & Binders, 24 Controlled & Modified Release, 21 Direct Compression, 20 Thickeners and Stabilizers, 18 Disintegrants & Superdisintegrants, 16 Solubilizers, 16 Granulation, 15 Taste Masking, 13 Chewable & Orodispersible Aids, 12 Lubricants & Glidants, 11 Topical, 11 Co-Processed Excipients, 9 Parenteral, 9 Film Formers & Plasticizers, 7 Emulsifying Agents, 6 Rheology Modifiers, 5 Empty Capsules, 5 API Stability Enhancers, 4 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

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

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 49 News #PharmaBuzz

3 Data Compilation #PharmaFlow
49 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 5 Regulatory FDF Prices, 6 Annual Reports

1 US Medicaid Prescriptions
5 Regulatory FDF Prices
6 Annual Reports

MARKET PLACE

3 APIs

3 APIs

PATENTS & EXCLUSIVITIES

87 US Patents, 34 US Exclusivities, 3 Health Canada Patents

87 US Patents
34 US Exclusivities
3 Health Canada Patents

$ API Ref.Price (USD/KG) : 554,135 Xls

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filter Applicant Reset all filters

8 All

01 2HIKMA

02 6NOVARTIS

filter Dosage Reset all filters

8 All

01 2SOLUTION;ORAL

02 6TABLET;ORAL

filter Regulatory Info Reset all filters

8 All

01 3DISCN

02 3RX

03 2Blank

filter Brand Name Reset all filters

8 All

01 6MEKINIST

02 2TRAMETINIB DIMETHYL SULFOXIDE

filter RLD Reset all filters

8 All

01 2No

02 4Yes

03 2Blank

Polpharma Trametinib

List of Suppliers

Product Main Page

01

HIKMA

MAGHREB PHARMA

Not Confirmed

HIKMA

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : No

TE Code :

TRAMETINIB DIMETHYL SULFOXIDE

Brand Name : TRAMETINIB DIMETHYL SULFOXIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG

Approval Date : 2024-08-06

Application Number : 219002

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

HIKMA

MAGHREB PHARMA

Not Confirmed

HIKMA

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : No

TE Code :

TRAMETINIB DIMETHYL SULFOXIDE

Brand Name : TRAMETINIB DIMETHYL SULFOXIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG

Approval Date : 2024-08-06

Application Number : 219002

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

NOVARTIS

MAGHREB PHARMA

Not Confirmed

NOVARTIS

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

TRAMETINIB DIMETHYL SULFOXIDE

Brand Name : MEKINIST

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG

Approval Date : 2013-05-29

Application Number : 204114

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

NOVARTIS

MAGHREB PHARMA

Not Confirmed

NOVARTIS

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

TRAMETINIB DIMETHYL SULFOXIDE

Brand Name : MEKINIST

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2013-05-29

Application Number : 204114

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

NOVARTIS

MAGHREB PHARMA

Not Confirmed

NOVARTIS

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

TRAMETINIB DIMETHYL SULFOXIDE

Brand Name : MEKINIST

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG

Approval Date : 2013-05-29

Application Number : 204114

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

NOVARTIS

MAGHREB PHARMA

Not Confirmed

NOVARTIS

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

TRAMETINIB DIMETHYL SULFOXIDE

Brand Name : MEKINIST

Dosage Form : SOLUTION;ORAL

Dosage Strength : EQ 0.05MG BASE/ML

Approval Date : 2023-03-16

Application Number : 217513

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

NOVARTIS

MAGHREB PHARMA

Not Confirmed

NOVARTIS

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD :

TE Code :

Brand Name : MEKINIST

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Approval Date :

Application Number : 217513

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

NOVARTIS

MAGHREB PHARMA

Not Confirmed

NOVARTIS

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD :

TE Code :

Brand Name : MEKINIST

Dosage Form : SOLUTION;ORAL

Dosage Strength : 4.7MG

Approval Date :

Application Number : 217513

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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