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Trametinib

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ACTIVE PHARMA INGREDIENTS

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

DEVELOPMENTS

18 Drugs in Development

18 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

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TABLET;ORAL - EQ 0.5MG, TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG

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 Granulation, 16 Solubilizers, 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 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 48 News #PharmaBuzz

GLOBAL SALES INFORMATION

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

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Polpharma	Poland	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	39561	TRAMETINIB DIMETHYL SULFOXIDE	2024-06-19	Active	II	N/A
28/03/2025	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	40493	TRAMETINIB	2024-09-29	Active	II	N/A

Trametinib

Trametinib

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

17 API Suppliers

6 USDMF

1 EU WC

8 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

18 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

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

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 Granulation

16 Solubilizers

15 Taste Masking

13 Chewable & Orodispersible Aids

12 Lubricants & Glidants

11 Topical

11 Co-Processed Excipients

9 Parenteral

TABLET;ORAL - EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons