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

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Selumetinib
FDA Orange Book

European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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

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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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pharmacompass-2-m-2025-10-20

Selumetinib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

3 API Suppliers, 1 USDMF, 2 NDC API, 2 Listed Suppliers, $ API Reference Price

3 API Suppliers
1 USDMF
2 NDC API
2 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

59 Drugs in Development

59 Drugs in Development

FINISHED DOSAGE FORMULATIONS

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

16 FDF Dossiers
6 FDA Orange Book
6 Europe
2 Australia
2 South Africa

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 21 News #PharmaBuzz

1 Data Compilation #PharmaFlow
21 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 5 Annual Reports

1 US Medicaid Prescriptions
5 Annual Reports

MARKET PLACE

3 APIs, 1 FDF Dossiers

3 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents, 4 US Exclusivities, 6 Health Canada Patents

16 US Patents
4 US Exclusivities
6 Health Canada Patents

$ API Ref.Price (USD/KG) : 94,852 Xls

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filter Applicant Reset all filters

6 All

01 2ASTRAZENECA

02 4ASTRAZENECA LP

filter Dosage Reset all filters

6 All

01 2CAPSULE; ORAL

02 2CAPSULE;ORAL

03 2GRANULE;ORAL

filter Regulatory Info Reset all filters

6 All

01 2RX

02 4Blank

filter Brand Name Reset all filters

6 All

01 6KOSELUGO

filter RLD Reset all filters

6 All

01 2Yes

02 4Blank

List of Suppliers

Product Main Page

01

ASTRAZENECA

OTS 2025

Not Confirmed

ASTRAZENECA

OTS 2025

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

RLD : Yes

TE Code :

SELUMETINIB SULFATE

Brand Name : KOSELUGO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2020-04-10

Application Number : 213756

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

ASTRAZENECA

OTS 2025

Not Confirmed

ASTRAZENECA

OTS 2025

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

RLD : Yes

TE Code :

SELUMETINIB SULFATE

Brand Name : KOSELUGO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 25MG BASE

Approval Date : 2020-04-10

Application Number : 213756

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

ASTRAZENECA LP

OTS 2025

Not Confirmed

ASTRAZENECA LP

OTS 2025

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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Post an Enquiry

Digital Content

RLD :

TE Code :

SELUMETINIB

Brand Name : KOSELUGO

Dosage Form : GRANULE;ORAL

Dosage Strength : 5MG

Approval Date :

Application Number : 219943

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

ASTRAZENECA LP

OTS 2025

Not Confirmed

ASTRAZENECA LP

OTS 2025

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

RLD :

TE Code :

SELUMETINIB

Brand Name : KOSELUGO

Dosage Form : GRANULE;ORAL

Dosage Strength : 7.5mg

Approval Date :

Application Number : 219943

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

ASTRAZENECA LP

OTS 2025

Not Confirmed

ASTRAZENECA LP

OTS 2025

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

RLD :

TE Code :

SELUMETINIB

Brand Name : KOSELUGO

Dosage Form : CAPSULE; ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 219943

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

ASTRAZENECA LP

OTS 2025

Not Confirmed

ASTRAZENECA LP

OTS 2025

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

RLD :

TE Code :

SELUMETINIB

Brand Name : KOSELUGO

Dosage Form : CAPSULE; ORAL

Dosage Strength : 25MG

Approval Date :

Application Number : 219943

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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