Ivosidenib | All | Licensing, EU CTD Dossiers, Formulation Suppliers | PharmaCompass.com

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Ivosidenib
FDF Dossiers

Evonik

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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With Fermion, start the journey of your innovative API.

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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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Temad- We think of world-class quality.

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Ivosidenib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

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

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

DEVELOPMENTS

47 Drugs in Development

47 Drugs in Development

FINISHED DOSAGE FORMULATIONS

7 FDF Dossiers, 1 FDA Orange Book, 4 Europe, 1 Canada, 1 Australia

7 FDF Dossiers
1 FDA Orange Book
4 Europe
1 Canada
1 Australia

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 47 News #PharmaBuzz

2 Data Compilation #PharmaFlow
47 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 1 Regulatory FDF Prices

2 US Medicaid Prescriptions
1 Regulatory FDF Prices

PATENTS & EXCLUSIVITIES

31 US Patents, 6 US Exclusivities, 2 Health Canada Patents

31 US Patents
6 US Exclusivities
2 Health Canada Patents

$ API Ref.Price (USD/KG) : 11,008 Xls

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7 All

01 5Servier

02 1Servier Canada

03 1Servier Laboratories (Aust.) Pty. Ltd.

filter Dosage Reset all filters

7 All

01 1Compressed Pellets

02 2Film Coated Tablet

03 1TABLET (IMMEDIATE RELEASE)

04 1TABLET;ORAL

05 1Tablet, film-coated

06 1Blank

filter Regulatory Info Reset all filters

7 All

01 1Allowed

02 1Approved

03 1Authorized

04 1Prescription

05 1RX

06 2Blank

filter Brand Name Reset all filters

7 All

01 2TIBSOVO

02 5Tibsovo

filter Country Reset all filters

7 All

01 1Australia

02 1Canada

03 1Norway

04 1Spain

05 1Sweden

06 1Switzerland

07 1USA

List of Suppliers

Product Main Page

01

Servier

FNCE

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Servier

FNCE

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Digital Content

Regulatory Info : RX

Registration Country : USA

Brand Name : TIBSOVO

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Packaging :

Approval Date : 2018-07-20

Application Number : 211192

Regulatory Info : RX

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Servier

FNCE

Not Confirmed

Servier

FNCE

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Norway

Brand Name : Tibsovo

Dosage Form : Tablet, film-coated

Dosage Strength : 250 mg

Packaging : Bottle 60item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Servier

FNCE

Not Confirmed

Servier

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Brand Name : Tibsovo

Dosage Form : Film Coated Tablet

Dosage Strength : 250mg

Packaging :

Approval Date : 04/05/2023

Application Number : 20220304000047

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Servier

FNCE

Not Confirmed

Servier

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Allowed

Registration Country : Switzerland

Ivosidenibum

Brand Name : Tibsovo

Dosage Form : Compressed Pellets

Dosage Strength : 250mg

Packaging :

Approval Date : 13/06/2024

Application Number : 69077

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Servier

FNCE

Not Confirmed

Servier

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Brand Name : Tibsovo

Dosage Form : Film Coated Tablet

Dosage Strength : 250MG

Packaging :

Approval Date : 2024-02-05

Application Number : 1231728001

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Servier Canada

FNCE

Not Confirmed

Servier Canada

FNCE

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

Brand Name : TIBSOVO

Dosage Form : TABLET (IMMEDIATE RELEASE)

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number : 2549980

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Servier Laboratories (Aust.) Pty. L...

Country

FNCE

Not Confirmed

Servier Laboratories (Aust.) Pty. L...

Country

FNCE

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Tibsovo

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

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