Erdafitinib | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Erdafitinib
Europe

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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Inke S.A: APIs manufacturing plant.

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Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Erdafitinib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

5 API Suppliers, 2 NDC API, 4 Listed Suppliers

5 API Suppliers
2 NDC API
4 Listed Suppliers

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

FINISHED DOSAGE FORMULATIONS

15 FDF Dossiers, 3 FDA Orange Book, 9 Europe, 3 Canada

15 FDF Dossiers
3 FDA Orange Book
9 Europe
3 Canada

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 3MG, TABLET;ORAL - 4MG, TABLET;ORAL - 5MG

TABLET;ORAL - 3MG
TABLET;ORAL - 4MG
TABLET;ORAL - 5MG

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 20 News #PharmaBuzz

2 Data Compilation #PharmaFlow
20 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

1 US Medicaid Prescriptions

MARKET PLACE

1 APIs, 1 FDF Dossiers

1 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

51 US Patents, 3 US Exclusivities, 4 Health Canada Patents

51 US Patents
3 US Exclusivities
4 Health Canada Patents

Xls

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FILTER :

filter Applicant Reset all filters

9 All

01 3Janssen-Cilag Ag

02 3Janssen-Cilag International N.V.

03 3Janssen-Cilag International Nv

filter Active Ingredients Reset all filters

9 All

01 9Erdafitinib

filter Dosage Form Reset all filters

9 All

01 9Film Coated Tablet

filter Country Reset all filters

9 All

01 3Spain

02 3Sweden

03 3Switzerland

filter Brand Name Reset all filters

9 All

01 9Balversa

List of Suppliers

Product Main Page

01

Janssen-Cilag International Nv

FNCE

Not Confirmed

Janssen-Cilag International Nv

FNCE

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

Regulatory Info : Approved

Registration Country : Sweden

Erdafitinib

Brand Name : Balversa

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 22/08/2024

Application Number : 20230909000014

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Janssen-Cilag International Nv

FNCE

Not Confirmed

Janssen-Cilag International Nv

FNCE

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

Regulatory Info : Approved

Registration Country : Sweden

Erdafitinib

Brand Name : Balversa

Dosage Form : Film Coated Tablet

Dosage Strength : 4mg

Packaging :

Approval Date : 22/08/2024

Application Number : 20230909000021

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Janssen-Cilag International Nv

FNCE

Not Confirmed

Janssen-Cilag International Nv

FNCE

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

Regulatory Info : Approved

Registration Country : Sweden

Erdafitinib

Brand Name : Balversa

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 22/08/2024

Application Number : 20230909000038

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Janssen-Cilag Ag

FNCE

Not Confirmed

Janssen-Cilag Ag

FNCE

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

Regulatory Info : Allowed

Registration Country : Switzerland

Erdafitinib

Brand Name : Balversa

Dosage Form : Film Coated Tablet

Dosage Strength : 3mg

Packaging :

Approval Date : 14/01/2025

Application Number : 67660

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Janssen-Cilag Ag

FNCE

Not Confirmed

Janssen-Cilag Ag

FNCE

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

Regulatory Info : Allowed

Registration Country : Switzerland

Erdafitinib

Brand Name : Balversa

Dosage Form : Film Coated Tablet

Dosage Strength : 4mg

Packaging :

Approval Date : 14/01/2025

Application Number : 67660

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Janssen-Cilag Ag

FNCE

Not Confirmed

Janssen-Cilag Ag

FNCE

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

Regulatory Info : Allowed

Registration Country : Switzerland

Erdafitinib

Brand Name : Balversa

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 14/01/2025

Application Number : 67660

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Janssen-Cilag International N.V.

FNCE

Not Confirmed

Janssen-Cilag International N.V.

FNCE

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

Regulatory Info : Authorized

Registration Country : Spain

Erdafitinib

Brand Name : Balversa

Dosage Form : Film Coated Tablet

Dosage Strength : 3MG

Packaging :

Approval Date : 2024-08-27

Application Number : 1241841004

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Janssen-Cilag International N.V.

FNCE

Not Confirmed

Janssen-Cilag International N.V.

FNCE

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

Regulatory Info : Authorized

Registration Country : Spain

Erdafitinib

Brand Name : Balversa

Dosage Form : Film Coated Tablet

Dosage Strength : 4MG

Packaging :

Approval Date : 2024-08-27

Application Number : 1241841009

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Janssen-Cilag International N.V.

FNCE

Not Confirmed

Janssen-Cilag International N.V.

FNCE

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

Regulatory Info : Authorized

Registration Country : Spain

Erdafitinib

Brand Name : Balversa

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 2024-08-27

Application Number : 1241841011

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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