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Erdafitinib bulk supplier for pharma manufacturers

Erdafitinib 3 mg, 4 mg, 5 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 3 mg, 4 mg, 5 mg

Reference Brands: Balversa (USA)

Category: Oncology Cancer Care

Erdafitinib is an oral FGFR inhibitor for advanced urothelial (bladder) cancer with susceptible FGFR3 genetic changes. It is made by Janssen and sold as Balversa in 3 mg, 4 mg and 5 mg tablets, and is still under patent with no approved generic. Supply is through authorised distribution or named-patient import; ask us which route fits your country.

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Product Description:

Erdafitinib is an oral pan-FGFR tyrosine kinase inhibitor, active against fibroblast growth factor receptors 1 through 4. Its approved use is in locally advanced or metastatic urothelial carcinoma carrying susceptible FGFR2 or FGFR3 alterations, in patients who have progressed on prior therapy. It is a genuinely biomarker-gated drug: eligibility depends on a companion diagnostic identifying the alteration, and without that testing infrastructure the product cannot be used.

The toxicity profile follows directly from the target. Hyperphosphataemia is on-target rather than idiosyncratic — FGF23 signalling governs renal phosphate handling — and serum phosphate is used to titrate the dose upward rather than simply as a safety check. Serous retinopathy and central serous chorioretinopathy require ophthalmic monitoring, and nail, skin and oral mucosal toxicity are common enough to affect adherence.

Sourcing notes. Originator product, on patent, with no generic route. Treat enquiries as innovator supply or named-patient import rather than contract manufacturing. Market access depends on FGFR companion diagnostics being available in the destination country — a buyer without that testing pathway cannot use the product at any price.

Also known as: erdafitinib (Spanish, French, Italian), erdafitinibe (Portuguese), Erdafitinib (German), إردافيتينيب (Arabic).

How Erdafitinib is supplied today, and licensing ahead of patent expiry

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access
Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing
A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives
Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule
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Frequently Asked Questions


Erdafitinib is used to treat adult patients with advanced or metastatic cancers (such as urothelial carcinoma) that have specific FGFR genetic alterations and whose disease has progressed following prior therapy.


Erdafitinib is a small‑molecule tyrosine kinase inhibitor structurally designed to block fibroblast growth factor receptors. It targets abnormal FGFR activity in certain cancer cells.


The trade name of erdafitinib is Balversa.


Balversa (erdafitinib) is manufactured by Janssen Pharmaceuticals.


The generic name of the product is erdafitinib.


The brand name of erdafitinib is Balversa.


Erdafitinib is manufactured under regulated pharmaceutical standards by Janssen Pharmaceuticals and associated licensed manufacturers for distribution in the USA, EU, UK, and other approved regions.

Adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed after at least one prior systemic therapy. An FDA-approved companion test confirms the alteration.

No. Erdafitinib is patented and marketed by Janssen as Balversa; there is no approved generic.

Through local registration where it exists, or by named-patient or special import routes where it is not registered. PharmaTradz helps with the paperwork for authorised supply.

Balversa (Erdafitinib) is developed and sold by Johnson & Johnson (Janssen). PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.

El erdafitinib es un inhibidor de la cinasa del receptor del factor de crecimiento de fibroblastos (FGFR) indicado en adultos con carcinoma urotelial localmente avanzado o metastásico con alteraciones genéticas de FGFR3 sensibles, cuya enfermedad ha progresado tras un tratamiento sistémico previo. Se utiliza con receta y bajo la supervisión de un oncólogo con experiencia. PharmaTradz facilita a importadores, distribuidores y hospitales con licencia el suministro de erdafitinib procedente de fabricantes con certificación GMP.

O erdafitinibe é um inibidor da quinase do receptor do fator de crescimento de fibroblastos (FGFR) indicado para adultos com carcinoma urotelial localmente avançado ou metastático com alterações genéticas suscetíveis de FGFR3, cuja doença progrediu após tratamento sistêmico prévio. É usado com prescrição e sob supervisão de um oncologista experiente. A PharmaTradz facilita para importadores, distribuidores e hospitais licenciados o fornecimento de erdafitinibe de fabricantes com certificação GMP.

L'erdafitinib est un inhibiteur de la kinase du récepteur du facteur de croissance des fibroblastes (FGFR) indiqué chez l'adulte atteint d'un carcinome urothélial localement avancé ou métastatique présentant des altérations génétiques sensibles de FGFR3, dont la maladie a progressé après un traitement systémique antérieur. Il est prescrit sur ordonnance et utilisé sous la surveillance d'un oncologue expérimenté. PharmaTradz permet aux importateurs, distributeurs et hôpitaux agréés de s'approvisionner en erdafitinib auprès de fabricants certifiés BPF (GMP).

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