Erdafitinib

Xi'an Faithful BioTech Co., Ltd: Your Trusted Erdafitinib Manufacturer & Supplier

Xi'an Faithful BioTech Co., Ltd specializes in specialty active pharmaceutical ingredients such as Erdafitinib, focusing on the supply of high-quality pharmaceutical raw materials and intermediates, providing stable and compliant Edoxaban for pharmaceutical companies, and helping customers achieve value transformation from research and development to commercialization.

Erdafitinib Introduction

Erdafitinib is an orally administered, potent pan-FGFR (fibroblast growth factor receptor) family tyrosine kinase inhibitor. Its molecular formula is C₂₅H₃₀N₆O₂, and its molecular weight is 446.56. It was approved by the FDA in 2019 for the treatment of locally advanced or metastatic urothelial carcinoma harboring FGFR3 gene mutations. It inhibits cancer cell growth signaling by blocking the kinase activity of FGFR1/2/3/4.

Specifications 

Application area of Erdafitinib

Erdafitinib is primarily used in the research and industrial production of oral targeted tablets, targeting the manufacture of drugs for the treatment of locally advanced and metastatic urothelial carcinoma carrying FGFR2 and FGFR3 susceptibility gene mutations. It is mainly used in the treatment of tumors that have progressed after platinum-based chemotherapy. Erdafitinib is also being explored for new drugs related to cholangiocarcinoma and other FGFR-mutant solid tumors. On the research side, it supplies universities and third-party pharmacological institutions to conduct experiments related to FGFR signaling pathways, tumor cell proliferation inhibition, and target resistance mechanisms, covering the entire chain from milligram-level small-scale trials and pilot-scale amplification to continuous commercial mass production. The market demand for targeted anti-tumor active pharmaceutical ingredients continues to rise.

Main Advantages

Precisely targets the FGFR pathway: As a pan-FGFR inhibitor, it acts simultaneously on FGFR1-4, effectively blocking key signaling pathways driving tumor growth.

Oral administration, high patient compliance: Once-daily oral tablets, taken with or without food, facilitate long-term treatment management.

High purity, controllable quality: The reported synthesis process can achieve a product purity of 99.4%, with an overall yield of up to 54%.

Contact us allen@faithfulbio.com or Whats App：+86 13137770562

Why choose us

• As your upstream partner, our first commitment is quality. Our Erdafitinib is produced under strict production conditions, and key indicators such as content and related substances (individual impurities<0.1%) meet the requirements of the International Pharmacopoeia.
• Secondly, with stable supply and deep cooperation with core production enterprises, Edoxaban powder has a year-round inventory of spot goods, which can be shipped out as soon as possible after placing an order, without the need for long waiting times.

Quality Control

R&D Results

Packaging and Transportation

After-Sales Service

Qualification Certification

Exhibition

FAQ

Q1: Does the impurity level of Erdafitinib meet the standards for generic drug application?

A1: Multi-stage recrystallization process strictly controls single and total impurities, ensuring stable purity. Each batch comes with complete test chromatograms and a Certificate of Analysis (COA), meeting the requirements for formulation application.

Q2: Will the mixing of raw materials and tablet excipients lead to agglomeration or abnormal tableting?

A2: The crystal particle size is controllable, the powder has excellent flowability, and it blends stably with conventional oral excipients, smoothly adapting to the entire tablet manufacturing process.

Q3: Will the target inhibitory activity easily decrease after low-temperature, light-protected storage?

A3: The crystal structure is stable, and under compliant storage conditions, it is not easily decomposed or deteriorated. Even after long-term storage, it maintains stable FGFR pathway inhibitory capacity.

Contact US

We keep high purity Erdafitinib in stock. Contact us allen@faithfulbio.com or Whats App：+86 13137770562 any time .