Gefitinib

Синонимы: Iressa, ZD1839, 4-(3-chloro-4-fluorophenylamino)-7-methoxy-6-(3-morpholinopropoxy)quinazoline, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholin-4-ylpropoxy)quinazolin-4-amine

Gefitinib has become a mainstay in the targeted treatment of non-small cell lung cancer (NSCLC), particularly for patients whose tumors harbor EGFR mutations. As the first EGFR tyrosine kinase inhibitor approved for clinical use, it continues to drive steady demand from generic drug manufacturers, CDMO partners, and research institutions worldwide.

Chemically, gefitinib is a synthetic anilinoquinazoline derivative. It works by reversibly binding to the ATP-binding site of the epidermal growth factor receptor (EGFR) tyrosine kinase domain, blocking autophosphorylation and downstream signaling that fuels tumor cell proliferation. This mechanism makes it a valuable tool both as an active pharmaceutical ingredient (API) and as a reference standard in bioequivalence and pharmacological studies.

LyvBio supplies gefitinib with a purity of ≥99.0% (HPLC), meeting stringent pharmacopeial requirements. Our material is manufactured under cGMP conditions and is available for immediate shipment from stock, serving formulation development, clinical trial supply, and commercial production needs.

Product Overview & Composition

Gefitinib is a small-molecule kinase inhibitor belonging to the quinazoline class. It is practically insoluble in water but dissolves readily in organic solvents such as DMSO, which is typical for this chemical family. The compound is stable under normal storage conditions and is typically handled as a fine crystalline powder.

Our gefitinib API is produced through a multi-step synthesis followed by recrystallization to achieve high chemical purity. Each batch is tested for identity, assay, and impurity profile to ensure consistency and compliance with ICH guidelines. The material is non-hygroscopic and shows good flow properties, making it suitable for tablet and capsule formulations.

Applications & Product Lines

• Generic drug manufacturing: Used as the active ingredient in gefitinib tablets for the treatment of EGFR-mutated NSCLC.
• Research and development: Serves as a positive control or reference compound in EGFR inhibition studies and cancer biology research.
• Bioequivalence studies: Supplied to CROs and CDMOs for comparative bioavailability testing against the originator product.
• Formulation development: Employed in the development of immediate-release solid oral dosage forms.
• Analytical standards: Available as a high-purity reference material for HPLC method development and validation.

Quality Control Standards

Bulk Packaging & Supply

• Packaging: 25 kg net in fiber drum with double LDPE liner. Custom packaging available upon request.
• MOQ: 1 kg
• Срок выполнения заказа: 3–5 рабочих дней (товары, имеющиеся в наличии)
• Documentation: COA, MSDS, TDS provided with each shipment. Additional documentation (e.g., stability data, impurity profiles) available on request.

Frequently Asked Questions

What is the minimum order quantity (MOQ) for gefitinib?

Our standard MOQ is 1 kg. For smaller quantities, please contact our sales team to discuss your specific requirements.

How long does delivery take?

For stock items, delivery typically takes 3-5 business days after order confirmation.

Can you provide a COA and samples?

Yes, we provide a COA for every batch. Samples are available upon request to qualified customers for evaluation purposes.

Contact & Ordering Information

• Company: LyvBio Co., Ltd.
• Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
• Email: info@lyvbio.com
• Phone: +86-29-65816888

send us your specification for a quotation.