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Gefitinib bulk supplier for pharma manufacturers

Gefitinib 250 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 250 mg

Reference Brands: Iressa (US/EU)

Category: Oncology Cancer Care

Gefitinib is used in the treatment of non-small cell lung cancer. It is used in patients in which it has spread to other parts of the body, who have abnormal epidermal growth factor receptor (EGFR) genes, and who have not had previous treatment for cancer.

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Product Description:

Gefitinib was among the first drugs to show that a lung cancer could be defined by a mutation rather than by its appearance under a microscope. It inhibits the tyrosine kinase domain of the epidermal growth factor receptor. In unselected patients the results were unimpressive; in patients whose tumours carry activating EGFR mutations — exon 19 deletions or the L858R substitution — response rates exceed seventy per cent, because those tumours depend entirely on the receptor for survival.

It is used as first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer, taken once daily. Rash and diarrhoea are the common toxicities and rash severity tracks with response. Interstitial lung disease is uncommon but can be fatal and occurs at notably higher rates in some East Asian populations. Resistance develops after roughly a year, most often through the T790M mutation, which is why re-biopsy at progression guides the next step.

Sourcing notes. Off patent with generic tablets widely available, making it the most affordable EGFR inhibitor. EGFR mutation testing is mandatory at the destination — without a testing pathway this product cannot be used on label, however low the price. Oral solid, room temperature.

Gefitinib — third party manufacturing & bulk supply

Gefitinib 250 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Gefitinib is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Gefitinib listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Gefitinib is listed as Tablets in 250 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Gefitinib is referenced against Iressa (US/EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.

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