Afatinib bulk supplier for pharma manufacturers

Afatinib 20 mg, 30mg, 40 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 20 mg, 30mg, 40 mg

Reference Brands: Gilotrif (USA), Giotrif (EU/UK)

Afatinib is a small-molecule tyrosine kinase inhibitor that irreversibly blocks signaling by the epidermal growth factor receptor (EGFR/ErbB) family (including EGFR, HER2, HER4). It is used primarily for adult patients with metastatic non-small-cell lung cancer (NSCLC) whose tumours harbour certain EGFR gene mutations, and also for squamous NSCLC progressing after platinum-based chemotherapy.

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Product Description:

Afatinib is a second-generation EGFR inhibitor that binds irreversibly, forming a covalent bond with the receptor rather than competing reversibly as gefitinib and erlotinib do. It also blocks HER2 and HER4, making it a pan-ErbB inhibitor. The irreversible binding gives deeper and longer target suppression, at the cost of more skin and gastrointestinal toxicity, because normal tissue EGFR is inhibited just as thoroughly.

It is used first-line for non-small cell lung cancer with activating EGFR mutations, and it has particular evidence in the uncommon mutations — G719X, L861Q, S768I — where other agents perform less well. Diarrhoea is near-universal and is the main dose-limiting effect; it needs anticipatory management with loperamide and dose reduction rather than discontinuation. Acneiform rash, stomatitis and nail inflammation follow from EGFR blockade in skin. It is taken on an empty stomach, since food substantially reduces absorption.

Sourcing notes. Generic versions have appeared in several markets, so patent position should be confirmed locally. EGFR mutation testing is a prerequisite. Third-generation agents now dominate first-line use where the T790M resistance pathway matters, which shapes where afatinib demand persists.

Afatinib — third party manufacturing & bulk supply

Afatinib 20 mg, 30mg, 40 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

Afatinib 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 Afatinib 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

Afatinib is used for the treatment of non-small cell lung cancer (NSCLC) that has specific mutations in the epidermal growth factor receptor (EGFR) gene. It is also indicated for metastatic NSCLC and certain cases of squamous cell carcinoma of the lung. Afatinib helps block cancer cell growth by inhibiting EGFR and other related receptor tyrosine kinases.

Afatinib is made from the active ingredient afatinib dimaleate, which is an irreversible inhibitor of the ErbB family of receptors, including EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4).

The trade name of Afatinib is Gilotrif in the United States and Giotrif in the European Union and the United Kingdom.

Afatinib (Gilotrif/Giotrif) is developed and marketed by Boehringer Ingelheim Pharmaceuticals.

The generic name is Afatinib Dimaleate.

The brand names are Gilotrif and Giotrif.

Afatinib is manufactured by Boehringer Ingelheim at its facilities in Germany and the United States under strict international quality and regulatory standards.