Description
Afatinib Film-Coated Tablets (20 mg / 30 mg / 40 mg)
Healthy Inc is a specialized global supplier and exporter of advanced oncology, precision medicine, and targeted high-containment therapeutics. We provide ultra-high-purity, kinetically optimized Afatinib Tablets, manufactured in WHO–GMP certified, strictly segregated high-containment oncology facilities. This “Second-Generation Tyrosine Kinase Inhibitor (TKI)” is a premium strategic export to cancer research hospitals, specialized oncology clinics, and government health ministries, serving as the globally mandated first-line intervention for EGFR mutation-positive Non-Small Cell Lung Cancer (NSCLC).
Product Overview
This formulation operates as a “Molecular Master Switch.” Afatinib is engineered to provide a permanent blockade of the receptors that drive tumor growth, offering a more durable response than earlier reversible therapies.
Mechanism 1 (Irreversible Covalent Binding): Unlike first-generation TKIs that “sit” on the receptor and can be bumped off, Afatinib forms a permanent covalent bond with the kinase domain. Once Afatinib binds, that receptor is permanently deactivated until the cell recycled it.
Mechanism 2 (Pan-ErbB Family Inhibition): Afatinib is a “Pan-HER” inhibitor. it blocks signaling from EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4). This multi-receptor blockade helps overcome the “escape pathways” that tumors use to become resistant to simpler drugs.
Mechanism 3 (Targeted Mutation Sensitivity): It is exceptionally potent against the most common EGFR mutations, specifically Exon 19 deletions and Exon 21 (L858R) substitutions, physically stopping the uncontrolled cell division that characterizes metastatic lung cancer.
Product Composition & Strength
We supply this product in multiple strengths to allow for precise dose titration based on patient tolerability.
| Active Ingredient | Strength | Primary Clinical Function |
| Afatinib (as Dimaleate) USP/Ph.Eur. | 20 mg / 30 mg | The Dose-Adjustment Unit: Used for patients requiring a lower dose due to gastrointestinal or skin toxicity. |
| Afatinib (as Dimaleate) USP/Ph.Eur. | 40 mg | The Standard Therapeutic Anchor: The globally validated starting dose for first-line treatment of EGFR+ NSCLC. |
| Excipients | Proprietary Matrix | Bio-Stable Coating: Engineered to protect the sensitive dimaleate salt and ensure consistent systemic absorption. |
Technical & Logistics Specifications
HS Code: 3004.90.99 (Medicaments containing other active substances – Oncology/Targeted Therapy)
CAS Number: 850140-72-6 (Afatinib)
Dosage Form: Film-Coated Tablet
Packaging: Alu-Alu Blisters. Protects the API from light and environmental humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.
Manufacturing Authority & Compliance
OEB 5 High-Containment: Afatinib is a highly potent cytotoxic agent. Our facility utilizes Dedicated Oncology Blocks with negative pressure and isolator technology to ensure zero cross-contamination.
API Salt Stability: Our manufacturing process focuses on the absolute stability of the Dimaleate salt, ensuring consistent bioavailability and $T_{max}$ (peak concentration) for predictable clinical efficacy.
Primary Indications
Oncology: First-line treatment of patients with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have non-resistant EGFR mutations.
Squamous NSCLC: Treatment of patients with advanced squamous cell carcinoma of the lung progressing after platinum-based chemotherapy.
Precision Care: Management of tumors with “uncommon” EGFR mutations where first-generation drugs are less effective.
Dosage & Administration
Standard Adult Dosing: 40 mg once daily.
Administration: Must be taken on an empty stomach. No food should be consumed for at least 3 hours before and at least 1 hour after taking the dose.
Important: Tablets must be swallowed whole with water.
Safety Warning: Severe Diarrhea. Afatinib frequently causes significant GI distress; patients should have anti-diarrheal medication (like Loperamide) available. Dermatological Toxicity: Monitor for severe rash and paronychia (nail bed infections). Interstitial Lung Disease (ILD): Withhold treatment immediately if the patient develops unexplained pulmonary symptoms.
Global Export & Contract Manufacturing
Healthy Inc is a premier Oncology Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-end Targeted TKIs. Whether you are a National Cancer Program in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.
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