Description

Gefitinib Film-Coated Tablets (250 mg)

Healthy Inc is a specialized global supplier and exporter of advanced high-containment oncology, pulmonology, and targeted antineoplastic therapeutics. We provide ultra-high-purity, kinetically precise Gefitinib Film-Coated Tablets (250 mg), manufactured in WHO–GMP certified, strictly segregated high-containment (OEB 4) oral solid dosage facilities. This “Targeted EGFR Tyrosine Kinase Inhibitor (TKI)” is a massive-volume, highly lucrative export to thoracic oncology centers, lung cancer treatment networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line curative and maintenance intervention for metastatic Non-Small Cell Lung Cancer (NSCLC) harboring specific EGFR mutations.

Product Overview

This highly advanced formulation represents the absolute pinnacle of precision respiratory medicine. Instead of blindly attacking all rapidly dividing cells, it acts as a highly intelligent “biochemical sniper,” seeking out and disabling the exact mutated proteins that cause lung cancer cells to multiply, leaving healthy cells largely untouched.

The “EGFR Blockade & Cellular Apoptosis” Specialist:

• Mechanism 1 (The EGFR/HER1 Tyrosine Kinase Paralyzer): In a significant percentage of Non-Small Cell Lung Cancers (especially in Asian populations and non-smokers), a genetic mutation causes the Epidermal Growth Factor Receptor (EGFR) to become hyperactive, constantly signaling the cancer to grow and spread. Gefitinib is brilliantly engineered to fit perfectly into the ATP-binding pocket of this specific mutant tyrosine kinase enzyme. By locking into this pocket, it physically paralyzes the enzyme, instantly shutting down the “multiply and survive” signal pathways (like RAS/MAPK and PI3K/AKT).
• Mechanism 2 (Forced Apoptosis): Once the survival signals are cut off by Gefitinib, the lung cancer cells can no longer replicate or maintain their structure. The tumor is forcefully driven into apoptosis (programmed cellular suicide), leading to rapid, massive tumor shrinkage and clearing of the lungs.
• The “Genotype-Specific” Paradigm: Gefitinib fundamentally altered the oncology landscape. It is not for all lung cancers. It is strictly indicated for tumors possessing specific sensitizing EGFR mutations (such as exon 19 deletions or exon 21 L858R substitution mutations). This guarantees highly targeted, massive-volume procurement demands from advanced genomic-testing oncology hospitals.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Oncology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• OEB 4 High-Containment & Bioequivalence Engineering (CRITICAL COMPLIANCE): Gefitinib is a potent, targeted antineoplastic agent. Manufacturing this compound in standard generic facilities is strictly prohibited due to the severe risk of cross-contamination. Our production takes place in dedicated High-Containment Isolator blocks (OEB 4) equipped with terminal HEPA filtration, ensuring absolute safety for operators. Furthermore, Gefitinib’s solubility is highly pH-dependent. Our formulation utilizes elite surfactants (like SLS) and undergoes rigorous *in-vitro* dissolution testing to guarantee identical pharmacokinetic bioequivalence to the originator brand, ensuring that lung cancer patients maintain the exact plasma levels required for survival.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of severe thoracic malignancies:

• Non-Small Cell Lung Cancer (NSCLC): First-line treatment of adult patients with locally advanced or metastatic NSCLC who have activating mutations of the EGFR-TK (such as exon 19 deletions or exon 21 L858R substitution mutations).

Dosage & Administration

Recommended Dosage (Strictly as per Thoracic Oncologist Guidelines):

• Standard Adult Dosing: 250 mg taken orally once daily. Therapy is continued until disease progression or unacceptable toxicity occurs.
• Administration: Can be taken with or without food. Tablets must be swallowed whole. For patients with severe dysphagia, the tablet may be dispersed in half a glass of non-carbonated water.
• The Antacid Rule: Drugs that heavily elevate gastric pH (like Proton Pump Inhibitors or H2 blockers) significantly reduce the absorption of Gefitinib. They should be avoided or strictly timed.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Interstitial Lung Disease (ILD) – FATAL WARNING: Gefitinib can cause severe, acute-onset Interstitial Lung Disease or pneumonitis, which is frequently fatal. If a patient presents with sudden worsening of shortness of breath, cough, or fever, the drug must be interrupted immediately and permanent discontinuation instituted if ILD is confirmed.
• Severe Hepatotoxicity: Profound, sometimes fatal liver damage can occur. Periodic liver function testing (transaminases, bilirubin, and alkaline phosphatase) is absolutely mandatory before and during treatment.
• Severe Skin Reactions (The Efficacy Paradox): Gefitinib violently attacks the EGFR receptors in the skin, causing severe acneiform rash, dry skin, and paronychia. Paradoxically, the presence of this severe rash is often a clinical indicator that the drug is successfully attacking the cancer.
• Embryo-Fetal Toxicity: Gefitinib can cause extreme fetal harm or death. Highly effective contraception must be utilized by women of childbearing potential during therapy and for at least two weeks after stopping the drug.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Thoracic Oncology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antineoplastics, Tyrosine Kinase Inhibitors (TKIs), and OEB 4 High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for national lung cancer programs in the CIS or a B2B Pharma Marketplace partner for Southeast Asia, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.