Description

Erlotinib Film-Coated Tablets (100 mg / 150 mg)

Healthy Inc is a specialized global supplier and exporter of advanced high-containment oncology, thoracic pulmonology, and targeted antineoplastic therapeutics. We provide ultra-high-purity, kinetically stabilized Erlotinib (as Hydrochloride) Film-Coated Tablets (100 mg / 150 mg), manufactured in WHO–GMP certified, strictly segregated high-containment (OEB 4) oral solid dosage facilities. This “Advanced EGFR Tyrosine Kinase Inhibitor (TKI)” is a massive-volume, incredibly high-value export to thoracic oncology centers, gastrointestinal cancer networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for both mutated Non-Small Cell Lung Cancer (NSCLC) and locally advanced, unresectable Pancreatic Cancer.

Product Overview

This highly advanced formulation operates as a highly specific biochemical sniper. It bypasses healthy tissue and seeks out the hyperactive, mutated epidermal growth factor receptors (EGFR/HER1) that are actively fueling the rapid, uncontrolled division of lung and pancreatic carcinomas.

The “Dual-Target EGFR Blockade & Pancreatic Rescue” Specialist:

• Mechanism 1 (The Tyrosine Kinase Paralyzer): In certain aggressive cancers, the EGFR protein is mutated into a constant “on” position, flooding the tumor cell with survival and replication signals. Erlotinib is structurally engineered to fit perfectly into the intracellular ATP-binding pocket of this receptor. By occupying this pocket, Erlotinib physically blocks the receptor from phosphorylating, instantly severing the tumor’s communication lines (the PI3K/AKT and MAPK pathways).
• Mechanism 2 (Forced Tumor Apoptosis): Deprived of its continuous survival signals, the structural integrity of the cancer cell collapses. The tumor is violently forced into apoptosis (programmed cellular suicide), leading to massive tumor necrosis and rapid regression of metastatic lesions in the lungs.
• Mechanism 3 (The Pancreatic Synergy): Pancreatic cancer is notoriously resistant to standard chemotherapy. However, when Erlotinib is co-administered with IV Gemcitabine, it aggressively attacks the EGFR overexpression common in pancreatic tumors, significantly extending overall survival in one of the deadliest, most difficult-to-treat human malignancies.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips or heavy-gauge HDPE bottles to ensure the absolute chemical stability of the targeted antineoplastic API.

*Pack Sizes: 3×10 Alu-Alu Blisters or Bottles of 30 (Optimized specifically for strict 30-day chronic oncology dispensing regimens).

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 & pH-Dissolution Engineering (CRITICAL COMPLIANCE): Erlotinib is a potent antineoplastic agent. Manufacturing this compound in standard facilities is strictly prohibited due to severe cross-contamination risks. Our production takes place in dedicated High-Containment Isolator blocks (OEB 4) equipped with terminal HEPA filtration. Furthermore, Erlotinib’s solubility drops precipitously in non-acidic environments. Our formulation utilizes elite surfactants and extreme-shear granulation to guarantee identical pharmacokinetic bioequivalence to the originator brand, ensuring total clinical efficacy regardless of the patient’s baseline gastric pH.

Therapeutic Indications (Human Use)

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

• Non-Small Cell Lung Cancer (NSCLC): First-line treatment, maintenance therapy, or second/third-line treatment of patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
• Pancreatic Cancer: First-line treatment, in combination with gemcitabine, of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Dosage & Administration

Recommended Dosage (Strictly as per Oncologist Guidelines):

• NSCLC: 150 mg taken orally once daily.
• Pancreatic Cancer: 100 mg taken orally once daily (in combination with gemcitabine).
• The Empty Stomach Mandate (CRITICAL): Erlotinib MUST be taken on an empty stomach, at least 1 hour before or 2 hours after the ingestion of food. Taking this drug with food massively and unpredictably spikes its bioavailability, leading to catastrophic, lethal toxicity.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Interstitial Lung Disease (ILD) – FATAL WARNING: Like Gefitinib, Erlotinib can cause severe, sudden-onset Interstitial Lung Disease (ILD) or pneumonitis, which is frequently fatal. If a patient presents with sudden worsening of shortness of breath or cough, the drug must be interrupted immediately.
• Gastrointestinal Perforation: Erlotinib significantly increases the risk of tears or holes developing in the stomach or intestines (GI perforation), a catastrophic emergency. Patients concurrently taking NSAIDs, steroids, or anti-angiogenic agents are at extreme risk.
• The Antacid / PPI Rule (Efficacy Failure): Drugs that elevate gastric pH (Proton Pump Inhibitors like Omeprazole, or H2 Blockers like Ranitidine) will drastically reduce the absorption of Erlotinib. They must be avoided, or staggered strictly according to oncology protocols, to prevent the tumor from relapsing due to under-dosing.
• Severe Exfoliative Skin Conditions: Erlotinib violently attacks the EGFR receptors in the skin, frequently causing agonizing bullous, blistering, and exfoliative skin conditions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
• Embryo-Fetal Toxicity: Causes extreme fetal harm. Highly effective contraception is mandatory during therapy and for at least one month after the final dose.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and 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 pancreatic cancer programs in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products