Description

Imatinib Mesylate Film-Coated Tablets (100 mg / 400 mg)

Healthy Inc is a specialized global supplier and exporter of advanced high-containment oncology, hematology, and targeted antineoplastic therapeutics. We provide ultra-high-purity, kinetically precise Imatinib Mesylate Film-Coated Tablets (100 mg / 400 mg), manufactured in WHO–GMP certified, strictly segregated high-containment (OEB 4) oral solid dosage facilities. This “Targeted Tyrosine Kinase Inhibitor (TKI)” is a massive-volume, highly lucrative export to hematology-oncology centers, leukemia 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 Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumors (GIST).

Product Overview

This highly advanced formulation represents the absolute pinnacle of precision medicine. Instead of blindly poisoning all rapidly dividing cells (like traditional chemotherapy), it acts as a highly intelligent “biochemical sniper,” seeking out and disabling the exact mutated proteins that cause specific cancers to multiply, leaving healthy cells largely untouched.

The “BCR-ABL & c-KIT Tyrosine Kinase Blockade” Specialist:

• Mechanism 1 (The BCR-ABL Leukemia Paralyzer): In Chronic Myeloid Leukemia (CML), a genetic mutation creates the “Philadelphia chromosome,” which produces an abnormal, constantly active enzyme called BCR-ABL tyrosine kinase. This enzyme continuously tells white blood cells to multiply uncontrollably. Imatinib is brilliantly engineered to fit perfectly into the ATP-binding pocket of this specific mutant enzyme. By locking into this pocket, it physically paralyzes the enzyme, instantly shutting down the “multiply” signal and forcing the leukemia cells into apoptosis (cellular suicide).
• Mechanism 2 (The c-KIT GIST Eradicator): Beyond leukemia, Imatinib is the globally mandated lifeline for severe gastrointestinal cancers known as GISTs. In these tumors, a different mutated receptor called c-KIT (CD117) drives the cancer. Imatinib acts as a profound competitive inhibitor of the c-KIT receptor tyrosine kinase, rapidly shrinking aggressive, inoperable gastrointestinal tumors.
• The “Lifelong Chronic Maintenance” Paradigm: Because Imatinib is a highly tolerable oral tablet rather than a toxic IV infusion, patients with CML take this medication daily for decades. It fundamentally altered the oncology landscape by turning a terminal blood cancer into a chronically managed condition, guaranteeing massive, continuous, lifelong procurement demands for national health systems.

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 mesylate salt.

*Pack Sizes: 10×10 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 & Bioequivalence Engineering (CRITICAL COMPLIANCE): Imatinib is a potent, targeted antineoplastic agent. Manufacturing this compound in standard generic facilities is strictly prohibited. Our production takes place in dedicated High-Containment Isolator blocks (OEB 4) equipped with terminal HEPA filtration, ensuring absolute safety for operators and zero cross-contamination. Furthermore, our formulation undergoes rigorous *in-vitro* dissolution testing to guarantee identical pharmacokinetic bioequivalence to the originator brand, ensuring that leukemia patients maintain the exact plasma levels required to keep the cancer in deep molecular remission.

Therapeutic Indications (Human Use)

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

• Chronic Myeloid Leukemia (CML): First-line treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome-positive (Ph+) CML in chronic phase, accelerated phase, or blast crisis.
• Acute Lymphoblastic Leukemia (ALL): Treatment of adult patients with relapsed or refractory Ph+ ALL.
• Gastrointestinal Stromal Tumors (GIST): Treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant GIST.
• Dermatofibrosarcoma Protuberans (DFSP): Treatment of adult patients with unresectable, recurrent, or metastatic DFSP.

Dosage & Administration

Recommended Dosage (Strictly as per Hemato-Oncologist Guidelines):

• Adult CML (Chronic Phase) & GIST: Typically 400 mg taken orally once daily.
• Adult CML (Accelerated Phase / Blast Crisis): 600 mg to 800 mg daily (if 800 mg, given as 400 mg twice daily).
• Administration (The “Gastric Protection” Rule): To minimize severe gastrointestinal irritation, the tablets MUST be administered with a full meal and a large glass of water.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Severe Fluid Retention & Edema: Imatinib frequently causes severe, sometimes life-threatening fluid retention, including pleural effusion, pericardial effusion, and massive ascites. Elderly patients and those with cardiac histories must be closely monitored and managed with rapid diuretics.
• Hepatotoxicity: Severe, potentially fatal liver damage can occur. Bilirubin and hepatic transaminases must be monitored monthly before and during treatment.
• Severe Gastrointestinal Hemorrhage: GIST patients are at a particularly high risk of severe, rapid gastrointestinal bleeding, as the tumor shrinks and pulls away from the bowel wall.
• Embryo-Fetal Toxicity (Absolute Contraindication): FATAL WARNING: Imatinib can cause extreme fetal harm or death. Highly effective contraception must be utilized by women of childbearing potential during therapy and for 14 days 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 Hemato-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 leukemia 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.