Description

Imatinib Capsules (Imatinib Mesylate)

Healthy Inc is a specialized global supplier and exporter of advanced oncology, hematology, and targeted molecular therapeutics. We provide ultra-high-purity Imatinib Capsules (100 mg / 400 mg), manufactured in WHO–GMP certified, dedicated negative-pressure oncology facilities. This “First-in-Class Tyrosine Kinase Inhibitor (TKI)” is a massive-value, essential export to comprehensive cancer centers, hematology wards, and government health ministries in LATAM, the Middle East, Southeast Asia, and Africa, serving as the definitive, globally trusted intervention for Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumors (GIST).

Product Overview

This formulation contains Imatinib Mesylate, a groundbreaking targeted therapy that completely revolutionized the treatment of specific blood cancers by attacking the cancer at its genetic root.

The “Precision BCR-ABL Blocker” Specialist:

• Mechanism 1 (BCR-ABL Inhibition): In CML, a genetic abnormality (the Philadelphia chromosome) creates a mutant fusion protein called BCR-ABL. This protein acts as an enzyme (a tyrosine kinase) that is stuck in the “on” position, signaling white blood cells to multiply uncontrollably. Imatinib physically jams into the ATP-binding pocket of this mutant enzyme, completely paralyzing it. Deprived of their growth signal, the leukemic cells rapidly undergo apoptosis (cell death) while healthy cells are left largely unharmed.
• Mechanism 2 (c-KIT & PDGFR Inhibition): Beyond leukemia, Imatinib powerfully inhibits the receptor tyrosine kinases for platelet-derived growth factor (PDGF) and stem cell factor (c-KIT). Mutations in c-KIT are the primary driver of Gastrointestinal Stromal Tumors (GIST), making Imatinib the absolute gold standard for this historically untreatable cancer.
• The Targeted Therapy Advantage: Unlike traditional cytotoxic chemotherapy that indiscriminately destroys all rapidly dividing cells (causing hair loss, severe nausea, and profound immunosuppression), Imatinib is a “smart drug.” It selectively targets the exact molecular engine driving the tumor, offering unprecedented survival rates with vastly superior patient quality of life.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in highly secure, moisture-resistant Alu-Alu blister strips or heavy-gauge HDPE bottles for chronic dispensing.

*Pack Sizes: 10×10 Alu-Alu Blisters or HDPE Bottles of 30/120 capsules (Optimized for strict daily oncology adherence programs).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Oncology Procurement Boards.

Manufacturing Authority

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

• Polymorph Stability Validation: Imatinib API exists in multiple crystalline forms (polymorphs). The alpha-form is highly unstable, while the beta-form is therapeutically stable. Our manufacturing process utilizes advanced X-ray powder diffraction (XRPD) testing to guarantee absolute beta-polymorph stability throughout the entire blending and encapsulation process, ensuring clinical efficacy is never compromised.
• OEB-4 Containment Protocols: As a potent targeted therapy, manufacturing is executed within completely dedicated, negative-pressure oncology blocks. Closed-loop powder handling guarantees zero operator exposure and absolute prevention of cross-contamination with other pharmaceutical lines.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe hematological and solid-tumor 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, and adjuvant treatment following complete surgical resection.
• Myelodysplastic/Myeloproliferative Diseases (MDS/MPD): Treatment of patients with MDS/MPD associated with PDGFR gene re-arrangements.

Dosage & Administration

Recommended Dosage (Strictly as per Board-Certified Oncologist/Hematologist):

• Administration (GASTRIC PROTECTION RULE): Imatinib is highly irritating to the stomach. It MUST be taken with a heavy meal and a large glass of water to drastically minimize severe gastrointestinal irritation and nausea.
• Standard Adult Dosing: 400 mg/day for chronic phase CML; can be escalated to 600 mg or 800 mg/day for accelerated phase or blast crisis.
• Handling Precautions: Caregivers handling the capsules must wash their hands before and after administration. Pregnant women should not open or handle crushed/broken capsules.

Safety Warnings (CRITICAL):

• Severe Fluid Retention & Edema: Imatinib frequently causes severe, sometimes life-threatening fluid retention. Patients must be closely monitored for rapid weight gain, pleural effusion (fluid around the lungs), pericardial effusion, and severe ascites. Diuretics and dose reduction may be required.
• Hematologic Toxicity: Can cause profound, life-threatening neutropenia, thrombocytopenia, and anemia. Complete blood counts (CBC) must be performed weekly for the first month, biweekly for the second month, and periodically thereafter.
• Hepatotoxicity & GI Hemorrhage: Severe and occasionally fatal liver injury has been reported. Liver function tests (LFTs) must be monitored carefully. Patients with GIST are also at a significantly increased risk of severe gastrointestinal hemorrhage.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Oncology Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for national leukemia programs in Africa or a B2B Pharma Marketplace partner for the Middle East, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Specialty Medicine Wholesaler receives WHO-GMP certified products at competitive rates.