Description

Deferasirox Dispersible (DT) & Film-Coated Tablets (FCT) (90 mg / 125 mg / 250 mg / 360 mg / 500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced hematology, orphan drugs, and targeted heavy-metal chelation therapeutics. We provide ultra-high-purity, kinetically optimized Deferasirox Dispersible Tablets (125mg / 250mg / 500mg) and Film-Coated Tablets (90mg / 360mg), manufactured in WHO–GMP certified, high-capacity, dual-matrix oral solid dosage facilities. This “Once-Daily Tridentate Oral Iron Chelator” is a massive-volume, highly critical export to hematology networks, thalassemia treatment centers, mega-NGOs, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, apex intervention for patients suffering from catastrophic transfusional and non-transfusional iron overload.

Product Overview

This highly advanced formulation operates as a highly specific, once-daily molecular “scavenger” for toxic heavy metals. Patients with severe chronic anemias accumulate massive, lethal amounts of iron in their liver and heart. Deferasirox physically binds to this free iron, permanently neutralizing its toxicity and routing it into the bile for safe excretion.

The “Once-Daily Tridentate Chelator” Specialist:

• Mechanism 1 (The 2:1 Tridentate Complex): Deferasirox is a tridentate chelator with a massive, highly specific affinity for iron. It takes exactly two molecules of Deferasirox to completely surround and bind one atom of Ferric iron (Fe3+). Once bound, the iron is trapped in a stable, non-toxic complex that is primarily routed through the liver and safely excreted in the patient’s feces (unlike Deferiprone, which utilizes the kidneys).
• Mechanism 2 (The “Once-Daily” Compliance Revolution): Deferasirox has a remarkably long terminal half-life of 8 to 16 hours. This allows it to provide 24-hour continuous chelation of toxic iron from a single, once-daily dose. This “Once-Daily” protocol drastically reduces patient burnout and secures near-perfect therapeutic compliance in both pediatric and adult populations.
• Mechanism 3 (The FCT vs. DT Matrix Evolution): The original Dispersible Tablets (DT) contain lactose and require the patient to drink a gritty, unpleasant suspension on an empty stomach, causing high rates of severe gastrointestinal distress. The newer Film-Coated Tablets (FCT) completely eliminate the lactose, utilize a densified active matrix (reducing the required milligram dose by 30%), and can be swallowed whole with a light meal, completely revolutionizing patient tolerability.

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Dual-Matrix Engineering & Bioequivalence Profiling (CRITICAL COMPLIANCE): Manufacturing both the DT and FCT versions of Deferasirox requires elite pharmaceutical dexterity. The Dispersible formulation must shatter uniformly in liquid without leaving large, un-swallowable lumps, while the Film-Coated formulation must be perfectly densified to achieve an identical Area Under the Curve (AUC) at a 30% lower milligram dose. Our hematology suites utilize advanced laser diffraction particle sizing and rigorous in-vitro dissolution profiling to guarantee absolute pharmacokinetic bioequivalence for both formats.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized lifelong management of heavy metal toxicity:

• Transfusional Iron Overload: Treatment of chronic iron overload due to frequent blood transfusions in patients with beta-thalassemia major, sickle cell disease, and other chronic anemias (patients 2 years of age and older).
• Non-Transfusion-Dependent Thalassemia (NTDT): Treatment of chronic iron overload in patients 10 years of age and older with NTDT syndromes who require chelation but do not require regular transfusions.

Dosage & Administration

Recommended Dosage (Strictly as per Hematologist Guidelines):

• FCT Administration (Swallowable): Should be swallowed whole with water once daily, preferably on an empty stomach or with a light meal. DO NOT chew or crush.
• DT Administration (Dispersible): Must be completely dispersed by stirring in a glass of water, orange juice, or apple juice until a fine suspension is formed. Must be taken on an completely empty stomach at least 30 minutes before food.
• The Antacid/Cation Sparing Rule: Deferasirox will aggressively bind to aluminum. It MUST NOT be taken simultaneously with aluminum-containing antacids.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Renal Failure): Can cause acute renal failure, sometimes fatal. Serum creatinine and creatinine clearance must be monitored in all patients before initiating therapy and frequently thereafter.
• BLACK BOX WARNING (Hepatic Failure): Can cause severe, life-threatening hepatic failure. Serum transaminases and bilirubin must be monitored closely.
• BLACK BOX WARNING (Gastrointestinal Hemorrhage): Fatal gastrointestinal hemorrhages, including ulcers and perforations, have occurred. It must be used with extreme caution in patients taking NSAIDs, corticosteroids, or anticoagulants.
• Auditory & Ocular Toxicity: Can cause high-frequency hearing loss and lens opacities (cataracts). Annual auditory testing and slit-lamp eye examinations are mandatory.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Hematology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Iron Chelators, Orphan Drugs, and Dual-Matrix Dispersible/FCT Formulations. Whether you are looking for a reliable Government Tender Supplier for national thalassemia 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.