Deferiprone Film-Coated Tablets (500 mg / 1000 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 Deferiprone Film-Coated Tablets (500 mg / 1000 mg), manufactured in WHO–GMP certified, high-capacity macrodose oral solid dosage facilities. This “Bidentate 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, life-saving intervention for patients suffering from catastrophic transfusional iron overload.
Product Overview
This highly advanced formulation operates as a highly specific, molecular “scavenger” for toxic heavy metals. Patients requiring chronic blood transfusions accumulate massive, lethal amounts of iron in their organs because the human body has no natural mechanism to excrete excess iron. Deferiprone physically binds to this free iron, rendering it water-soluble so the kidneys can flush it out of the body.
The “Cardiac Iron Scavenger & Bidentate Chelator” Specialist:
- Mechanism 1 (The 3:1 Bidentate Complex): Deferiprone is a bidentate chelator, meaning it takes exactly three molecules of Deferiprone to completely surround and bind one atom of Ferric iron (Fe3+). Once bound, the iron is trapped in a stable, non-toxic, water-soluble complex that is rapidly excreted in the patient’s urine.
- Mechanism 2 (The Cardiac Rescue Paradigm): The primary cause of death in Thalassemia patients is iron-induced heart failure. Deferiprone’s small molecular weight and lipophilic nature allow it to easily cross cell membranes and enter the myocardial (heart) cells. It is clinically proven to be vastly superior to older IV drugs at stripping highly toxic, unbound iron directly out of the heart tissue, literally saving the patient from fatal arrhythmias.
- Mechanism 3 (The “Oral Freedom” Compliance): Before oral chelators, patients relied on Deferoxamine, which required agonizing 8-to-12 hour daily subcutaneous infusions via a mechanical pump. This grueling regimen caused massive patient burnout and non-compliance, leading to early death. Deferiprone replaced the pump with a swallowable tablet, completely revolutionizing global thalassemia care and massively driving up survival rates.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Macrodose Tablet, packed exclusively in highly secure, heavy-gauge HDPE bottles to ensure the absolute physical and chemical stability of the massive active pharmaceutical payload.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Deferiprone USP/Ph.Eur. | 500 mg | The Standard Titration Unit: The baseline therapeutic dose utilized for precise, weight-based titration in pediatric and lower-weight thalassemia patients. |
| Deferiprone USP/Ph.Eur. | 1000 mg | The Hematology Macrodose: The massive therapeutic payload required to minimize the total daily pill burden for adult patients suffering from severe, refractory iron overload. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Povidone K-30 / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Polymeric Film | Diluent / Superdisintegrant / Binder / Glidant / Heavy Film-Coating (Engineered specifically utilizing advanced High-Shear Wet Granulation. Because a 1000mg tablet is inherently massive, it must be highly densified to remain swallowable, heavily coated to mask its severe bitterness, and packed with elite disintegrants to ensure it shatters instantly in the stomach) |
*Pack Sizes: Heavy-Gauge HDPE Bottles of 50 or 100 (Optimized specifically for massive, multi-pill daily chronic dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Hematology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Hematology/Chelators) |
| CAS Number | 30652-11-0 (Deferiprone) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | Heavy-Gauge HDPE Bottles with Child-Resistant Caps (STRICTLY MANDATORY). Given the massive pill volume required per month, high-density bottles are mandated to protect the formulation from physical degradation and environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Macrodose Densification & Disintegration Profiling (CRITICAL COMPLIANCE): The daily dose of Deferiprone is massive (up to 100 mg/kg/day). An adult patient may need to swallow seven or eight 1000mg tablets every single day. If a generic manufacturer fails to densify the powder, the pill becomes the size of a golf ball and impossible to swallow. If they press it too hard, it becomes a brick that fails to dissolve. Our hematology suites utilize elite rotary presses and superdisintegrant matrices to guarantee a streamlined, swallowable tablet that delivers 100% rapid gastric absorption.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized lifelong management of heavy metal toxicity:
- Transfusional Iron Overload: Treatment of patients with thalassemia syndromes, sickle cell disease, or other chronic anemias who have developed severe iron overload due to chronic blood transfusions, particularly when current chelation therapy (like Deferoxamine) is inadequate or intolerable.
Dosage & Administration
Recommended Dosage (Strictly as per Hematologist Guidelines):
- Standard Dosing: 25 mg/kg to 33 mg/kg of body weight, taken orally three times a day (TID), for a total daily dose of 75 mg/kg to 100 mg/kg.
- The Food Sparing Protocol: Should ideally be taken on an empty stomach to maximize absorption. However, if the patient experiences severe nausea (a common side effect), it can be taken with meals.
- The Cation Separation Mandate: Deferiprone will aggressively bind to *any* metal. It MUST be taken at least 4 hours apart from any aluminum-based antacids, iron supplements, or zinc/vitamin supplements; otherwise, the drug will bind to the supplement in the gut and be completely wasted.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Agranulocytosis & Neutropenia): Deferiprone can cause life-threatening agranulocytosis (a catastrophic drop in white blood cells), leaving the patient highly vulnerable to fatal septic infections. Absolute Neutrophil Count (ANC) must be monitored every single week during therapy. If the patient develops a fever or sore throat, therapy must be halted immediately.
- Reddish-Brown Urine Discoloration (Harmless): As the drug binds to iron and is excreted by the kidneys, the patient’s urine will turn a dark, alarming reddish-brown. Patients must be heavily counseled that this is a sign the drug is working, not hematuria (blood in the urine).
- Gastrointestinal Toxicity: Severe nausea, vomiting, and abdominal pain are frequent, especially during the first few weeks of therapy, which can impact compliance.
- Hepatic Fibrosis: Liver enzymes must be monitored closely, as long-term iron overload and chelation therapy can exacerbate liver enzyme elevations.
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 High-Volume Macrodose Formulations. Whether you are looking for a reliable Government Tender Supplier for national thalassemia 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.