Hydroxyurea Film-Coated Tablets (200 mg / 300 mg / 400 mg / 500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced hematology, high-containment oncology, and pediatric orphan-drug therapeutics. We provide ultra-high-purity, kinetically precise Hydroxyurea Film-Coated Scored Tablets, manufactured in WHO–GMP certified, strictly segregated high-containment (OEB 4) oral solid dosage facilities. This “Ribonucleotide Reductase Inhibitor & HbF Reactivator” is a massive-volume, life-saving export to hematology centers, global NGO sickle-cell initiatives, pediatric oncology networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, foundational intervention for Sickle Cell Anemia and severe Myeloproliferative Neoplasms.

Product Overview

This highly advanced antimetabolite formulation operates on two completely different biological fronts depending on the disease state. In oncology, it acts as a rapid “brake” on out-of-control cellular division. In sickle cell disease, it acts as an epigenetic genetic switch, forcing the bone marrow to produce a healthy, alternative form of oxygen-carrying blood.

The “HbF Reactivator & Cytoreductive” Specialist:

• Mechanism 1 (The Sickle Cell Lifeline – HbF Upregulation): In Sickle Cell Disease (SCD), mutated Hemoglobin S polymerizes, causing red blood cells to collapse into rigid “sickle” shapes that block blood vessels and cause agonizing, tissue-killing vaso-occlusive crises. Hydroxyurea chemically forces the bone marrow to switch back to producing Fetal Hemoglobin (HbF)—the healthy hemoglobin babies are born with. Because HbF does not sickle, the red blood cells remain round and flexible, completely halting the pain crises and drastically extending the patient’s lifespan.
• Mechanism 2 (The DNA Synthesis Blockade): In myeloproliferative blood cancers (like Polycythemia Vera or Essential Thrombocythemia), the bone marrow produces dangerously thick, clot-prone blood by overproducing red blood cells or platelets. Hydroxyurea violently inhibits the enzyme ribonucleotide reductase. This cuts off the supply of building blocks needed to make DNA, immediately paralyzing cells in the S-phase of division and crashing the dangerously high blood counts back to safe levels.
• The “Scored Tablet” Pediatric Advantage: Standard Hydroxyurea is sold as a 500mg capsule, which is impossible to dose accurately for a 15kg child with Sickle Cell. By engineering a deeply scored, high-density tablet (often in multiple weight-based strengths like 200mg or 1000mg triple-scored), we allow physicians to dial in the exact mg/kg dose required without exposing caregivers to toxic powder.

Product Composition & Strength

We supply this product as a Precision-Blended, Scored Film-Coated Tablet, packed exclusively in highly secure, handler-protective Alu-Alu blister strips or heavy-gauge HDPE bottles to ensure absolute chemical stability and prevent accidental cytotoxic exposure.

*Pack Sizes: Bottles of 100 or 10×10 Alu-Alu Blisters (Optimized specifically for massive-volume NGO procurement and chronic lifetime dispensing).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, NGO Procurement Boards, and Hospital Procurement Boards.

Manufacturing Authority

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

• OEB 4 High-Containment & Cytotoxic Handling (CRITICAL COMPLIANCE): Hydroxyurea is a potent, DNA-altering antimetabolite. Manufacturing this compound requires absolute isolation to prevent lethal exposure to factory workers and catastrophic cross-contamination of other drugs. Our production occurs in entirely segregated High-Containment Blocks (OEB 4) utilizing closed-loop isolators and terminal HEPA filtration. Furthermore, our heavy film-coating completely seals the carcinogenic dust, ensuring that parents breaking a scored tablet for their child are not exposed to aerosolized chemotherapy.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of severe blood disorders and malignancies:

• Sickle Cell Anemia: To reduce the frequency of painful crises and reduce the need for blood transfusions in adult and pediatric patients with sickle cell anemia with recurrent moderate to severe painful crises.
• Polycythemia Vera & Essential Thrombocythemia: High-risk patients requiring rapid cytoreduction of red blood cells and platelets to prevent fatal strokes and thrombotic events.
• Chronic Myelogenous Leukemia (CML): Utilized for rapid white blood cell reduction prior to initiating TKI therapy (like Imatinib) or for palliative care in resistant disease.
• Head and Neck Cancer: Used concomitantly with irradiation therapy for local control.

Dosage & Administration

Recommended Dosage (Strictly as per Hematologist Guidelines):

• Sickle Cell Disease: Strictly weight-based. Typically initiated at 15 mg/kg/day as a single daily dose, titrated up to a maximum of 35 mg/kg/day based on blood counts and fetal hemoglobin response.
• Oncology/Myeloproliferative Disorders: Typically 15 to 30 mg/kg/day or a massive dose of 80 mg/kg administered once every third day.
• Handling Protocol: Caregivers must wash hands immediately after handling the tablets or cutting them. Pregnant women must never handle this medication.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Severe Myelosuppression): Hydroxyurea is highly toxic to the bone marrow. It will cause severe leukopenia, neutropenia, thrombocytopenia, and anemia. Strict Complete Blood Counts (CBC) are mandatory every 2 weeks during titration and every 2 to 3 months during maintenance.
• BLACK BOX WARNING (Secondary Malignancies): Hydroxyurea is highly carcinogenic. Long-term use significantly increases the risk of developing secondary leukemias and severe skin cancers. Patients must protect their skin from sun exposure.
• Embryo-Fetal Toxicity (Teratogenic): Can cause profound fetal death and severe birth defects. Strict contraception is mandatory for both men and women during and long after therapy.
• Cutaneous Vasculitis & Ulcerations: Can cause severe, non-healing leg ulcers and gangrene, especially in patients who have previously received interferon therapy.

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 Antimetabolites, Cytotoxics, and Pediatric Scored Formulations. Whether you are looking for a reliable Government Tender Supplier for Sickle Cell 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.