Description
Hydroxychloroquine Sulfate Film-Coated Tablets (200 mg / 400 mg)
Healthy Inc is a specialized global supplier and exporter of advanced rheumatology, immunology, and anti-malarial therapeutics. We provide ultra-high-purity, kinetically precise Hydroxychloroquine Sulfate Film-Coated Tablets (200 mg / 400 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Immunomodulatory DMARD & Plasmodicidal Agent” is a massive-volume, highly lucrative export to rheumatology centers, autoimmune specialized clinics, tropical medicine networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, foundational intervention for Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), and uncomplicated Malaria.
Product Overview
This highly advanced formulation operates as an epigenetic and cellular modifier. In autoimmune diseases, it quietly suppresses the overactive immune pathways that cause the body to attack its own joints and organs. In parasitic infections, it acts as a lethal chemical trap within the parasite’s digestive system.
The “Lysosomal pH Modifier & TLR Blocker” Specialist:
- Mechanism 1 (The Autoimmune Blockade – Lysosomal pH Alteration): Hydroxychloroquine is highly “lysosomotropic”—it actively accumulates inside the acidic lysosomes of immune cells (like macrophages). Once inside, it drastically raises the pH (makes it more alkaline). This completely paralyses the enzymes required for the macrophage to process and present auto-antigens to T-cells, effectively shutting down the primary communication line that triggers autoimmune attacks in Rheumatoid Arthritis.
- Mechanism 2 (Toll-Like Receptor Inhibition): In Systemic Lupus Erythematosus (SLE), the immune system’s Toll-Like Receptors (specifically TLR 7 and 9) incorrectly identify the patient’s own DNA/RNA as a viral threat, triggering massive inflammation. HCQ physically blocks these receptors, plummeting the production of destructive interferons and drastically reducing life-threatening Lupus flare-ups.
- Mechanism 3 (The Plasmodicidal Trap): When used as an anti-malarial, HCQ accumulates in the food vacuole of the Plasmodium parasite inside human red blood cells. The parasite digests hemoglobin, creating a highly toxic byproduct called heme. Normally, the parasite converts this into a harmless crystal. HCQ violently blocks this conversion, causing the toxic heme to build up and literally dissolve the parasite from the inside out.
Product Composition & Strength
We supply this product as a Precision-Blended, Heavy-Coated Tablet, packed exclusively in highly secure, light-blocking Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the photolabile active ingredient.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Hydroxychloroquine Sulfate USP/Ph.Eur. | 200 mg | Global Rheumatology Standard: Base therapeutic unit for daily chronic maintenance in SLE and RA, allowing for exact mg/kg dosing based on ideal body weight to prevent toxicity. |
| Excipients | Dibasic Calcium Phosphate / Pregelatinized Starch / Magnesium Stearate / Polyethylene Glycol / Premium Titanium Dioxide Opadry Film | Diluent / Binder / Lubricant / Heavy Opacifying Film-Coating (Engineered specifically to form an impenetrable light barrier against UV degradation, while completely masking the intensely bitter taste of the sulfate salt to ensure long-term patient compliance) |
*Pack Sizes: Bottles of 100 or 10×10 Blisters (Optimized specifically for strict 3-to-6 month chronic rheumatology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Rheumatology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Rheumatology/Anti-Malarial) |
| CAS Number | 747-36-4 (Hydroxychloroquine Sulfate) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the formulation from environmental humidity and light degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Photostability & Taste-Masking Engineering (CRITICAL COMPLIANCE): The commercial success of chronic HCQ therapy depends entirely on formulation engineering. Hydroxychloroquine is exceptionally bitter; a poorly coated tablet will induce immediate nausea and non-compliance. Furthermore, the API is highly sensitive to light. Our facilities utilize advanced fluid-bed film-coating technology to apply a heavy, uniform layer of Titanium Dioxide-enriched polymers. This creates a perfect light shield and guarantees a smooth, tasteless swallow for lifelong autoimmune patients.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of autoimmune and parasitic diseases:
- Systemic Lupus Erythematosus (SLE): The foundational, lifelong therapy to prevent severe organ damage, skin lesions, and joint pain in both chronic discoid and systemic lupus.
- Rheumatoid Arthritis (RA): Used as a primary DMARD (often in combination with Methotrexate) for acute and chronic rheumatoid arthritis.
- Malaria: Treatment of uncomplicated malaria caused by Plasmodium falciparum, P. malariae, P. ovale, and P. vivax (in geographic areas where chloroquine resistance is not documented).
Dosage & Administration
Recommended Dosage (Strictly as per Rheumatologist Guidelines):
- Rheumatoid Arthritis & SLE: Maintenance doses are strictly calculated based on ideal body weight, typically 200 mg to 400 mg daily, not exceeding 5 mg/kg/day to minimize retinal toxicity.
- Administration (The Gastrointestinal Rule): Tablets MUST be taken with a meal or a glass of milk to drastically reduce the severe stomach upset and cramping associated with the drug.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX EQUIVALENT (Irreversible Retinal Toxicity): Chronic, high-dose use of HCQ can cause severe, irreversible damage to the macula of the eye (Bull’s-eye maculopathy), leading to permanent blindness. Mandatory baseline ophthalmological exams and annual OCT retina scans are required for all chronic users.
- Severe Cardiotoxicity & QT Prolongation: HCQ prolongs the QT interval of the heart. Co-administration with other QT-prolonging drugs (like Azithromycin or Amiodarone) can trigger Torsades de Pointes and fatal cardiac arrest.
- Severe Hypoglycemia: HCQ can cause profound, life-threatening drops in blood sugar levels (hypoglycemia) even in patients who do not have diabetes.
- G6PD Deficiency: Patients with a genetic G6PD deficiency are at a high risk of severe red blood cell destruction (hemolysis) when taking this medication.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Rheumatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced DMARDs, Immunomodulators, and Photostable Formulations. Whether you are looking for a reliable Government Tender Supplier for lupus clinics 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.








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