Description

Clofazimine Micronized Lipid-Matrix Tablets (50 mg / 100 mg)

Healthy Inc is a specialized global supplier and exporter of advanced infectious disease, orphan drug, and targeted high-containment antimycobacterial therapeutics. We provide ultra-high-purity, kinetically optimized Clofazimine Tablets (50 mg / 100 mg), manufactured in WHO–GMP certified, high-precision lipid-matrix oral solid dosage facilities. This “Phenazine Dye Antimycobacterial & Anti-Inflammatory” is a massive-volume, highly strategic export to infectious disease networks, leprosy eradication programs, MDR-TB clinics, mega-NGOs (Global Fund, WHO procurement), and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for Multibacillary Leprosy and drug-resistant Tuberculosis.

Product Overview

This highly advanced formulation operates as a devastating, dual-action biochemical weapon against the world’s most resilient mycobacteria. Not only does it physically destroy the bacteria’s ability to replicate, but it simultaneously suppresses the host’s hyperactive immune response, preventing the catastrophic nerve damage associated with leprosy reactions.

The “Phenazine DNA Saboteur & ENL Suppressant” Specialist:

• Mechanism 1 (The Mycobacterial DNA Blockade): Clofazimine is a highly lipophilic phenazine dye. It penetrates the thick, waxy cell wall of the mycobacterium and binds directly to the guanine bases of the bacterial DNA. This violently blocks the template function of the DNA, completely halting bacterial replication. Furthermore, it generates highly toxic intracellular Reactive Oxygen Species (ROS) that lethally damage the bacteria from the inside out.
• Mechanism 2 (The ENL Anti-Inflammatory Sweep): A major complication of leprosy is Erythema Nodosum Leprosum (ENL)—a violent, immune-mediated inflammatory reaction that destroys peripheral nerves and causes severe pain. Clofazimine possesses profound, systemic anti-inflammatory properties. It actively suppresses T-lymphocyte proliferation and neutrophil phagocytosis, controlling the ENL reaction and preventing permanent disability and disfigurement.
• Mechanism 3 (The Lipophilic Tissue Accumulation): Because it is highly fat-soluble, the drug actively accumulates in fatty tissues and the reticuloendothelial system (macrophages). This creates a massive intracellular reservoir of the drug precisely where the mycobacteria try to hide, ensuring sustained, long-term bacterial eradication.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Infectious Disease Distributors, and NGO Procurement Boards.

Manufacturing Authority

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

• Lipophilic Bioavailability Engineering (CRITICAL COMPLIANCE): Clofazimine is essentially a red plastic dye. If a generic manufacturer simply presses raw Clofazimine powder into a tablet, 100% of it will pass through the patient unabsorbed. Our infectious disease suites utilize rigorous laser-diffraction API micronization and elite self-emulsifying lipid excipients. We guarantee that our solid tablet delivers the exact same rapid, high-yield pharmacokinetic absorption as the original soft-gelatin capsule, ensuring absolute clinical cure rates for global eradication programs.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized eradication of severe mycobacterial infections:

• Leprosy (Hansen’s Disease): A mandatory component of the WHO Multi-Drug Therapy (MDT) for multibacillary leprosy, utilized strictly in combination with Rifampicin and Dapsone.
• Erythema Nodosum Leprosum (ENL): Treatment of acute, severe ENL (Type 2 lepra reactions).
• Multi-Drug Resistant Tuberculosis (MDR-TB): A highly critical, Group B core agent used off-label in the WHO’s recommended longer and shorter regimens for the treatment of MDR-TB and RR-TB (Rifampicin-Resistant TB).

Dosage & Administration

Recommended Dosage (Strictly as per WHO/Infectious Disease Guidelines):

• The “Fatty Meal” Mandate (CRITICAL): This tablet MUST be taken with meals, preferably a high-fat meal, or with milk. Taking this lipophilic drug on an empty stomach drastically decreases its absorption and severely limits its life-saving clinical efficacy.
• MDT Dosing (Leprosy): Typically 300 mg once a month (supervised) and 50 mg daily (unsupervised) in combination therapy.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Gastrointestinal Crystal Deposition (FATAL WARNING): Because it is highly lipophilic, long-term or high-dose use causes Clofazimine crystals to physically deposit in the intestinal mucosa and mesenteric lymph nodes. This can trigger severe abdominal pain, massive GI bleeding, splenic infarction, and fatal bowel obstruction. Patients complaining of severe abdominal pain must be evaluated immediately.
• Skin Discoloration & Psychological Trauma: Clofazimine is a dark red dye. Within weeks of starting therapy, it will turn the patient’s skin, sweat, tears, urine, and feces a striking red, brownish, or nearly black color. This is harmless but completely unavoidable, and it can take months or years to fade after stopping the drug. Intensive pre-treatment psychological counseling is absolutely mandatory, as the discoloration can cause severe social stigma and depression, leading to patients abandoning their cure.
• QTc Prolongation: Associated with severe cardiac arrhythmias and QTc prolongation, particularly when combined with other MDR-TB drugs like Bedaquiline or Delamanid. ECG monitoring is required.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Mega-NGO Outbreak Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antimycobacterials, Orphan Drugs, and Complex Lipid-Matrix Tableting Formulations. Whether you are looking for a reliable Government Tender Supplier for national leprosy programs in Africa or a B2B Pharma Marketplace partner for the CIS, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.