Description

Sofosbuvir & Ledipasvir Tablets (400 mg / 90 mg)

Healthy Inc is a specialized global supplier and exporter of advanced antiviral, hepatology, and critical-care infectious disease therapeutics. We provide ultra-high-purity, kinetically synchronized Sofosbuvir (400 mg) & Ledipasvir (90 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision dedicated antiviral containment facilities. This “Genotype-Specific Direct-Acting Antiviral (DAA)” is a high-value, massive-volume export to hepatology centers, infectious disease NGOs, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, definitive cure for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, 5, and 6.

Product Overview

This highly advanced Fixed-Dose Combination (FDC) perfectly synchronizes two distinct, highly potent antiviral mechanisms to completely shut down the Hepatitis C virus’s ability to replicate and assemble, physically eradicating the virus from the patient’s liver.

The “Genotype 1 Eradication” Specialist:

• Mechanism 1 (The Replication Halter – Sofosbuvir 400mg): Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor. It acts as a toxic, defective building block. When the Hepatitis C virus attempts to copy its RNA to multiply, it accidentally incorporates Sofosbuvir into its genetic chain. This instantly terminates the chain, physically halting viral replication.
• Mechanism 2 (The Assembly Blocker – Ledipasvir 90mg): Ledipasvir is a potent, highly targeted NS5A inhibitor. The NS5A protein is absolutely critical for the physical assembly of new virus particles (virions). By paralyzing this protein, Ledipasvir ensures that any surviving viral fragments cannot assemble into infectious viruses, neutralizing the disease.
• The Genotype 1 & 4 Champion: While newer drugs are pan-genotypic, this specific FDC remains the most heavily prescribed and historically proven cure for HCV Genotype 1 (the most common strain globally, particularly in North America, Europe, and Japan) and Genotype 4 (highly prevalent in the Middle East and Africa), boasting cure rates (SVR12) frequently exceeding 96-99%.

Product Composition & Strength

We supply this product as a Precision-Engineered Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant heavy-gauge HDPE bottles containing exactly 28 tablets to perfectly align with strict clinical dispensing cycles.

*Pack Sizes: Heavy-Density HDPE Bottles of 28 Tablets (Patients require 1 to 6 bottles for standard 8, 12, or 24-week cure regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Advanced FDC Solubilization Engineering: Ledipasvir is practically insoluble in water, making its absorption within the human gastrointestinal tract extremely difficult. Our manufacturing utilizes advanced spray-drying or hot-melt extrusion technologies to create an amorphous solid dispersion of Ledipasvir (utilizing Copovidone). This elite-level engineering ensures the drug dissolves completely, guaranteeing the maximum bioavailability necessary to achieve a virologic cure.

Therapeutic Indications (Human Use)

Indicated for the comprehensive eradication of Hepatitis C:

• Chronic Hepatitis C (HCV): Treatment of adult and pediatric patients with chronic HCV genotype 1, 4, 5, or 6 infection.
• Patient Profiles: Approved for patients without cirrhosis or with compensated cirrhosis. In patients with advanced, decompensated cirrhosis, or for post-liver transplant patients, this FDC must be used in combination with Ribavirin.

Dosage & Administration

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

• Standard Adult Dosing: One tablet taken orally once daily for 12 weeks. (Certain treatment-naive non-cirrhotic Genotype 1 patients may qualify for an 8-week regimen, while treatment-experienced cirrhotic patients may require 24 weeks).
• Administration: Can be taken with or without food. The tablet should be swallowed whole.
• Gastric pH Requirement (CRITICAL DOSE TIMING): The solubility of Ledipasvir drops catastrophically if the stomach is not acidic. Patients taking antacids must separate them by 4 hours. H2-receptor antagonists (like Famotidine) can be taken simultaneously or 12 hours apart. Proton Pump Inhibitors (PPIs like Omeprazole) must be taken simultaneously with the FDC under fasting conditions, and the PPI dose must not exceed 20 mg.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Hepatitis B Reactivation Risk): All patients must be tested for evidence of current or prior Hepatitis B virus (HBV) infection before initiating this drug. The rapid clearance of HCV by this DAA can cause the immune system to fatally ignore a dormant HBV infection, leading to massive HBV reactivation, fulminant hepatitis, hepatic failure, and death.
• Severe Bradycardia with Amiodarone: Co-administration of this FDC with the antiarrhythmic medication Amiodarone can cause severe, life-threatening symptomatic bradycardia (dangerously slow heart rate) and fatal heart block. Co-administration is generally not recommended.
• P-gp Inducers: Drugs that are potent P-glycoprotein inducers (like Rifampin, Carbamazepine, or St. John’s wort) will rapidly clear Sofosbuvir and Ledipasvir from the blood, severely reducing their therapeutic effect and leading to catastrophic treatment failure. Co-administration is contraindicated.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and NGO Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antiviral Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Government Tender Supplier for HCV eradication programs in the Middle East or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.