Description

Ledipasvir Film-Coated Tablets (90 mg)

Healthy Inc is a specialized global supplier and exporter of advanced infectious disease, hepatology, and high-value antiviral therapeutics. We provide ultra-high-purity, kinetically precise Ledipasvir Film-Coated Tablets (90 mg), manufactured in WHO–GMP certified, high-precision solid-dispersion oral dosage facilities. This “NS5A Inhibitor Direct-Acting Antiviral” is an ultra-high-value export to hepatology centers, international infectious disease NGOs, custom-regimen eradication programs, and health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as a globally mandated, curative combination-therapy component for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, 5, and 6.

Product Overview

This highly advanced formulation operates as a biochemical paralyzing agent against the Hepatitis C virus. It completely circumvents the human immune system, directly targeting the physical scaffolding the virus uses to build and transport new viral copies, effectively trapping and eradicating the virus within the liver cell.

The “NS5A Assembly Paralyzer” Specialist:

• Mechanism 1 (The NS5A Blockade): The Hepatitis C virus requires a specific non-structural protein, known as NS5A, to assemble new viral particles and secrete them out of the hepatocyte to infect healthy liver tissue. Ledipasvir is a highly potent, hyper-selective NS5A inhibitor. It aggressively binds to this protein, instantly paralyzing the viral assembly line. Without NS5A, the virus cannot build its protective shell or escape the cell, completely halting the spread of the infection.
• Mechanism 2 (The Viral Replication Complex Disruption): Beyond just stopping assembly, NS5A is also intimately involved in the viral replication complex. By binding to it, Ledipasvir warps the structure of the entire replication web, causing a rapid, exponential crash in the patient’s viral load within the first few days of therapy.
• The Monotherapy Prohibition (CRITICAL CLINICAL DIRECTIVE): Ledipasvir cannot and must not be used alone. The Hepatitis C virus mutates incredibly fast. If Ledipasvir is given as a monotherapy, the virus will develop total drug resistance within days. It is universally mandated to be co-administered with a backbone polymerase inhibitor (like Sofosbuvir) to trap the virus in a dual-pathway crossfire, guaranteeing a permanent 12-week cure (SVR12).

Product Composition & Strength

We supply this product as a Precision-Blended, Solid-Dispersion Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips or heavy-gauge HDPE bottles to ensure the absolute chemical survival of the complex antiviral API.

*Pack Sizes: Bottles of 28 or 10×10 Blisters (Optimized specifically for strict 4-week dispensing intervals to match custom DAA combination regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Amorphous Solid Dispersion Engineering (CRITICAL COMPLIANCE): Ledipasvir is practically insoluble across the entire physiological pH range. Standard generic tablet pressing will result in zero clinical absorption and complete therapeutic failure. Our facilities overcome this by utilizing advanced Hot Melt Extrusion (HME) or Spray Drying techniques. We physically trap the Ledipasvir molecules inside a highly soluble Copovidone matrix, converting the drug into an “amorphous” state. This pharmaceutical engineering guarantees instant dissolution in the gut, ensuring the patient receives the exact curative plasma levels required to eradicate the virus.

Therapeutic Indications (Human Use)

Indicated strictly for use IN COMBINATION with other Direct-Acting Antivirals for the targeted eradication of the Hepatitis C Virus (HCV):

• Chronic Hepatitis C (Flexible Regimens): Used in combination with Sofosbuvir (and sometimes Ribavirin) for the treatment of adult and pediatric patients with HCV genotype 1, 4, 5, or 6 infection.
• Custom State-Tender Stockpiling: Procured as a standalone unit by health ministries to allow hepatologists to custom-titrate specific multi-drug regimens for patients failing standard therapies.

Dosage & Administration

Recommended Dosage (Strictly as per Hepatologist / WHO Guidelines):

• Standard Adult Dosing: 90 mg taken orally once daily, strictly co-administered with an appropriate viral polymerase inhibitor (e.g., Sofosbuvir 400 mg).
• Administration: Can be taken with or without food. Must be swallowed whole.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Hepatitis B Reactivation): FATAL CLINICAL ALERT: Eradicating HCV rapidly alters the liver’s immune environment. In patients co-infected with Hepatitis B (HBV), this can cause the HBV to violently reactivate, leading to fulminant hepatic failure and death. All patients MUST undergo baseline HBV screening before taking any DAA.
• The Acid-Reduction Bioavailability Crash: Ledipasvir’s solubility plummets in non-acidic environments. If a patient takes strong antacids, H2 blockers, or Proton Pump Inhibitors (PPIs) concurrently, the Ledipasvir will not absorb, causing the Hepatitis C cure to fail entirely. PPIs must be strictly managed or avoided.
• Fatal Bradycardia Risk (Combination Protocol): When Ledipasvir is used alongside Sofosbuvir, co-administration with the antiarrhythmic drug Amiodarone can cause profound, fatal cardiac arrest.
• P-gp Inducers: Co-administration with strong P-glycoprotein inducers (like Rifampin or St. John’s Wort) will drastically reduce Ledipasvir blood levels, leading to viral relapse and the creation of drug-resistant HCV strains.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Infectious Disease Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antivirals, Direct-Acting Antivirals (DAA), and Solid-Dispersion Formulations. Whether you are looking for a reliable Government Tender Supplier for flexible HCV eradication programs in the CIS or a B2B Pharma Marketplace partner for Africa, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.