Description

Ledipasvir & Sofosbuvir Film-Coated Tablets (90 mg / 400 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 synchronized Ledipasvir & Sofosbuvir Film-Coated Tablets (90 mg / 400 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Dual Direct-Acting Antiviral (DAA) FDC” is an ultra-high-value, massive-volume export to hepatology centers, international infectious disease NGOs, government eradication programs, and health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, curative intervention for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, 5, and 6.

Product Overview

This highly advanced formulation operates as a dual-strike biochemical assassin against the Hepatitis C virus. It completely bypasses the human immune system and attacks the virus’s replication machinery directly, shattering its ability to multiply and permanently clearing it from the liver.

The “NS5A & NS5B Viral Eradicator” Specialist:

• Mechanism 1 (The NS5B Polymerase Blockade – Sofosbuvir): Sofosbuvir is a nucleotide analog prodrug. Once inside the liver cell, it is converted into its active triphosphate form. It perfectly mimics the natural building blocks of viral RNA. When the HCV NS5B RNA-dependent RNA polymerase attempts to copy the viral genome, it mistakenly incorporates Sofosbuvir. Because Sofosbuvir lacks a crucial chemical bond, the RNA chain physically cannot continue. This causes immediate, catastrophic chain termination, completely halting viral replication.
• Mechanism 2 (The NS5A Assembly Inhibitor – Ledipasvir): While Sofosbuvir stops the printing of new genetic material, Ledipasvir directly binds to the NS5A protein. This protein is absolutely required for assembling the virus particles and secreting them out of the liver cell to infect other tissues. By paralyzing NS5A, Ledipasvir completely shuts down viral assembly and drastically alters the viral replication complex.
• The “12-Week SVR12” Cure Paradigm: Together, these two mechanisms form an impenetrable biological firewall. Within 8 to 12 weeks of daily oral dosing, the viral load drops to zero. If the virus remains undetectable 12 weeks after finishing the medication (SVR12), the patient is considered permanently, medically cured, drastically eliminating the risk of Hepatocellular Carcinoma (Liver Cancer) and end-stage cirrhosis.

Product Composition & Strength

We supply this product as a Precision-Blended, Dual-Active FDC Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips or heavy-gauge HDPE bottles with specialized desiccants to ensure the absolute chemical survival of the complex antiviral APIs.

*Pack Sizes: Bottles of 28 (Optimized specifically for the strict 4-week dispensing intervals required for 8, 12, or 24-week curative 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.

• DAA Solubility Synchronization & Bioequivalence (CRITICAL COMPLIANCE): The success of a Hepatitis C cure relies entirely on maintaining constant, high drug levels in the blood. If a generic tablet suffers from poor dissolution, the viral load will rebound, and the virus will mutate into a highly resistant, incurable strain. Our facilities utilize advanced wet granulation and elite dissolution-enhancing polymers (like Copovidone) to ensure that the poorly soluble Ledipasvir perfectly matches the rapid absorption profile of Sofosbuvir. This guarantees clinical bioequivalence to the originator brand, providing governments with a fail-safe eradication tool.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized eradication of the Hepatitis C Virus (HCV):

• Chronic Hepatitis C: Treatment of adult and pediatric patients with HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
• Advanced Liver Disease: Used in combination with Ribavirin for patients with decompensated cirrhosis or for patients who have undergone a liver transplant.

Dosage & Administration

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

• Standard Adult Dosing: One tablet (90 mg/400 mg) taken orally once daily.
• Treatment Duration: Strictly 8, 12, or 24 weeks depending on the patient’s viral genotype, prior treatment history, and the presence or absence of severe cirrhosis.
• 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: Patients who are co-infected with Hepatitis B and Hepatitis C face a catastrophic risk. When the DAA rapidly clears the Hep C virus, the Hepatitis B virus will violently reactivate, leading to fulminant hepatic failure and death. All patients MUST be tested for active or prior HBV infection before initiating therapy.
• Fatal Bradycardia with Amiodarone: Co-administration of Ledipasvir/Sofosbuvir with the antiarrhythmic drug Amiodarone can cause profound, fatal symptomatic bradycardia (cardiac arrest). They must never be used together.
• P-gp Inducers (Viral Relapse Warning): Drugs that heavily induce P-glycoprotein (like Rifampin, St. John’s Wort, or Carbamazepine) will massively decrease the absorption of Ledipasvir and Sofosbuvir, leading to total clinical failure and viral relapse.
• Acid-Reducing Agents (PPIs): The solubility of Ledipasvir is highly dependent on stomach acid. Overuse of Proton Pump Inhibitors (like Omeprazole) or taking them at the wrong time will prevent the drug from absorbing.

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, DAA Combinations, and Curative FDC Formulations. Whether you are looking for a reliable Government Tender Supplier for mass 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.