Description

Sofosbuvir & Velpatasvir Tablets (400 mg / 100 mg)

Healthy Inc is a specialized global supplier and exporter of advanced antiviral, hepatology, and life-saving infectious disease therapeutics. We provide ultra-high-purity, kinetically synchronized Sofosbuvir (400 mg) & Velpatasvir (100 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision dedicated antiviral facilities. This “Pan-Genotypic 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) infection.

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 multiply, physically eradicating it from the liver.

The “Pan-Genotypic HCV Cure” Specialist:

• Mechanism 1 (The Replication Halter – Sofosbuvir 400mg): Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor. It acts as a 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 – Velpatasvir 100mg): Velpatasvir is a potent NS5A inhibitor. The NS5A protein is absolutely critical for both the replication of the viral RNA and the physical assembly of new virus particles (virions). By blocking this protein, Velpatasvir ensures that any surviving viral fragments cannot assemble into infectious viruses.
• The Pan-Genotypic Advantage (The Clinical Revolution): Older HCV treatments only worked on specific genotypes (strains) of the virus, requiring developing nations to perform highly expensive genotyping blood tests before treatment. This FDC is Pan-Genotypic—it cures genotypes 1, 2, 3, 4, 5, and 6 with a success rate exceeding 95%. It has completely revolutionized global HCV eradication protocols by allowing a universal “test and treat” approach without genotyping.

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 12-week clinical dispensing cycles.

*Pack Sizes: Heavy-Density HDPE Bottles of 28 Tablets (Patients require exactly 3 bottles for a standard 84-day / 12-week cure).

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: Velpatasvir is practically insoluble in water, making its absorption within the human body extremely difficult. Our manufacturing utilizes advanced spray-drying or hot-melt extrusion technologies to create an amorphous solid dispersion of Velpatasvir (often utilizing Copovidone). This elite-level engineering ensures the drug dissolves completely in the gastrointestinal tract, 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 patients with chronic HCV genotypes 1, 2, 3, 4, 5, or 6 infection.
• Patient Profiles: Approved for patients without cirrhosis or with compensated cirrhosis. In patients with severe, decompensated cirrhosis, 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 exactly 12 weeks.
• Administration: Can be taken with or without food. The tablet should be swallowed whole.
• Gastric pH Requirement (CRITICAL): The solubility of Velpatasvir drastically decreases as gastric pH increases. Patients taking antacids, H2-receptor antagonists (like Famotidine), or Proton Pump Inhibitors (PPIs like Omeprazole) must follow strict staggering protocols. Co-administration with Omeprazole should be avoided, but if medically necessary, the FDC must be taken with food 4 hours before the Omeprazole.

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 heart medication Amiodarone can cause severe, life-threatening symptomatic bradycardia (dangerously slow heart rate) and heart block. Co-administration is generally not recommended.
• P-gp Inducers: Drugs that are potent P-glycoprotein inducers (like Rifampin or St. John’s wort) will rapidly clear Sofosbuvir and Velpatasvir from the blood, severely reducing their therapeutic effect and leading to 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 Africa or a B2B Pharma Marketplace partner for Southeast Asia, 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.