Description

Sofosbuvir Tablets (400 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 stabilized Sofosbuvir Film-Coated Tablets (400 mg), manufactured in WHO–GMP certified, high-precision dedicated antiviral containment facilities. This “Nucleotide Analog NS5B Polymerase Inhibitor” is a massive-volume, essential export to hepatology centers, infectious disease NGOs (like MSF), and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, foundational backbone for all modern Hepatitis C Virus (HCV) eradication therapies.

Product Overview

This formulation contains Sofosbuvir, the revolutionary Direct-Acting Antiviral (DAA) that completely transformed the global landscape of Hepatitis C treatment, shifting it from a highly toxic, injectable interferon regimen to a highly tolerable, oral cure.

The “HCV Eradication Backbone” Specialist:

• Mechanism (The Chain Terminator): Sofosbuvir is a highly sophisticated nucleotide prodrug. Once inside the liver cell, it is metabolized into its active form (GS-461203). The Hepatitis C virus uses an enzyme called NS5B RNA-dependent RNA polymerase to copy its genetic material and multiply. Because the active form of Sofosbuvir looks identical to the virus’s natural building blocks, the virus mistakenly incorporates it into its growing RNA chain. This instantly causes “chain termination,” physically halting the virus’s ability to replicate.
• The Universal Foundation: Sofosbuvir possesses a phenomenally high barrier to viral resistance and is effective against all HCV genotypes (1 through 6). Because of this, it serves as the mandatory anchor drug in almost all combination HCV therapies globally.
• Combination Imperative: It is critical for clinical networks to understand that Sofosbuvir must never be used as a monotherapy. To achieve a virologic cure, it must always be co-administered with other targeted antivirals, such as Daclatasvir, Velpatasvir, Ledipasvir, or Ribavirin, depending on the patient’s genotype and liver cirrhosis status.

Product Composition & Strength

We supply this product as a Precision-Blended Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant heavy-gauge HDPE bottles or ultra-dense Alu-Alu blister strips to ensure the absolute chemical stability of the nucleotide analog.

*Pack Sizes: Heavy-Density HDPE Bottles of 28 Tablets (Optimized exactly for 4-week clinical dispensing cycles, with a standard cure requiring 12 to 24 weeks).

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.

• Dedicated Antiviral Containment & Moisture Control: Manufacturing highly potent Direct-Acting Antivirals requires strict facility segregation. Our Sofosbuvir is produced in dedicated, low-humidity antiviral blocks operating under severe negative pressure with multi-stage HEPA filtration. This guarantees zero cross-contamination with other drug classes and ensures the incredibly hygroscopic API does not degrade prior to final bottle sealing.

Therapeutic Indications (Human Use)

Indicated for the comprehensive eradication of Hepatitis C in combination with other medicinal products:

• Chronic Hepatitis C (HCV): Treatment of chronic HCV infection in adults and pediatric patients (3 years of age and older, based on weight).
• CRITICAL LIMITATION: The specific combination drug required (e.g., Daclatasvir, Ribavirin, Peg-interferon) and the duration of therapy (12 or 24 weeks) are strictly dependent on the patient’s viral genotype and the presence or absence of compensated/decompensated cirrhosis.

Dosage & Administration

Recommended Dosage (Strictly as per Hepatologist Guidelines):

• Standard Adult Dosing: One 400 mg tablet taken orally once daily in combination with other HCV antivirals.
• Administration: Can be taken with or without food. The tablet must be swallowed whole to mask the extremely bitter taste of the active ingredient.
• Severe Renal Impairment: No dose adjustment is required for patients with mild to moderate renal impairment, but its use in patients with severe renal impairment (eGFR < 30 mL/min) or End-Stage Renal Disease requiring hemodialysis has historically required strict specialist monitoring.

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 Sofosbuvir-based therapy. The rapid clearance of HCV can cause the immune system to ignore a dormant HBV infection, leading to massive HBV reactivation, fulminant hepatitis, hepatic failure, and death.
• Severe Bradycardia with Amiodarone: Co-administration of Sofosbuvir with another DAA (like Daclatasvir or Simeprevir) alongside the heart medication Amiodarone can cause severe, life-threatening symptomatic bradycardia and fatal heart block. Co-administration is strictly avoided.
• P-gp Inducers (Treatment Failure): Drugs that are potent P-glycoprotein inducers (like Rifampin, Carbamazepine, Phenytoin, or St. John’s wort) will rapidly clear Sofosbuvir from the bloodstream, severely reducing its therapeutic effect and leading to catastrophic viral resistance and treatment failure.

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 Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Bulk Indenting, ensuring that every Authorized Medicine Wholesaler receives WHO-GMP certified products at competitive rates.