Description

Daclatasvir Dihydrochloride Film-Coated Tablets (30 mg / 60 mg)

Healthy Inc is a specialized global supplier and exporter of advanced virology, hepatology, and targeted Direct-Acting Antiviral (DAA) therapeutics. We provide ultra-high-purity, kinetically optimized Daclatasvir (as Dihydrochloride) Film-Coated Tablets (30 mg / 60 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Next-Generation NS5A Inhibitor” is a massive-volume, highly critical export to infectious disease networks, mega-NGOs (like the Global Fund), hepatology clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, interferon-free backbone for the absolute eradication and cure of Chronic Hepatitis C Virus (HCV).

Product Overview

This highly advanced formulation operates as a direct, structural saboteur of the Hepatitis C virus. It does not rely on boosting the patient’s immune system; instead, it physically enters the infected liver cell and permanently paralyzes the specific machinery the virus uses to clone itself.

The “NS5A Paralyzer & Pan-Genotypic Cure” Specialist:

• Mechanism 1 (The NS5A Blockade): The Hepatitis C virus requires a highly specific, non-structural protein called NS5A to replicate its viral RNA and assemble new viral particles (virions). Daclatasvir binds with immense, picomolar affinity to the N-terminus of the NS5A protein. This violent structural distortion instantly halts both viral replication and assembly, causing the viral load in the blood to plummet to undetectable levels within days.
• Mechanism 2 (The Interferon-Free Revolution): Historically, HCV required Pegylated-Interferon injections, which caused agonizing, chemotherapy-like side effects and extreme depression. Daclatasvir is entirely oral and remarkably well-tolerated. It effectively ended the Interferon era, replacing a toxic, 48-week ordeal with a simple, highly tolerable 12-week pill regimen.
• Mechanism 3 (The Sofosbuvir Synergy Mandate): CRITICAL NOTE: Daclatasvir is never used as a monotherapy. It is scientifically engineered to be paired with an NS5B polymerase inhibitor—almost universally Sofosbuvir. Together, they create a devastating “Pan-Genotypic” (Genotypes 1 through 6) cure with success rates exceeding 95%, regardless of whether the patient has liver cirrhosis or HIV co-infection.

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Dose Flexibility & CYP3A4 Compliance (CRITICAL COMPLIANCE): The global rollout of Daclatasvir relies heavily on treating populations that are co-infected with HIV. Because Daclatasvir is metabolized by CYP3A4, concurrent use with HIV antiretrovirals forces the Daclatasvir dose to be either halved (30mg) or increased (90mg). By providing highly stable, clinically proven 30mg and 60mg configurations, our virology suites guarantee that global infectious disease specialists can safely customize regimens without risking viral relapse or toxic overdose.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized eradication of blood-borne viral infections:

• Chronic Hepatitis C (HCV): Indicated for use strictly in combination with Sofosbuvir (with or without Ribavirin) for the treatment of patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection.

Dosage & Administration

Recommended Dosage (Strictly as per Hepatologist Guidelines):

• Standard Adult Dosing: 60 mg taken orally once daily, in combination with Sofosbuvir 400 mg, for 12 weeks.
• With Strong CYP3A Inhibitors (e.g., Ritonavir, Ketoconazole): Dose MUST be reduced to 30 mg once daily.
• With Moderate CYP3A Inducers (e.g., Efavirenz): Dose MUST be increased to 90 mg once daily.
• Administration: Can be taken with or without food.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Hepatitis B Virus Reactivation): Eradicating HCV rapidly alters the liver’s immune environment. In patients co-infected with Hepatitis B (HBV), this can trigger a violent, catastrophic reactivation of the HBV virus, leading to fulminant hepatic failure and death. All patients MUST be screened for current or prior HBV infection before initiating DAA therapy.
• Fatal Bradycardia with Amiodarone: Co-administration of Amiodarone (a cardiac antiarrhythmic) with Daclatasvir + Sofosbuvir is strictly contraindicated. It triggers sudden, severe, and frequently fatal symptomatic bradycardia (heart stoppage).
• CYP3A4 Inducer Contraindication: Strictly contraindicated with strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, St. John’s Wort). These will completely destroy the blood levels of Daclatasvir, leading to catastrophic virologic failure and the creation of a mutated, drug-resistant super-virus.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Hepatology/Infectious Disease Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Direct-Acting Antivirals (DAAs), NS5A Inhibitors, and High-Precision Virological Formulations. Whether you are looking for a reliable Government Tender Supplier for national HCV eradication programs in Africa or a B2B Pharma Marketplace partner for the CIS, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.