Description

Entecavir Film-Coated Tablets (0.5 mg / 1.0 mg)

Healthy Inc is a specialized global supplier and exporter of advanced hepatology, infectious disease, and targeted high-containment antiviral therapeutics. We provide ultra-high-purity, kinetically precise Entecavir Film-Coated Tablets (0.5 mg / 1.0 mg), manufactured in WHO–GMP certified, high-precision micro-dosing oral solid dosage facilities. This “Guanosine Analogue & HBV Polymerase Inhibitor” is a massive-volume, highly lucrative export to hepatology centers, liver transplant networks, NGO infectious disease programs, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for lifelong viral suppression of Chronic Hepatitis B (HBV) with evidence of active viral replication.

Product Overview

This highly advanced formulation operates as a devastating “false building block” against the Hepatitis B virus. It actively infiltrates the viral replication machinery, sabotaging the virus’s ability to copy its DNA, driving viral loads down to undetectable levels, and physically reversing severe liver inflammation and fibrosis over time.

The “Reverse Transcriptase Blocker & High-Barrier Antiviral” Specialist:

• Mechanism 1 (The Intracellular Activation): Entecavir is a cyclopentyl guanosine analogue. Once it enters an infected human liver cell (hepatocyte), cellular enzymes rapidly phosphorylate it into its active form: Entecavir Triphosphate. This active metabolite is structurally disguised to look exactly like the natural building blocks the virus needs to multiply.
• Mechanism 2 (The 3-Stage Polymerase Paralyzer): The Hepatitis B virus uses a specialized enzyme called HBV polymerase (reverse transcriptase) to build its DNA. Entecavir Triphosphate violently competes with the natural substrate. When the viral enzyme grabs the Entecavir molecule, it permanently jams the machinery. It brilliantly inhibits all three stages of viral replication: (1) base priming, (2) reverse transcription of the negative strand, and (3) synthesis of the positive strand of HBV DNA.
• The “High-Barrier Resistance” Paradigm: Unlike first-generation antivirals (like Lamivudine), which the virus rapidly mutates to overcome, Entecavir has a massive “genetic barrier to resistance.” It requires the virus to make multiple, simultaneous complex mutations to survive. This makes Entecavir the ultimate, lifelong therapeutic anchor for keeping the liver safe from cirrhosis and hepatocellular carcinoma (liver cancer).

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Microdose Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips or heavy-gauge HDPE bottles to ensure the absolute chemical stability of the potent antiviral API.

*Pack Sizes: 3×10 Alu-Alu Blisters or Bottles of 30 (Optimized specifically for strict 30-day chronic hepatology dispensing regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Ultra-Microdose Content Uniformity & Bioavailability (CRITICAL COMPLIANCE): The engineering challenge of Entecavir defines its clinical safety. Standard generic manufacturers struggle to blend an ultra-potent 0.5 mg active ingredient evenly. If Content Uniformity fails, a patient receives a sub-therapeutic dose, allowing the virus to mutate, develop resistance, and trigger lethal liver failure. Our hepatology suites utilize elite geometric dry-blending and intensive HPLC batch-testing to guarantee 100% uniformity. This proves to major hospital boards that our dosing is clinically flawless and biologically perfect.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized lifelong management of severe viral liver disease:

• Chronic Hepatitis B (Compensated Liver Disease): Treatment of chronic HBV infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
• Decompensated Liver Disease: Treatment of chronic HBV in adults suffering from severe, decompensated liver cirrhosis (strictly using the 1.0 mg dose).

Dosage & Administration

Recommended Dosage (Strictly as per Hepatologist Guidelines):

• Nucleoside-Naive Patients: 0.5 mg taken orally once daily.
• Lamivudine-Refractory or Decompensated Cirrhosis: 1.0 mg taken orally once daily.
• The Empty Stomach Mandate (CRITICAL): Entecavir MUST be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). Taking this drug with a high-fat meal severely delays absorption and massively decreases systemic bioavailability, leading to dangerous viral breakthroughs.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Severe Exacerbation of Hepatitis B): FATAL WARNING: Severe acute exacerbations of Hepatitis B have been reported in patients who discontinue anti-hepatitis B therapy. Hepatic function must be monitored closely with both clinical and laboratory follow-up for at least several months in patients who stop taking Entecavir.
• BLACK BOX WARNING (Lactic Acidosis & Severe Hepatomegaly): Lactic acidosis and severe hepatomegaly with steatosis (fatty, violently enlarged liver), including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.
• HIV Cross-Resistance Warning: Entecavir is not recommended for patients co-infected with HIV and HBV who are not receiving Highly Active Antiretroviral Therapy (HAART). Using Entecavir alone in these patients will cause the HIV virus to mutate and develop severe drug resistance.
• Renal Dose Adjustment: Entecavir is cleared predominantly by the kidneys. Patients with renal impairment (creatinine clearance < 50 mL/min) MUST have their dose intervals drastically adjusted to prevent toxic drug accumulation.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Hepatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antivirals, Nucleoside Analogues, and Ultra-Microdose Content-Uniformity Assured Formulations. Whether you are looking for a reliable Government Tender Supplier for national Hepatitis B programs in Africa or a B2B Pharma Marketplace partner for Southeast Asia, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.