Description

Adefovir Dipivoxil Tablets (10mg)

Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc

1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Adefovir Dipivoxil Tablets in India. This nucleotide analog reverse transcriptase inhibitor (NtRTI) is a critical second-line treatment for Chronic Hepatitis B. We produce high-stability tablets designed to maintain potency in tropical climates. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and hepatology tenders.

2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Adefovir Dipivoxil Tablets | | Generic Name | Adefovir Dipivoxil USP / BP / IP | | Strength | 10mg | | Dosage Form | Uncoated / Film Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Antiviral (Hepatitis B) | | Shelf Life | 24 – 36 Months | | Packaging | 30s HDPE Bottle with Desiccant |

3. Manufacturing Adefovir Dipivoxil Tablets We divide our operations to ensure specialized focus.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Adefovir Dipivoxil is highly prone to degradation by moisture. To prevent this, we manufacture in Low-Humidity Suites and package the tablets in High-Density Polyethylene (HDPE) Bottles containing a silica gel desiccant. This ensures the tablet remains dry and effective throughout its shelf life, even after the patient opens the bottle.

• The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Adefovir Dipivoxil Tablets. We supply liver specialists and government health programs globally. We understand the importance of supply chain integrity for chronic viral suppression therapies.

4. Quality Assurance We test every batch rigorously.

• Degradation Products: We monitor for specific hydrolytic impurities to ensure the drug remains pure.

• Dissolution: We test how the tablet releases the drug. Consistent release is vital for maintaining viral suppression.

• Assay: We confirm the 10mg potency to ensure the dosage is sufficient to inhibit viral replication without causing excess toxicity.

5. Why Use Adefovir Dipivoxil Tablets? This drug stops the Hepatitis B virus from multiplying.

• Mechanism: It inhibits the HBV DNA Polymerase enzyme. It acts as a “chain terminator,” stopping the virus from building new DNA.

• Effect: It reduces the viral load in the blood and slows down liver damage (fibrosis/cirrhosis).

Key Indications:

• Treatment of Chronic Hepatitis B in adults with evidence of active viral replication.

• Used in patients with Lamivudine-resistant Hepatitis B virus (although Tenofovir is now often preferred, Adefovir remains a vital option in specific markets/cases).

6. Export and Regulatory Support We provide complete documentation for registration.

• Dossier: We offer CTD and ACTD formats.

• Certificates: We supply the Free Sale Certificate (FSC) and COPP.

• Logistics: We ship via FOB Mumbai or CIF.

7. Frequently Asked Questions

• Q: Who manufactures Adefovir Dipivoxil Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Why is it packed in a bottle? A: Bottles allow for a larger desiccant (drying agent) than blisters, which offers better protection against moisture for this specific molecule.

• Q: Is this a cure for Hep B? A: No, it suppresses the virus but does not cure it. It is a long-term treatment.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 10mg once daily, taken orally.

• Renal Impairment: Dosage interval must be adjusted in patients with kidney issues (Creatinine Clearance < 50 mL/min).

• Administration: Can be taken with or without food.

9. Side Effects and Precautions

• Nephrotoxicity (Kidney Warning): Adefovir can cause kidney damage, especially at higher doses or in patients with pre-existing risk factors. Regular monitoring of renal function (Creatinine/BUN) is mandatory.

• Lactic Acidosis: Rare but serious risk of lactic acidosis and severe hepatomegaly with steatosis.

• Exacerbation: Severe acute exacerbations of hepatitis have been reported in patients who discontinue anti-Hepatitis B therapy. Stop treatment only under medical supervision.

10. Storage Instructions

• Store below 25°C in a dry place.

• Critical: Keep the bottle tightly closed. Do not remove the silica gel sachet.

• Keep out of reach of children.