Description

Tenofovir Disoproxil Fumarate Tablets (300mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Tenofovir Disoproxil Fumarate (TDF) Tablets in India. This is a cornerstone Antiretroviral (ARV) medication used extensively worldwide for the treatment of HIV-1 Infection (in combination with other agents) and for the management of Chronic Hepatitis B (HBV).

We offer Contract Manufacturing (Third Party) services for this high-volume infectious disease therapy. As a first-line therapy recommended by the WHO, Tenofovir requires robust manufacturing capacity and strict adherence to quality standards. Our WHO-GMP certified facility in Mumbai utilizes high-speed tableting lines and moisture-controlled packaging lines to supply National Health Programs, NGOs, and hospitals across Africa, CIS countries, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Ensuring stability in tropical climates is critical for ARVs.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Moisture Sensitivity: Tenofovir Disoproxil Fumarate is sensitive to hydrolysis (breakdown by water). We manufacture these tablets in Low-Humidity Suites (< 30% RH) to prevent degradation into toxic byproducts.

  • Compression: We use specialized tooling to create high-density tablets that remain stable during transport.

  • Coating: We apply a robust Moisture Barrier Film Coating (Opadry AMB) to seal the tablet core from environmental humidity.

• The Exporter: Healthy Inc

  • Packaging: The preferred packaging for export is High-Density Polyethylene (HDPE) Bottles containing heavy-duty silica gel desiccants. This ensures the tablets remain dry and potent even after the bottle is opened by the patient, which is essential for chronic monthly therapy.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure rapid bioavailability.

• Assay: We confirm the potency is strictly within 90-110% limits.

• Related Substances: We strictly monitor for degradation products (Monoester and Isoproxil) and Enantiomeric purity to ensure patient safety over the shelf life.

5. Why Use Tenofovir (TDF)?

It is a “Backbone” of modern HIV and HBV treatment.

• Mechanism: It is a Nucleotide Reverse Transcriptase Inhibitor (NRTI). It works by blocking the reverse transcriptase enzyme, which the virus needs to replicate its DNA. This lowers the viral load in the body.

• Key Indications:

  • HIV-1 Infection: Used in combination with other ARVs (like Lamivudine and Efavirenz) to control the virus.

  • Chronic Hepatitis B: Highly effective at suppressing the HBV virus, reducing liver damage and the risk of cirrhosis/liver cancer.

• Advantage: Convenient Once-Daily Dosing improves patient adherence compared to older ARVs requiring multiple doses.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Tenofovir Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Does this cure HIV?

  A: No. There is currently no cure for HIV. Tenofovir helps keep the virus under control so the immune system can stay healthy.

• Q: Is it safe for kidneys?

  A: Tenofovir can cause kidney toxicity in some patients. Renal function (Creatinine) should be monitored regularly, especially in elderly patients.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One 300mg tablet once daily.

• Renal Adjustment: Dosage interval adjustment is required in patients with Creatinine Clearance < 50 mL/min.

• Administration: Swallow whole with water. Taking it with food increases bioavailability slightly.

9. Side Effects and Precautions

• Renal Toxicity: Risk of Fanconi syndrome and renal failure. Monitor serum creatinine and phosphorus.

• Bone Mineral Density (BMD): Long-term use can cause decreases in bone density (osteoporosis/osteomalacia). Calcium/Vitamin D supplementation may be advised.

• Lactic Acidosis: Rare but serious condition associated with NRTIs.

• Hepatitis B Exacerbation: Severe acute exacerbation of Hepatitis B may occur if Tenofovir is discontinued abruptly.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep bottle tightly closed. Do not remove the desiccant canister from the bottle.