Tenofovir Disoproxil Fumarate Tablets

1. Product Introduction

Tenofovir disoproxil fumarate (TDF) 300 mg is an oral nucleotide reverse transcriptase inhibitor used as part of combination antiretroviral treatment for HIV-1 infection and for treatment of chronic hepatitis B in appropriately selected patients. The supplied product is Abivir, a 300 mg film-coated tablet. TDF does not cure HIV or hepatitis B.

Healthy Life Pharma Pvt. Ltd. is identified in the supplied material as manufacturer and Healthy Inc as exporter. Manufacturing authorizations, certifications, market registrations and export capabilities should be verified before making commercial claims.

2. Product Specifications

3. Manufacturing Technology

TDF formulations require validated controls for material quality, blending, tablet compression, coating and moisture exposure. Appropriate film-coating and protective packaging can help maintain product stability where supported by product-specific studies.

Claims regarding particular equipment, humidity limits, proprietary coating systems or specific pack formats must be supported by the manufacturer’s validated process and approved dossier.

4. Quality Assurance

Batch release should follow approved specifications and validated analytical methods, including identity, assay, content uniformity, dissolution, related substances and relevant microbiological tests.

Stability studies, packaging qualification, GMP documentation and, where applicable, bioequivalence evidence should be available for regulatory review. Numerical acceptance limits must come from the approved pharmacopoeial or product-specific specification, not assumed generic values.

5. Therapeutic Uses and Mechanism

Tenofovir disoproxil fumarate is converted to tenofovir in the body and then to its active diphosphate form, which inhibits viral reverse transcriptase in HIV and viral polymerase in hepatitis B.

• HIV-1: Used with other antiretroviral agents; it must not be used as the sole HIV treatment.
• Chronic hepatitis B: May suppress HBV replication when clinically indicated and locally approved.
• Clinical oversight: Treatment selection depends on HIV/HBV status, renal function, co-medications and relevant national guidance.

6. Export and Regulatory Support

For B2B procurement, buyers may request the approved composition, product specification, certificate of analysis, manufacturing license, GMP evidence, stability data and registration documentation where available.

CTD/ACTD dossiers, COPP, FSC, WHO-GMP evidence, country-specific registrations, pricing, shipping terms and export permissions are subject to confirmation; their availability is not established by this page.

7. Frequently Asked Questions

Q: What is Abivir 300 mg?
A: The supplied brand name for a film-coated tablet containing tenofovir disoproxil fumarate 300 mg.

Q: Does TDF cure HIV?
A: No. It helps suppress HIV when taken as part of a prescribed combination regimen.

Q: Is kidney monitoring necessary?
A: Yes. Kidney function should be assessed before and during treatment as clinically indicated.

Q: Can a patient stop TDF suddenly?
A: Treatment should not be stopped without clinician advice, especially with hepatitis B coinfection because severe HBV flares can occur.

8. Dosage and Administration

For adults with adequate renal function, the commonly labeled TDF dose for indicated conditions is 300 mg orally once daily, but dosing must follow the approved local label and the prescribing clinician’s instructions. Renal impairment can require dosage-interval adjustment or an alternative treatment.

TDF may generally be taken with or without food depending on the product label. Do not independently change HIV combination therapy or stop treatment.

9. Side Effects and Precautions

• Kidney effects: Renal impairment and proximal renal tubulopathy, including Fanconi syndrome, can occur; monitor kidney function as indicated.
• Bone health: Decreases in bone mineral density and mineralization abnormalities may occur.
• Hepatitis B flare: Severe acute exacerbation of hepatitis B has been reported after discontinuation in patients with HBV.
• Other concerns: Nausea, diarrhea, headache and rare lactic acidosis; assess interactions with nephrotoxic medicines and other antiretrovirals.

Prescription-only information for qualified healthcare professionals; follow current prescribing information and national treatment guidelines.

10. Storage Instructions

Store according to the approved pack label, commonly at controlled room temperature in the original tightly closed container, protected from moisture. Keep desiccant in the bottle if supplied and instructed by the manufacturer. Do not use beyond the labeled expiry date; keep out of reach of children.