Description

Tenofovir, Lamivudine & Dolutegravir Tablets (TLD)

Healthy Inc is a specialized global supplier and exporter of advanced virology, immunology, and infectious disease therapeutics. We provide ultra-high-purity, kinetically synchronized Tenofovir Disoproxil Fumarate (300 mg) + Lamivudine (300 mg) + Dolutegravir (50 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-capacity oral solid dosage facilities. Globally recognized as the “TLD Regimen,” this Single-Tablet Regimen (STR) is a massive-volume, high-priority export to HIV/AIDS NGOs, global health funds, infectious disease clinics, and government health ministries in Africa, LATAM, the Middle East, and Southeast Asia, serving as the definitive, first-line standard of care for HIV-1 eradication and viral suppression.

Product Overview

This highly advanced Fixed-Dose Combination (FDC) brilliantly synchronizes two distinct classes of antiretroviral agents to completely shut down the HIV replication cycle from multiple angles, preventing viral mutation and resistance.

The “First-Line Viral Eradication” Specialist:

• Mechanism 1 (The NRTI Backbone – Tenofovir & Lamivudine): Both TDF and 3TC are Nucleoside/Nucleotide Reverse Transcriptase Inhibitors. They act as “false building blocks.” When the HIV virus attempts to copy its RNA into DNA to infect the host cell, it mistakenly incorporates these drugs into the developing DNA chain. Because they lack a crucial chemical attachment point, the chain cannot be continued. The viral DNA synthesis is violently terminated.
• Mechanism 2 (The Integrase Anchor – Dolutegravir): Even if some viral DNA manages to be synthesized, Dolutegravir acts as an impenetrable shield. It aggressively binds to the HIV integrase enzyme, physically preventing the viral DNA from integrating into the human CD4 cell’s genetic code. Without integration, the virus cannot establish a permanent infection or hijack the cell to make copies of itself.
• The TLD Clinical Advantage: Compared to older regimens (like those containing Efavirenz), TLD offers a significantly higher genetic barrier to resistance, vastly superior tolerability (fewer neuropsychiatric side effects), and incredibly rapid viral load suppression—all within a single, highly convenient daily pill.

Product Composition & Strength

We supply this product as a highly advanced Film-Coated Tablet, packed strictly in heavy-gauge HDPE bottles with integrated silica gel desiccants. This packaging is absolutely non-negotiable, as Tenofovir is highly susceptible to hydrolytic degradation in humid environments.

*Pack Sizes: HDPE Bottles of 30 or 90 Tablets (Optimized specifically for 1-month to 3-month NGO dispensing and adherence protocols).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Global Fund Procurement Boards, and HIV/AIDS NGOs.

Manufacturing Authority

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

• High-Tonnage FDC Formulation: Combining three distinct active ingredients into a single, swallowable tablet without compromising the dissolution profile of any individual molecule requires elite pharmaceutical engineering. Our facilities utilize advanced high-shear granulation and strictly validated multipoint HPLC dissolution testing to ensure the tablet releases all three APIs with the exact kinetic synchronicity required to prevent viral resistance.
• Mega-Volume Output: Because TLD is a lifelong, daily therapy for millions of patients globally, supply chain interruption is a matter of life and death. Our automated compression and bottling lines are scaled to meet the multi-million-bottle demands of global health tenders rapidly and reliably.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of retroviral infections:

• HIV-1 Infection: The complete, first-line treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents weighing at least 30 kg.

Dosage & Administration

Recommended Dosage (Strictly as per WHO and Infectious Disease Guidelines):

• Standard Adult Dosing: One tablet taken orally once daily.
• Administration: Can be taken with or without food. However, it MUST be taken at approximately the same time every day to maintain strict viral suppression. Missing doses can rapidly lead to the development of drug-resistant HIV strains.
• Cation Warning (CRITICAL): Dolutegravir’s absorption is severely compromised by polyvalent cations. The tablet must be taken 2 hours before or 6 hours after taking antacids (containing aluminum/magnesium) or calcium/iron supplements.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Hepatitis B Exacerbation (BLACK BOX EQUIVALENT): Both Tenofovir and Lamivudine are highly active against the Hepatitis B Virus (HBV). If a patient is co-infected with HIV and HBV, suddenly stopping this medication can cause a massive, potentially fatal, acute exacerbation of Hepatitis B. Liver function must be monitored closely for months after discontinuation.
• Renal Toxicity & Bone Mineral Density Loss: Tenofovir Disoproxil Fumarate (TDF) is associated with renal impairment (including acute renal failure and Fanconi syndrome) and decreases in bone mineral density. Renal function (creatinine clearance) must be assessed prior to initiation and monitored during therapy.
• Weight Gain & Metabolic Changes: Modern integrase inhibitors, particularly Dolutegravir, have been strongly associated with significant clinical weight gain and metabolic shifts when initiated.
• Immune Reconstitution Inflammatory Syndrome (IRIS): As the immune system rapidly recovers during initial TLD therapy, patients may develop a severe inflammatory response to hidden, latent opportunistic infections (like Tuberculosis or Cytomegalovirus), requiring urgent medical intervention.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Global Health NGOs. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antiretroviral Formulations, allowing bulk buyers to launch high-quality generic medicines under their essential label. Whether you are looking for a reliable PEPFAR/Global Fund Tender Supplier for massive HIV eradication programs in Africa or a B2B Pharma Marketplace partner for Southeast Asia, our logistics network ensures timely, life-saving delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every NGO Medicine Wholesaler receives WHO-GMP certified products at competitive rates.