Description

Emtricitabine & Tenofovir Disoproxil Fumarate Film-Coated Tablets (200 mg / 300 mg)

Healthy Inc is a specialized global supplier and exporter of advanced infectious disease, immunology, and targeted high-containment antiretroviral therapeutics. We provide ultra-high-purity, kinetically stabilized Emtricitabine & Tenofovir Disoproxil Fumarate (FTC/TDF) Film-Coated Tablets (200 mg / 300 mg), manufactured in WHO–GMP certified, strictly humidity-controlled oral solid dosage facilities. This “Dual NRTI/NtRTI Backbone” is a massive-volume, highly strategic export to infectious disease networks, mega-NGO procurement boards (PEPFAR, Global Fund), public health clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for both HIV-1 Treatment and HIV-1 Pre-Exposure Prophylaxis (PrEP).

Product Overview

This highly advanced formulation operates as an impenetrable biochemical firewall. It actively sabotages the HIV virus’s ability to convert its genetic material into a format that can infect human immune cells, simultaneously acting to suppress active infections and completely block new ones.

The “Reverse Transcriptase Chain-Terminator & PrEP” Specialist:

• Mechanism 1 (The Nucleotide Analogue – Tenofovir): Tenofovir Disoproxil Fumarate (TDF) is an acyclic nucleoside phosphonate (nucleotide) analogue. Once inside the cell, it is phosphorylated into its active form. It competes directly with the natural substrate required by the HIV-1 Reverse Transcriptase enzyme. When the virus mistakenly incorporates Tenofovir into its emerging DNA chain, the lack of a 3′-OH group makes it physically impossible for the next link to be added. The DNA chain is instantly terminated, and viral replication halts.
• Mechanism 2 (The Nucleoside Analogue – Emtricitabine): Emtricitabine (FTC) is a synthetic nucleoside analogue of cytidine. Operating via the exact same chain-terminating principle as Tenofovir, it attacks the reverse transcriptase enzyme from a slightly different molecular angle. Combining these two analogues creates a synergistic, high-barrier blockade that makes it exceptionally difficult for the HIV virus to mutate and develop resistance.
• Mechanism 3 (The PrEP Revolution): While used with a third agent to treat active HIV, FTC/TDF taken alone daily is the global gold standard for Pre-Exposure Prophylaxis (PrEP). By maintaining a constant level of these chain-terminators in the bloodstream and mucosal tissues, the drug physically prevents the HIV virus from establishing a permanent infection following a high-risk exposure, reducing transmission risk by over 99% when taken correctly.

Product Composition & Strength

We supply this product as a Precision-Blended, Hydrolytically Shielded Macrodose FDC Tablet, packed exclusively in highly secure, moisture-resistant heavy-gauge HDPE bottles or Alu-Alu blister strips to ensure the absolute chemical survival of the moisture-sensitive Tenofovir.

*Pack Sizes: Heavy-Gauge HDPE Bottles of 30 (Optimized specifically for massive NGO distribution and strict 30-day chronic daily dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Infectious Disease Distributors, and NGO Procurement Boards.

Manufacturing Authority

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

• Hydrolytic Defense & Macrodose Uniformity (CRITICAL COMPLIANCE): The clinical success of this ARV depends entirely on climate control during manufacturing. If the factory floor is humid, the TDF will degrade into useless adenine derivatives before the tablet is even pressed. Our infectious disease suites utilize elite dehumidification (RH < 30%), direct compression techniques, and immediate polymeric film-coating to seal the massive 500mg active core away from atmospheric water. This provides major international NGOs like PEPFAR with the absolute guarantee that our formulation will survive the supply chain and protect the patient.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized lifelong management and prevention of HIV-1:

• HIV-1 Treatment: In combination with other antiretroviral agents (such as Integrase Inhibitors or NNRTIs) for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
• HIV-1 Pre-Exposure Prophylaxis (PrEP): In combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents at high risk.

Dosage & Administration

Recommended Dosage (Strictly as per Infectious Disease Guidelines):

• Standard Adult Dosing (Treatment & PrEP): One tablet taken orally once daily.
• Administration: Can be taken with or without food. Tablets should be swallowed whole.
• Renal Impairment Adjustment: Because both drugs are heavily excreted by the kidneys, patients with significant renal impairment (CrCl < 50 mL/min) MUST have their dose intervals drastically adjusted (e.g., one tablet every 48 to 96 hours) to prevent toxic drug accumulation and acute renal failure.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Post-Treatment Exacerbation of Hepatitis B): FATAL WARNING: Both FTC and TDF are highly active against the Hepatitis B Virus (HBV). If a patient co-infected with HIV and HBV stops taking this medication, they can suffer a massive, severe acute exacerbation of Hepatitis B, leading to fatal liver failure. All patients must be tested for HBV before initiating therapy.
• BLACK BOX WARNING (PrEP in Unknown HIV Status): FATAL WARNING: FTC/TDF must NEVER be used for PrEP unless a negative HIV-1 test is confirmed immediately prior to initiation. Using a 2-drug regimen in a patient who already has HIV will cause the virus to rapidly develop incurable drug resistance.
• Renal Toxicity & Acute Kidney Injury: TDF is known to cause severe renal impairment, including acute renal failure and Fanconi syndrome. Routine monitoring of creatinine clearance and serum phosphorus is mandatory.
• Bone Mineral Density (BMD) Loss: TDF causes significant decreases in bone mineral density, leading to osteomalacia and an increased risk of severe, spontaneous bone fractures over long-term use.
• Lactic Acidosis & Severe Hepatomegaly: Rare but fatal cases of lactic acidosis and severe hepatomegaly with steatosis (fatty, violently enlarged liver) have been reported with the use of nucleoside analogues.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Mega-NGO Outbreak Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antiretrovirals, ARV Fixed-Dose Combinations, and Moisture-Shielded Macrodose Formulations. Whether you are looking for a reliable Government Tender Supplier for national PEPFAR programs in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.