Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumarate Film-Coated Tablets (600 mg / 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 Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Film-Coated Tablets, manufactured in WHO–GMP certified, strictly humidity-controlled, high-compression oral solid dosage facilities. This “Complete Single-Tablet Regimen (STR)” 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 a globally validated, standalone daily intervention for the comprehensive treatment of HIV-1 infection.
Product Overview
This highly advanced formulation operates as a complete, three-pronged biochemical blockade against the HIV virus. By combining two distinct classes of antiretrovirals into a single matrix, it simultaneously attacks the viral replication engine from multiple angles, preventing the virus from mutating and ensuring profound, long-term viral suppression.
The “Complete STR & Dual-Class RT Inhibitor” Specialist:
- Mechanism 1 (The Allosteric Lock – Efavirenz): Efavirenz is a potent Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI). Unlike the other two drugs, it does not pretend to be a DNA building block. Instead, it binds directly to a highly specific allosteric pocket on the HIV-1 Reverse Transcriptase enzyme. This physically alters the shape of the enzyme, locking it into a useless conformation and instantly paralyzing its ability to copy viral RNA into DNA.
- Mechanism 2 (The Chain Terminators – Emtricitabine & Tenofovir): Emtricitabine (FTC) and Tenofovir Disoproxil Fumarate (TDF) serve as the NRTI/NtRTI “backbone.” Once phosphorylated inside the cell, they compete with natural nucleotides. When the paralyzed viral enzyme attempts to build a DNA strand, it mistakenly grabs FTC or TDF. Because these molecules lack a 3′-OH group, the DNA chain is permanently terminated.
- The “STR Compliance” Revolution: HIV treatment fails when patients forget to take one of their multiple pills, allowing the virus to develop deadly resistance. By mathematically compressing an entire 3-drug regimen into a single, once-daily tablet, this FDC guarantees that a patient cannot accidentally take a partial dose, driving global adherence rates to unprecedented highs.
Product Composition & Strength
We supply this product as a Precision-Blended, Hydrolytically Shielded Mega-Dose FDC Tablet, packed exclusively in highly secure, moisture-resistant heavy-gauge HDPE bottles to ensure the absolute chemical survival of the moisture-sensitive Tenofovir and light-sensitive Efavirenz.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Efavirenz USP/Ph.Eur. | 600 mg | The NNRTI Anchor: The massive, highly lipophilic non-nucleoside payload required to force immediate, systemic viral suppression. |
| Emtricitabine (FTC) USP/Ph.Eur. | 200 mg | The Cytidine Analogue: Provides profound, long-acting intracellular viral suppression to reinforce the backbone. |
| Tenofovir Disoproxil Fumarate (TDF) USP/Ph.Eur. | 300 mg | The Nucleotide Backbone: The heavy-hitting chain terminator required to completely halt viral DNA elongation. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Hydroxypropyl Cellulose / Sodium Lauryl Sulfate / Magnesium Stearate / Premium Polymeric Film | Diluent / Superdisintegrant / Binder / Surfactant / Heavy Film-Coating (Engineered utilizing High-Compression Bi-Layer Technology to fuse 1,100mg of active API into a single, aerodynamically shaped tablet that remains easy for patients to swallow, heavily coated to lock out destructive tropical humidity) |
*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.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antivirals/ARV STR) |
| CAS Numbers | 154598-52-4 (EFV) / 143491-57-0 (FTC) / 202138-50-9 (TDF) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | Heavy-Gauge HDPE Bottles with Desiccant (STRICTLY MANDATORY). TDF is highly susceptible to hydrolytic degradation. Strict barrier packaging with integrated desiccants guarantees absolute chemical stability and maximum therapeutic potency across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Mega-Dose Compression & Hydrolytic Defense (CRITICAL COMPLIANCE): Formulating this STR is an extreme test of pharmaceutical physics. Combining over a gram of three distinct active ingredients usually results in a tablet that shatters during coating or is impossible for a sick patient to swallow. Our infectious disease suites utilize advanced high-shear wet granulation and massive rotary compression force to create a hyper-dense, streamlined core. Combined with strict dehumidification (RH < 30%) to protect the TDF, we guarantee WHO procurement agencies an elite, climate-proof product.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized lifelong management of HIV-1:
- Complete HIV-1 Treatment: Used alone as a complete regimen, or in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.
- Note: This drug is NOT indicated for Pre-Exposure Prophylaxis (PrEP) due to the CNS side effects of Efavirenz.
Dosage & Administration
Recommended Dosage (Strictly as per Infectious Disease Guidelines):
- Standard Adult Dosing: One tablet taken orally once daily.
- The Empty Stomach & Bedtime Mandate (CRITICAL): This tablet MUST be taken on an empty stomach, preferably at bedtime. If taken with a high-fat meal, the absorption of Efavirenz violently spikes by up to 50%, leading to massive drug accumulation and severe, terrifying central nervous system (CNS) toxicity. Taking it at bedtime allows the patient to sleep through the most intense side effects.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Severe Psychiatric & CNS Symptoms (Efavirenz Alert): Efavirenz crosses the blood-brain barrier and frequently causes severe psychiatric symptoms, including profound depression, suicidal ideation, aggressive behavior, and terrifying, vivid nightmares or hallucinations. Patients with a history of psychiatric disorders are at high risk.
- BLACK BOX WARNING (Post-Treatment Exacerbation of Hepatitis B): Both FTC and TDF are highly active against the Hepatitis B Virus (HBV). If a co-infected patient stops taking this medication, they can suffer a massive, severe acute exacerbation of Hepatitis B, leading to fatal liver failure.
- Renal Toxicity & Acute Kidney Injury: TDF causes severe renal impairment, including acute renal failure and Fanconi syndrome. Routine monitoring of creatinine clearance is mandatory.
- Severe Skin Reactions: Efavirenz can trigger severe, life-threatening skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Therapy must be halted immediately if a severe rash develops.
- Bone Mineral Density (BMD) Loss: TDF causes significant decreases in bone mineral density over long-term use.
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, Mega-Dose STRs, and Moisture-Shielded FDC 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.