Efavirenz Film-Coated Tablets (600 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 Film-Coated Tablets (600 mg), manufactured in WHO–GMP certified, high-compression, moisture-controlled oral solid dosage facilities. This “Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)” is a massive-volume, highly strategic export to infectious disease networks, mega-NGO procurement boards (PEPFAR, Global Fund), tuberculosis clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as a globally validated, standalone daily intervention for the comprehensive, combination treatment of HIV-1 infection.
Product Overview
This highly advanced formulation operates as a non-competitive, structural paralyzer of the HIV virus. Unlike nucleoside analogues that pretend to be DNA building blocks, Efavirenz physically attacks the viral replication enzyme itself, locking it into a rigid, useless state to stop the virus from multiplying.
The “Allosteric RT Inhibitor & TB Co-Infection” Specialist:
- Mechanism 1 (The Allosteric Pocket Blockade): The HIV-1 virus relies on an enzyme called Reverse Transcriptase (RT) to transcribe its viral RNA into human-compatible DNA. Efavirenz binds tightly and directly to a specific hydrophobic pocket near the catalytic site of this enzyme. This binding violently distorts the shape of the enzyme (allosteric inhibition), rendering it completely incapable of linking DNA building blocks together.
- Mechanism 2 (The High-Barrier NNRTI Anchor): Because it attacks a completely different site than standard NRTIs (like Tenofovir or Lamivudine), Efavirenz provides a critical “second front” in Combination Antiretroviral Therapy (cART). It rapidly drives viral loads down to undetectable levels within weeks of initiation.
- Mechanism 3 (The Tuberculosis Survival Pathway): In developing nations, HIV and Tuberculosis frequently occur together. The gold-standard TB drug, Rifampicin, is a massive CYP3A4 liver enzyme inducer that rapidly clears most HIV drugs from the blood, leading to ARV failure. Efavirenz is uniquely resilient; a 600 mg daily dose maintains highly effective viral suppression even in the presence of aggressive Rifampicin therapy, making it a critical lifeline in global health.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Macrodose 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 highly lipophilic active ingredient.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Efavirenz USP/Ph.Eur. | 600 mg | The Global NNRTI Macrodose: The massive therapeutic payload required to force immediate, systemic viral suppression when combined with a dual-NRTI backbone. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Sodium Lauryl Sulfate / Povidone K-30 / Magnesium Stearate / Premium Polymeric Film | Diluent / Superdisintegrant / Surfactant / Binder / Heavy Film-Coating (Engineered specifically utilizing powerful surfactants like Sodium Lauryl Sulfate to drastically increase the solubility of the notoriously lipophilic Efavirenz molecule, ensuring rapid and complete gastrointestinal absorption) |
*Pack Sizes: Heavy-Gauge HDPE Bottles of 30 or 10×10 Alu-Alu Blisters (Optimized specifically for massive NGO distribution and 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/ARVs) |
| CAS Number | 154598-52-4 (Efavirenz) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | Heavy-Gauge HDPE Bottles or Alu-Alu Blisters (STRICTLY MANDATORY). Ensures the physical integrity of the macrodose tablet and protects the formulation from degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Direct Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Lipophilic Macrodose Compression (CRITICAL COMPLIANCE): Efavirenz is intensely lipophilic (fat-soluble) and practically insoluble in water. Standard generic manufacturers who fail to optimize the granulation process will produce a “brick” that never dissolves in the patient’s stomach, leading to zero viral suppression and deadly HIV mutation. Our infectious disease suites utilize elite high-shear wet granulation, powerful surfactants, and rigorous dissolution profiling to guarantee that all 600mg of the API becomes highly bioavailable, perfectly matching originator pharmacokinetics.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized lifelong management of HIV-1:
- HIV-1 Treatment: Used in combination with other antiretroviral agents (always as part of a fully suppressive regimen) for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.
- TB/HIV Co-Infection: A preferred NNRTI anchor in patients undergoing concurrent treatment for active Tuberculosis with Rifampin-based regimens.
Dosage & Administration
Recommended Dosage (Strictly as per Infectious Disease Guidelines):
- Standard Adult Dosing: 600 mg taken orally once daily in combination with a dual-NRTI backbone.
- 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%. This massive overdose leads to severe, terrifying central nervous system (CNS) toxicity. Dosing at bedtime ensures the patient sleeps through the most intense neurological side effects.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Severe Psychiatric & CNS Symptoms: Efavirenz freely crosses the blood-brain barrier. It frequently causes severe psychiatric symptoms, including profound clinical depression, suicidal ideation, aggressive behavior, and terrifying, vivid nightmares or hallucinations. Therapy must be closely monitored in patients with a history of mental illness.
- Severe Skin Reactions (SJS/TEN): Can trigger severe, life-threatening skin reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis. Therapy must be halted immediately if a severe blistering rash develops.
- Hepatotoxicity: Severe and sometimes fatal hepatotoxicity has occurred. Liver enzymes (AST/ALT) must be monitored, especially in patients with underlying Hepatitis B or C.
- QTc Prolongation: Efavirenz can prolong the QT interval. It must be used with extreme caution in patients taking other medications known to cause cardiac arrhythmias (like certain antimalarials or antipsychotics).
- Teratogenicity (Pregnancy Warning): Historically linked to severe neural tube defects if used during the first trimester of pregnancy. Women of childbearing potential must undergo pregnancy testing before initiation and use highly effective barrier contraception.
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, NNRTI Anchors, and Dissolution-Optimized Macrodose Formulations. Whether you are looking for a reliable Government Tender Supplier for national PEPFAR/TB 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.