Description
Rifampicin + Isoniazid + Pyrazinamide + Ethambutol Tablets (4-FDC)
Healthy Incorporation and Healthy Life Pharma Pvt. Ltd. represent a top-tier, WHO–GMP certified pharmaceutical alliance headquartered in Mumbai, India. With over 45+ years of production excellence across tablets, capsules, and complex formulations, our organization is recognized globally for scale, reliability, and regulatory discipline.
We are one of India’s leading manufacturers, suppliers, and exporters of Rifampicin, Isoniazid, Pyrazinamide, and Ethambutol fixed-dose combination (FDC) tablets. Our products are delivered to Africa, LATAM, CIS, Asia, and the Middle East. Our expert formulation team ensures consistent quality, validated processes, and multi-strength offerings tailored for Government Tenders (NTEP/RNTCP), Global Fund procurement, institutional buying, and international distributors.
Product Overview
Rifampicin + Isoniazid + Pyrazinamide + Ethambutol Tablets are a first-line, multi-drug combination therapy (Quadruple Therapy) used for the intensive phase treatment of active pulmonary and extrapulmonary Tuberculosis. This FDC simplifies TB therapy, significantly improves patient adherence, reduces pill burden, and minimizes the risk of developing Multi-Drug Resistant TB (MDR-TB).
This combination is commonly prescribed as a generic equivalent to brands like Forecox, Rimstar, and Akurit-4.
Product Composition & Strength
We manufacture customized strengths commonly required for TB control programs.
| Product Code | Composition (R+H+Z+E) | Strength | Patient Category |
|---|---|---|---|
| HLP-4FDC-AD | Rifampicin + Isoniazid + Pyrazinamide + Ethambutol | 150mg + 75mg + 400mg + 275mg | Adults (Intensive Phase) |
| HLP-4FDC-PED | Rifampicin + Isoniazid + Pyrazinamide + Ethambutol | 75mg + 50mg + 150mg + 100mg | Pediatric / Kid (Dispersible) |
*Tailored strengths and private labeling available on request.
Mechanism of Action
This formulation provides a synergistic antibiotic action to target Mycobacterium tuberculosis at different stages:
- Rifampicin (R): Bactericidal against actively dividing bacteria.
- Isoniazid (H): Inhibits mycolic acid synthesis, essential for the cell wall.
- Pyrazinamide (Z): A sterilizing agent active against dormant intracellular bacilli.
- Ethambutol (E): Inhibits cell wall synthesis and prevents resistance development.
Technical & Logistics Specifications
Critical data for Tender Bidding, Import, and Regulatory Filing.
| HS Code | 3004.90.99 (Anti-Tubercular Medicaments) |
| Standards | USP / BP / IP (WHO Protocol Compliant) |
| Climate Stability | Zone IVb (Stability data available for hot/humid climates) |
| Packaging | Blister Pack (Alu-Alu/PVC) / 10 Tablets per Box / Hospital Bulk Jars |
| Shelf Life | 24 – 36 Months |
| Global Supply | Bulk supply for Tenders, NGOs, and Government Health Missions |
| Certificates | WHO-GMP, COPP, FSC, CTD/ACTD Dossier |
Therapeutic Indications
This combination is clinically indicated for:
- Active Tuberculosis (Initial intensive phase treatment).
- TB cases requiring strict multi-drug regimen adherence.
- Government and NGO-driven TB control campaigns (DOTS Strategy).
- High-burden geographies requiring standardized 4-drug therapy.
Precautions & Side Effects
Contraindications & Precautions:
Patients must disclose history of Liver disease, Kidney impairment, Diabetes, Genetic enzyme disorders, or Alcohol consumption. Pregnant and breastfeeding patients must consult a healthcare professional before initiating therapy.
Possible Side Effects:
Generally well-tolerated, but patients may experience:
- Common: Nausea, vomiting, abdominal discomfort, heartburn, headache, fever.
- Specific: Urine/sweat discoloration (Red/Orange) due to Rifampicin.
- Serious: Jaundice (liver toxicity), vision changes (optic neuritis), or peripheral numbness. Medical evaluation is recommended immediately in these cases.
Commercial Inquiries & Regulatory Support
For detailed specifications, MSDS, pricing, COAs, regulatory files, and custom strength requirements, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
If you require a formulation or strength not listed, our R&D team will assist with development and scale-up.
Legal Notice: All content, product data, and intellectual property on this page are owned by Healthy Incorporation & Healthy Life Pharma Pvt. Ltd. Unauthorized use is prohibited.







