Description
Roxithromycin Tablets (150 mg / 300 mg)
Healthy Inc is a specialized global supplier of high-stability macrolide antibiotics. We provide premium Roxithromycin Tablets, manufactured in WHO–GMP certified antimicrobial facilities. As a refined alternative to erythromycin with better gastric stability, this product is a primary export for pulmonology clinics, ENT specialists, and pediatric hospitals in Southeast Asia, Africa, and the CIS region.
Product Overview
Roxithromycin is a semi-synthetic macrolide antibiotic. It is specifically engineered to overcome the limitations of first-generation macrolides by offering higher acid stability, improved oral absorption, and a longer elimination half-life.
The “Acid-Stable” Macrolide Specialist:
- Mechanism of Action: Roxithromycin inhibits bacterial protein synthesis by binding to the 50S subunit of the 70S ribosome. This action blocks the translocation of peptides, effectively inhibiting the growth (bacteriostatic) of susceptible gram-positive and gram-negative aerobic bacteria.
- Enhanced Pharmacokinetics: Unlike erythromycin, Roxithromycin is not degraded by gastric acid. It achieves high concentrations in tissues—specifically the lungs, tonsils, and prostate—making it exceptionally effective for localized infections.
- Intracellular Potency: It penetrates macrophages and polymorphonuclear neutrophils, allowing it to target intracellular pathogens like Chlamydia and Legionella effectively.
Technical & Manufacturing Specifications
Formulated for rapid absorption and consistent therapeutic plasma levels.
| Technical Metric | Specification Standard |
|---|---|
| Active Ingredient | Roxithromycin BP / USP / IP |
| Dosage Form | Film-Coated Tablets |
| Assay (Purity) | 98.0% – 102.0% |
| HS Code | 3004.20.19 (Other Antibiotics) / 2941.90.90 |
| Stability | Validated for Zone IVb (Tropical) export conditions |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.
- Optimized Bioavailability: Our tablets are engineered to ensure $C_{max}$ is achieved within 1–2 hours, providing rapid relief from acute infectious symptoms.
- Moisture Protection: Macrolides can be sensitive to environmental moisture. We utilize Alu-Alu packaging and specialized film coatings to maintain potency even in humid tropical climates.
- Purity Standards: We strictly monitor for related substances such as Erythromycin A and other process-related impurities, ensuring a high safety profile and lower incidence of gastrointestinal side effects.
Therapeutic Indications & Clinical Symptoms
- Respiratory Tract Infections: Treatment of community-acquired pneumonia, acute bronchitis, and bronchopneumonia.
- ENT Infections: Management of pharyngitis, tonsillitis, and sinusitis.
- Skin & Soft Tissue Infections: Treatment of folliculitis, cellulitis, and impetigo.
- Urogenital Infections: Effective against non-gonococcal urethritis caused by Chlamydia trachomatis.
Dosage & Administration
- Adult Dose: Typically 150 mg twice daily or 300 mg once daily.
- Administration: Should be taken at least 15 minutes before food, as food can slightly decrease absorption.
- Drug Interactions: Caution is required when co-administered with ergot alkaloids or drugs metabolized by CYP3A4, although Roxithromycin has a lower affinity for these enzymes than erythromycin.
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Institutional Suppliers and Ministry of Health Tenders. We offer Third Party Manufacturing for Roxithromycin with full CTD Dossier and COPP support. Our logistics network ensures streamlined delivery to Vietnam, Nigeria, Kazakhstan, and the Philippines, providing WHO-GMP quality at competitive B2B prices.
Commercial Inquiries
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
