Description
Levofloxacin Tablets (250 mg / 500 mg / 750 mg)
Healthy Inc is a premier global supplier of advanced fluoroquinolone anti-infectives. We provide premium Levofloxacin Tablets, manufactured in WHO–GMP certified specialized antimicrobial facilities. As a broad-spectrum antibiotic with exceptional tissue penetration, this product is a primary export for respiratory clinics, urology centers, and Ministry of Health (MOH) tenders in Southeast Asia, Africa, and the Middle East.
Product Overview
Levofloxacin is the S-enantiomer of the racemic fluroquinolone ofloxacin. It is a third-generation fluoroquinolone specifically engineered to provide enhanced activity against Gram-positive pathogens, particularly Streptococcus pneumoniae, while maintaining potent activity against Gram-negative bacteria.
The “Respiratory Quinolone” Specialist:
- Mechanism of Action: Levofloxacin exerts its bactericidal effect by inhibiting DNA gyrase (Topoisomerase II) and Topoisomerase IV. These enzymes are vital for bacterial DNA replication and transcription. By blocking these enzymes, Levofloxacin causes rapid bacterial cell death.
- Superior Pharmacokinetics: Levofloxacin is characterized by nearly 100% oral bioavailability, allowing for easy transition from IV to Oral therapy. It reaches high concentrations in lung tissue, sinonasal mucosa, and prostate fluid.
- Broad-Spectrum Coverage: It is highly effective against “atypical” pathogens such as Chlamydia pneumoniae and Mycoplasma pneumoniae, as well as difficult-to-treat Gram-negative organisms like Pseudomonas aeruginosa (at 750 mg dosages).
Technical & Manufacturing Specifications
Formulated for rapid absorption and high molecular stability.
| Technical Metric | Specification Standard |
|---|---|
| Active Ingredient | Levofloxacin Hemihydrate BP / USP / IP |
| Dosage Form | Film-Coated Tablets |
| Available Strengths | 250 mg, 500 mg, 750 mg |
| HS Code | 3004.20.19 (Other Antibiotics) / 2933.59.90 |
| Packaging | Alu-Alu Blister (Mandatory for light/moisture protection) |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.
- Hemihydrate Stability: We use high-purity Levofloxacin Hemihydrate to ensure the most stable crystalline form, preventing degradation during the manufacturing process and ensuring a 36-month shelf life.
- Advanced Film Coating: Levofloxacin is inherently bitter. Our tablets utilize an odor-masking film coating that ensures patient comfort and compliance while protecting the API from light.
- Validated Bioequivalence: Every batch is validated against the innovator (Levaquin) to ensure identical $C_{max}$ and $T_{max}$ profiles, guaranteeing that the 500 mg or 750 mg dose delivers the expected clinical outcome.
Therapeutic Indications & Clinical Symptoms
- Community-Acquired Pneumonia (CAP): First-line treatment for bacterial pneumonia.
- Acute Sinusitis & Bronchitis: Effective management of acute exacerbations of chronic bronchitis.
- Complicated Urinary Tract Infections (UTIs): Including acute pyelonephritis.
- Chronic Bacterial Prostatitis: Due to superior penetration into the prostate gland.
- Skin and Soft Tissue Infections: Treatment of complicated and uncomplicated infections.
Dosage & Administration
- Standard Adult Dose: 500 mg or 750 mg once daily. The “Once-Daily” dosing significantly improves adherence compared to other quinolones.
- Administration: Can be taken with or without food. Ensure high fluid intake to prevent crystalluria.
- Safety Note: Contraindicated in patients with a history of tendon disorders. Avoid use with antacids containing magnesium or aluminum as they hinder absorption.
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Specialty Chest Hospitals and Ministry of Health Tenders. We offer Third Party Manufacturing for Levofloxacin with full CTD Dossier and COPP support. Our logistics network ensures secure transit to Vietnam, Nigeria, UAE, and the Philippines, providing WHO-GMP quality at competitive B2B prices.
Commercial Inquiries
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
