Levofloxacin

Levofloxacin, a broad-spectrum fluoroquinolone antibiotic, has become a cornerstone in the treatment of numerous bacterial infections due to its high efficacy, excellent oral and intravenous bioavailability, and favorable safety profile. It is widely prescribed by healthcare professionals for both community-acquired and nosocomial infections affecting various organ systems, including the respiratory tract, urinary tract, skin, and soft tissues.

At BluepillExpress, we offer full-service third-party manufacturing solutions for Levofloxacin in multiple strengths and dosage forms. With advanced manufacturing infrastructure, WHO-GMP compliance, and strong regulatory expertise, we enable pharmaceutical companies, hospitals, and global distributors to confidently launch high-quality Levofloxacin products tailored to their markets.

Product Overview

Product Name: Levofloxacin
Therapeutic Class: Antibacterial – Fluoroquinolone Class
Available Dosage Forms:

• Tablets: 250 mg, 500 mg, 750 mg
• Oral Solution/Syrup: 25 mg/mL or custom strengths (on request)
• Injection: Levofloxacin 500 mg/100 mL (IV Infusion Bottle or Vial)
• Dry Powder for Suspension (Pediatric use) – Available on demand

Route of Administration: Oral and Intravenous
Packaging Options:

• Tablets in blister or alu-alu packs (1×10, 10×10, etc.)
• Oral solution in HDPE or PET bottles with a measuring cap
• Infusion bottles or vials for parenteral use
• Mono-carton packaging with or without patient literature

Pharmacological Mechanism of Action

Levofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, two essential enzymes required for DNA replication, transcription, repair, and recombination. The inhibition results in rapid bacterial cell death. It is effective against a broad range of gram-positive and gram-negative organisms.

Key attributes include:

• Rapid absorption and high tissue penetration
• Long half-life enabling once-daily dosing
• Excellent coverage for both typical and atypical bacteria
• Effective against beta-lactam and macrolide-resistant strains

Indications

Levofloxacin is indicated for the treatment of a wide variety of bacterial infections, including:

• Acute bacterial sinusitis
• Community-acquired pneumonia
• Chronic bronchitis exacerbations
• Uncomplicated and complicated urinary tract infections
• Acute pyelonephritis
• Skin and soft tissue infections
• Prostatitis
• Anthrax (inhalational exposure) – post-exposure prophylaxis
• Traveler’s diarrhea
• Gonococcal infections (off-label use in some markets)
• Bone and joint infections (selected protocols)

Pharmacokinetic Properties

• Bioavailability: >99% for oral administration
• Half-life: 6 to 8 hours
• Protein Binding: 24–38%
• Metabolism: Minimal hepatic metabolism
• Excretion: Primarily via the kidneys

These characteristics support its use in both inpatient and outpatient care, with switch-over potential from IV to oral administration in progressive care.

Why Choose BluepillExpress for Levofloxacin Manufacturing?

1. WHO-GMP and ISO-Certified Manufacturing Facilities

Our facilities are certified by WHO-GMP, ISO 9001:2015, and FSSAI, with segregated zones for the production of antibiotics, tablets, liquids, and injectables. We maintain strict environmental and process control protocols including HVAC systems, HEPA filtration, automated filling, and in-line quality monitoring.

2. Regulatory Compliance and Technical Documentation

We ensure full compliance with international regulatory standards such as IP, USP, BP, and EP. Clients are provided with a complete regulatory support package that may include:

• Certificate of Analysis (CoA)
• Certificate of Origin
• GMP Certificate
• Free Sale Certificate
• CTD or ACTD format dossiers (available upon request)
• Method of Analysis (MoA)
• Batch Manufacturing Records (BMR)
• Material Safety Data Sheets (MSDS)
• Stability study reports

Our documentation is tailored to support swift market registration and tender participation in both regulated and semi-regulated markets.

3. Multiple Dosage Forms for Diverse Market Needs

BluepillExpress offers a wide range of Levofloxacin formulations:

• Tablets for retail pharmacies and hospitals
• Syrups or oral solutions for pediatric or geriatric care
• IV injections for institutional and emergency use
• Dry powder for suspension for pediatric markets

Formulations can be tailored for regional preference, including sugar-free syrups or flavored suspensions.

Custom Formulation and Packaging Options

We offer extensive formulation and packaging customization, including:

• Flavored oral liquids (orange, strawberry, pineapple)
• Tablet film-coating customization
• Sugar-free or preservative-free formulations
• Ready-to-infuse injection bottles
• Blister packs in aluminum, PVC, or PVDC
• Printed cartons with language-specific labeling
• QR coding and serialization (as per DSCSA or EU FMD requirements)

Packaging materials are sourced from FDA-approved vendors and undergo rigorous compatibility testing.

Quality Assurance and Quality Control

Our robust QA/QC systems ensure that every batch of Levofloxacin meets the highest industry standards. Tests conducted include:

• Identification and assay of active pharmaceutical ingredient (API)
• Dissolution and disintegration
• Uniformity of dosage units
• Microbiological testing for oral and liquid formulations
• pH, viscosity, and specific gravity for oral liquids
• Particulate matter testing (for IV solutions)
• Sterility and endotoxin testing for injectables
• Accelerated and real-time stability studies

Each batch is accompanied by validated analytical reports and stability profiles.

Global Export and Distribution

BluepillExpress exports Levofloxacin formulations to over 35 countries across Africa, Asia, the Middle East, Latin America, and the CIS region. Our international logistics and documentation support includes:

• Country-specific labeling and packaging
• Temperature-controlled shipping (for injections)
• Pharmacovigilance data support (where applicable)
• Pre-shipment inspection (SGS, Intertek, etc.)
• Documentation for customs clearance and registration
• End-to-end export coordination

Our experience in public health projects, government tenders, and institutional supply chains ensures prompt delivery and professional handling of orders.

Applications and Target Markets

Levofloxacin is widely used in both retail and institutional settings and is suited for:

• Hospital and emergency care units
• Public health campaigns for pneumonia or urinary infections
• Outpatient clinics and general practitioners
• Pediatric departments (syrup/dry powder use)
• Pharmaceutical tenders by governments or NGOs
• Private label and branded generic segments

Its broad-spectrum activity, convenience of administration, and excellent patient compliance make Levofloxacin a consistently high-demand product in all regions.

Third-Party Manufacturing Process

Our third-party manufacturing model ensures speed, flexibility, and quality:

1. Requirement Gathering & Quotation
   • Product strength, form, packaging preferences, target market
2. Agreement and Advance
   • Contract signing, terms of manufacturing and pricing
3. Product Development (if required)
   • Sample creation, formulation adjustments, regulatory review
4. Bulk Production & Quality Control
   • GMP production followed by in-process and final testing
5. Packaging & Labeling
   • Branding, label printing, serialization as per client specs
6. Shipping & Documentation
   • Complete export support and dispatch coordination

Lead time for production: typically 30 to 45 days depending on volume and customization.

Advantages of Partnering with BluepillExpress

• Access to a WHO-GMP-certified supply chain
• Dedicated R&D and formulation support
• Private label options for rapid market deployment
• Comprehensive regulatory support for faster product registration
• Scalable volumes for both pilot and commercial batches
• Transparent production process with real-time communication

Whether you are launching a new product line or fulfilling a large-scale institutional tender, BluepillExpress offers unmatched reliability, quality, and service.

Conclusion

As the global need for safe, effective, and broad-spectrum antibiotics increases, Levofloxacin continues to be a vital tool in the fight against bacterial infections. Its versatility across dosage forms, reliable clinical efficacy, and broad indication spectrum make it a staple in every antibiotic portfolio.

With BluepillExpress as your third-party manufacturing partner, you gain access to world-class infrastructure, regulatory expertise, and custom branding options that empower you to grow your brand and meet global demand with confidence.