Fidaxomicin

Description

1. Product Overview

Fidaxomicin is a high-potency, narrow-spectrum macrolide antibiotic specifically designed for targeted bacterial inhibition. It is primarily used in pharmaceutical manufacturing for the treatment of Clostridioides difficile infections, ensuring precise efficacy with minimal systemic impact. Strategically, Fidaxomicin is a critical component in modern antimicrobial therapies, offering superior pathogen-specific activity compared to broad-spectrum alternatives. Its robust pharmacological profile and stability make it a preferred choice for industrial-scale pharmaceutical formulation, supporting both clinical effectiveness and regulatory compliance. For global pharmaceutical manufacturers, Fidaxomicin represents a high-value, reliable active pharmaceutical ingredient (API) that enhances therapeutic outcomes while optimizing production efficiency.

2. Key Specifications & Technical Characteristics

• Chemical Composition: Fidaxomicin (C52H74O18) – macrolide structure
• Purity Level: ≥ 98% (HPLC assay)
• Physical Form: Off-white to pale yellow crystalline powder
• Solubility: Sparingly soluble in water; soluble in DMSO and methanol
• Particle Size: 20–100 µm (customizable milling available)
• Density: 0.35–0.45 g/cm³
• Packaging Options:
  • 1 kg vacuum-sealed aluminum foil bags
  • 5–25 kg HDPE drums with inner liner
• Shelf Life: 24 months under recommended storage conditions (cool, dry, away from light)

3. Core Industrial Applications

• Pharmaceutical Industry: Primary API in oral and intravenous formulations for Clostridioides difficile infection treatment.
• Operational Use Cases:
  • High-potency tablet and capsule production
  • Injectable formulation manufacturing
  • Clinical trial API supply
• Performance Advantages:
  • Exceptional pathogen specificity reduces collateral microbiota disruption
  • High chemical stability enhances shelf life and formulation consistency
  • Optimized bioavailability for targeted therapeutic outcomes
• Efficiency & Cost Advantages:
  • Minimal dosage requirement reduces overall API consumption
  • Consistent particle size and purity ensure smooth downstream processing

4. Competitive Advantages

• Quality Consistency: Manufactured under cGMP conditions, ensuring uniformity across batches
• Supply Reliability: Established production lines with robust inventory management
• Logistics Capability: Global shipping with temperature-controlled transport options
• Price Competitiveness: Economically optimized for bulk procurement
• Sustainability: Eco-conscious manufacturing practices minimize environmental impact
• Technical Support: Comprehensive documentation, including Certificates of Analysis (CoA) and regulatory compliance support

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): 20 MT (bulk)
• Loading Capacity: Approx. 20 MT per 20-foot container (bulk packaging)
• Delivery: Available under FOB, CIF, or DDP terms depending on destination

Fidaxomicin positions itself as a strategically critical, high-value API for industrial pharmaceutical applications, balancing clinical efficacy, supply reliability, and cost efficiency.