Cefdinir

Description

1. Product Overview

Cefdinir is a third-generation cephalosporin antibiotic active pharmaceutical ingredient (API) widely used in the formulation of oral antibacterial medications. It is primarily utilized by pharmaceutical manufacturers for the production of capsules, tablets, and suspension formulations targeting a broad range of bacterial infections. The key value proposition lies in its proven efficacy, broad-spectrum antibacterial activity, and strong market demand in both branded and generic drug segments. Strategically, Cefdinir remains an essential API in global healthcare supply chains, offering manufacturers a reliable and commercially viable molecule for anti-infective portfolios.

2. Key Specifications & Technical Characteristics

• Chemical Composition:
  • Cefdinir (C₁₄H₁₃N₅O₅S₂)
  • Cephalosporin-class β-lactam compound
• Purity Level / Grade:
  • Pharmaceutical grade (USP/EP/BP compliant)
  • Typical purity: ≥ 98.0%
  • Controlled impurity profile per pharmacopeial standards
• Physical Characteristics:
  • Form: Crystalline powder
  • Color: Off-white to light yellow
  • Odor: Odorless or slight characteristic odor
  • Particle size: Micronized or standard as required
  • Solubility: Slightly soluble in water
• Packaging Options:
  • Double-lined, pharmaceutical-grade HDPE drums
  • Aluminum foil bags within fiber drums
  • Custom packaging per GMP requirements
• Shelf Life:
  • Typically 24–36 months under recommended storage conditions
  • Store in a cool, dry environment, protected from light and moisture

3. Core Industrial Applications

Primary Industries:

• Pharmaceutical manufacturing
• Contract development and manufacturing organizations (CDMOs)
• Generic drug producers
• Healthcare product manufacturers

Operational Use Cases:

• Formulation of oral solid dosage forms (capsules, tablets)
• Production of dry powder suspensions for reconstitution
• Integration into anti-infective drug portfolios
• Bulk API supply for global pharmaceutical distribution

Performance & Cost Advantages:
Cefdinir offers broad-spectrum antibacterial activity against both Gram-positive and Gram-negative organisms, making it a versatile and widely prescribed API. Its established clinical profile and regulatory acceptance reduce development risk and accelerate time-to-market for generic manufacturers. Additionally, it provides strong commercial viability due to sustained demand and favorable cost-performance balance in antibiotic formulations.

4. Competitive Advantages

• Quality Consistency: Manufactured under strict GMP conditions with validated batch-to-batch uniformity
• Supply Reliability: Scalable production capacity ensuring uninterrupted global supply
• Logistics Capability: Secure, compliant international shipping with temperature and moisture control
• Price Competitiveness: Optimized production economics supporting competitive API pricing
• Sustainability Benefits: Efficient synthesis processes with controlled waste management systems
• Technical Documentation: Full regulatory support including DMF, COA, SDS, and stability data

Positioned as a strategic sourcing decision, Cefdinir enables pharmaceutical manufacturers to ensure product quality, regulatory compliance, and cost-effective production within competitive global markets.

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): BULK 20MT
• Loading Capacity (MT per container): Approximately 10–15 MT per 20’ container (subject to packaging configuration and regulatory handling requirements)