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Warfarin Sodium
CAS No.: 0129-06-06
Synonym: Coumadin, Warfarin
Mol. Formula: C₁₉H₁₅NaO₄
Mol. Weight: 330.31 g/mol
ATC Code: B01AA03
Therapeutic Category: Anticoagulant
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Warfarin Sodium API in Canada quality is critical for producing safe and effective anticoagulant formulations. High-quality Warfarin Sodium must comply with stringent pharmacopeial and regulatory standards for purity, assay, residual solvents, and impurity profile. GMP-compliant manufacturing, validated synthesis methods, and advanced analytical testing ensure consistent batch quality, stability, and reliable therapeutic performance in finished dosage forms. Maintaining high API quality minimizes risks and ensures patient safety.

2) Comprehensive Documentation
Complete documentation is essential for regulatory compliance and global product approvals. This includes Drug Master Files (DMF), Certificates of Analysis (COA), stability data, method validation reports, impurity profiling, and full traceability records. Comprehensive technical dossiers support pharmaceutical manufacturers in regulatory submissions, audits, and quality assurance processes, facilitating faster approvals and compliance with international standards.

3) Secure Supply Chain
A robust and secure supply chain ensures uninterrupted availability of Warfarin Sodium API. Measures include qualified raw material sourcing, controlled manufacturing processes, GDP-compliant storage and transport, and real-time tracking. Such protocols reduce risks of contamination, counterfeiting, and delivery delays, ensuring consistent production for essential anticoagulant therapies.

4) Manufacturer & Supplier Expertise
Experienced manufacturers bring deep technical knowledge of Warfarin Sodium synthesis, optimizing yield, controlling impurities, and ensuring scalable production. Their expertise guarantees regulatory compliance, cost efficiency, and consistent API performance suitable for global markets.

5) Amber Lifesciences’ Role
Amber Lifesciences supplies high-quality Warfarin Sodium API with complete documentation, a secure supply chain, and strong technical support. Their commitment enables pharmaceutical companies to develop safe, effective, and competitive anticoagulant formulations worldwide.

Active Pharmaceutical Ingredient (API) – Not for Direct Human or Veterinary Use.