Epirubicin HCl 56390-09-1 — China API Manufacturer | EP USP R&D to Production

China Manufacturing Landscape for Epirubicin HCl

Epirubicin Hydrochloride (CAS 56390-09-1) is an anthracycline antineoplastic agent widely used in chemotherapy regimens for breast cancer, gastric cancer, ovarian cancer, and soft tissue sarcomas. As a stereoisomer of Doxorubicin with an improved therapeutic index, Epirubicin HCl remains a critical component of oncology treatment protocols worldwide. China has developed world-class manufacturing capabilities for this high-potency API, with our production facility serving as a reliable supply source for pharmaceutical formulators and generic drug manufacturers across global markets.

Our dedicated cytotoxic API manufacturing platform has been purpose-built for anthracycline production, incorporating the stringent containment, quality control, and environmental protection measures required for these potent compounds. With significant production capacity and a proven track record of regulatory compliance, we offer international pharmaceutical companies a dependable China-based sourcing option for Epirubicin HCl API.

Manufacturing Process & Facility Overview

Our Epirubicin HCl manufacturing process begins with fermentation-derived doxorubicin as a starting material, followed by selective epimerization at the C-4 position of the daunosamine sugar moiety. This semi-synthetic approach ensures consistent molecular identity while leveraging our established fermentation expertise. The synthesis is conducted under controlled pharmaceutical conditions in dedicated high-containment reactors with automated process control systems monitoring critical parameters including temperature, pH, and reaction kinetics in real time.

Post-synthesis purification employs a combination of preparative chromatography and controlled crystallization to achieve the high chemical purity demanded by pharmacopeial specifications. The HPAPI manufacturing suite operates under negative pressure cascade with OEL (Occupational Exposure Limit) controls below 1 μg/m³, featuring isolator technology for powder handling operations, integrated continuous air monitoring, and validated decontamination protocols between production campaigns.

Quality Standards & Multi-Pharmacopeial Compliance

Epirubicin HCl produced at our facility meets the stringent quality requirements specified in European Pharmacopoeia (EP) and United States Pharmacopeia (USP) monographs. Our complete testing program includes assay determination by validated HPLC method (purity ≥98.0%), chromatographic purity with full related substances profile, specific optical rotation measurement, identification by UV absorption spectroscopy and HPLC retention time matching, water content by Karl Fischer titration, bacterial endotoxin testing by LAL method, and heavy metals analysis by ICP-MS.

Enhanced quality controls specific to oncology APIs include extended hold-time studies, complete in-process testing at critical synthesis stages, and full characterization of the impurity profile against qualified reference standards. Our QC laboratory maintains validated analytical methods with demonstrated equivalence to pharmacopeial procedures.

Regulatory Documentation & Export Support

We maintain complete regulatory dossiers to support customer registration activities in regulated and semi-regulated markets worldwide. Available documentation includes Drug Master File (DMF) filings, Certificate of Suitability (CEP) applications with EDQM, complete impurity fate and purge analysis, ICH-compliant stability data packages, process validation documentation, and detailed analytical method validation reports. Batch-specific Certificates of Analysis, MSDS/SDS documents, and Certificates of Origin are provided with every shipment.

Our regulatory affairs team provides ongoing technical support for customer drug applications, including preparation of responses to regulatory authority questions and submission of post-approval variations as needed.

Packaging & Global Logistics

Epirubicin HCl is packaged in amber Type I glass bottles with PTFE-lined stoppers, sealed in secondary aluminum containers with desiccant, and packed in qualified UN-rated outer shipping containers. Standard packaging configurations include 5 g, 10 g, 50 g, 100 g, and 500 g units. All packaging operations occur within containment isolators under nitrogen atmosphere to protect product quality and operator safety.

Temperature-controlled cold chain shipping (2-8°C) is standard for all Epirubicin HCl shipments, utilizing validated thermal packaging systems with continuous temperature monitoring via calibrated data loggers. We coordinate shipments through specialized pharmaceutical logistics providers experienced in dangerous goods and cytotoxic compound transport, with full IATA DGR documentation for air freight and IMDG Code compliance for sea freight.

Competitive Pricing & Supply Reliability

As a manufacturer with dedicated HPAPI production infrastructure and optimized fermentation processes, we deliver Epirubicin HCl at highly competitive competitive prices. Our pricing model accommodates various procurement strategies including spot purchases, quarterly contracts, and multi-year supply agreements with price stability guarantees. Volume-based tiered pricing provides additional cost advantages for larger procurement commitments.

Production continuity is ensured through careful campaign planning, strategic raw material stockpiling, and maintenance of finished goods safety stock. Our dedicated oncology API production line operates with demonstrated supply reliability exceeding 96%, and we provide advance notification of production schedules to enable customer planning and inventory management.

Epirubicin HCl Technical Specifications