Doxorubicin HCl 25316-40-9 — China API Manufacturer | EP USP R&D to Production

China Manufacturing Landscape for Doxorubicin HCl

Doxorubicin Hydrochloride (CAS 25316-40-9) is a cornerstone anthracycline chemotherapy agent used worldwide in the treatment of numerous malignancies including breast cancer, lung cancer, ovarian cancer, lymphomas, and leukemias. As one of the most prescribed cytotoxic drugs globally, reliable supply of high-purity Doxorubicin HCl API is critical for pharmaceutical manufacturers and healthcare systems. China has become a major production center for Doxorubicin HCl, with specialized high-potency API manufacturing facilities delivering pharmaceutical-grade material to formulation companies across six continents.

Our dedicated oncology API production facility represents a significant investment in high-containment manufacturing infrastructure, specifically designed for the safe and compliant production of cytotoxic compounds. With rigorous containment protocols, advanced purification technology, and complete quality systems, we serve as a trusted supply partner for generic pharmaceutical manufacturers and contract development organizations requiring consistent Doxorubicin HCl API.

Manufacturing Process & Facility Overview

Doxorubicin HCl production at our facility employs fermentation of Streptomyces peucetius var. caesius, followed by multi-step extraction and purification processes. The fermentation stage utilizes validated seed culture preparation and main fermentation in stainless steel bioreactors under precisely controlled conditions. The downstream processing involves solvent extraction, column chromatography, salt formation, and recrystallization to achieve the high purity required for injectable formulations.

The entire manufacturing process is conducted within a purpose-built high-potency API (HPAPI) facility featuring negative pressure containment suites, HEPA-filtered laminar flow systems, and closed material transfer protocols. Personnel protection measures include powered air-purifying respirators (PAPRs) and full body protection. The facility is equipped with validated decontamination systems and continuous environmental monitoring to ensure operator safety and product integrity throughout the manufacturing campaign.

Quality Standards & Multi-Pharmacopeial Compliance

Our Doxorubicin HCl API is manufactured and released against specifications meeting European Pharmacopoeia (EP) and United States Pharmacopeia (USP) monograph requirements. The complete analytical testing program includes assay by validated HPLC method (purity ≥98.0%), identification by UV, IR, and HPLC, related substances profiling including specific monitoring of doxorubicinone and other known impurities, endotoxin testing by LAL method, sterility testing per pharmacopeial methods, and particulate matter assessment.

Given the critical nature of oncology APIs, our quality system incorporates enhanced controls including 100% in-process testing, environmental monitoring throughout production, and extended stability programs under ICH long-term and accelerated conditions. The facility has been successfully inspected by NMPA and has supported customer filings with the FDA and EMA.

Regulatory Documentation & Export Support

Complete regulatory documentation is provided to support customer drug registration and import processes worldwide. Our standard documentation package includes detailed Certificates of Analysis, Drug Master File (DMF) documentation filed with the US FDA, a Certificate of Suitability (CEP) application with EDQM for European market access, full impurity profile documentation, and stability data per ICH Q1A guidelines. Additional documentation such as process validation reports, cleaning validation data, and environmental monitoring records is available upon request.

Our regulatory affairs team provides ongoing support throughout the customer registration lifecycle, including responses to regulatory queries, update reports for post-approval changes, and annual product quality review summaries.

Packaging & Global Logistics

Doxorubicin HCl is packaged under controlled conditions in amber glass bottles with PTFE-lined closures, sealed within secondary aluminum containers, and packed in UN-rated outer packaging suitable for dangerous goods transport. Standard packaging units include 10 g, 50 g, 100 g, and 500 g configurations. All packaging operations are conducted within containment facilities with nitrogen overlay to protect the product from moisture and light exposure.

International shipping is arranged through specialized pharmaceutical logistics providers experienced in cytotoxic compound transport. We offer temperature-controlled shipping (2-8°C) with continuous temperature monitoring via data loggers. Shipments are coordinated through Shanghai Pudong International Airport for air freight or Shanghai/Ningbo seaports for ocean freight, with full dangerous goods documentation prepared in compliance with IATA DGR and IMDG Code requirements.

Competitive Pricing & Supply Reliability

Our specialized HPAPI manufacturing infrastructure enables efficient production of Doxorubicin HCl at scale, translating to competitive competitive pricing for international pharmaceutical companies. We offer structured pricing programs with volume commitments and annual supply agreements that provide cost stability for budget planning while ensuring priority production scheduling for contracted customers.

Supply security is maintained through strategic inventory management and dual-sourced raw material procurement. Our production planning system integrates customer demand forecasts to optimize batch scheduling, and we maintain safety stock to accommodate urgent order requirements. On-time delivery performance exceeds 95% across all oncology API product lines.

Doxorubicin HCl Technical Specifications