Remdesivir 1809249-37-3 — China API Manufacturer | USP/EP R&D to Production

China Manufacturing Landscape for Remdesivir

Remdesivir (CAS 1809249-37-3) has become one of the most strategically significant antiviral APIs produced in China since the global COVID-19 response accelerated domestic manufacturing capabilities. Chinese pharmaceutical manufacturers invested heavily in nucleotide analogue synthesis infrastructure beginning in 2020, establishing dedicated production lines that now represent a substantial share of global Remdesivir API capacity. Our production facility operates as a primary source for international buyers seeking reliable, cost-effective Remdesivir bulk supply for finished dosage manufacturing across regulated and semi-regulated markets worldwide.

China’s position in the Remdesivir supply chain is reinforced by vertically integrated raw material sourcing, with key intermediates including GS-441524 and specialized ribose derivatives produced domestically. This vertical integration eliminates multi-tier supply dependencies, ensuring uninterrupted production capability and competitive competitive pricing that downstream manufacturers in India, Southeast Asia, the Middle East, and Latin America rely upon for their own formulation programs.

Manufacturing Process & Facility

Our Remdesivir manufacturing employs a multi-step convergent synthesis route starting from protected ribose intermediates and cyano-substituted pyrrolotriazine nucleobase precursors. The synthesis involves stereoselective phosphoramidation as a critical step to establish the correct prodrug configuration, followed by chiral purification and controlled crystallization to achieve the required polymorphic form. All reaction steps are conducted under strict inert atmosphere conditions with continuous in-process monitoring of temperature, pH, and reaction progression via inline HPLC.

The production facility comprises ISO Class 7 (Class 10,000) cleanrooms for final-stage synthesis and isolation, supported by dedicated solvent recovery systems, automated filtration and drying equipment, and segregated packaging suites. Annual production capacity exceeds 500 kg of Remdesivir API, with scalability to 1,500 kg through validated campaign scheduling. The facility holds current China NMPA certification and has successfully passed inspection by multiple international regulatory authorities.

Quality Standards & Multi-Pharmacopeial Compliance

Remdesivir API manufactured at our facility is produced to meet stringent quality specifications aligned with USP monograph requirements and European Pharmacopoeia reference standards. Purity by HPLC consistently exceeds 99.5%, with individual specified impurities controlled below 0.10% and total impurities below 0.50%. Chiral purity is verified by chiral HPLC to confirm stereochemical integrity at the phosphorus center, a critical quality attribute for this prodrug.

Each batch undergoes complete analytical testing including assay by HPLC, residual solvent analysis by headspace GC per ICH Q3C guidelines, heavy metals screening by ICP-MS, water content by Karl Fischer titration, particle size distribution analysis, and endotoxin testing by LAL method. Stability studies are conducted under ICH Q1A conditions (25°C/60% RH long-term, 40°C/75% RH accelerated) with validated shelf-life data supporting 24-month storage when maintained at recommended conditions.

Regulatory Documentation

We provide complete regulatory support documentation packages tailored to destination market requirements. Standard documentation includes a full Drug Master File (DMF) in CTD format suitable for US FDA, EU ASMF, and other regulatory submissions. Certificates of Analysis (CoA) with full impurity profiling, Certificate of Quality Compliance, TSE/BSE statement confirming no animal-derived materials in the synthesis, and process validation reports are provided with each shipment. For customers pursuing ANDA or generic dossier filings, we supply comparative dissolution data, reference standard characterization, and method transfer packages to facilitate smooth analytical method adoption.

Packaging & Logistics

Remdesivir API is packaged in double-layer pharmaceutical-grade PE bags within sealed aluminum drums, with each container holding 1 kg, 5 kg, or 25 kg net weight as specified by the customer. All packaging materials are validated for compatibility with the API and meet ICH Q1A stability requirements. Desiccant sachets and nitrogen headspace purging are employed to protect against moisture and oxidative degradation during transit. Shipments are arranged via temperature-controlled air freight from Shanghai Pudong or Guangzhou Baiyun airports, with cold chain documentation and real-time GPS temperature monitoring provided upon request. Standard delivery to major international destinations is 7-12 business days door-to-door, with DDP and CIF Incoterms available.

Competitive Pricing & Supply Reliability

As a direct manufacturer supplier with no intermediary trading layers, we offer Remdesivir API at genuinely competitive prices that reflect actual manufacturing cost efficiencies. Volume-tiered pricing structures are available for annual purchase agreements, with additional discounts applicable for multi-API procurement programs. Our manufacturing scheduling allows for 4-6 week lead times on standard orders and expedited 2-3 week turnaround for urgent requirements. Safety stock programs can be arranged for customers requiring guaranteed supply continuity, with dedicated batch reservation and priority scheduling agreements available for strategic accounts.

Remdesivir Specifications