Cidofovir CAS 113852-37-2 — China API Manufacturer | USP/EP R&D to Production

Product Overview & China Manufacturing Landscape

Cidofovir is an acyclic nucleotide phosphonate antiviral agent with potent activity against cytomegalovirus (CMV), herpes simplex virus, and other DNA viruses. With CAS number 113852-37-2 and molecular formula C₈H₁₄N₃O₆P, cidofovir is primarily used for the treatment of CMV retinitis in immunocompromised patients and is being investigated for additional antiviral indications. The molecule’s complex phosphonate chemistry and the need for high chiral purity limit the number of qualified global manufacturers. China has approximately 3-4 NMPA-registered producers of cidofovir API, with combined annual capacity of 3-5 metric tons. Our facility has invested heavily in nucleotide analog chemistry capabilities, positioning us as one of the most technically capable Chinese producers of this specialty antiviral API.

Our Manufacturing Process & Facility Standards

Cidofovir synthesis is a multi-step process involving construction of the cytosine nucleobase, formation of the acyclic phosphonate side chain, and stereoselective coupling to establish the required (S)-configuration at the chiral center. Key synthetic challenges include the phosphonate ester formation and deprotection steps, which require careful control to avoid diastereomer formation and phosphonate hydrolysis. Our production is conducted in a dedicated antiviral API suite within our 10,000 square meter production facility, featuring ISO 14644-1 Class 7 cleanroom environments and specialized glass-lined reactor systems for phosphonate chemistry. In-process controls include chiral HPLC monitoring at three critical stages (enantiomeric purity ≥99.0% ee), phosphorus content verification by ICP-OES, residual phosphonate ester intermediate tracking, and intermediate crystallization purity gates. The final purification employs preparative chromatography followed by controlled crystallization to achieve the required polymorphic form. Batch sizes range from 5-20 kg per campaign with cycle times of 15-20 days.

Quality Standards & Multi-Pharmacopeial Compliance

Our cidofovir API meets USP-NF and European Pharmacopoeia specifications. Typical assay values are 98.5-100.5% on an anhydrous basis. Quality control parameters include: chiral purity (≥99.0% ee by chiral HPLC), related substances (total impurities ≤1.0%), phosphorus content within theoretical range (10.5-11.5%), residual solvents per ICH Q3C, water content by Karl Fischer (per pharmacopeial specification), heavy metals by ICP-MS (individual elements per ICH Q3D), and bacterial endotoxin testing (≤0.5 EU/mg for parenteral-grade material). Since cidofovir is administered intravenously, our quality standards for the injectable-grade product include additional particulate matter testing, container-closure integrity verification, and enhanced microbial control throughout manufacturing. Full COA documentation with complete impurity profiling accompanies every shipment. Stability data per ICH Q1A support a 24-month shelf life under recommended storage conditions.

Regulatory Documentation & Registration Support

Our cidofovir regulatory package includes: NMPA drug registration certificate, Chinese DMF, US FDA Type II DMF, and European ASMF available for customer MAA referencing. Current quality certificates and FDA facility registration are maintained. Given the specialty nature of this API, we provide particularly complete technical documentation including: detailed process description with starting material justification per ICH Q11, complete impurity characterization with structural elucidation of all specified impurities by NMR and MS, genotoxic impurity risk assessment per ICH M7, and nitrosamine risk assessment. Our regulatory team supports customer registration activities with CTD Module 3.2.S documentation preparation, coordination of pre-approval inspections, and technical consultation on formulation-related API specifications. We have supported successful customer filings in the US, EU, India, and Brazil.

Packaging, Storage & Global Logistics

Cidofovir API is packaged under nitrogen atmosphere in pharmaceutical-grade amber glass bottles with PTFE-lined closures, placed into aluminum cans with desiccant. Standard packaging sizes are 100 g, 500 g, 1 kg, and 5 kg. Storage conditions require 2-8°C in a dry environment protected from light, with validated shelf life of 24 months. All international shipments utilize cold chain logistics with validated temperature maintenance. Air freight is the standard shipping method (3-7 days globally), with specialized pharmaceutical courier services available for urgent orders. Temperature data loggers are included in every shipment, and shipment conditions are documented from facility gate to destination. Our export team prepares complete documentation including COA, MSDS, commercial invoices, and any market-specific certificates required by the customer.

Competitive Pricing & Supply Reliability

Cidofovir is a specialty API commanding premium pricing reflecting its synthetic complexity. Our China-based manufacturing delivers substantial cost advantages over Western sources — typically 40-55% savings for equivalent pharmacopeial quality. MOQ is 100 g for initial evaluation, with commercial orders from 500 g. Pricing is quoted per gram for small quantities and per kilogram for commercial volumes, with significant tiering for annual commitments. We offer flexible supply arrangements including spot orders, quarterly scheduled deliveries, and annual contracts with guaranteed capacity reservation. Our current production capacity supports 30-50 kg monthly output. Key intermediates and starting materials are maintained in strategic inventory for 6+ months to buffer against supply chain disruptions. We recommend customers provide rolling 6-month forecasts to optimize production scheduling and ensure timely delivery.

Product Specifications