Cyclosporin A CAS 59865-13-3 — China API Manufacturer | ChP/USP/EP R&D to Production

Product Overview & China Manufacturing Landscape

Cyclosporin A (ciclosporin) is a cyclic undecapeptide immunosuppressant used to prevent organ transplant rejection and treat autoimmune conditions including psoriasis, rheumatoid arthritis, and dry eye disease. With CAS number 59865-13-3 and molecular formula C₆₂H₁₁₁N₁₁O₁₂, cyclosporin A remains one of the most important immunomodulatory APIs in global pharmaceutical manufacturing, listed on the WHO Essential Medicines List. China has approximately 6-8 NMPA-registered manufacturers of cyclosporin A API, with combined annual production capacity of 80-120 metric tons. Our production facility in Zhejiang Province has specialized in cyclic peptide fermentation and purification for over 15 years, establishing deep expertise in the unique challenges of producing this structurally complex API at commercial scale.

Our Manufacturing Process & Facility Standards

Cyclosporin A is produced exclusively by fermentation of the fungus Tolypocladium inflatum (Beauveria nivea) under controlled submerged culture conditions. Our fermentation facility operates 50,000-150,000 liter bioreactors with optimized media composition and process parameters that have been refined over hundreds of production batches. Post-fermentation processing involves organic solvent extraction from the mycelial biomass, followed by multi-stage chromatographic purification (silica gel column chromatography, preparative HPLC) and controlled crystallization to achieve the required polymorphic form and purity. Manufacturing takes place in our 15,000 square meter production facility with ISO 14644-1 Class 7 cleanroom environments for all post-extraction processing. In-process controls include HPLC potency monitoring at each purification stage, cyclosporin B/C/D congener content tracking (critical impurity control), solvent residue analysis by headspace GC, water activity measurement during crystallization, and endotoxin screening for injectable-grade production campaigns. Batch consistency across 100+ commercial batches shows assay RSD below 1.2%.

Quality Standards & Multi-Pharmacopeial Compliance

Our cyclosporin A API meets ChP 2020, USP-NF (cyclosporine monograph), and EP 11.0 (ciclosporin monograph) specifications. Typical assay values are 98.5-101.0% on an anhydrous basis. Key quality parameters include: cyclosporin B content (≤1.0% per EP), cyclosporin C content (≤0.5%), other related cyclosporins (each ≤0.5%, total ≤2.5%), residual solvents per ICH Q3C (particular attention to dichloromethane, ethyl acetate, and acetone), water content (≤2.0% by Karl Fischer), heavy metals (≤10 ppm), and optical rotation confirming correct stereochemistry. For ophthalmic formulation customers, we produce enhanced-purity grades with tighter related substance limits and additional particulate matter testing. Bacterial endotoxin testing (≤5 EU/mg) is standard for injectable-grade material. Stability studies per ICH Q1A confirm 36-month shelf life at 2-8°C. Comprehensive COA documentation with full chromatographic impurity profiles accompanies every shipment.

Regulatory Documentation & Registration Support

Our cyclosporin A regulatory portfolio includes: NMPA drug registration certificate, US FDA Type II DMF, European CEP from EDQM, current quality certificates from Chinese provincial drug authority and international audit firms, and FDA facility registration. Our site has been inspected by US FDA and EU member state inspectorates with satisfactory outcomes. Given cyclosporin A’s importance as a transplant medicine and the complexity of the fermentation-derived manufacturing process, our regulatory documentation is particularly comprehensive. Available materials include: CTD Module 3.2.S dossier with detailed fermentation process description, strain characterization and banking procedures, extraction and purification process validation, complete impurity characterization with all cyclosporin congeners identified by LC-MS/MS, and manufacturing site master file. Our regulatory team provides dedicated support for customer registrations, including coordination of pre-approval inspections and preparation of technical responses to regulatory queries.

Packaging, Storage & Global Logistics

Cyclosporin A API is packaged under nitrogen atmosphere in double-sealed aluminum foil bags within HDPE drums, with desiccant sachets included. Standard packaging sizes are 500 g, 1 kg, 5 kg, and 10 kg per unit. Storage conditions require 2-8°C in a dry environment protected from light, with validated shelf life of 36 months. All international shipments utilize cold chain logistics with temperature monitoring throughout transit. Air freight is the recommended shipping method (3-7 days globally) to minimize transit time and temperature excursion risk. Refrigerated sea freight is available for large volume orders (30-35 days to European ports). Each shipment includes calibrated temperature data loggers, and our logistics team provides proactive shipment tracking and immediate communication of any transit anomalies. Complete export documentation including COA, MSDS, commercial invoice, and certificates of origin is prepared within 2 business days of shipment scheduling.

Competitive Pricing & Supply Reliability

Cyclosporin A is a high-value specialty API, and our fermentation-based production platform in China delivers significant cost advantages over European sources. Competitive pricing typically offers 35-50% savings compared to Western manufacturers for equivalent pharmacopeial quality. MOQ is 500 g for evaluation purposes, with commercial orders from 5 kg. Pricing is structured per kilogram with substantial tiering for larger volumes and annual commitments. We offer annual supply contracts with quarterly pricing reviews, capacity reservation agreements for customers requiring guaranteed allocation, and flexible delivery schedules to match customer production planning. Our monthly production capacity of 3-5 metric tons provides comfortable supply coverage for our customer base. Fermentation raw material (media components, seed culture) inventory is maintained for 6+ months, and finished API safety stock of 500+ kg is available for rapid order fulfillment.

Product Specifications