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Scale-up & Production

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Positioning: One-stop platform from process scale-up to commercial delivery

Leveraging our 5.000-ton annual fine chemical intermediates production base, we provide customers with end-to-end CMO/CDMO services from pilot scale-up to commercial production. Whether it is small-batch production for clinical stages or large-scale supply after market launch, Runyi delivers reliable support through a stable, compliant, and efficient production system.

Base Capabilities:

●Production base area: 50 mu

●Total design capacity: 5.000 tons/year

●Phase I capacity achieved: 1.555 tons/year

●Production facilities: Class A workshop, power center, storage tank farm, wastewater treatment station

●Utilities: Water, electricity, steam fully in place

Core Capabilities:

●Process scale-up: lab route optimization → pilot validation → commercial production, ensuring process robustness

●Quality control: full-chain traceability system from raw material receipt, in-process control (IPC), to finished product release

●Compliance: aligned with international standards such as ISO 9001. cGMP, ICH Q7

Delivery Scale:

Kilogram → Ton

Service Scope:

●Clinical stage drug production

●Commercial product contract manufacturing (CMO)

●Joint R&D and manufacturing (CDMO): integrated collaboration from process development to production delivery

Representative Product Capacities:

●2.4.6-Trichloroaniline: 2.000 t/a

●2.7-Dihydroxy-9-fluorenone: 500 t/a

●Other pharmaceutical intermediates: ~2.500 t/a

Business Synergy: Integrated Advantage from R&D to Production

The three business divisions of Runyi New Material do not operate in isolation but form an organic synergy:

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Source innovation Flexible delivery Scale production

●Process development provides mature technical routes for custom synthesis

●Custom synthesis validates process feasibility for scale production

●Scale production feeds back to process development, continuously optimizing cost and yield

With our closed-loop “R&D – Pilot – Production” integration capability, we help customers accelerate their journey from concept to product in high-growth fields such as innovative pharmaceuticals and optoelectronic materials.