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In addition to SD, our technologies meet several needs of pharmaceutical companies, from API to drug production.

At Fuji Chemical, we offer contract manufacturing services for a wide range of activities from API production to drug product for producing high-value APIs and drug products.
Every process is subject to rigorous cGMP control. We can design a continuous process involving API manufacture, SD processing, and drug production. Where necessary, we can prepare various application dossiers according to CTD, chemical substances control law, and rule for new chemical compound application based on the Labor Safety and Sanitation Law.

SD solutions

Total solution for drug development (API/SD/drug product)

API Synthesis (solution for process development)
Fine Chemical Group has been engaged in developing safe and efficient synthetic route of API (process development) based on our long-standing experience and knowledge about organic chemistry and process chemistry, and in due course has acquired patents.
We have improved the basic process by identifying more appropriate reagents and optimizing reaction conditions, with an aim to propose a cheap and efficient manufacturing process.
API production (solution for scale-up production)
Before initiating scale-up production, safety measures are studied against dangers, including static electricity and explosions. A safe and reliable API production method is finalized after considering the heat generation from reactions and cooling and stirring efficiencies. The Process Development Department shares data with the Quality Control and Manufacturing Departments so that a reliable quality assurance system is formulated and commercial production can be carried out smoothly.
APIs & SD processing (solution for drug intermediates)
We can provide highly functional APIs by combining our API manufacturing ability based on reliable technology and cGMP standards; drug design technology that involves maximizing the characteristics of various excipients determined during excipient development activities; and value-added function obtained from SD process. We can provide contract-based services for these processes from API synthesis to pharmaceutical bulk manufacture in a sequential, cGMP compliant manner.
APIs & SD processing, drug production (total solution for drug production)
cGMP compliant contract manufacturing is possible from API synthesis to drug product manufacture.
APIs, Drug production (solution for particle design)
We can provide contract manufacturing services for API particulate design according to customer's needs, by using SD process, milling technology, etc.
  • · Fluid bed drying
  • · Micronization
  • · Controlled crystallization
  • · Wet milling
  • · Freeze drying