In a production process of granules containing abiologically active substance, variation in the elutionprofile of the biologically active substance is reduced byheating the temperature of granules to about 50°C or higherand maintaining the temperature for about 1 minute orlonger. By setting the spray speed to about 90 mg/min ormore per 1 g of cores when a spray agent for a primaryagent containing the biologically active substance issprayed while spraying a binding liquid to the cores andsetting the total feeding weight per unit area for acentrifugal fluidized bed coating granulation machine toabout 1.5 g/cm2 or more, the variation in the elutionprofile of the biologically active substance from thegranules is reduced.