Abstract: OBJECTIVE To study the formulation and manufacturing process of Miriplatin for Injection. METHODS The control range of manufacturing process and formulation were confirmed through choosing the kinds of freeze-drying solvent, solubility study of miriplatin, formulation selection and study on pre-freezing process. RESULTS The mixed solvents of tert-butyl alcohol and cyclohexane were selected to make freeze-drying formulation, the optimum ratio of cyclohexane was in the range of 10%-30%, the optimal drug concentration was in the range of 5-25 mg·mL^-1, stage pre-freezing method was used as final freeze-drying process. CONCLUSION The formulation and manufacturing process is feasible. The self-made drug product is shown the same with and reference listed drug in pharmaceutical aspects. The production cost can be greatly saved compared with the original grinding process.