If the submitting drug substance with two or more crystalline hydrate formulas, should DMF divide into different applications? If a drug substance has different solvated forms (hydrates), is it required to file a separate DMF for each of the hydrate?

刊登日期:2020-07-22  |  點閱次數 : 960 次 

Yes, a separate DMF should be filed for each of the hydrates.



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