Is it required to submit separate DMFs for the same drug substance but with different grades of particle sizes (different particle size distributions) ?

刊登日期：2020-07-22 | 點閱次數 : 755 次

In principle, it is not required to submit separate DMFs for the same drug substance with different particle size distributions, particle size distributions may be listed in the drug substance specification.

(中文版)

	What are the requirements for filing a DMF or API application where the drug subs
	If the submitting drug substance with two or more crystalline hydrate formulas, s

返回前一頁

Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

Is it required to submit separate DMFs for the same drug substance but with different grades of particle sizes (different particle size distributions) ?

Web design