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Can different domestic agents submit DMF applications of the same drug substance from the same manufacturer?
刊登日期:2020-07-22 | 點閱次數 : 890 次
Yes, they can. Different agents will receive DMF approval letters with different DMF numbers.
(中文版)
The DMF is divided into two parts – an open (or applicant’s) part and a closed
Can a drug substance from two or more manufacturers be submitted for a DMF applic
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