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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
28/11/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 31402 GANCICLOVIR USP 2017-02-18 Active II Complete 2017-03-07 2017-02-15
28/11/2024 CHANGZHOU KONY PHARMACEUTICAL CO., LTD. CN 213 105 Changzhou
China
SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTD 28973 GANCICLOVIR 2015-04-02 Active II Complete 2016-06-02 2015-08-07