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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
25/04/2025 ChemWerth Inc
U.S.A
CHEMWERTH INC 31477 ZIPRASIDONE MESILATE TRIHYDRATE 2018-10-10 Active II Complete 2018-11-26 2018-10-18
25/04/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 38745 ZIPRASIDONE MESYLATE TRIHYDRATE 2023-08-23 Active II Complete 2023-10-12 2023-08-22