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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
24/02/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 27106 PITAVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) 2013-05-07 Active II Complete 2013-09-14 2013-05-07
24/02/2025 Fuxin Long Rui Pharmaceutical
China
FUXIN LONG RUI PHARMACEUTICAL CO LTD 33489 PITAVASTATIN CALCIUM 2019-05-30 Active II N/A