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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
05/02/2026 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 41330 PITAVASTATIN CALCIUM (PROCESS-II) 2025-11-26 Active II Complete 2026-01-22 2025-12-10
29/01/2026 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