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List of Drug Master Files (DMF) of Pitavastatin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 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
26/09/2024 Hetero Drugs
India
HETERO DRUGS LTD 27255 PITAVASTATIN CALCIUM 2013-07-16 Active II Complete 2013-09-22 2013-07-10