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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
28/10/2024 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 33180 EMPAGLIFLOZIN 2018-09-27 Active II Complete 2019-02-15 2018-10-09
28/10/2024 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 35345 EMPAGLIFLOZIN 2020-10-31 Active II N/A