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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
29/07/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 34666 ROXADUSTAT 2020-03-31 Active II Complete 2020-11-05 2020-09-30
29/07/2025 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 36797 ROXADUSTAT 2022-02-16 Active II N/A