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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
28/03/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 37679 SIPONIMOD FUMARIC ACID 2022-11-16 Active II Complete 2022-12-16 2022-11-15
28/03/2025 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 36596 SIPONIMOD FUMARIC ACID 2021-12-09 Active II Complete 2022-12-22 2022-11-10