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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
12/12/2025 Lupin Manufacturing Solutions
India
LUPIN MANUFACTURING SOLUTIONS LTD 26316 RUFINAMIDE USP 2012-10-09 Active II Complete 2013-04-23 2012-11-13
29/11/2025 Alivus Life Sciences
India
ALIVUS LIFE SCIENCES LTD 26209 RUFINAMIDE 2012-10-23 Active II Complete 2013-04-24 2012-11-06