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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
29/11/2025 Cosma (C.F.M. Group)
Italy
COSMA SPA 25717 MILNACIPRAN HYDROCHLORIDE 2012-02-23 Active II Complete 2013-07-05 2012-12-20
12/12/2025 Lupin Manufacturing Solutions
India
LUPIN MANUFACTURING SOLUTIONS LTD 26620 MILNACIPRAN HYDROCHLORIDE 2013-01-09 Active II Complete 2013-04-25 2013-01-09