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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 Seqens
France
CU CHEMIE UETIKON GMBH 17860 DALFAMPRIDINE 2004-11-29 Active II N/A
29/11/2025 Enaltec Labs
India
ENALTEC LABS PRIVATE LTD 25695 DALFAMPRIDINE 2012-05-15 Inactive II N/A