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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
28/06/2025 Ami Lifesciences Private Limited
India
AMI LIFESCIENCES PRIVATE LTD 38309 ESLICARBAZEPINE ACETATE 2023-04-25 Active II N/A
28/06/2025 Minakem (formerly Delmar Chemicals)
Canada
DELMAR CHEMICALS INC 31791 ESLICARBAZEPINE ACETATE 2017-06-05 Active II Complete 2018-07-27 2017-06-09