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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 Honour Lab
India
HONOUR LAB LTD 33384 ELUXADOLINE 2018-12-19 Active II Complete 2019-02-21 2018-12-12
28/06/2025 Alkem Laboratories
India
ALKEM LABORATORIES LTD 33372 ELUXADOLINE 2019-01-02 Active II Complete 2019-03-01 2018-12-21