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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 TAPI Technology & API Services
Israel
TAPI NL BV 33752 DIROXIMEL FUMARATE 2019-04-03 Active II Complete 2019-08-22 2019-04-01
28/06/2025 Honour Lab
India
HONOUR LAB LTD 36019 DIROXIMEL FUMARATE 2021-09-20 Active II Complete 2021-11-10 2021-09-02