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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
28/03/2025 Aarti Pharmalabs
India
AARTI PHARMALABS LTD 35796 BENZYL(2S)-2-(8-AMINO-1-BROMOIMIDAZO[1,5-A]PYRAZIN-3-YL)PYRROLIDINE-1-CARBOXYLATE(VP-023) 2021-04-20 Active II N/A
28/03/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 36029 ACALABRUTINIB 2021-06-30 Active II Complete 2021-08-30 2021-06-18