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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
30/12/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 36029 ACALABRUTINIB 2021-06-30 Active II Complete 2021-08-30 2021-06-18
30/12/2025 Cipla
India
CIPLA LTD 35762 ACALABRUTINIB 2021-05-03 Active II Complete 2021-06-03 2021-04-16