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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 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 31631 IBRUTINIB 2017-06-08 Active II Complete 2017-07-05 2017-04-17
28/03/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 32880 IBRUTINIB 2018-07-02 Active II Complete 2018-09-05 2018-06-06