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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 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 32074 IVABRADINE HYDROCHLORIDE 2017-09-30 Active II Complete 2020-08-12 2020-07-22
28/03/2025 Beijing Huikang Boyuan Chemical Tech
China
BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTD 28658 IVABRADINE HYDROCHLORIDE 2014-09-29 Active II N/A