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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 GLAND PHARMA LIMITED
India
GLAND PHARMA LTD 23173 TIROFIBAN HYDROCHLORIDE 2009-10-07 Active II Complete 2014-02-05 2013-09-12
28/03/2025 Wisdom Pharmaceutical
China
WISDOM PHARMACEUTICAL CO LTD 32701 TIROFIBAN HYDROCHLORIDE 2018-04-13 Active II Complete 2019-04-12 2018-05-25