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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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 33217 TIPIRACIL HYDROCHLORIDE 2018-09-28 Active II N/A
28/03/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 33787 TIPIRACIL HYDROCHLORIDE 2019-04-18 Active II Complete 2019-05-28 2019-04-22