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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 33948 NITISINONE 2019-07-17 Active II Complete 2020-08-28 2020-08-06
28/03/2025 Nuray Chemicals Private Limited
India
NOVITIUM PHARMA LLC 31250 NITISINONE 2017-01-02 Active II Complete 2017-02-01 2016-12-26