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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
28/10/2024 Aurore Life Sciences
India
AURORE LIFE SCIENCES PRIVATE LTD 36761 INDOMETHACIN USP 2022-02-03 Active II Complete 2022-05-11 2022-03-31
28/10/2024 Chemi SpA
Italy
CHEMI SPA 4394 INDOMETHACINE USP XX 1982-01-18 Inactive II N/A