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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 Nuray Chemicals Private Limited
India
NOVITIUM PHARMA LLC 33166 CARGLUMIC ACID 2018-12-07 Active II Complete 2019-01-11 2018-12-14
28/03/2025 Dipharma SA
Switzerland
DIPHARMA SA 39329 CARGLUMIC ACID 2024-02-06 Active II Complete 2024-05-06 2024-02-01