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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
27/02/2026 Granules India Limited
India
GRANULES INDIA LTD 39693 POTASSIUM OXYBATE 2025-03-31 Active II Complete 2025-05-02 2025-04-22
27/02/2026 Cambrex Corporation
U.S.A
CAMBREX CHARLES CITY INC 35872 POTASSIUM OXYBATE 2022-04-26 Active II Complete 2022-07-25 2022-05-17