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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 Symbiotec Pharmalab
India
SYMBIOTEC PHARMALAB PRIVATE LTD 23899 PREDNISOLONE SODIUM PHOSPHATE USP 2010-06-18 Active II Complete 2016-06-10 2016-05-27
28/03/2025 ACS DOBFAR SPA
Italy
ANTIBIOTICOS SPA 2376 PREDNISOLONE SODIUM PHOSPHATE BULK 1974-12-18 Inactive II N/A