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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
25/04/2025 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 16452 SULBACTAM SODIUM USP (STERILE BULK) 2003-03-07 Active II N/A
25/04/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 39513 SULBACTAM SODIUM USP (STERILE) PROCESS-II 2024-02-27 Active II N/A