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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 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 16452 SULBACTAM SODIUM USP (STERILE BULK) 2003-03-07 Active II N/A
27/02/2026 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 19805 SULBACTAM SODIUM USP (STERILE) BULK 2006-09-25 Active II N/A