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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
28/10/2024 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 21594 CILASTATIN SODIUM (STERILE BULK) 2008-05-05 Active II Complete 2013-11-20 2013-11-04
28/10/2024 Auronext Pharma Private Limited
India
AURONEXT PHARMA PRIVATE LTD 28929 CILASTATIN SODIUM USP (STERILE) 2015-01-02 Inactive II N/A