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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 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 29102 ERTAPENEM SODIUM 2015-04-13 Active II Complete 2015-09-30 2015-04-17
28/03/2025 Asymchem Laboratories
China
ASYMCHEM LABORATORIES FUXIN CO LTD 29473 ERTAPENEM SODIUM 2015-06-12 Inactive II N/A