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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
04/06/2025 Unimark Remedies
India
UNIMARK REMEDIES LTD 28382 STERILE MIXTURE FOR MEROPENEM AND SODIUM CARBONATE (DRUG PRODUCT INTERMEDIATE) 2014-06-19 Active II N/A
04/06/2025 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 30487 SODIUM CARBONATE STERILE LYOPHILIZED 2016-08-09 Active II N/A