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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
29/01/2026 Unimark Remedies
India
UNIMARK REMEDIES LTD 28280 DORIPENEM STERILE 2014-05-30 Active II Complete 2014-10-10 2014-06-18
29/01/2026 Auronext Pharma Private Limited
India
AURONEXT PHARMA PRIVATE LTD 28212 DORIPENEM MONOHYDRATE (STERILE) 2014-05-03 Inactive II N/A