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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 Auronext Pharma Private Limited
India
AURONEXT PHARMA PRIVATE LTD 28212 DORIPENEM MONOHYDRATE (STERILE) 2014-05-03 Inactive II N/A
28/03/2025 Hospira, Inc.
U.S.A
HOSPIRA HEALTHCARE INDIA PVT LTD 25239 DORIPENEM (STERILE) 2011-11-07 Inactive II N/A