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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
28/06/2025 Ami Lifesciences Private Limited
India
AMI LIFESCIENCES PRIVATE LTD 40707 SALCAPROZATE SODIUM 2024-11-26 Active IV N/A
28/06/2025 Apothecon Pharmaceuticals
India
NAVINTA LLC 36388 SALCAPROZATE SODIUM 2021-10-27 Active IV N/A