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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
29/11/2025 Ami Lifesciences Private Limited
India
AMI LIFESCIENCES PRIVATE LTD 37981 SEVELAMER CARBONATE 2023-01-25 Active II N/A
12/12/2025 Lupin Manufacturing Solutions
India
LUPIN MANUFACTURING SOLUTIONS LTD 22293 SEVELAMER CARBONATE 2008-12-09 Active II Complete 2013-02-08 2012-11-26