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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 Ami Lifesciences Private Limited
India
AMI LIFESCIENCES PRIVATE LTD 39342 MIROGABALIN BESYLATE 2023-12-29 Active II N/A
28/03/2025 Lee Pharma
India
LEE PHARMA LTD 38908 MIROGABALIN BESYLATE 2023-09-20 Active II N/A