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List of Drug Master Files (DMF) of ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 Ami Lifesciences Private Limited
India
AMI LIFESCIENCES PRIVATE LTD 39342 MIROGABALIN BESYLATE 2023-12-29 Active II N/A
26/09/2024 Lee Pharma
India
LEE PHARMA LTD 38908 MIROGABALIN BESYLATE 2023-09-20 Active II N/A