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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
28/11/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 39197 GABAPENTIN ENACARBIL 2023-12-01 Active II Complete 2023-12-20 2023-11-29
28/11/2024 Dasami Lab
India
DASAMI LAB PRIVATE LTD 33386 GABAPENTIN ENACARBIL 2019-03-29 Active II Complete 2019-05-10 2019-02-21