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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
25/04/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 28277 ALCAFTADINE 2014-05-08 Active II Complete 2015-01-05 2014-11-24
25/04/2025 Apicore
India
APICORE PHARMACEUTICALS PRIVATE LTD 32382 ALCAFTADINE 2018-01-07 Active II N/A