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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 Arch Pharmalabs
India
ARCH PHARMALABS LTD 22162 NEVIRAPINE ANHYDROUS USP 2008-11-05 Inactive II N/A
28/03/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 24520 NEVIRAPINE ANHYDROUS USP (PROCESS II) 2011-01-17 Active II Complete 2015-05-01 2015-04-09