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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
29/01/2026 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 30868 GEFITINIB 2016-09-19 Active II Complete 2016-12-13 2016-09-08
29/01/2026 Cdymax
India
CDYMAX (INDIA) PHARMA PRIVATE LTD 40456 GEFITINIB 2024-09-03 Active II N/A