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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 Amoli Organics
India
AMOLI ORGANICS PRIVATE LTD 23028 DICLOFENAC POTASSIUM USP 2009-08-12 Active II Complete 2017-10-27 2017-10-16
25/04/2025 Cambrex Corporation
U.S.A
CAMBREX PROFARMACO CORK LTD 13934 DICLOFENAC POTASSIUM 1999-01-08 Inactive II N/A