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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 Nuray Chemicals Private Limited
India
SS PHARMA LLC 38577 CEVIMELINE HYDROCHLORIDE USP 2023-09-28 Active II Complete 2023-11-13 2023-09-27
28/03/2025 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INC 22509 CEVIMELINE HYDROCHLORIDE HEMIHYDRATE 2009-02-06 Active II N/A