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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 Emnar Pharma
India
EMNAR PHARMA PRIVATE LTD 32458 ACOTIAMIDE HYDROCHLORIDE HYDRATE 2018-01-22 Active II N/A
28/03/2025 Zeria Pharmaceutical
Japan
ZERIA PHARMACEUTICAL CO LTD 20144 ACOTIAMIDE HYDROCHLORIDE 2007-01-12 Inactive II N/A