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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
12/01/2026 Apex Healthcare Limited
India
APEX HEALTHCARE LTD 42324 BUPIVACAINE HYDROCHLORIDE USP 2025-08-21 Active II N/A
30/12/2025 Moehs Iberica
Spain
MOEHS IBERICA SL 22228 BUPIVACAINE HYDROCHLORIDE 2008-11-24 Active II Complete 2013-01-29 2013-01-07