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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 PMC Isochem
France
PMC ISOCHEM 7453 LOPERAMIDE HYDROCHLORIDE 1988-04-28 Active II N/A
28/03/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 7340 LOPERAMIDE HYDROCHLORIDE 1988-02-17 Active II Complete 2017-01-19 2016-11-28