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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 Anmol Chemicals
India
ANMOL CHEMICALS PRIVATE LTD 41549 MEGLUMINE USP 2025-07-07 Active IV N/A
30/12/2025 Bayer AG
Germany
SCHERING AG 4308 MEGLUMINE (D(-) N- METHYLGLUIAMINE) 1981-08-28 Inactive II N/A