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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
27/02/2026 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 37632 MIGALASTAT HYDROCHLORIDE 2023-02-26 Active II N/A
27/02/2026 Lupin Manufacturing Solutions
India
LUPIN MANUFACTURING SOLUTIONS LTD 36729 MIGALASTAT HYDROCHLORIDE 2022-03-31 Active II Complete 2022-06-09 2022-05-26