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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
    29/11/2025 Metrochem API Private Limited
    India
    		 METROCHEM API PRIVATE LTD 37632 MIGALASTAT HYDROCHLORIDE 2023-02-26 Active II N/A
    12/12/2025 Lupin Manufacturing Solutions
    India
    		 LUPIN MANUFACTURING SOLUTIONS LTD 36729 MIGALASTAT HYDROCHLORIDE 2022-03-31 Active II Complete 2022-06-09 2022-05-26
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