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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 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 36083 RALTEGRAVIR POTASSIUM USP 2021-06-30 Active II N/A
12/12/2025 Lupin Manufacturing Solutions
India
LUPIN MANUFACTURING SOLUTIONS LTD 34206 RALTEGRAVIR POTASSIUM USP (CRYSTALLINE) 2019-09-30 Active II Complete 2022-09-15 2022-08-25