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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 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 39315 RALTEGRAVIR POTASSIUM USP 2023-12-30 Active II Complete 2024-02-14 2023-12-22
28/03/2025 Emcure Pharmaceuticals
India
EMCURE PHARMACEUTICALS LTD 26935 RALTEGRAVIR POTASSIUM 2013-03-28 Inactive II N/A