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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
24/02/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 34905 BETADEX SULFOBUTYL ETHER SODIUM USP 2020-06-01 Active IV N/A
24/02/2025 GLAND PHARMA LIMITED
India
GLAND PHARMA LTD 30714 BETADEX SULFOBUTYL ETHER SODIUM USP- NF 2016-09-27 Active IV N/A