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List of Drug Master Files (DMF) of Bilastine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 39332 BILASTINE 2023-12-29 Active II N/A
26/09/2024 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 36965 BILASTINE 2022-04-30 Active II N/A