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List of Drug Master Files (DMF) of Alosetron 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 27470 ALOSETRON HYDROCHLORIDE 2013-09-23 Active II Complete 2014-02-28 2013-09-25
26/09/2024 Nuray Chemicals Private Limited
India
NURAY CHEMICALS PVT LTD 27378 ALOSETRON HYDROCHLORIDE 2013-09-16 Active II Complete 2013-10-19 2013-09-12