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

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$ API Ref.Price (USD/KG) : 20,255Xls download

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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 33846 CARIPRAZINE HYDROCHLORIDE 2019-05-30 Active II N/A
26/09/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 33956 CARIPRAZINE HYDROCHLORIDE PREMIX 2019-06-26 Active II Complete 2019-07-23 2019-06-26