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

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$ API Ref.Price (USD/KG) : 916,238Xls 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 USV Private Limited
India
USV PRIVATE LTD 35768 ETELCALCETIDE HYDROCHLORIDE 2021-07-22 Active II Complete 2021-09-07 2021-03-24
26/09/2024 Auro Peptides Limited
India
AURO PEPTIDES LTD 35386 ETELCALCETIDE HYDROCHLORIDE 2020-11-12 Active II Complete 2021-01-11 2020-11-12