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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
28/03/2025 Auro Peptides Limited
India
AURO PEPTIDES LTD 35386 ETELCALCETIDE HYDROCHLORIDE 2020-11-12 Active II Complete 2021-01-11 2020-11-12
28/03/2025 MSN Laboratories
India
MSN LIFE SCIENCES PRIVATE LTD 35097 ETELCALCETIDE HYDROCHLORIDE 2020-09-01 Active II Complete 2020-10-23 2020-09-01