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List of Drug Master Files (DMF) of ZD4522 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 669Xls 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 HEC Pharm
China
RUYUAN HEC PHARM CO LTD 35343 Rosuvastatin intermediate RSV01 2020-11-05 Active II N/A
26/09/2024 MSN Laboratories
India
MSN LABORATORIES PRIVATE LTD 23599 TERTIARY BUTYL AMINE SALT OF ROSUVASTATIN [ROUTE CODE - ROC1] 2010-03-02 Inactive II N/A