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

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$ API Ref.Price (USD/KG) : 360,846Xls 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 Chirogate International
Taiwan
CHIROGATE INTERNATIONAL INC 28340 TREPROSTINIL SODIUM 2016-08-15 Active II N/A
26/09/2024 Nuray Chemicals Private Limited
India
SS PHARMA LLC 30861 TREPROSTINIL SODIUM 2016-09-27 Active II Complete 2017-02-16 2016-09-20