Please Wait
Applying Filters...

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

Menu
$ API Ref.Price (USD/KG) : 635Xls download

Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.

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 Centrient Pharmaceuticals
Netherlands
CENTRIENT PHARMACEUTICALS NETHERLANDS BV 31410 ROSUVASTATIN CALCIUM 2017-03-28 Active II Complete 2017-11-17 2017-05-23
26/09/2024 Minakem (formerly Delmar Chemicals)
Canada
DELMAR CHEMICALS INC 29190 ROSUVASTATIN CALCIUM 2015-12-03 Active II Complete 2016-04-08 2015-09-25