loader
Please Wait
Applying Filters...

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

Client Email Product
Menu
$ API Ref.Price (USD/KG) : 177,032Xls 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 Auro Peptides Limited
India
AURO PEPTIDES LTD 35493 GLATIRAMER ACETATE 2020-12-25 Active II Complete 2021-02-08 2020-12-24
26/09/2024 CordenPharma
Germany
AMNEAL PHARMACEUTICALS LLC 27723 GLATIRAMER ACETATE 2013-12-12 Active II Complete 2014-06-05 2013-11-22