Axoglatiran® FS: Generic of Copaxone® Preparation Based on Glatiramer Acetate

May 22, 2018

Title

Axoglatiran® FS: Generic of Copaxone® Preparation Based on Glatiramer Acetate

Author

Yu. V. Skornyakov, A. A. Deryabin, O. V. Skornyakova

Year

2017

Journal

Pharmaceutical Chemistry Journal

Abstract

General information about the synthesis and properties of glatiramer acetate (GA) drug substance and the principles and methods for verifying the pharmaceutical identity of GA drug substance and Copaxone® and generic Axoglatiran® FS (INN) that are based on it was presented. Registration certificate No. LP-003572 dated Apr. 18, 2016, was issued by the RF for the first domestic GA-based generic drug Axoglatiran® FS.

Instrument

J-815

Keywords

Circular dichroism, Secondary structure, Pharmaceutical, Biochemistry