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


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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.

About the authors

Yu. V. Skornyakov

Nordic Chemical Co., Ministry of Health of Russia

Author for correspondence.
Email: skorn506@mail.ru
Russian Federation, Moscow, 123001

A. A. Deryabin

Perm Chemical Co.

Email: skorn506@mail.ru
Russian Federation, Perm, 614034

O. V. Skornyakova

M. V. Lomonosov Moscow State University

Email: skorn506@mail.ru
Russian Federation, Moscow, 119991


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