Axoglatiran® FS: Generic of Copaxone® Preparation Based on Glatiramer Acetate
- Authors: Skornyakov Y.V.1, Deryabin A.A.2, Skornyakova O.V.3
-
Affiliations:
- Nordic Chemical Co., Ministry of Health of Russia
- Perm Chemical Co.
- M. V. Lomonosov Moscow State University
- Issue: Vol 51, No 4 (2017)
- Pages: 301-306
- Section: Drugs
- URL: https://journals.rcsi.science/0091-150X/article/view/244582
- DOI: https://doi.org/10.1007/s11094-017-1603-6
- ID: 244582
Cite item
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.
Keywords
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