Axoglatiran® FS: Generic of Copaxone® Preparation Based on Glatiramer Acetate
- Autores: Skornyakov Y.1, Deryabin A.2, Skornyakova O.3
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Afiliações:
- Nordic Chemical Co., Ministry of Health of Russia
- Perm Chemical Co.
- M. V. Lomonosov Moscow State University
- Edição: Volume 51, Nº 4 (2017)
- Páginas: 301-306
- Seção: Drugs
- URL: https://journals.rcsi.science/0091-150X/article/view/244582
- DOI: https://doi.org/10.1007/s11094-017-1603-6
- ID: 244582
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Resumo
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.
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Sobre autores
Yu. Skornyakov
Nordic Chemical Co., Ministry of Health of Russia
Autor responsável pela correspondência
Email: skorn506@mail.ru
Rússia, Moscow, 123001
A. Deryabin
Perm Chemical Co.
Email: skorn506@mail.ru
Rússia, Perm, 614034
O. Skornyakova
M. V. Lomonosov Moscow State University
Email: skorn506@mail.ru
Rússia, Moscow, 119991