Three registration lots of dolutegravir manufactured at Servier Pharmaceutical Plant in Russia (located in Moscow, Serdix pharmaceutical plant of Servier Group until 2017) successfully passed stability tests and comparative dissolution kinetics tests.
The updated dossier containing name of the new Russian manufacturer was sent to the Russian Ministry of Health in order to make changes to the registration certificate.
The design of localization project allows simultaneous launch of full cycle manufacturing (production of finished dosage form) without any intermediate stages, such as the secondary packaging. The transfer of manufacturing technology and analytical methods, which was made in 2016, ensures the proper control of manufacturing operations and quality. The Shianogi plant (Tokushima, Japan), that manufactures the substance, has successfully passed the Russian GMP compliance inspection.
“The joint team of ViiV Healthcare, GSK and Servier successfully passed another important stage of the large-scale localization project to manufacture dolutegravir in Russia. We are making every effort to ensure that dolutegravir, which was recognized by the World Health Organization (WHO) as a significant step forward in the treatment of HIV, becomes available to patients in Russia as soon as possible,” said Alexander Sokolov, the General Manager of ViiV Healthcare LLC.