On May 24, 2018, GSK and Servier signed an agreement to launch the manufacturing of innovative HIV drug Tivicay® (INN: dolutegravir) in the production facility of Servier Rus pharmaceutical plant in Moscow.
Under the terms of agreement, the full-cycle manufacturing of finished dosage form will be launched no later than May 2019.
Dolutegravir is designed to treat HIV infection in combination with other antiretroviral drugs. It was approved for use in Russia in 2014 and, since 2018, was included in the list of vital and essential drugs.
The parties have already implemented the technology transfer, transfer of analytical methods, manufactured pilot batches, and conducted the required testing and relevant registration procedures. Regulatory approval of Servier Rus as a Russian production site for manufacturing the drug is expected to be completed in 2018.
The agreement is signed for 5 years, starting from the production of first commercial batches. The basic manufacturing plan established by the agreement provides for the output of one million packages with possibility of further increase, which will fully meet a demand for this drug in Russia.