MSD, an innovative global pharmaceutical company, and AKRIKHIN, a leading Russian pharmaceutical manufacturer, announced the successful localization of 100 mg finished dosage form of sitagliptin, an oral antihyperglycemic drug for type 2 diabetes mellitus.
The project was implemented as a part of strategic partnership between the companies, which dates back to 2012 and is aimed at transferring the pharmaceutical manufacturing technology to Russia.
Sitagliptin is manufactured at the production facility of AKRIHIN JSC in the Moscow region in full compliance with GMP standards. The manufacturing includes incoming quality control, preparation of active pharmaceutical ingredient and excipients, preparation of finished dosage form, packaging, and release quality control.
The Russian-made drug will become available in Russian pharmacies in Q2 2018. The lots of sitagliptin, that are currently in circulation, have been packaged at AKRIHIN plant. By the end of 2018, the company plans to manufacture up to 200 thousand packages of sitagliptin, starting with the stage of finished dosage form preparation.
The project involves the transfer of technological processes, installation of additional equipment for production lines and laboratories, and additional training of personnel. Overall, MSD and AKRIHIN JSC will invest 330 million rubles in the project.