Russian Insulin: Within the Pharma-2020 Strategy
Novouralsk plant Medsintez has completed the check for bioidentity of own substance for insulin production. In the near future the plant will withdraw from using imported raw materials. A marketing authorization certificate for the substance is to be obtained, and amendments are to be made to the current pharma monograph as to the supplier of insulin substance. The company management team is planning to complete the task by the end of 2016.
Currently Medsintez Plant is manufacturing insulins from the French substance. But, following the strategy for development of pharmaceutical industry “Pharma 2020”, assuming providing full cycle of manufacture by 2020 of 90 per cent vital and essential drugs in the country, the site began to manufacture the insulin substance. The scientific team of the plant created various variants of bacterial strains for insulin production. They were checked from the point of view of optimal production parameters. An in 2012 a strain of bacteria required for production of insulin products was patented.
Now there is all reason to open full cycle production of insulin products both for Russian and international market. The plant is already supplying the products to Ukraine, and is authorizing finished pharmaceutical forms in the European Union, Pakistan and other countries. Negotiations with Iran and Vietnam are ongoing