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19 September

“National Biotechnology” building a new pharmaceutical factory

On 15-17 September an exhibition within the framework of the VII All-Russia Forum “Health of the Nation is the Basis of Russia’s Prosperity” took place. “National Biotechnology”, a Russian producer of human recombinant full cycle insulin, presented a project of a new manufacturing complex for the production of drugs, the construction of the complex being underway.

The All-Russia Forum “Health of the Nation is the Basis of Russia’s Prosperity” is an annual event of the National Health League and the Ministry of Public Health and Social Development of the Russian Federation. The Forum is the most extensive federal platform for the demonstration of the state and corporate programs, projects, services and goods for healthy lifestyle.

The exhibition stand of “National Biotechnology”, being a part of the Moscow Region projects’ exposition, was visited by Leo Bokeriya, the president of the all-Russian public organization of the National Health League, and by Vladimir Semenov, the Minister of Health of the Moscow Region, who emphasized the relevance of the implemented project for the Russian pharmaceutical branch and the country in general.

The high tech automated manufacturing complex of “National Biotechnology” OAO is being built in the town of Obolensk in Serpukhov District of the Moscow Region. New production capacities allow the company to scale up the existing production of human recombinant insulin (Rinsulin R and Rinsulin NPH), launch an industrial line of insulin cartridges and insulin analogs production. Moreover, the new factory will produce original state-of-the-art drugs for the treatment and prevention of diabetes and other socially significant diseases.

The factory’s production capacities account for 20 million vials and 5 million cartridges per year. Investments in the first construction stage exceed 400 million rubles. The end of construction and the production site commissioning are planned for the second quarter of 2012. The layout of production premises, equipment placement and fitting will be carried out with regard to the current versions of the RF effective norms and standards, including the EU Guidelines on Good Manufacturing Practice for Medical Products of the European Commission (GMP EU).

Today “National Biotechnology” OAO is the only Russian enterprise producing human recombinant  insulin using a full-cycle principle: from substance synthesis to finished medical products. The substance quality provided by “National Biotechnology” OAO was highly estimated by three certified independent laboratories in Germany - Proteome Factory AG, Protylic GmbH, Labor L + S AG, which confirmed compliance with the European and American pharmacopeias.

The company produces a standard sample of human recombinant insulin, which is used as a State Standard Reference Sample by the national supervision bodies for testing drugs produced in Russia and imported from other countries.

Since 2001, “Geropharm” has been a strategic partner of “National Biotechnology” OAO and an exclusive distributor of its medical products.

“Building a new manufacturing complex was required in view of the company plans for capacity expansion as well as manufacturing of innovative products that are currently being developed,” said Peter Rodionov, the company CEO. “On a national scale high-quality domestic human recombinant full cycle insulin production and the building of a new industrial complex is a further step on the way to the import substitution program and the country’s medicinal security.”