On September 23, the Governor of Saint Petersburg, G. S. Poltavchenko, in the framework of his visit to the investment objects of the city visited GEROPHARM Group of Companies production site within Pushkinskaya industrial zone where the first line of production was launched for testing.
Development of production of substances in the Russian Federation is one of the priority tasks set for the pharmaceutical industry by the government. GEROPHARM is aiming at creation of the modern highly technological production of original and generic medicinal products including the drugs having no analogues in terms of local content within the Russian Federation.
The total are of the complex is 14,000 m2. Investments into the construction of the 1st and 2nd lines – 3.3 billion rubles. Production complies with GMP standards, 90 % of the processes are fully automated.
The factory will produce active pharmaceutical substances for original products to treat neurological, ophthalmological diseases and climacteric syndrome, as well as substances of gene-engineering insulin and insulin analogues. Finished dosage form will be produced at GEROPHARM production site in Obolensk.
Industrial production of the substances for original products will begin in November of 2017. The second line of production of human gene-engineering insulins and analogue insulins is expected to be launched in November of 2018. Capacity of the line will amount to 1,000 kg of the substance per year that will be sufficient to meet the demand of Russians for insulin completely (about 800 kg per year) and expand export opportunities of the company.
While designing the factory, modern technological solutions and the best world experience of organizing pharmaceutical production was applied. A high level of industrial and ecological safety is secured at the production site.
Development of biotechnologies is the priority area of work in GEROPHARM. Currently, the company is developing analogue insulins in its own R&D center in Strelna based on the requirements of the Russian Healthcare Ministry and the most advanced experience – of leadership of EMEA and FDA – that provides for a high export potential of the projects.
GEROPHARM became the first Russian company to organize and conduct clamp studies of insulin analogues in Russia. One of them has been successfully completed and the outcomes of clinical trials have been submitted to the Healthcare Ministry.
Launch of this GEROPHARM production will facilitate meeting the demand of the Russian Healthcare Ministry for domestic medicinal products to treat socially important diseases prevailing among the overall incidences in the Russian Federation including diabetes, providing independence of the Russian market of insulins from the import substance, developing economics of the region and it will create highly technological new jobs.