Dobrolek (Pharmeko)

The Dobrolek LLC company is the enterprise for production (packaging) of finished pharmaceutical products in the form of the bulk and packaged in primary packaging medicinal product (balk-product). Cumulative production capacities allow to produce for September, 2019 more than 10 millions packages of medicines a year. The quality management system acts on the enterprise, the functional systems intended for personnel training, carrying out audit of suppliers of raw materials and materials, carrying out monitoring of quality of the produced drugs are also implemented. The quality management system regularly undergoes audit. Results of the booked audits confirm that the Dobrolek company conforms to requirements of proper production practice and is capable to provide quality of the medicines produced on the Russian market.

Dobrolek LLC is included into vertically integrated Pharmeko holding which includes several segments different on functionality, but connected by uniform vision and the purposes. The company performs production of a full stroke of modern medicines based on own pharmaceutical enterprises conforming to the most modern requirements of production organization and quality control (GMP) is engaged in research and development of domestic innovation medicines, implements joint projects with the largest foreign pharmaceutical companies. Pharmeko is among the Russian pharmaceutical holdings pursuing policy of development of high technologies and stimulation of the innovation production in Russia.

History

2019: The agreement with Roche on production of hypodermic medicine for treatment of an inhibitory form of hemophilia And

On September 23, 2019 it became known that the International innovative company of Roche signed the agreement with Dobrolek LLC (enters into Pharmeko Group) of localization of production in Russia of the innovation medicine for treatment of an inhibitory form of hemophilia And emitsizumab. The ceremony was held in Svetlogorsk in the presence of the First Deputy Minister of Industry and Trade Sergey Tsyba.

Emitsizumab (Gemlibra) — the reference medicine for hypodermic introduction approved in 2018 in Russia for prevention of bleedings at patients with an inhibitory form of hemophilia And. For September, 2019 in Russia there are 6,500 people with hemophilia And, from them 300 — with an inhibitory form, these are mainly children.

According to terms of the contract, Roche will provide the Dobrolek broadcast of production technologies of an emitsizumab, including methods of quality control, and an uninterrupted supply in the Russian Federation to products of in-bulk necessary for production. In turn Dobrolek will organize production according to Rules of proper production practice (GMP) and also storage and distribution of medicine in the territory of the Russian Federation. Within the project necessary retrofitting of production capacities and laboratories, personnel training will be carried out.

Emitsizumab will be issued at capacities of Dobrolek LLC in Moscow in the form of solution for hypodermic introduction of 150 mg/ml and 30 mg/ml. The production process will include secondary packaging and the releasing quality control. The first batch of the emitsizumab made on enterprise capacities will come to the Russian market in September, 2020.

Production capacities of Dobrolek LLC will allow to provide completely the needs of the Russian health care for an emitsizumaba, including in case of its inclusion in the 12 high cost nozologiya List. The corresponding request is sent to Roche to the Commission on formation of lists of medicines for medical application.

We welcome development of cooperation of the Russian and international pharmproizvoditel in the direction of production in Russia of medicines for treatment of diseases from the list of 12 high cost nozologiya. It promotes deepening of integration of Russia into world production processes and also expansion of the competences and experience necessary for development of the export potential of the domestic companies, told Sergey Tsyb, the First Deputy Minister of Industry and Trade of the Russian Federation

For our company important, that medicine of our trademark irrespective of where it is produced — at our plant or at the enterprise of the partner, completely met all applicable rules and quality requirements. For September, 2019 in Russia 17 Roche drugs are produced. We are glad to an opportunity to expand our localized portfolio thanks to cooperation with Dobrolek company. We are sure that production of an emitsizumab at the enterprise in Moscow will promote increase in its availability to the patients who faced an inhibitory form of hemophilia And, especially children noted Lars Nielsen, the chief representative "F. Hoffman-la Roche Ltd." in Moscow