FSUE “Endopharm” showed Alexander Bogomaz, Governor of the Bryansk Region, how the process of harvesting the first industrial crop of the domestic variety of opium poppy “Maral” is organized, and what technologies for processing plant raw materials are used in the "ENDOPHARM Agro" branch.
The investment project implemented by FSUE “Endopharm” jointly with the Ministry of Industry and Trade of Russia in the Bryansk region is aimed at ensuring the country’s drug safety for a number of vital and socially important drugs through their full-cycle production, including increasing local content in manufacturing opium analgesics in the Russian Federation.
Since 1998, a legislative ban on the cultivation of narcotic plants for the production of medicines has been in force. The position of state authorities in relation to poppy as a potential source of abuse on the background of the social and economic crisis that accompanied the collapse of the Soviet Union led to a complete cessation of poppy cultivation in the country, including by state-owned agricultural enterprises. Opium substances have not been produced in Russia for more than 30 years due to the lack of own plant raw materials and processing capacities.
In January 2019, the Government of the Russian Federation supported the initiative of the Ministry of Industry and Trade of the Russian Federation and Federal State Unitary Enterprise “Endopharm” to lift the ban on the cultivation of opium poppy and the processing of poppy straw into pharmaceutical substances, and submitted a relevant bill to the State Duma.
In parallel with the process of modernizing legislation in this area, preparatory work was carried out for about five years. For this period, FSUE “Endopharm” organized work on breeding and state registration of domestic poppy varieties on the basis of the Penza Scientific Agricultural Institute, and the necessary amount of seed material was accumulated. At the same time, the scientific subdivision of FSUE “Endopharm” developed technologies for the industrial extraction of opium alkaloids from poppy straw.
In 2021, the Enterprise created an agricultural branch in the Bryansk region – “Endopharm Agro” located on a land plot of area of about 7,000 hectares.
This year, opium poppy was experimentally sown on an area of about 400 hectares, agricultural technologies, as well as methods for ensuring the safety of the cultivation and processing of poppy straw, were practised, including at a specialized high-tech processing complex built at the branch this year.
“The Bryansk Region has not only experience in cultivating fine-grained oilseed crops, but also possesses the most advanced technologies that we shared with FSUE “Endopharm”. Despite the fact that the year is trial and difficult for this type of crop due to weather conditions, it was possible to harvest up to 500 kg per hectare. I’m sure that’s just the beginning" – Alexander Bogomaz commented.
Now the agricultural branch of FSUE “Endopharm” is carrying out the necessary set of works to prepare for the sowing season in 2023 on all available farmland areas.
The properties of the “Maral” poppy variety allow for its possible bilateral use. The productivity of this variety makes it possible to harvest from the sown areas of the branch the volume of raw materials necessary to fully meet the annual needs of the Russian Federation in the morphine hydrochloride, as well as to close a certain part of the country’s need for poppy seeds for food purposes.
In total, FSUE “Endopharm” invested about 800 million rubles of its own funds in the agricultural project.
At the “Pochep” branch of FSUE “Endopharm”, Alexander Bogomaz got acquainted with the technological processes for the production of active pharmaceutical ingredients (APIs). He visited research laboratories where work is underway as part of a large-scale investment project that provides for commissioning in 2025, within the branch, of an industrial complex for the production of APIs from plant and animal raw materials, as well as those obtained by chemical synthesis.
The total investment in this project implemented jointly with the Ministry of Industry and Trade of Russia is more than 10 billion rubles, including FSUE Endopharm’s own funds.
Three experimental sites for scaling and transferring technologies for the production of APIs of its own design, as well as substances licensed for small-scale production are organized in the “Pochep” branch as part of investment program of FSUE “Endopharm”.
The amount of financing for the reconstruction and technical equipment of production sites with a total area of more than 600 m2 amounted to about 50 million rubles.
Until the end of this year, the “Pochep” branch plans to develop seven titles of pilot and industrial series of APIs, including substances for the production of morphine-type drugs of high social significance. Also, by the end of the year, the branch will complete the practising and scaling of the technology for the production of API “Human chorionic gonadotropin” for the full-cycle production of the drug, which is in high demand in the treatment of a number of diseases of the reproductive system in women and men.
Currently, commercial batches of the drug “Stapredin” are already being produced at experimental sites, domestic technologies for the production of APIs such as cytochrome, immunotim, aprotinin, and sodium heparin are being developed.
Over the past half-year, the scientific division of the “Pochep” branch has replenished with 22 specialists, including five graduates of Russia’s leading universities in the field of chemical and biochemical technologies, who, having gained the necessary experience, will become the basis of staff potential for the industrial production of APIs in the “Pochep” branch.
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