On July 19, at the invitation of General Director of FSUE Endopharm (hereinafter referred to as Company) Mr. Mikhail Fonarev, the Pochep and ENDOPHARM Agro Branches were visited by Mr. Alexander Bogomaz, Governor of Bryansk Oblast, Mr. Valentin Subbot, Chairman of Bryansk Regional Duma and Mr. Andrey Bardukov, Deputy Governor of Bryansk Oblast.
The investment projects of FSUE Endopharm implemented jointly with the Ministry of Industry and Trade of Russia provide for the creation of a modern high technology complex for cultivation of plant materials, production of a full cycle of at least 60 domestic active pharmaceutical ingredients and the manufacture of medicinal products therefrom in various forms of release.
The investment project consists of stages and is aimed at ensuring the medicinal safety of the country for a number of vital and socially significant medicinal products through the organization of their full cycle manufacture including the full localization of manufacture of opium analgesics in the Russian Federation in order to ensure the national sovereignty of the Russian Federation in this segment.
“In the Russian Federation, from 1998 to 2019, there was a legislative ban on the cultivation of narcotic plants for the production and manufacture of narcotic drugs and psychotropic substances in dosage forms. In fact, the industrial cultivation of opium poppy in the country has been stopped since the beginning of the 90s of the last century due to the collapse of the Soviet Union and the absence of processing production of poppy straw in the substance of morphine, thebaine, codeine, etc. in the territory of the Russian Federation. The only plant for the manufacture of substances of this type remained in Shymkent of the Republic of Kazakhstan. In addition, the complication of the criminal drug situation in the country also contributed to the cessation of cultivation. It was from the beginning of the 90s that the Russian Federation purchased the necessary substances in the states of Europe and India.
In 2019, the Government of the Russian Federation supported the initiative of the Ministry of Industry and Trade 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 in Russia to ensure the country's drug safety in the strategically important segment of opium analgesics.
Federal Law No. 168-FZ dated July 03, 2019 simultaneously with the lifting of this ban created a legal framework for the cultivation of narcotic plants for the production of narcotic drugs and psychotropic substances used for medical purposes and (or) in veterinary medicine.
The INCB (International Narcotics Control Board) supported the right of Russia as a party to the 1961 Convention to cultivate opium poppy in order to obtain poppy straw for the needs of its own pharmaceutical and food industries. Visiting FSUE Endopharm in 2017, Mr. Viroy Sumyay, Chairman of the INCB, highly appreciated the activities of the Company aimed at increasing the availability of pain relief and preventing the diversion of controlled drugs and substances into illegal circulation.
Over the past 5 years, FSUE Endopharm has been working on the creation of varieties of opium poppy of domestic selection which resulted in the breeding of a new variety “Maral” and obtaining a patent from the State Commission of the Russian Federation for the Testing and Protection of Breeding Achievements (FSBI Gossortkomissiya). At the beginning of 2021, the Maral variety was included in the State Register of Breeding Achievements Approved for Use.
The domestic variety "Maral" has a low content of alkaloids which makes plants of this variety unattractive for illegal production and consumption of drugs. At the same time, the alkaloid extraction technologies modernized and adapted by the scientific divisions of FSUE Endopharm will allow the production of high-quality pharmaceutical substance morphine hydrochloride from low alkaloid raw materials," Mr. Mikhail Fonarev explained when examining poppy crops in the branch of the Endopharm Agro Company.
It is no coincidence that it was decided to grow an agricultural crop that is complex and necessary for ensuring the drug safety of the country in Bryansk Oblast. The region has a unique experience in growing fine-grained oilseeds. Today, thanks to the use of scientific developments, advanced technologies and experience of the best agricultural enterprises in the industry, the region is a leader in terms of production and yield of rapeseed.
Since 2021, specialists of FSUE Endopharm on the basis of their own licensed agricultural laboratory have been working at adaptation of the technologies for the growing of the Maral poppy variety to the soil and climatic conditions of Bryansk Oblast.
At the same time, the ENDOPHARM Agro Branch carried out activities to form a core of personnel including agronomists, breeders, machine operators to bring the real estate complex and the agricultural machinery fleet into compliance with regulatory requirements, to license activities in the field of legal circulation of narcotic drugs, psychotropic substances and their precursors, the licensing of fields intended for the cultivation of narcotic plants, preparation for poppy sowing, design and construction of a high technology complex for the primary processing of opium poppy seeds.
It should be noted that the ENDOPHARM Agro Branch meets all the requirements established by law for the cultivation of opium poppy including the protection of crops.
Mr. Mikhail Fonarev, during his visit to ENDOPHARM Agro, noted the active support of the region and personally Governor of the region, Mr. Alexander Bogomaz in providing the best experts to help the agronomists of Company in the cultivation of poppy crops, as well as in the provision of adapted technologies for sowing small-grained crops.
At Pochep Branch of FSUE Endopharm along with the Ministry of Industry and Trade of Russia, an investment project is being implemented that provides for the creation of a large industrial complex for manufacture of active pharmaceutical ingredients from raw materials of plant and animal origin and obtained by chemical synthesis by 2025.
The total investment in the project which includes 4 stages is more than 7 billion rubles.
At the first stage, in July 2022, Laboratory Building was put into operation at Pochep Branch of FSUE Endopharm. More than 1000 m2 of the laboratory space has been reconstructed and equipped with modern equipment with the arrangement of chemical and microbiological laboratory facilities. The main purpose of the laboratories is to carry out incoming quality control of active pharmaceutical ingredients and raw materials used for manufacture of active pharmaceutical ingredients.
The total volume of investment in Laboratory Building amounted to 165 million rubles of which the cost of purchasing equipment was more than 40 million rubles. The capacity of the laboratories is about 30 thousand studies per year. The number of scientific personnel in 2022 is more than 40 employees.
“I am pleased that You, Aleksandr Vasilyevich, pay great attention to the development of industrial enterprises in the region and, in particular, FSUE Endopharm. Together with You, we create conditions for young scientists to work at the enterprise. We provide good conditions for them – decent salaries, development opportunities, advanced training; You are developing the infrastructure of Pochep District, building sports complexes, medical institutions,”- thanked Mr. Mikhail Fonarev, Governor of Bryansk Oblast.
Additionally, within the framework of the FSUE Endopharm's own investment program, 3 sites have been arranged in Laboratory Building, designed for scaling and transferring technologies for manufacture of active pharmaceutical ingredients developed by the scientific divisions of Company and licensed for small-scale manufacture of active pharmaceutical ingredients. The amount of extra-budgetary financing for the reconstruction and technical equipment of manufacture sites with a total area of more than 600 m2 amounted to circa 50 million rubles.
Until the end of 2022, it is planned to develop pilot and industrial batches of at least 7 types of active pharmaceutical ingredients including pharmaceutical substances for manufacture of strategically important painkillers from the group of centrally acting analgesics and to develop and scale up the technology for manufacture of domestic pharmaceutical substance Chorionic Gonadotropin for the arrangement of a full-cycle production of the corresponding medicinal product demanded by the healthcare system required in IVF protocols (in vitro fertilization) and for the treatment of a number of diseases of the reproductive system in women and men.
At the next stage, by 2025, a large-scale manufacture will be arranged at Pochep Branch which will allow for manufacture of at least 60 types of domestic active pharmaceutical ingredients yearly.
Summing up, Mr. Alexander Bogomaz, Governor of Bryansk Oblast noted: “Several years ago, Government of the Russian Federation made a very right decision – to transfer the site of the former chemical waste disposal plant to Moscow Endocrine Plant (FSUE Endopharm). We see that already today the Company is consistently implementing plans to fulfill an important state task aimed at the provision of medicinal safety of our country.
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