A working meeting of the heads of FSUE "Endopharm", the Department of Health of the Moscow city and capital's medical institutions took place at the manufacturing site of the Moscow Endocrine Plant.
The participants of the meeting discussed topical issues of the implementation of programs in the area of healthcare and the provision of medicines in the capital.
"Today, Moscow has many opportunities to ensure the availability of medicinal products needed by the capital's healthcare institutions to provide medical care to patients. This work has been systematically carried out for several years, the existing mechanisms also enable us to monitor the rate of medicinal products shortage and flexibly adapt to new circumstances" — said the Deputy Head of the Moscow City Health Department Julia Antipova. She added that a big role in the ongoing work is given to the development of the capital's pharmaceutical industry and the practice of signing offset agreements.
It is no coincidence that Deputy Head of the Department of Health stressed out that the site of FSUE "Endopharm" was chosen to hold the working meeting: "The Moscow Endocrine Plant is one of the largest pharmaceutical manufacturers in the capital. In the context of the import substitution strategy in the area of medicines, the enterprise is an excellent example for dispelling stereotypes that domestic medicines are somehow inferior to foreign medicines."
Heads of the capital's healthcare institutions got acquainted with the nomenclature of products manufactured by FSUE "Endopharm", as well as with a wide range of competencies of the Enterprise in the area of scientific research and manufacture of medicines. Participants of the working meeting got acquainted with the conditions for the release of medicinal products in ampoules, vials and single-dose syringes, noting a high level of the operating culture, technical equipment of laboratories and workshops, qualifications of personnel of FSUE "Endopharm".
The Enterprise manufactures about 140 medicinal products in various dosage forms. 75% of them are included in the List of Vital and Essential Drugs. A third part of the product nomenclature of FSUE "Endopharm" consists of medicinal products containing narcotic and psychotropic substances and used to provide medical care to palliative patients, including central-acting analgesics for the treatment of chronic pain syndrome.
"FSUE "Endopharm organizes consistent availability of manufactured narcotic and psychotropic medicinal products and fulfillment of obligations to provide them to all regions of the Russian Federation in accordance with the Distribution Plan approved by the Ministry of Industry and Trade of the Russian Federation. Our social responsibility as a manufacturer is the availability of the entire line of manufactured medicinal products to the consumer, including in conditions of unpredictability of international market relations," noted the Director General of FSUE "Endopharm" Mikhail Fonarev.
By 2025, the Enterprise will manufacture of 60 necessary pharmaceutical substances in the "Pochep" branch. 12 of them are already being manufactured.
The segment of medicinal narcotic drugs and psychotropic substances has fully mastered the manufacture of its own substances buprenorphine, remifentanil, as well as the substance fentanyl, necessary for the manufacture of analgesic transdermal patches used in palliative patients. A low-tonnage release of the sodium oxybate substance is being organized until the end of the year. With regard to the "gold standard" of anesthesia according to WHO recommendations – morphine medicinal products — FSUE "Endopharm" has fully developed the technology of manufacture of the corresponding domestic active pharmaceutical ingredient from the own plant raw materials, as well as derivatives — codeine and thebaine. By the end of 2023, sites for the manufacture of proprietary substances propionylphenylethoxyethylpiperidine, trimeperidine, ketamine, clonazepam and midazolam will be put into operation. The development of technology for the manufacture of the clobazam substance has begun.
Organization of manufacture of the own substances nefopam, epinephrine, atropine, lornoxicam is of high availability.
"One of the priorities today is the release of our own substance human chorionic gonadotropin (HCG) for the organization of a full cycle of manufacture of a medicinal product being in extreme demand in the treatment of a number of diseases of the female and male reproductive system. The Enterprise has completed the development and scaling of the technology of manufacture of HCG substance from the urine of pregnant women. As a part of the pilot project, collection of the necessary biological raw materials is organized on a systematic basis in 4 regions of Russia. In the near future, 4 more regions of the country are expected to join the project and further expand regional involvement is planned. A site for HCG substance manufacture was put into operation in the "Pochep" branch of FSUE "Endopharm". The samples of the medicinal product manufactured from the own substance correspond in quality to all indicators of the regulatory documentation approved by the Ministry of Health of the Russian Federation, and are in the process of studying stability for the registration purposes. Along with that, since middle January, the Enterprise has started release of commercial batches of HCG medicinal products manufactured from a foreign substance. It is planned to release more than 100 thousand packages of the mdicinal product by the end of March," commented Alfiya Gabidova, Deputy Director General for Science of FSUE "Endopharm".
The Enterprise is actively investing in the expansion of manufacture and new developments, and the decision to include new names, pharmaceutical presentations and dosages of medicinal products in the implementation program of FSUE "Endopharm" is made in close cooperation with the professional medical community.
Since mid-February 2023, the Enterprise will start to supply medicinal products under an offset agreement signed with the Moscow City Health Department in 2021. Over the previous two years, FSUE "Endopharm", jointly with the Ministry of Industry and Trade of the Russian Federation, invested 1 billion rubles in the development and introduction of new medicinal products, expansion of laboratory and industrial capacities, high-tech equipment, having received from the city a guarantee of stable demand for the range of products required by the capital's healthcare system.
As a result of the meeting, the participants reached certain agreements on improving the mechanisms of interaction in order to ensure continuous provision of necessary medicinal products for citizens.
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