In 2023, the Ural pharmaceutical plant Medsintez Plant LLC celebrated its 20th anniversary. Today, it is a modern full-cycle biotechnological enterprise that develops and manufactures pharmaceutical substances and drugs that meet international GMP and ISO standards. The Medsintez Plant has been present on the Russian and foreign markets for over 20 years and is an active participant of drug import substitution programs in the Russian Federation.
Drug quality, safety and efficacy as a priority for 20 years
In 2007, the Medsintez Plant became the first pharmaceutical company in Russia being awarded the Russian Government Prize for Quality. Availability of its own research center, advanced quality control laboratories, as well as the competence of personnel in terms of organizing production in accordance with GMP requirements greatly contribute to the success of the enterprise.
The plant has organized a multi-stage quality control system at each drug production phase; compliance with storage conditions of drugs, factors of production environment and processes are continuously monitored, among other things, the company regularly undergoes inspections by independent companies.
Drug safety for Russian diabetics
In 2008, the Medsintez Plant launched Russia's first production of genetically engineered human insulin according to international GMP standards. This not only made it possible to return the Russian market to domestic insulin producers, but also led to serious reduction in prices for foreign analogues of the preparation. By enhancing production capabilities, the enterprise, with the support of the Industrial Development Fund of the Russian Federation, created an insulin substance from its own producer strain and developed a technology for its production.
Today, the Plant is implementing the full-cycle production of the entire line of products of genetically engineered human insulin Rosinsulin and analogue forms of insulins—Rosinsulin Aspart R and Rosinsulin Glargine from its own substances. The Medsintez Plant has developed and patented the design of disposable and reusable injection pens that ensure high precision dosing of the preparation.
Triazavirin survived the pandemic
In 2014, the plant organized the full-cycle production of the original antiviral drug Triazavirin, which is effective for the treatment and prevention of viral diseases and has a wide range of direct antiviral activity against RNA viral infections, such as influenza, ARVI, COVID-19.
During the COVID-19 pandemic, Triazavirin saved dozens of lives—more than 2.5 million patients with COVID-19, influenza and ARVI received therapy using the drug. In 2020, many studies were carried out, thanks to which the drug was included in a number of guidelines, protocols for treatment and prevention of COVID-19, influenza and ARVI, including the standard for the diagnosis and treatment of nCoV infection in military personnel of the Armed Forces of the Russian Federation.
Triazavirin is included in the federal clinical recommendations of the Ministry of Health of Russia for treatment of influenza and ARVI in adults and this is the only direct-acting antiviral drug approved for the prevention of COVID-19. In 2022, clinical studies of the efficacy and safety of the drug at 100 mg dosage in children aged 12–17 years with a diagnosis of acute respiratory viral infections were successfully completed. Today, the drug is undergoing clinical trials in children aged 6 to 11 years.
Reproductive technologies
Since 2019, the Medsintez Plant, in cooperation with IVFarma, has been producing the substance and finished dosage form of the first Russian drug of recombinant human follicle-stimulating hormone (FSH) for the treatment of infertility—Primapur. The drug is used in the IVF procedure and is included in the List of Vital and Essential Drugs. FSH production capacity is 200–250 % of the existing Russian market. Primapur is successfully used in clinics throughout Russia—more than 60 thousand IVF cycles have been performed using the drug and more than 20 thousand children have been born.
Today, the company is developing a set of drugs for treatment of infertility, such as recombinant human chorionic gonadotropin (hCG) and Cetrorelix, which will ensure drug safety for Russia in this area and independence from import supplies.
Latest biotechnological developments
The past two years have seriously affected the operation of the enterprise due to cessation of supplies of some components from the USA and Europe. The team did a tremendous amount of work to find substitutes in Russia and China. At the same time, it gave the plant a huge incentive for development, in particular, to find new suppliers and create its own production of Russian-made reagents. In the new conditions, the company managed to establish the production of not only new drugs, but of entire groups of them.
In 2023, the Medsintez Plant, in collaboration with the Promomed Group of Companies, launched a full-cycle production of hypoglycemic agents based on Liraglutide and Semaglutide for treatment of type 2 diabetes.
In 2023, the company launched the production of the first Russian species-specific insulins for veterinary use, Vinsuvet (separately for cats and dogs).
Domestic production of these drugs will make it possible to bridge the shortage of similar drugs that arose in the country back in 2022, associated with the cessation of supplies from foreign manufacturers.
Contract manufacturing
One of the areas of development of the Medsintez Plant is contract manufacturing, which includes the manufacture of products under the customer’s trademark. Among partners of the enterprise are the largest international pharmaceutical companies such as Bayer, STADA, iVFarma, Promomed, etc. The Medsintez Plant invites partners to cooperate in the field of research, innovation and production, including the localization of technologies and production of global manufacturers of medical and paramedical products in the plant's facilities.
For the drug safety of Russia
National drug safety is a priority of the Medsintez Plant: highly qualified specialists of the enterprise are able to develop new drugs, organize production sites in the shortest possible time, equip them with high-tech equipment and ensure uninterrupted supplies of drugs to hospitals and pharmacies of the country.
The Medsintez Plant’s engineering capacity, competencies in biotechnological processes, interaction with scientific institutions, as well as the ability to develop and produce own devices for administering injectable drugs open up new horizons for the Plant in developing new innovative medicines. Fruitful cooperation with state authorities on programs of affordable drug supply to the population is underway.