MEDSINTEZ PLANT – THE BACKBONE OF RUSSIAN PHARMACEUTICAL INDUSTRY!
The ban on the import of medicines and raw materials for their production into Russia by foreign companies is becoming an incentive for the rapid development of domestic pharmaceuticals. The pharmaceutical company Medsintez is a leading plant in the Urals for the production of medicines. Its representatives declare: “It is a high-tech production which is able to provide the Russian market with almost any import-substituting drugs, which is facilitated by a strong scientifi c base of the enterprise and its powerful equipment.” Indeed, the quality of the company’s products has been marked with the highest awards, and the production itself is a guarantor of drug safety in Russia. We learned about the history of the Medsintez innovative plant, its capabilities, its own development of raw materials, expansion of the product line, international cooperation, as well as the development and import substitution in the field of pharmaceuticals at the enterprise.
Pharmaceutical plant Medsintez is located in the Sverdlovsk region, in the city of Novouralsk. The company has been operating since 2003. In two decades, the plant has grown from a small project for the production of infusion solutions to a backbone enterprise of the country, an innovative giant developing medicines for both the Russian and foreign markets.
Medsintez is a key healthcare company in the Sverdlovsk region. It is the base organization of regional associations such as the Ural Biomedical Cluster and the Association of Medical and Pharmaceutical Manufacturers of the Sverdlovsk region. Th e products of the plant are in demand, and its production capacity is able to meet the needs of Russians in high-quality and aff ordable drugs by 100%. The high standards of the company’s products, its latest technologies, constant scientific research and focus on import substitution ensure drug safety of Russia. In addition, Medsintez works with other pharmaceutical companies as a contract manufacturing site.
High-tech Russian production at the Medsintez plant ensures the world-class quality and safety of manufactured medicines. Control over finished products is carried out in the plant’s laboratories accredited by Roszdravnadzor and FMBA of Russia. Back in 2007, the Medsintez plant became the fi rst pharmaceutical company in Russia to be awarded the Russian Government Prize in the fi eld of quality, which was received from the President of the Russian Federation Vladimir Putin.
Medsintez is a full-cycle biotechnology company capable of developing and manufacturing medicines based on its own substances produced by chemical and biotechnological synthesis methods. The enterprise produces genetically engineered and analogue human insulin Rosinsulin, recombinant human follicle-stimulating hormone Primapur, innovative antiviral drug Triazavirin. It also continues to produce infusion solutions and solutions for automatic apheresis.
The development of the above-mentioned medicines were the landmark events in the development and formation of the enterprise. In 2008, the Medsintez plant launched the country’s first production of genetically engineered human insulin in accordance with international GMP standards. This made it possible to return the attention of Russian consumers to domestic drugs, thereby aff ecting the cost of foreign analogues. It should be noted that the Rosinsulin is produced in dosage forms convenient and familiar to consumers: vials, cartridges and syringe pens. The plant has developed and patented its own project of a disposable and reusable syringe pen, its mechanism is capable of dosing the drug with high accuracy. At the moment, the capacity of the production makes it possible to satisfy the needs of the Russian market for insulin products by 100%.
The project of Import-substituting production of genetically engineered and analogue insulin from its own substance has been implemented at the plant since 2014 with the support of the Industry Development Fund. Within the framework of the project, Medsintez has launched a full cycle production of the entire line of Rosinsulin drugs and Rosinsulin Aspart R, and a decision is expected from the Ministry of Health of the Russian Federation to add its own analogue drug, Rosinsulin Glargin, to the State Register of Medicines. The industrial production capacity of the substance of genetically engineered human insulin reaches 400 kg per year. The main economic advantages of pharmaceutical development include: independence from currency fluctuations and a complete rejection of the purchase of imported raw materials, as well as the sale of fi nished drugs at a lower price compared to imported analogues..
In August 2014, in parallel with the project for the production of insulin based on its own substance, Medsintez was engaged in obtaining a registration certificate for the antiviral drug Triazavirin, the production of the substance and fi nished dosage forms of which is also organized at the plant.
The antiviral drug Triazavirin was developed by Ural scientists on the basis of the original molecule, that is, it has no analogues and generics. The drug is effective for the treatment and prevention of viral diseases, has a wide range of direct antiviral activity against RNA viral infections, such as infl uenza, SARS, COVID-19, tick-borne encephalitis, etc. The production capacity of the plant is able to meet 30% of the country’s need. Triazavirin is included in the Federal Clinical Recommendations of the Ministry of Health of Russia for the treatment of acute respiratory viral infections and infl uenza in adults, and from 2021, by decision of the Ministry of Health of the Russian Federation, the drug is sold from pharmacies without a prescription.
In 2020, during the fight against a new coronavirus infection, numerous studies were conducted on the basis of large medical organizations in Russia and the high effi ciency and safety of Triazavirin in the treatment of coronavirus was established. Thanks to the research, Triazavirin was included in the treatment protocols for patients with COVID-19 of the Moscow Health Department, the Russian Ministry of Defense and other regulatory documents.
In addition, the antiviral drug Triazavirin has received recognition at the international level. In China, under the guidance of Academician Yang Baofeng, President of Harbin Medical University, clinical trials were conducted, as a result of which Triazavirin was included in the Chinese guidelines for the use of pharmacological agents in the treatment of coronavirus infection. Also, as a result of cooperation, an international group of specialists was formed to quickly solve the problems of developing programs and organizing research on antiviral drugs in China and Russia. Th e constant exchange of experience between the medical communities of the countries helped to build the most reliable protection of the population from new infectious challenges.
It is important to say that since the beginning of the coronavirus pandemic, Medsintez has been a partner of The National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya on the organization of industrial production of the Sputnik V vaccine. In 2020, a production site was launched, a technological transfer was made, and a test batch of the drug was released in 2021. Currently, the process of including the production site of the Medsintez plant in the registration certifi cate of the N.F. Gamaleya for the release of the Sputnik V vaccine.
Since 2018, Medsintez has implemented another biotechnological project for the production of the latest development in the field of reproductive technologies in cooperation with IVPharma: the enterprise has produced the substance of recombinant follicle-stimulating hormone and produced the first Russian drug for the treatment of human infertility – Primapur. Th is domestic development is necessary for modern medicine in Russia to overcome reproductive problems of the population. Th e drug is 100% Russian-made, it was included in the list of vital drugs. Medsintez developed and was the fi rst in Russia to start producing the most convenient form of FSH release – disposable syringe pens, the maximum production of which reaches 1 million pcs/year, which is 200% of the existing market. During the first year, 12 industrial batches of the drug were produced. Primapur was used in 50 clinics throughout Russia for the treatment of more than 8,000 patients.
Production plans of Medsintez are ambitious, but absolutely feasible. The company is preparing to launch its own production of reagents for the creation of pharmaceuticals, which will ensure the replacement of inaccessible imported components on the Russian market. Now the plant is working on the production of pharmacopeial acetonitrile, which was previously produced only in Europe.
Prepared by Daria Bakarina
Source: «RUSSIAN BUSINESS GUIDE» magazine
