The «Medsintez» plant was founded in 2003. Today, it is part of the Ural Biomedical Cluster Non-Profit Partnership, which comprises more than 20 member companies.
In March 2004, the plant received a license for medicine production.
In 2005, the plant implemented the МС ISO 9001:2000 quality control system. The medicine production organization as well as quality control are certified for compliance with the European GMP requirements.
In 2007, «Medsintez» was awarded a prize of the Government of the Russian Federation in the field of quality for achieving significant results in quality of products and services as well as for implementing highly effective management techniques.
In January 2008, the «Medsintez» plant obtained a license for the production of finished dosage forms of genetically engineered human insulin. In the same year, with the participation of the Sverdlovsk region's Governor, E. Rossel, Russia's first workshop certified in accordance with the EU GMP requirements to produce finished forms of genetically engineered human insulin was launched. The quality control of raw materials and products is carried out in an analytical and a microbiological laboratories accredited by Roszdravnadzor of Russia.
In 2009, the «Medsintez» plant was recognized as a Diploma Winner of the Commonwealth of Independent States Award for achievements in the field of product and service quality.
In November 2012, Bayer, the international chemical and pharmaceutical corporation, and the Medsintez plant signed a strategic partnership agreement. The purpose of cooperation was the production of drugs for infectious diseases. The first jointly produced drug was the Avelox antibiotic, a new-generation antibacterial remedy with a wide spectrum of effects.
In July 2013, the plant successfully passed the Bayer AG certification audit before producing its first validation series of the Avelox antibiotic. The infusion solution shop was audietd for compliance with GMP directives and Bayer AG standards. Test series were produced, and a transfer of analytical and microbiological methods between «Medsintez» and «Bayer» labs was carried out. In the fall of 2013, three validation series were produced and sent to a stability test.
In October 2013, before a visit of state inspectors from Ukraine, the workshop for finished dosage forms of genetically engineered human insulin passed a preparatory audit for compliance with GMP requirements.
In September 2014, the «Medsintez» plant received a registration certificate for the production of Triazavirin®, a new antiviral drug.
Another significant event for «Medsintez» in 2014 was the launch of the «Import-Substituting Production of Genetically Engineered and Analog Insulin from Domestic Substance» project. The Industry Development Fund of the Russian Federation supported the project by providing the Ural plant with a loan in the amount of 183 million roubles. As part of the project, a modern genetics and biotechnology R&D lab and a pilot zone for the development of an insulin substance production technology were created.
«Medsintez» began to actively develop its biotechnological area of work to create its own substance of genetically engineered insulin and analogues of the latter.
In Q1 2015, a solid dosage form workshop with a capacity of up to 30 tons per year was launched. The commercial production of Triazavirin® began.
In 2015, the infusion solution workshop's product range expanded significantly: the manufacturing of contrast media under the BayerAG' trademarks - Ultravist and Magnevist - was launched.
In September 2017, the plant registered its first insulin substance, Rosinsulin. At the end of January 2018, an application was submitted to include Aspart into the state drug register as an analog insulin substance . The first phase of clinical trials of the most complex drug, Rosinsulinaglargin, began. Finished dosage forms based on Aspart, Medsintez's proprietary insulin substance, are planned to enter the market by 2019, while Glargin insulin - by 2021.
Also, in 2017, the company passed a full-scale audit by BureauVeritasCertification. The audit confirmed that the plant fully complies with the ISO 9001:2015 version of European quality standards. The entire production meets EU GMP requirements.
The plant's high level of quality and technology standards as well as its equipment capabilities attract international partners to produce their medicines in Russia.
So, in 2017, the Medsintez plant has produced the first test series of Zenix, a modern antibiotic, which is part of STADA's product portfolio in Russia. Now, the drug undergoes stability tests too. Another antibiotic will appear in the list of Medsintez drugs after the completion of tests and registration activities, by mid-2018.
An important achievement of 2017 was the fact that the Triazavirin® antiviral remedy got included in the 'Influenza in Adults' Federal Clinical Guidelines of the Ministry of Health of the Russian Federation. Edited by Irina Shestakova, Chief Infectious Disease Expert of the Ministry of Health of Russia.
Cooperation with Bayer, the German corporation, continues. In 2017, a test series of Avelox in solid, tablet form was released.
In 2018, the Medsintez Plant became a member of the Association of Medical and Pharmaceutical Manufacturers of the Sverdlovsk Region, created at the suggestion and with the support of the Minister of Health of the Sverdlovsk Region A. I. Tsvetkov and the Ministry of Industry and Science of the Sverdlovsk Region.
At the end of 2018, as part of the project to create own insulin substance and analogues, the analogue insulin substance, Rosinsulin Aspart, was registered. The Ministry of Health of Russia has already issued a decision to include the medicine in the State Register of Medicines for medical use. At the moment, the decision of the Ministry of Health of the Russian Federation to add another analogue drug, Rosinsulin Glargine, in the State Register of Medicines is expected. Medsintez plans to bring finished dosage forms based on its own insulin substances Aspart to the market by 2021, and Insulin Glargine – by 2022.
Since 2018, the Medsintez Plant, in cooperation with the iVFarma company, has been implementing a biotechnological project to produce the latest development in the field of reproductive technologies – the company produces the substance and finished dosage form of the first Russian recombinant follicle-stimulating hormone (FSH) for treatment of human infertility Primapur®, used in the in vitro fertilization (IVF) procedure. In 2019, the Medsintez Plant produced the first four batches of the pharmaceutical substance of Primapur®, as well as the first four industrial batches of finished dosage forms for clinics. Primapur® is produced in the form of an easy-to-use disposable pen injector. The maximum production volume of the drug at the Medsintez Plant will be up to 30 grams of the substance per year (up to 1 million disposable pen injectors), which is 200–250% of the existing Russian market.
The Medsintez Plant continues research to expand the clinical indications for the use of Triazavirin®. Thus, in 2019, the second phase was carried out, and in June 2020, the third phase of clinical trials of Triazavirin® for treatment of ARVI was successfully completed, as a result of which the high efficacy and safety of treatment with this medicine were established.
During the fight against COVID-19, the antiviral medicine Triazavirin® won the international recognition. In January 2020, the Chinese Consulate General requested that Triazavirin® be provided to Heilongjiang Province (the city of Harbin) to combat the COVID-19 outbreak. Clinical trials conducted by a team of Chinese scientists led by Yang Baofeng, Academician and President of Harbin Medical University, have proven the efficacy of Triazavirin® against COVID-19. As a result of the studies, the medicine was included in the Chinese Guidelines for the Use of Pharmacological Agents in the Treatment of COVID-19. In addition, on August 13, 2020, the permission was received to conduct a randomized, double-blind clinical trial of the efficacy of Triazavirin® against COVID-19 in the Republic of South Africa.
On May 15, 2020, the Board of Studies of the Ural State Medical University approved the guidelines On the Use of Triazavirin for the Treatment and Post-exposure Prevention of COVID-19.
In the spring of 2020, two high-tech automatic lines for the production of three-layer protective masks with a high filtration layer were promptly launched at the Medsintez Plant. The productivity is 4–5 mln pcs. of disposable masks per month. In the context of combating the spread of the Coronavirus disease, own regional production of protective equipment will meet the demand in hospitals and pharmacies in the Sverdlovsk Region.
On June 19, 2020, the Government Commission on Improving the Sustainability of the Development of the Russian Economy included the Medsintez Plant in the list of systemic companies in Russia.
From August to December 2020, on behalf of the Governor of the Sverdlovsk Region E. V. Kuyvashev, under the leadership of the Ural State Medical University of the Ministry of Health of Russia, on the basis of a large city hospital (City Clinical Hospital No. 14), studies were conducted on the use of Triazavirin® in relation to the novel coronavirus infection, as a result of which high efficacy and safety of its both preventive and therapeutic use were established in patients with COVID-19. The final reports were submitted to the Ministry of Health of Russia for the inclusion of Triazavirin® in the interim guidelines of the Ministry of Health of the Russian Federation "Prevention, Diagnosis and Treatment of COVID-19".
From March to November 2020, numerous studies were carried out, practical experience was gained and the high efficacy of Triazavirin® in the treatment of COVID-19 was established on the basis of large healthcare organizations, such as the Military Medical Academy, hospitals of the Moscow Health Department, Krasnoyarsk State Medical University, etc. During real clinical practice, the medicine was included in a number of guidelines, protocols for treatment and prevention of COVID-19 and ARVI, including:
• "Clinical protocol for treatment of patients with COVID-19" of the Moscow City Health Department, 2020 and 2021.
• Methodological recommendations "On the use of Triazavirin for the treatment and post-exposure prevention of COVID-19" of the Ministry of Health of the Sverdlovsk Region.
• Methodological recommendations "Drug Therapy for Acute Respiratory Viral Infections (ARVI) in Outpatient Practice During the COVID-19 Epidemic", version 2 dated 16/4/2020.
Throughout 2020, Triazavirin® was supplied not only in Russia, but also abroad, including the deliveries of the medicine to the CIS countries, the Republic of South Africa, Kenya, etc.
Since 2020, the Medsintez Plant has been producing solutions of sterile anticoagulants and hemopreservatives for automated apheresis, such as ACD-A, CPD-50, SAG-M, PAGGSM, Glycerin 57.1%, Sodium chloride 0.9% with glucose 0 ,2%, Sodium chloride 12%, Sodium citrate 4%, Trombosol. The solutions are produced in various dosages from 100 ml to 2,500 ml in own pharmaceutical packaging. The production capacity at the Medsintez Plant makes it possible to fully satisfy the current demand in Russia for solutions for automated apheresis.
Also in 2020, the Medsintez Plant began working on the creation of its own genetically engineered vaccine Ural against the Coronavirus disease, which will be hypoallergenic and effective against any type of COVID-19. In December, preclinical studies of the medicine started. The project is currently on hold due to the difficulty of scaling the technology.
The Medsintez Plant is a partner of the Gamaleya Research Center of Epidemiology and Microbiology in the organization of industrial production of the Sputnik V vaccine against COVID-19. The production site was launched and the technological transfer was made in 2020, and a test batch of the medicine was produced in 2021. Currently, the process of including the production site of the Medsintez Plant in the registration certificate of the Gamaleya Center for the production of the Sputnik V vaccine is in progress.
In 2020, the Medsintez Plant is increasing the production capacity of Primapur®, a medicine for the treatment of infertility. In total, 12 industrial batches were produced in the first year of release of the medicine into civilian circulation. Primapur® was used in 50 clinics throughout Russia for the treatment of more than 8,000 patients.
The project of Import-substituting Production of Genetically Engineered and Analogue Insulin is being implemented with the support of the Industrial Development Fund. In December 2020, Rosinsulin Glargine own analogue insulin substance (100 IU/mL) was registered, medicines of the entire line of genetically engineered insulin Rosinsulin Medsintez and analogue insulin Rosinsulin Aspart R from the own substance were registered, as well as a decision by the Ministry of Health of the Russian Federation is expected on adding own analogue medicine Rosinsulin Glargine to the State Register of Medicines for the subsequent production of finished dosage forms. In December 2021, the analogue insulin medicine Rosinsulin Glargine 300 Medsintez (300 IU/ml) was registered.
In 2020, the Medsintez Plant received a license for the production of medicines for veterinary use for the further production of the first Russian insulins for animals.
On May 14, 2021, the Ministry of Health of Russia made a decision to amend the registration certificate for Triazavirin® – the medicine was given the over-the-counter status of dispensing from pharmacies, and the indications for use in relation to viral infections were significantly expanded.
In 2021, based on the positive results of a preclinical study of Triazavirin, a set of documents was submitted to the Ministry of Health of Russia for obtaining permission to conduct a clinical trial of the medicine (100 mg caps) in order to confirm its efficacy and safety for the treatment of children aged 12–17 years with a diagnosis of ARVI.
Also in 2021, based on all previous clinical trials and accumulated clinical experience with the medicine, Triazavirin was included in the draft updated federal clinical guidelines of the Russian Ministry of Health for the treatment of influenza and ARVI as a medicine with a direct antiviral effect with a high level of persuasiveness of A1 recommendations.
On February 15, 2022, the Russian Ministry of Health published Federal Clinical Guidelines for the Treatment of Acute Respiratory Viral Infections (ARVI) in Adults. One of the three medicines for etiotropic therapy of ARVI was the antiviral medicine Triazavirin, which confirmed the recognition of the medicine by the scientific community and evidence-based medicine.
In 2022, the Medsintez Plant is ready 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 pharmacopoeial acetonitrile, which is necessary for the operation of a large number of research laboratories. This reagent was formerly produced only in Europe.
In addition, if necessary, the high-tech production of the Medsintez Plant is able to produce any import-substituting medicines based on monoclonal antibodies.
In 2022, multicenter clinical trials of Triazavirin at a dosage of 100 mg for the treatment of ARVI in children aged 12–17 were successfully completed. Triazavirin showed a high efficacy and a good safety profile. Currently, an approval is expected for multicenter double-blind clinical trials in children of the next age group – from 6 to 11 years.
The solemn opening of the workshop for the production of biotechnological substances for the reproductive health of women took place at the Medsintez Plant on November 2022. Since 2018, the Medsintez Plant, in cooperation with iVFarma, has been producing the first Russian preparation of recombinant follicle-stimulating hormone (FSH) for the treatment of human infertility – Primapur®. With the opening of the new workshop, the plant has obtained new production facilities to provide domestic medicine with modern highly-demanded drugs. Thus, the production capacity of the FSH preparation at the plant is up to 30 grams of the substance, up to 1 million disposable syringe pens per year. The Medsintez Plant is ready to meet 200% of the annual demand for FSH preparations in Russia. Solving the issues of import substitution, the company conducts research and development work to prepare for the production of other hormonal preparations necessary for the IVF procedure. New preparations of human chorionic gonadotropin and human gonadotropin-releasing hormone antagonist are currently at the stage of preliminary work before being submitted for registration with the Russian Ministry of Health.
In 2022, the Medsintez Plant received a GMP compliance certificate for the production site of biotechnological medicines for veterinary use. So, in 2023, it is planned to produce the first Russian insulins for animals.
An important event in 2023 for the Medsintez Plant was the inclusion of its own analog medicine Rosinsulin Glargine (100 IU/ml) in the State Register of Medicines. Thus, the Medsintez plant has launched the production of a full cycle of the entire line of products of genetically engineered human insulin Rosinsulin and analogue insulins – Rosinsulin Aspart R and Rosinsulin Glargine from its own substances.
In 2023, the company launched the production of the first Russian species-specific insulins for veterinary use: Vinsuvet Glargine ANIMALPEN for cats and Vinsuvet Mix 30/70 ANIMALPEN for dogs. In the absence of the foreign drug on the Russian market, our own production of veterinary insulin will become a reliable support for pet owners in caring for their pets' health. The drug is available in the most convenient form – a disposable prefilled syringe pen.
To expand the international partnership, in June 2023, Medsintez Plant LLC signed a Memorandum of Understanding with Central Pharmaceutical Company CPC1, JSC. The purpose of signing the document is to develop cooperation and mutual promotion in the development of products for the present and future. The company plans to complete the construction project of a plant for the production of antidiabetic drugs in the Republic of Vietnam and bring the products to the Vietnamese pharmaceutical market.
In 2023, to ensure the drug safety of our country, the Medsintez Plant, in collaboration with the Promomed Group of Companies, launched the production of a full cycle of hypoglycemic drugs for the treatment of type II diabetes mellitus: Liraglutide and Semaglutide. Due to the departure of foreign manufacturers from Russia, these drugs were included in the list of drugs in shortage. While the incidence of type II diabetes today is 90% of the total number of diabetic patients. The drugs are available in the most convenient dosage form – a disposable pre-filled syringe pen. The company will be able to meet 100% of Russia's needs for these drugs.
On October 26, 2023, a new indication was added to the instructions for medical use of the Triazavirin drug – now the drug can also be used for the prevention of COVID-19. Triazavirin is the only direct-acting antiviral drug approved for the prevention of COVID-19 approved by the Ministry of Health of the Russian Federation.
In 2024 the full-cycle production of the world's first registered recombinant human albumin for widespread use in medicine was launched. Recombinant albumin is identical to the natural human albumin, however, it’s production process eliminates the risk of contamination with infectious agents such as hepatitis viruses, human immunodeficiency viruses, etc., as well as associated blood plasma proteins (α-, β-, γ-globulin fractions). The production of recombinant albumin does not depend on the number of donors and allows the drug to be produced on a large scale. The drug is produced in the most convenient for use polyethylene five-layer containers.
The plant management sees further development prospects in manufacturing new types of medical products and exploring new markets. The pharmaceutical area is developing through the implementation of projects for the development of genetically engineered and antiviral drugs and active pharmaceutical ingredients.
