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.
The plant management sees further development prospects in manufacturing new types of medical products and exploring new markets. The pharmaceutical area is supposed to be developed by implementing a number of projects to organize the production of medicines and active pharmaceutical substances.