The Medsintez Plant, a partner of the VIII All-Russian GMP Conference with international participation, celebrates its 20th anniversary

It is worth noting that the Plant is located in Novouralsk, a town in the Sverdlovsk region, as is the venue for the event. Today, the Medsintez innovative plant is one of the largest pharmaceutical enterprises in Russia, which specializes in the development and production of medicines, veterinary drugs, medical products and active pharmaceutical ingredients.

In 2007, the Medsintez Plant became the first pharmaceutical company in Russia to be awarded the Russian Government Prize for Quality. In 2008, the company launched Russia’s first production of genetically engineered human insulin that fully complies with international Good Manufacturing Practice standards. This played a big role in import substitution and increase of the availability of the most important preparation for Russian patients.

Developing production, Medsintez, with the support of the Industrial Development Fund of the Russian Federation, created insulin substance from its own producing bacterium, developed a technology for its production, and today uses it in its own production of finished drugs. Thus, the Medsintez Plant became the first full-cycle biotechnological company in the Urals, which not only produces, but also develops medicines.

Today, in addition to insulin, the Plant produces specialized drugs and products for medical use, such as recombinant human follicle stimulating hormone, antiviral preparations, anticoagulant solutions, antibiotics. The drugs are available in all dosage forms: pills, capsules, injection and infusion solutions in large and small volumes.

The production areas of the Plant are organized in full compliance with the GMP requirements. The Plant has organized a multi-stage quality control system at each stage of drug production — control of input raw materials, in-process control of intermediate products, control of finished products. There is also continuous monitoring of compliance with storage conditions for medicines, production facilities and processes, including by independent companies.
Research is carried out in the research, microbiological, chromatographic, and control-analytical laboratories of the Plant. The structure of the Directore for Quality Division (including quality control and quality assurance departments) meets the GMP standards in full. In addition, all plant employees were trained in GMP requirements in special training organizations and directly at the enterprise.

The operations of the Medsintez Plant attracts foreign partners. For example, during the pandemic, the antiviral drug Triazavirin developed by the Plant reached the international level. Clinical trials of the drug were held in Russia and China, where its effectiveness against COVID-19 was confirmed. As a result, the drug was recommended for treating coronavirus disease both in China and in the Russian Federation. Triazavirin is a direct antiviral drug recommended by the Ministry of Health of the Russian Federation for treating influenza and ARVI.

To expand the international partnership, in June 2023, the Medsintez Plant signed a Memorandum of Understanding with Central Pharmaceutical Company CPC1, JSC. The purpose of signing the document is to develop cooperation and mutual advancement in developing products for the present and future. The short-term plans are to complete the construction project of a plant for producing anti-diabetic preparations in the Republic of Vietnam and bring the products to the Vietnamese pharmaceutical market.

Since the 2023 GMP conference has participants from other countries, they will be especially interested in the experience of such interaction, which, among other things, will be shared by experts from the Medsintez Plant.

Material prepared on the basis of: PRO GMP