Ukrainian medicines of European quality: how “Farmak” introduces innovations and constantly expands the geography of exports
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The pharmaceutical industry occupies an important place in the economy of Ukraine. As shown first by the COVID-19 pandemic, and later by a full-scale war, the presence of strong local drug manufacturers is an important component of national security and defense capability.
In times of peace, the farm is characterized by high investment activity in innovation, science-intensive component and the level of cooperation with the relevant international community. Ukrainian pharmaceutical companies generate high product added value within the country and are active exporters of drugs abroad.
Sustainable and crisis-resistant local production of medicines is important for the country, as the health and well-being of the population depends on it. In the conditions of war and post-war reconstruction, it is important for the state to invest in the development of knowledge-intensive industries industries that do not require extensive growth.
Ukraine has everything necessary to become a new Eastern European hub that can partially reduce the dependence of the EU health care system on supplies of raw materials and finished medicines from China and India.
Which, in turn, will lead to an impulse in the development and production of quality medicines for the Ukrainian patient.
For this, we as a country have several important prerequisites – sufficient production capacity, qualified personnel for the production of medicines or active pharmaceutical ingredients.
Ukrainian medicines of European quality
In order for medicinal products to enter the Ukrainian market, manufacturers and importers must confirm compliance with national GMP (Good Manufacturing Practice) standards.
GMP – is part of the quality assurance system, a guarantee that pharmaceutical products are manufactured and controlled according to quality standards and in accordance with a trade license.
But in order to be competitive abroad, it is necessary to constantly confirm high quality standards by passing international inspections. Among Ukrainian pharmaceutical companies, Farmak has the largest number of GMP certificates issued by European regulators.
It is covered by them production of drugs in various forms, starting from tablets, capsules, ointments, ending with suppositories, drugs in the form of emulsions, suspensions, as well as operations for product quality control.
This certificate is issued by the European regulatory authorities on the basis of a detailed verification of compliance with all the requirements of pharmaceutical production established by the European Union.
GMP certificates issued by an EU member state are recognized throughout the European Union.
Farmak received its first EU GMP certificate in 2005 from the regulatory body of Latvia. Since then, production inspection has been carried out by regulatory bodies of various countries.
Today, Farmak is inspected not only by regulatory bodies, but also by foreign partner companies from Great Britain, Switzerland, Germany, Poland, Israel, etc., which order the production of their products at Farmak’s facilities.
How is quality controlled?
5 laboratories are responsible for quality control in the company. They undergo an average of 10 Ukrainian and foreign inspections per year. Laboratory devices and equipment that control the quality of medicines at the plant are manufactured in the EU.
The cost of a unit of such equipment can reach up to UAH 10 million, and there are 514 of them only in the laboratories of the Farmak quality control department.
Each finished medicinal product is simultaneously sent to different laboratories, where it is checked for a number of indicators. In general, the company’s laboratories own 135 test methods, which are approved by the world’s leading pharmacopoeias: European Pharmacopoeia, British Pharmacopoeia and US Pharmacopoeia.
“Farmak” works on the development of medicines in 12 of its own laboratories, and also involves more than 50 companies and R&D centers from all over the world in scientific partnership.
Technological production and digitization of processes as a driving force
At Farmak, the processes are automated and digitized. Each step in the manufacture of medicines is recorded in a database from which information cannot be deleted.
During GMP inspections, which the regulatory body can assign to the manufacturer on a scheduled or unscheduled basis, the processes and data recorded in the computerized system are also analyzed.
Another area where “Farmak” introduced a digital approach – process control. Production equipment is synchronized with the computer system using special sensors and programs. Accordingly, the management staff can observe the production processes in the same way as the operator sees them on site, without leaving his office.
A complete production cycle and a wide range of medicines
There are many enterprises in Ukraine that remain dependent on the import of raw materials for a long time. However, there are also examples of companies that already have experience in the production of medicinal products in a full cycle – from independent production of active pharmaceutical ingredients (API) to finished products.
In particular, in 2015, the Farmak company launched its own API production in Shostka, Sumy region, and invested 40 million US dollars in this project.
In addition to reducing dependence on global market conditions, such a decision allows the company to partially control the cost of finished medicines and avoid a shortage of important medicines on the Ukrainian market.
The company manufactures medicinal products in all therapeutic areas. Among the main ones are endocrinological, gastroenterological, cardiology, neurological, anti-cold and other medicines.
In total, the company’s product portfolio includes more than 400 names of medicines.
Constant expansion of export geography
According to Proxima Research, since 2010 “Farmak” has been the leader of the pharmaceutical market of Ukraine in monetary terms, and also one from the largest exporters of medicines.
Currently “Farmak” exports its medicinal products to more than 50 countries of the world, in particular, to 15 EU countries, including Germany, Poland, Italy, Sweden, etc. Since 2020, the company has launched exports to Mexico, Colombia, and a year later – to Brazil, Bolivia and a number of African countries.
The company has representative offices in Uzbekistan, Kazakhstan, Kyrgyzstan and Vietnam, as well as international offices in Poland and the UAE. In 2023, marketing companies in the Czech Republic and Slovakia were acquired. Next year, “Farmak” opens its own production in Spain.
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