The pharmaceutical company Farmak (Kyiv) stands for mutual recognition of the results of good manufacturing practice (GMP) checks in production of medicines within the framework of the Ukraine-EU industrial dialogue. “A key prerequisite for realizing cooperation opportunities between the Ukrainian and European pharmaceutical sectors is to update the scope of the future ACAA agreement (Agreement on Conformity Assessment and Acceptance of Industrial Goods) with the EU. First of all, to include provisions on the mutual recognition of the results of audits of good manufacturing practice in the pharmaceutical sector (GMP),” Yevhenia Piddubna, the director for corporate communications at Farmak, told Interfax-Ukraine.
She also noted the high potential for the participation of the Ukrainian pharmaceutical industry in the diversification of European supply chains for critical medicines in the face of the COVID-19 pandemic.
Farmak is one of the oldest pharmaceutical companies in Ukraine, specializing in the production of modern high-tech drugs. At the company’s production sites, a pharmaceutical quality system has been introduced and it is constantly being improved in accordance with the current regulatory requirements and in accordance with international standards: ISO, GMP (Good Manufacturing Practice). The company undergoes several international inspections and audits annually.
The company is included in the top 100 largest taxpayers in Ukraine. In 2020, Farmak paid taxes totaling more than UAH 712 million, including UAH 120 million to the Kyiv city budget.
Farmak is a member of the Manufacturers of Medications of Ukraine association.
A team of Ukrainian researchers, which included scientists from JSC Farmak pharmaceutical company and the Hromashevsky Institute of Epidemiology and Infectious Diseases, have developed a PCR test capable of detecting even new strains of the Sars-Cov-2 coronavirus. According to the company’s press release, the availability of technological equipment purchased by Farmak allowed for the first time in Ukraine to carry out the sequencing procedure. This is “reading” the sequence of nucleotides in the RNA of the virus “as spelling a text.”
“Sequencing allows, in case of revealing differences in the genetic text (mutations), to draw conclusions about the presence of new strains of the virus. The results of the study, in fact, confirmed the presence of a new strain of coronavirus in Ukraine,” the researchers said.
The results of the study, as well as information about the virus strains circulating in Ukraine since the beginning of the pandemic, have already been posted in the GISAID international initiative promoting the rapid sharing of data from all influenza viruses and the coronavirus causing COVID-19.
Farmak said that on March 3, the research team confirmed that the new PCR test system developed by the pharmaceutical company’s specialists, in addition to the already widespread strains, also detects the new UK variant of coronavirus.
The Farmak test system was based on the TaqPath COVID 19 RT PCR Kit (Thermo Scientific, the United States), which is authorized by the U.S. Federal Drug Administration (FDA). High quality components made in the United States are used for the production of the new SARS-CoV-2 test kit.
The quality of the new test kit is confirmed by the relevant findings of the Hromashevsky Institute of Epidemiology and Infectious Diseases of the Academy of Medical Sciences of Ukraine (Kyiv) and the Mechnikov Institute of Microbiology and Immunology of the Academy of Medical Sciences of Ukraine (Kharkiv). Reference trials of the PCR test kit are carried out in private and public laboratories in Ukraine (Kharkiv, Dnipro, Zaporizhia, Vinnytsia), confirming its effectiveness.
Farmak said that the new test kit has opened up to pre-purchasing.
The Farmak pharmaceutical company (Kyiv), thanks to the decision of Kyiv City Council to sell a land plot to the pharmaceutical company, plans to develop an R&D cluster project.
According to a press release on the company’s website, on February 11 this year, Kyiv City Council, by an absolute majority of votes, decided to sell the company the land on which the production facilities of Farmak plant have been located for 95 years.
The intended use of land defined by the document is the operation and maintenance of a complex of buildings and structures.
“Farmak expresses gratitude to the deputies for supporting the development of a virtuous and transparent business. Production facilities, research facilities, the laboratory and technical complex of the enterprise are internationally certified and meet the high requirements of European standards. Now, thanks to the positive decision of the city council, we will be able to implement another ambitious project – the creation of a pharmaceutical R&D cluster to build up scientific and technical potential,” executive director of the company Volodymyr Kostiuk said.
He recalled that over the past 25 years, Farmak has invested more than $ 300 million in the modernization of the enterprise.
Technical director of Farmak Andriy Goy, in turn, emphasized that the creation of the R&D cluster will be a step forward towards the development of biomedical research and development in Ukraine and an important step towards the transformation of Kyiv into the capital of the European level.
“The main capital of Kyiv should be precisely an intellectual product,” he said.
The company is confident that the emergence of an R&D cluster will contribute to an increase in revenues to the city budget from knowledge-intensive sectors of the economy.
Farmak pharmaceutical company supports a balanced approach to revising state sanitary rules for the development of settlements in terms of reducing the sanitary zones of pharmaceutical companies.
“Farmak supports the gradual revision of state sanitary rules for planning and building up settlements in terms of reducing the sanitary zone of enterprises producing medicines. The process of revising state sanitary rules should be balanced and gradual, with constant expert monitoring of the level of impact of the enterprise’s work on the environmental situation and public health,” the company said in a statement posted on its website.
The company emphasizes that the current state sanitary rules adopted in 1996 are outdated and do not comply with the norms and rules that are in force in the EU.
“Now drug manufacturers use modern and safer equipment, the latest air and water purification systems, etc. The company has repeatedly informed the public about the removal of the production of active pharmaceutical ingredients that have the greatest impact on the environment outside Kyiv,” the company recalls.
Farmak notes that at present some media are conducting a targeted information attack on Kyiv-based plant Farmak.
“The most likely goal of the customers of the publications is to manipulate public opinion and Kyiv City Council deputies to clear the site in Podil for the next construction,” the company noted, stressing that the desire to build more residential buildings should not prevail over common sense.
“Neither the healthcare system, nor the economy of the country and, in particular, of Kyiv, can today afford to get rid of a European level manufacturer of medicines, a conscientious taxpayer, one of the best employers and exporter of products with high added value, to please the interests of individual business groups,” Farmak said.
“We are deeply convinced, provided that the general plan of the city is correctly drawn up, various formats of buildings can harmoniously coexist, as can be seen from numerous examples in the EU,” the report says.
The pharmaceutical company JSC Farmak (Kyiv) has received a request from the Ministry of Health and scientists regarding the possibility of its involvement in clinical trials of a Ukrainian vaccine against COVID-19, the company has told Interfax-Ukraine.
“Farmak has recently received a request from the Ministry of Health and scientists about the possibility of involving the company in clinical trials of the Ukrainian vaccine against COVID-19. Also, the state received a request for the possibility of industrial production of the vaccine (if its safety and effectiveness are proved),” the company said.
Currently, Farmak is studying the request: the company’s experts are analyzing the available materials related to the development and are consulting with scientists and representatives of the Ministry of Health.
As reported, the state intends to fund clinical trials of the vaccine.
Farmak manufactures medicines in all fourteen therapeutic groups. Among the main directions are anti-cold, endocrinological, gastroenterological, cardiological, neurological portfolios. The company annually introduces to the market about 20 new complex-component modern drugs, and about 100 drugs are currently in development.
Over the past five years, Farmak’s investments in the scientific and technical complex, production equipment, and research activities amounted to UAH 3.4 billion.
In 2019, Farmak received a net profit of UAH 1.056 billion, which is almost the same as in 2018 at UAH 1.05 billion, while in 2018 Farmak increased its net profit by 25.16%.
JSC Farmak is a member of the Manufacturers of Medications of Ukraine Association.
According to the unified state register of legal entities and individual entrepreneurs, the ultimate beneficial owner of Farmak is the head of the supervisory board, Filya Zhebrovska, who owns 80% of the company’s shares.
The website of the Farmak pharmaceutical company (Kyiv) is visited by about 400,000 people per month.
According to a Farmak’s press release, the pharmaceutical company entered the top 10 companies according to the Company Transparency Index 2019, calculated by the Corporate Governance Professional Association in cooperation with the Corporate Social Responsibility Development center and with the support of CIPE and assistance of the Ministry for Development of Economy, Trade and Agriculture.
The top 10 index leaders provide more than 50% of the information that was included in the evaluation categories, while the overall level of transparency of the websites of other companies in Ukraine is about 25%.
The Index survey showed that most often companies post information related to environmental protection, labor relations, work with communities, corporate governance, company management, composition of the supervisory board, information for investors, anti-corruption programs on their websites.
Executive Director of Farmak Volodymyr Kostiuk said that “information openness is a requirement of the time, without which the company cannot become successful.”
“International investors and partners are actively exploring the information space about the company. This is extremely important for us. After all, we export products to 28 countries,” he said.
Kostiuk said that Farmak publishes financial statements according to international standards every year. And having become a member of the UN Global Compact, in 2020 Farmak first published the company’s non-financial statements.
“In addition to the main website of the company, we also have the websites of our representative offices, where relevant information for these countries is collected. The company also has active pages on social networks Facebook, Instagram, and YouTube. Only on Facebook, 24,000 users have already subscribed to the Farmak page,” he said.