The pharmaceutical company PJSC Farmak (Kyiv) has confirmed the compliance with the GMP of the Eurasian Economic Union (EAEU), which is a prerequisite for registration/re-registration and sale of drugs in the markets of the EAEU member countries, in particular in Belarus, Kazakhstan, Kyrgyzstan.
According to the company’s press release, the inspection of the pharmaceutical company at the beginning of 2021 was carried out by representatives of the Republic of Belarus, who checked production, warehouse, laboratory facilities and the functioning of the pharmaceutical quality system.
“The presence of the EAEU certificate becomes a prerequisite for the registration/re-registration and sale of drugs in the markets of the EAEU member states (Belarus, Kazakhstan, Kyrgyzstan, etc.) and will reduce the number of inspections carried out by local regulatory bodies of the EAEU member states,” a press release says.
The company is currently preparing to be tested for compliance with the FDA to enter the U.S. market, executive director of the Farmak company Volodymyr Kostiuk specified.
The company recalled that in 2020 the drug Dexamethasonum, which the company produces, successfully passed the WHO prequalification and is included in the list of drugs with confirmed quality and effectiveness in the treatment of HIV/AIDS and COVID-19.
As reported, Farmak at the end of 2020 increased the share of exports to 29.6% in total sales. Export deliveries by the end of the year increased by 40%.