At the beginning of 2021, the representatives of the Republic of Belarus inspected Farmak’s manufacturing, warehouse, laboratory facilities and the functioning of its pharmaceutical quality system. Following the inspection, the Company’s facilities engaged in manufacturing of finished medicinal products have got the EAEU GMP Certificate.
The EAEU GMP Certificate becomes a prerequisite for the registration/re-registration and sale of medicinal products in the markets of the EAEU member states (Belarus, Kazakhstan, Kyrgyzstan, etc.) and will reduce the number of inspections carried out by local regulatory authorities of the EAEU member states.
“The key thing for us is to provide consumers with high-quality innovative medicines. To achieve this, we strictly adhere to all international standards and requirements for the manufacture of medicinal products. This is clearly confirmed by the certification following world inspections which Farmak passes every year. We are now preparing for the FDA* compliance inspection to enter the U.S. market,” said Volodymyr Kostiuk, Chief Executive Officer of Farmak.
Today, Farmak’s facilities engaged in manufacturing of finished medicinal products have not only the national GMP certificate, but are also certified by the European regulatory authorities. This makes it possible to sell products in markets with particularly stringent requirements for the quality and safety of medicinal products.
Besides, last year, Dexamethasoni Phosphas with dexamethasone as an active substance was successfully prequalified by the World Health Organization and is listed among the medicinal products with proven quality and efficacy in 2 groups: HIV/AIDS and COVID-19.
At year-end 2020, Farmak increased its exports by 40%, having shipped products to more than 30 countries in the EU, Central and South America, the CIS, the Middle East, Asia, etc. Today, the share of exports in the Company’s total sales is 29.6%.
*U.S. Food and Drug Administration
