PJSC "Pharmak" (Kyiv), one of the largest pharmaceutical manufacturers in Ukraine, has received confirmation of compliance for tablets "Validol" the requirements of the Office of the sanitary supervision by the Food and Drug Administration of the United States (Food and Drug Administration, FDA).
According to the website of the company, FDA inspection took place from 7 to 13 November 2012.
Demonstration of compliance with tablets "Validol" the requirements of FDA, allowing to withdraw the drug to the U.S. market, was the first positive experience of "Pharmak" in passing the inspection FDA.
As reported, "Pharmak" plans to be certified by the standards of the FDA in 2014. However, the company noted that "the standard FDA — a long-term future of our strategy."
At the same time, in the short term, "Pharmak" planned project partner of the international drug manufacturing at its facilities by the standards of FDA.
"Pharmak" certified by European standards GMP (Good Manufacturing Practice, Good Manufacturing Practice).
PJSC "Pharmak" plans by 2020 to reach sales of $ 1 billion by 2020 "Pharmak" plans to reduce the share of sales in the domestic market from 80% to 60% of total sales, and focus, in particular, with 10% of sales on the well- regulated markets of Eastern Europe, CIS countries (excluding Russia) and in the Russian market.
In 2012, "Pharmak" increased its net profit by 11.85% as compared to 2011 — up to 272.722 million UAH. Sales rose by 15% — to 1.7 billion USD.
The final beneficiary of the "Pharmak", which also includes two subsidiary companies, three special purpose entities and one associate, is the CEO of the parent bank "Pharmak" Phil Zhebrovskaya.
FDA (Food and Drug Administration) — Management of the sanitary supervision by the Food and Drug Administration of the United States. It is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, medical devices, veterinary products, and cosmetics.