Dmytro Shymkiv, the chairman of the board of directors of Darnitsa Group, said that the Darnitsa company has completed a number of studies of generic drugs in laboratories of the EU countries. At that, he clarified that the clinical part of all the tests was carried out in Ukraine and only after that the biological materials were transferred to European laboratories for final analyses.
A generic is a drug that contains a certain chemical – an active ingredient that is identical to the one patented by the company – the primary developer of the drug. The generic drug must be bioequivalent to the original. In other words, it must have the same therapeutic effect, as well as a similar level of safety and tolerance. To confirm bioequivalence one must have analysis conducted, thus, the companies developing generics send samples of their products to the laboratories of the original manufacturers or independent expert bioanalytical research centers.
This is exactly what the Darnitsa company has done. Dmytro Shymkiv stated that the concern is responsible to its consumers. Therefore, in order to ensure the effectiveness and safety of its medicines, the plant has sent the biomaterials of the developments to the competent European laboratories. When choosing a research partner, Darnitsa Group was guided by one main requirement: the bioanalytical laboratory must have a sufficient clinical base to comply with international requirements and ensure that research is carried out at the highest level. Clarifying information about partner laboratories, Dmytro Shymkiv highlighted that the pharmaceutical company “Darnitsa” has been successfully cooperating with the Czech bioanalytical service Quinta-Analytica for many years. It has an excellent clinical base and an impeccable reputation in the pharmaceutical industry.
Going back to the drugs that Darnitsa sent for the examination of the conformity with the therapeutic equivalence and safety requirements, we are talking about 8 names. Their development, research and clinical trials have taken place in Ukraine since 2018. These generics are to treat the cardiovascular and central nervous systems illnesses. Now, thanks to the efforts of the Darnitsa Group, Ukrainians can buy effective new generation drugs at affordable prices.