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Dmytro Shymkiv commented on the completion of a range of investigations on Darnytsia generic drugs in the EU laboratories

MGSDMay 17, 20212 min read
Dmytro Shymkiv, the head of Darnytsia
Dmytro Shymkiv, the head of Darnytsia. Supplied Photo.
Dmytro Shymkiv, the Chairman of the Board of Directors of Darnytsia Group, reported that the Darnytsia company had completed a range of investigations on generic drugs in the European laboratories. Also, he clarified that the clinical part of all tests was carried out in Ukraine. And only after that, the biological materials were transferred to laboratories in the EU for final analyzes.
The generic takes an integral part of investigations, Shymkiv added. It is a drug that contains a chemical. The generic is an active pharmaceutical ingredient identical to the one patented by the company that initially developed the drug. The generic drug must be bioequivalent to the original one. In brief, generic drugs must have the same therapeutic effect, level of safety, and tolerance. In order to establish bioequivalence, generic companies deliver samples of their products to the laboratories of the original manufacturers or independent expert bioanalytical research centers. The Darnytsia company followed the same strategy. Dmytro Shymkiv noted that the concern is responsible to its consumers. Therefore, in order to ensure the effectiveness and safety of its drugs, the company delivered the biomaterials of the developments to competent European laboratories. When choosing a research partner, Darnytsia Group adhered to one crucial criterion: whether the bioanalytical laboratory has a sufficient clinical base to comply with international requirements and provide research at the highest level. Clarifying information about the partner laboratories, Dmytro Shymkiv noted that the Darnytsia pharmaceutical company had successfully cooperated with Quinta-Analytica, the Czech bioanalytical service, for many years. It possesses an excellent clinical base and an impeccable reputation in the pharmaceutical industry. When it comes to Darnytsia drugs sent to check compliance with therapeutic equivalence and safety, it is about 8 drug names. Since 2018, their development, research, and clinical tests were undertaken in Ukraine. The action of these generics is aimed at treating the cardiovascular and central nervous systems. Thanks to the efforts of the Darnytsia Group, Ukrainians can now purchase effective new-generation drugs at reasonable prices. (PR)

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