Darnitsa has registered the pharmaceutical substance hydroxychloroquine14 April 2020
Darnitsa has registered the pharmaceutical substance hydroxychloroquine which has been included to the national protocol for the treatment of the coronavirus infection (COVID-19) as an experimental therapy drug.
Drugs containing hydroxychloroquine as the active substance are used to treat patients with COVID-19 in the USA, Japan and European countries under clinical trials provided that the patients consent is required without fail.
“Darnitsa has obtained the state registration for hydroxychloroquine and continues the process of necessary actions to commence the manufacture of the finished medicinal product,” Dmytro Shymkiv, Chairman of the Board of Directors of Darnitsa Group, reported. “We have registered the substance hydroxychloroquine within the shortest time possible due to prompt actions of the State Expert Center and the Ministry of Health. We thank Tetiana Dumenko and the team of the State Expert Center and the Ministry of Health for understanding and the speedy response in this important issue.”
The therapy with medicinal products containing hydroxychloroquine as the active substance is used for patients with moderate and severe COVID-19 only in a hospital setting under the care of a physician and with the informed consent of the patient.
Previously Darnitsa has declared its readiness to manufacture medicines containing hydroxychloroquine. The principal prerequisite for the organization of such production is the active engagement of the Ministry of Health in regulatory matters.
“We are already carrying the active substance, hydroxychloroquine, to Ukraine. We’ve managed to reserve it for ourselves when most countries blocked the export of this substance. Today we are waiting for the Ministry of Health to fulfill the actions stipulated by the revised version of the laws “Fundamental Principles of Legislation on Healthcare” and “On Medicinal Products” which came into effect as from April 1, 2020. Then we will be able to move on.”