Darnitsa received the Australian GMP Certificate

April 8, 2022. Darnitsa pharmaceutical company announces that it has received a certificate of compliance with the Good Manufacturing Practice (GMP) requirements from the Australian regulatory authority. Subject to that certification were Darnitsa's sterile production facilities: ampoule and infusion production shops. The company team has been working on this  three years along. This cerification allows the company to significantly expand the geography of drug exports. 

Australia is one of the countries with a strict regulatory policy in the field of drug circulation control, so this certificate once again confirms the high quality of Darnitsa products. Since 2003, the production facilities of "Darnitsa" company hold a GMP certificate issued by the Inspectorate of the State Service of Ukraine. Since 2016 the Company holds the GMP certificate issued by the Lithuanian Regulatory Authority.

The international GMP  (Good Manufacturing Practice) standard  is the main document for certification of pharmaceutical industries around the world. Medicines and active pharmaceutical ingredients are manufactured in strict accordance with its requirements. The company's GMP certificate confirms that the products are manufactured under strictly regulated conditions that exclude foreign substances' ingress (contamination), and follow the necessary quantitative and qualitative composition requirements, being packed properly (that guarantees retaining their properties throughout the entire shelf life), stored and transported as duly appropriate.

"Ukrainian business is the basis for further development and restoration of Ukraine. As the country's largest producer, the Darnitsa company actively supports the state's economy. Today we received the Australian GMP certificate, so now we have the opportunity to expand our export potential in this direction. This March, we signed a license agreement with the Medicines Patent Pool to develop and manufacture a generic version of the Pfizer oral drug for COVID-19 treatment with the right to supply it to 95 countries worldwide.  The Company looks two steps ahead, moves on, and continues its development. We believe in victory over the aggressor!"- said Dmitry Shymkiv, Chairman of the Darnitsa Group Board of Directors.

Reference

PJSC pharmaceutical company "Darnitsa" was founded in 1930. Since 1998, Darnitsa is the leader in Ukrainian pharma industry in terms of drug production in kind. Strategic areas of products portfolio development include cardiology, neurology, and pain management.

*in physical terms Proxima Research, 2021-2022