During the reinspection, the production conditions at the Company’s 11 sites manufacturing sterile and non-sterile medicinal products, including four new production sites, were audited.
Farmak JSC is expecting the inspection report within the term established by the Croatian laws.
The positive result of the reinspection will facilitate Farmak’s expansion to the European markets.
According to the notice of the State Service of Ukraine on Medicines and Drug Control, “The passing of such procedure and the extension of the GMP certificate validity for Farmak, a Ukrainian manufacturer, is a confirmation of the quality of medicinal products manufactured by the Company, as well as their marketing authorizations”.
Previous inspections by HALMED, the Croatian regulatory agency, were conducted at Farmak JSC in 2015. Following the inspections, the Company obtained the corresponding GMP certificates.
