In 2004, SIMA – MIHOV was approved by Basell to manufacture stoppers of Purell with regard to packaging of solution for infusion. At the request of Basell, the drug master file (DMF) of Purell was supplemented and the U.S. Food and Drug Administration (FDA) was notified in writing, as required.


A reference from the pharmaceutical company Actavis is presented below. Other references could be provided upon request.