Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today announces six months data from its stability study with HyNap-Dasa tablets manufactured in commercial scale. Six months stability data on commercially manufactured HyNap-Dasa demonstrates that the tablets complies with specifications and that they can be used in an upcoming ANDA filing.
In February 2020 stability studies were initiated with HyNap-Dasa tablets manufactured in commercial scale according to GMP-standard. In accordance with regulatory requirements three batches were put on stability at accelerated conditions (40oC and 75% relative humidity) and normal conditions (25oC and 60% relative humidity). Xspray now announces that the six months data have been analyzed and show compliance with the specification.
“As expected, the stability study showed good results, which is necessary for the filing for market approval in the US. We continue to work intensively on the preparations to be able to file an application for market approval for HyNap-Dasa as soon as possible. In late September we are awaiting the results from the second bioequivalence study with HyNap-Dasa, thereafter we will decide on the best strategy for our upcoming ANDA filing,” comments Per Andersson.