On 21 March 2023, Swissmedic lifted the suspension of medicinal product authorisations and distribution activities of Amino AG. Manufacturing activities remained suspended. Following further measures taken by the company, the manufacture of non-sterile medicinal products at the Gebenstorf site is now permitted.
Establishment licence of Amino AG: Manufacture of non-sterile medicinal products permitted again at the Gebenstorf site
Manufacturing and distribution activities at the Belp site still suspended
11.05.2023
The company took further actions to ensure GMP/GDP-compliant manufacturing. Swissmedic has therefore lifted the suspension of the establishment licence for the manufacture of non-sterile medicinal products at the Gebenstorf site. Further measures are still required at the Belp site, where the existing suspensions therefore remain in place.
Manufacture and technical release of non-sterile medicinal products by Amino AG at the Gebenstorf site is permitted again with immediate effect. Sterile production continues to be suspended and can only be restarted once further corrective actions have been implemented and inspected.