SYNTHETIC DATA

SWISS PRODUCTION SITE: south Switzerland, in Bedano near Lugano. About 70 km North from Milano.

PERSONNELS: about 100 employees

CERTIFICATION: cGMP issued by Swissmedic

ACTIVITY: under contract manufacturing production of modified release solid oral form in pellets, tablet or resinate dispatched in bulk. If requested, capsule filling and/or blistering and/or packaging for pharmacy is feasible.

ADVANCED TECHNOLOGIES: coating-pans, Extrusion-spheronisation, Ion-Exchange resinates

FINAL DOSIFICATION: hard gelatine capsules or tablets

CAPACITY: today with one shift, about 120 millions doses monthly equivalent to about 1.4 billions doses or 350 tons/yearly.

POTENTIAL CAPACITY: with double shift, about 200 millions doses monthly.

REGULATORY ACTIVITIES: supports the clients with the preparation of new dossiers and up to date of existing ones following regulatory requirements in CTD format.

R&D: more than 40 years of experience in our field, new development related activities (study, development, scale up production, validations and stability) to collect data to generate the CTD dossier (technical part) for registration purposes.