Fabbrica Italiana Sintetici SpA (FIS) is an Italian privately owned and independent company, dedicated to developing and manufacturing APIs, advanced intermediates and fine chemicals for the worldwide pharmaceutical industry. Its main cGMP production site is located in Montecchio Maggiore, Italy, with a capacity of 1,450m³, and another site, recently revamped to cGMP level, is located in Termoli, Italy, with an additional 340m³ capacity.
FIS offers a large and continuously evolving generics API product list, among them benzodiazepines (tranquilisers, antipsychotics and controlled substances), antidepressives, antibacterials, antimycotics, antimigraine, steroids, antiepileptics, anticancer and active cosmetic ingredients. It proudly represents one of the largest European providers of contract manufacturing services.
FIS can also provide an integrated service from R&D to full-scale production, from grammes to tons, including a full cGMP Pilot Plant with 30m³ of total capacity, full regulatory support for NDAs and ANDAs, and experience for worldwide registrations.
For over 40 years FIS has been regularly inspected by the FDA. The last inspection in May 2005 was successfully passed without any FDA Form 483 observation. Additionally, successful inspections have been carried out by PMDA Japan and the Korean KFDA, as well as guesting an average of 25 customer audits per year.
This, together with a special attention to customer service, the environment (FIS is member of the Responsible Care Program), and the skills of FIS staff among the highest on the market, make FIS the best choice for a successful partnership.
