F.I.S. – Fabbrica Italiana Sintetici S.p.A. is a global leader in the development of generic APIs. Our portfolio covers many therapeutic areas including CNS, controlled substances, antibacterials, anti-inflammatory drugs, diuretics, steroidal products, hormone replacement, cardiovascular drugs, alimentary tract and metabolism-active substances.

Our R&D capabilities encompass all parameters critical for pharmaceutical development of oral, injectable, and sterile APIs including: crystallization, polymorphism screening, crystal habit, amorphous status, bulk API lyophilization, and micronization.

After 60 years targeting the international market, FIS generic APIs are delivered to more than 70 countries.

Our NGLU (New Generic Launching Unit) is a fully dedicated business unit for the development and launch of new generic APIs. This task force consists of professionals from several key departments collaborating to develop new products, including:

• A fully dedicated R&D team.
• Continuous intellectual property support from project idea to DMF filing.
• Regulatory support with a ‘Generic’ mind-set.
• Committed quality assurance resources.
• Focused procurement support.
• Strong project management to help the team deliver on target.