FIS has over 50 years of experience in process validation of GMP API production in Europe, positioning as one of the largest cGMP manufacturer.
• 55 different APIs currently produced, combining both generic APIs and patent protected APIs
• Approximately 470 mt/yr of APIs produced
• Approximately 410 mt/yr of cGMP intermediates produced
• API production quantitities range from few kilograms/yr to 90 mt/yr
• 15 APIs exceed 10 mt/yr, while others range from 3-5 mt/yr
FIS policy of sharing the information is regulated under a CDA (Confidential Disclosure Agreement).
FIS has as internal policy, to share with the data with the customer and related information that is generated in each phase of the project. Therefore, the customer retains the ownership of the information obtained during the course of the project.