The American Food and Drug Administration (FDA) inspected the production of anti-cancer active pharmaceutical ingredients (API) of the business unit Pharmaceutical Ingredients (Chemicals Division) within the period of March 1st – March 4th. It was the 6th FDA-audit the business unit enjoyed since 1988. Focus was on Pt-based and organic APIs.

Beside production, R&D and analytical laboratories an intensive inspection of all necessary documentation was performed.

After 4 days inspection the FDA only announced minor recommendations, which will be implemented on short term. No 483-report was issued. This finally confirmed the high level of product quality coming from production and R&D as well as the high quality of all internal processes.

The FDA approval represents an extremely important milestone to expand this international business further on.