Most of our active pharmaceutical ingredients are authorised by the FDA, the US Food and Drug Administration

FDA compliance letter

FDA approval enables Ercros to enter the world's most demanding markets

85% of the pharmaceuticals division's production volume of active pharmaceutical ingredients (APIs) are authorised by the FDA (Food and Drug Administration).

The FDA is responsible for protecting public health and ensuring the efficacy and safety of human and veterinary medicines in the US. FDA clearance is mandatory for exporting any pharmaceutical product to this country.

Drugs that are authorised by the FDA gain prestige and international projection as they are not only suitable to be marketed in the USA, but also in other markets that take the North American market as a reference due to the high level of quality demanded of the pharmaceutical products marketed there.

Our pharmaceuticals division is regularly inspected by FDA agents to ensure compliance with their strict regulations.


Main street of the Aranjuez factory
Detail of a person working in the sterile plant of the Aranjuez factory.
Logo de la FDA Food and Drug Administration