GMP and GDP
The EU has authorised the production and distribution of our pharmaceutical ingredients
The quality of our pharmaceutical ingredients is accredited by GMP and GDP standards
The production and distribution of active pharmaceutical ingredients (API) by Ercros are accredited by the following standards:
- Good Manufacturing Practices (GMP), which describes the minimum standards that must be met by drug production processes to ensure the quality of their products.
- Good Distribution Practices (GDP), which describes the minimum standards to ensure that the quality and integrity of medicines are maintained throughout the supply chain.
The European Medicines Agency (EMA) - in Spain, through the Spanish Agency of Medicines and Medical Devices ( (AEMPS) - coordinates inspections to verify compliance with these standards by companies which, such as Ercros, manufacture and market medicines in Europe.
The FDA has approved Ercros' GMP authorisation issued by the AEMPS. This is one of the first approvals made by the FDA following the agreement with the AEM in which they mutually recognise the inspections of manufacturing plants.
Ercros receives the main national and international certifications for its products.
Biological fermentation plants at the Aranjuez factory.