Knowledge Center

Article / Jun 01, 2009

Substandard APIs: we must tackle the problem together

  • Guy Villax
Pharmaceutical Technology Europe, June, 2009

Contrary to what some would have you believe, the use of substandard APIs in European medicines puts patient health and pharmaceutical manufacturers' reputations at risk. Most APIs destined for the EU come from Asian plants that have never been inspected by an EU official. To ensure a minimum level of quality, agencies and regulators from both sides of the Atlantic must work together to provide API compliance oversight.