Companies that missed the 31 July deadline to evaluate their chemically synthesized active pharmaceutical ingredients (APIs) to identify those at risk of nitrosamine contamination are being advised to contact the European Directorate for the Quality of Medicines & HealthCare (EDQM) with a new justifiable timeline.
On 17 August, the EDQM said it would not grant any more extensions for such risk evaluations for APIs, even though sponsors of finished pharmaceutical products in Europe were...