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Europe Stands Firm On Nitrosamine Assessment Deadline For APIs

Companies Can Suggest New Timeline In Justified Cases

 
• By Vibha Sharma

The European Directorate for the Quality of Medicines & HealthCare says it will not extend the deadline for nitrosamine-related risk assessment of active substances even though an extension is in place for assessments of finished products.

woman in a laboratory microscope with microscope slide in hand.toned image.
Nitrosamine impurities have been found in marketed medicines in the recent past • Source: Shutterstock

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,...

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