Nectar Lifesciences receives 7 observations from EDQM for API facility

The European regulator will conduct a re-inspection of the facility to verify the compliance

Nectar Lifesciences Limited has announced that the API manufacturing facility, located at U-2, Village Saidpura, Tehsil Dera Bassi, District SAS Nagar (Mohali), Punjab of the Company, has recently undergone a joint inspection conducted by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Spanish Agency of Medicines and Medical Devices (AEMPS). This inspection aimed to assess of compliance with EuGMP standards. Following the inspection, seven observations including four critical, were noted.

The company is in the process of preparing a Corrective Action and Preventive Action (CAPA) report to address the observations. The Company upholds quality and compliance with utmost importance and remain committed to be compliant with the cGMP quality standards.

The European regulator will conduct a re-inspection of the facility to verify the compliance and CAPA submitted which may lead to EuGMP approval.