European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Spanish Agency of Medicines and Medical Devices (AEMPS) have concluded joint inspection at Nectar Lifesciences’ API manufacturing facility, located at U-2, Village Saidpura, Tehsil Dera Bassi, District SAS Nagar (Mohali), Punjab. 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.
Nectar Lifesciences (NLL) is a knowledge driven organization which constitutes a vital part of fast growing Indian Pharmaceutical Industry.
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