Nectar Lifesciences Ltd has disclosed that its API manufacturing facility in Punjab was flagged by European regulators for multiple compliance issues following a recent inspection.The facility, located in Saidpura, Punjab, underwent a joint inspection by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Spanish Agency of Medicines and Medical Devices (AEMPS) to assess compliance with European Good Manufacturing Practices (EuGMP).
The inspection resulted in seven observations, including four classified as critical, the company notified in a stock exchange filing.
Nectar Lifesciences stated that it is in the process of submitting a Corrective Action and Preventive Action (CAPA) report to address these observations. The company reaffirmed its commitment to maintaining quality standards and compliance with cGMP regulations.Also read: Sun Pharma to acquire Checkpoint Therapeutics for $355 million in cash and milestone payments
The inspection resulted in seven observations, including four classified as critical, the company notified in a stock exchange filing.
Nectar Lifesciences stated that it is in the process of submitting a Corrective Action and Preventive Action (CAPA) report to address these observations. The company reaffirmed its commitment to maintaining quality standards and compliance with cGMP regulations.Also read: Sun Pharma to acquire Checkpoint Therapeutics for $355 million in cash and milestone payments
The European regulator is expected to conduct a re-inspection to verify corrective measures, which will determine whether the company receives EuGMP approval.
While the announcement came post-market hours, investor sentiment turned negative ahead of the news. Shares of Nectar Lifesciences fell 5% to ₹27.76 on the BSE.
Regulatory scrutiny of pharmaceutical manufacturing facilities has increased in recent years, with global agencies tightening compliance norms.
