European Regulators Raise Concerns Over Nectar Lifesciences’ API Facility

11 Mar 2025 , 01:42 PM

Nectar Lifesciences Ltd has said multiple compliance issues have been flagged by European regulators, against its Active Pharmaceutical Ingredient (API) manufacturing facility located in Saidpura, Punjab. The inspection was a joint review between the EDQM and the Spanish Agency of Medicines and Medical Devices.

The facility was inspected primarily to assess its compliance with European Good Manufacturing Practices (EuGMP). After the said assessment, the regulators have raised seven compliance observations, which pointed towards the operational and quality control measures. These included four critical observations that could adversely affect the quality of the products and the compliance of the regulator.

The nitrate was a part of the inspection, the company said in the filing offered through the stock exchange, adding that it would take corrective action to address the regulatory compliance concerns. Following the issuance of the statement, the company is to seek to work closely with European regulators to address matters described in the statement and ensure ongoing compliance with EuGMP standards.

Judicious Quality Control, compliance to global safety standards and strong quality assurance systems in place are the key drivers for pharmaceutical manufacturing facilities as regulatory scrutiny has become higher than ever before.