Eris Lifesciences has announced that its Swiss Parenterals Units 1 and 2 in Ahmedabad, Gujarat, have been inspected by HALMED, the Agency for Medicinal Products and Medical Devices of Croatia, from March 9th to 13th, 2026. The inspection has resulted in a list of non-compliance observations.
The observations, which are procedural in nature, require improvements to align with the principles and guidelines of Good Manufacturing Practice (GMP) under the Directive (EU) 2017/1572. Eris Lifesciences is committed to executing remediation actions and submitting Corrective and Preventive Actions (CAPAs) to address these issues.
The company plans to request HALMED to conduct a follow-on inspection after implementing the necessary improvements. Despite the non-compliance findings, Eris Lifesciences has stated that the business impact is expected to be minimal. However, there will be a delay in the commercialisation of the EU-Contract Development and Manufacturing Organisation (CDMO) product pipeline.
Eris Lifesciences emphasises its commitment to maintaining the highest quality manufacturing standards at its facilities. The company has assured that it will keep the stock exchanges informed of any further developments related to the inspection.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).