According to reports from CNBC TV18 and The Economic Times, Eris Lifesciences Ltd announced on Monday, April 20, that Croatia's medicines regulator HALMED has issued non-compliance observations following an inspection of its subsidiary Swiss Parenterals Ltd.'s manufacturing units in Ahmedabad, Gujarat. The inspection was conducted between March 9 and 13, 2026, covering Unit 1, which produces general liquid and dry powder injectables, and Unit 2, which manufactures betalactam dry powder injectables.
As reported by CNBC TV18 and The Economic Times, the company has received the observations and will respond within the stipulated timelines while taking necessary steps to reinstate approvals for both facilities. The observations are procedural in nature and relate to improvements required to align with Good Manufacturing Practice (GMP) guidelines under EU Directive (EU) 2017/1572. The company plans to implement remediation measures, submit corrective and preventive actions (CAPAs), and request a follow-on inspection by the regulator. Eris Lifesciences emphasizes its commitment to maintaining the highest quality manufacturing standards at its facilities.
According to the company's filing reported by CNBC TV18 and The Economic Times, the impact on existing business is expected to be minimal, although there may be delays in the commercialisation of its EU-focused CDMO product pipeline. 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. The company reiterated its commitment to maintaining high manufacturing standards and said it would update stock exchanges on further developments.
