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Eris Lifesciences Ltd on Monday, April 20, said 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, according to an exchange filing.
The company said it has received the observations and will respond within the stipulated timelines while taking necessary steps to reinstate approvals for both facilities, as per the filing.
Eris Lifesciences said 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.
The company added that 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. It reiterated its commitment to maintaining high manufacturing standards and said it would update stock exchanges on further developments, according to the filing.
Shares of Eris Lifesciences Ltd ended marginally lower on Monday, April 20, by 0.91% at 1,432.40 on the NSE.
