Eris Lifesciences: Croatian Agency Inspects Swiss Parenterals Facilities
Eris Lifesciences announced that HALMED, the Croatian Agency for Medicinal Products and Medical Devices, inspected its subsidiary Swiss Parenterals Ltd.'s manufacturing facilities in Ahmedabad from March 9th to 13th, 2026. The company has received a list of non-compliance observations, which are described as procedural and requiring improvements to meet GMP standards. Eris Lifesciences plans to respond to HALMED within stipulated timelines, execute remediation actions, and submit CAPAs to request a follow-on inspection. The company anticipates minimal impact on its existing business but a potential delay in the commercialization of its EU-CDMO product pipeline. Eris Lifesciences is committed to maintaining high manufacturing standards and will provide further updates.
Key Highlights
- Croatian agency inspected Swiss Parenterals facilities in Ahmedabad.
- Received list of procedural non-compliance observations.
- Company to submit corrective actions and request follow-on inspection.
- Minimal impact on existing business expected.
- Potential delay in EU-CDMO product pipeline commercialization.
Price Impact
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