HALMED Inspects Eris Lifesciences Units, Issues Non-Compliance Observations
Eris Lifesciences Limited has confirmed that the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) conducted an inspection of the company's Swiss Parenterals units. The inspection covered Unit 1 and Unit 2, located in Ahmedabad, Gujarat, and resulted in the receipt of a list of non-compliance observations.The inspection took place over multiple days, running from March 9 to March 13, 2026. The company stated that the observations pertain to both Unit 1, which handles general liquid and dry powder injectables, and Unit 2, which focuses on betalactam dry powder injectables.
According to Eris Lifesciences Limited, the observations are procedural in nature. Achieving compliance requires improvements to align with the principles and guidelines of Good Manufacturing Practices (GMP) under Directive (EU) 2017/1572.
The company confirmed that it will execute remediation actions and submit Corrective and Preventive Actions (CAPAs) to the agency, and subsequently request a follow-on inspection.
Key details regarding the inspection and status are summarized below:
| Detail | Description |
|---|---|
| Authority | HALMED - Agency for Medicinal Products and Medical Devices of Croatia |
| Inspection Period | March 9 to March 13, 2026 |
| Units Inspected | Unit-1 (general liquid and dry powder injectables) and Unit-2 (betalactam dry powder injectables) |
| Nature of Findings | Procedural non-compliance, requiring improvements to achieve GMP compliance. |
| Immediate Impact | Minimal impact on existing business operations. |
| Business Outlook | Anticipated delay in the commercialization of the EU-CDMO product pipeline. |
ERIS Stock Price Movement
Eris Lifesciences Limited shares today slipped by 1.02%, settling at ₹1432.4 in post-market trading. The stock was supported by a volume of 56,908 shares, finishing its session within a range of ₹1417.3 and ₹1460.Source:
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