Eris Lifesciences Receives HALMED Observations on Ahmedabad Units, Plans Corrective Actions
New Delhi: Eris Lifesciences Limited has informed that HALMED, Croatia's Agency for Medicinal Products and Medical Devices, conducted an inspection of Swiss Parenterals Ltd.'s Unit 1 and Unit 2 in Ahmedabad between March 9 and March 13, 2026, following which the company has received a list of non-compliance observations, with the firm stating it will undertake corrective actions and that the impact on existing business remains minimal though delays in EU-CDMO commercialization are expected.
The inspection covered Unit 1, which manufactures general liquid and dry powder injectables, and Unit 2, which handles betalactam dry powder injectables. The company confirmed that it has now received the observations from the regulatory authority.
According to the company, all the observations are procedural in nature and require improvements to align with Good Manufacturing Practices (GMP) principles under Directive (EU) 2017/1572.
Eris Lifesciences stated that it will respond to the agency within the stipulated timelines and initiate necessary remediation steps, including execution of corrective and preventive actions (CAPAs). The company also plans to request a follow-on inspection by HALMED after implementing the required measures.
In terms of business impact, the company indicated that there will be minimal effect on its existing operations. However, there could be a delay in the commercialization of its EU-focused Contract Development and Manufacturing Organisation (CDMO) product pipeline.
