Eris Lifesciences has received the inspection findings from the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) regarding its manufacturing units in Ahmedabad. The inspection, conducted between March 9 and March 13, 2026, resulted in a list of procedural non-compliance observations. The company is currently preparing its response and remediation plans, noting that the impact on existing business operations is expected to be minimal.
Inspection Overview
Following a recent audit of its facilities in Ahmedabad, Eris Lifesciences has addressed findings from the Agency for Medicinal Products and Medical Devices of Croatia (HALMED). The inspection, which took place from March 9 to March 13, 2026, covered Unit 1, which handles general liquid and dry powder injectables, and Unit 2, focused on betalactam dry powder injectables.
Nature of Observations and Remediation
The agency identified several procedural observations during the audit. According to the company, these items require improvements to ensure full alignment with GMP principles under the Directive (EU) 2017/1572. Eris Lifesciences has confirmed its commitment to maintaining high-quality manufacturing standards and is currently in the process of executing the necessary remediation actions and preparing Corrective and Preventive Actions (CAPAs) to be submitted to the agency.
Operational Impact
Management has indicated that the inspection results will have a minimal impact on the company’s existing business operations. However, the remediation process will result in a delay in the commercialization of the European CDMO product pipeline. The company plans to request a follow-on inspection from the agency once the remedial measures have been implemented to reinstate the requisite approvals for both facilities.
Source: BSE
