According to the company, the observations are procedural in nature and require improvement to achieve compliance with the principles and guidelines of good manufacturing practice (GMP) under the Directive (EU) 2017/1572. The company said it will undertake remediation measures, submit corrective and preventive action plans (CAPAs), and request HALMED to conduct a follow-up inspection.

The company said the impact on current business operations is likely to be minimal while commercialization of the EU-CDMO product pipeline may face delays.

Eris Lifesciences is an Indian pharmaceutical company and a leading player in the domestic branded formulations market. The company is engaged in the manufacturing and marketing of pharmaceutical products.

The company has reported 19.05% increase in consolidated net profit to Rs 99.72 crore on a 10.91% increase in revenue to Rs 800.89 crore in Q3 FY26 as compared with Q3 FY25.