Mumbai, April 21 -- HALMED (Agency for Medicinal Products and Medical Devices of Croatia) inspected the unit-1 (general liquid and dry powder injectables) and Unit-2 (betalactam dry powder injectables) from 9 to 13th March 2026. Following the inspection, the company received a list of non-compliance observations for Unit-1 and Unit-2.

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...