Mumbai, Aug. 22 -- The letter follows a regulatory inspection conducted at the site from 3rd to 7th February 2025. The company stated that it is working closely with the US FDA to resolve the issues raised and reiterated its commitment to upholding cGMP (current Good Manufacturing Practices) standards across all its manufacturing facilities. "We uphold quality and compliance with utmost importance and are committed to addressing the concerns at the earliest," the company said in an official statement.

As per an earlier exchange filing dated 8 February 2025, the USFDA inspection at the Jigani unit concluded with six observations. Hikal had confirmed it would address each observation and submit its response within the stipulated timeframe....