Natco Pharma Kothur facility receives favorable FDA inspection outcome

Natco Pharma Limited, in an announcement dated September 18, 2025, informed stock exchanges that its Pharma division located in Kothur, Hyderabad, India, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA). The inspection report classifies the facility as "Voluntary Action Indicated (VAI)."

This classification follows an inspection conducted by the FDA at the Kothur facility. The VAI status indicates that, although objectionable conditions or practices were found, the agency is not inclined to take or recommend regulatory action at this time.

The company shared this information with both BSE Limited and the National Stock Exchange of India Ltd, referencing previous communications from October 19, 2023, April 9, 2024, and June 19, 2025. This update is provided for the information and records of the exchanges and investors.