Shares of Natco Pharma Limited are in focus after the company announced that its pharma division in Kothur, Hyderabad, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA). The facility has been classified as “Voluntary Action Indicated” (VAI), following an inspection.
This classification indicates that the FDA’s observations do not warrant any regulatory or enforcement action, allowing Natco Pharma to continue manufacturing and exporting from the site. It is considered a relatively positive outcome, as the VAI status confirms that while some corrective actions may be necessary, the facility is deemed compliant overall.
The update comes after previous disclosures in October 2023, April 2024, and June 2025 regarding the inspection process.
