The US Food and Drug Administration (FDA) has completed an inspection at NATCO Pharma’s Pharma division located in Kothur, Hyderabad, India.

The facility has received an Establishment Inspection Report (EIR) with a classification of “Voluntary Action Indicated (VAI), the company said in an exchange filing.

VAI means the FDA found objectionable conditions or practices, but doesn’t require immediate administrative or regulatory action.

NATCO Pharma markets and distributes its products across more than 50 countries, with key markets including the United States, India, Canada, and Brazil, while also maintaining a presence in regions such as Indonesia, Thailand, Australia, Singapore, and China. NATCO operates through 11 subsidiaries, including two step-down subsidiaries.

For the quarter ended June 30, 2025, NATCO reported consolidated revenue of INR 1,390.6 crore, compared to INR 1,410.7 crore in the same quarter last year. EBITDA stood at INR 632.7 crore, representing a margin of 45.5 percent. Consolidated net profit for the period was INR 480.3 crore.

NATCO confirmed that business faced pricing pressure in the US product portfolio and incurred increased R&D expenses in high-value projects during the quarter.