Natco Pharma’s API plant in Chennai gets VAI tag from U.S. FDA

The U.S. Food and Drug Administration has issued an establishment inspection report with a voluntary action indicated (VAI) classification to Natco Pharma’s active pharmaceutical ingredient (API) facility in Manali, Chennai.

The U.S. FDA in November, following an inspection, had issued Form 483 with seven observations, the company said on Friday in a filing on receipt of the EIR. The classification, of an inspected unit, as VAI tag means objectionable conditions or practices were found but the regulator is not prepared to take or recommend any administrative or regulatory action.

On Thursday, announcing the December quarter results, Natco Pharma reported consolidated net profit increased more than 14% to ₹151.3 crore compared to ₹132.4 crore a year earlier. The higher net profit came on 8% increase in total revenue to ₹705.4 crore as (₹651.1 crore). The company has declared an interim dividend of ₹1.50 per equity share (face value of ₹2 each).

For the September quarter, the company had posted a net profit of ₹517.9 crore and total revenue of ₹1,463 crore.