Natco Pharma says it has a mitigation plan to deal with the adverse impact of the US Food and Drug Administration’s (USFDA) recent observations on its Kothur plant.

Asked about the impact of the observations by the US drug regulator last month, Rajeev Nannapaneni, Director and Chief Executive Officer, Natco Pharma, said that the company had responded to the observations and would wait to hear back from the USFDA.

“I think the impact will be minimal because the company has always done this mitigation with its top products. All our top revenue items — our top five, six revenue items — have an approval from our Vizag site in addition to the Hyderabad Kothur site,’‘ he said.

Lenalidomide, which is the biggest revenue item, has approval from both Vizag and Hyderabad, except for two strengths — 2.5 mg and 20 mg — which account for about 7 per cent of the total lenalidomide production. “Overall, I think our impact will be minimal… let’s wait for the classification of the inspection and we’ll make a decision,’‘ he added. 

Natco Pharma posted a 134 per cent increase in consolidated total revenue at Rs 1,061 crore for the second quarter of FY24, as against Rs 452 crore for the same period last year. 

The net profit for the period on a consolidated basis was Rs 369 crore (Rs 59 crore). 

Company business was strong during the quarter due to growth in formulation exports and increased sales in  domestic agribusiness.