Natco Pharma shares jump over 4% after USFDA classifies Hyderabad facility as VAI

Natco Pharma shares on Thursday, September 18, climbed over 4.2% to ₹893.45 apiece on the NSE after the US Food and Drug Administration (USFDA) issued an establishment inspection report (EIR) classifying its pharma division facility in Kothur, Hyderabad, as voluntary action indicated (VAI).

“……we bring to your notice that the update for the U.S. Food and Drug Administration (FDA) had conducted an inspection at our Pharma division located in Kothur, Hyderabad, India. The unit has now received an Establishment Inspection Report (EIR) classifying the facility as "Voluntary Action Indicated (VAI,” the pharmaceutical company said in a regulatory filing on Thursday. 

This means that the FDA found only minor issues during inspection, and the company can fix these voluntarily. No regulatory action is needed in this matter, which means that approvals for the facility won’t be delayed, and this is seen as a positive outcome. 

The company depicted confidence in addressing the observations within the stipulated timeline and reiterated that it remains committed to cGMP compliance and supplying high-quality products to its customers all around the world.  

Natco Pharma share performance

The stock hit its intraday high of ₹896.95 per share during the early morning session on Thursday, rising by 4.6%. It was at its 52-week high of ₹1,583.10 on September 17, 2024, while it touched its yearly low of ₹726.80 per share on April 7, 2025. 

Over the last five days, Natco Pharma shares have added 4.27%, while they are trading up by 2.17% compared to a month ago. 

In the last six months, the scrip has risen by as much as 10.75%. However, year-to-date, the stock is down 36.06%. 

At around 11:13 am, the stock was trading 4.1% up at ₹892.4 apiece on the NSE. 

Natco Pharma Q1 results

For the first quarter of the current fiscal year (Q1 FY26), Natco Pharma reported a 22.1% year-on-year (YoY) drop in its consolidated net profit to ₹480 crore against ₹668.5 crore posted in the year-ago period. 

The company’s revenue from operations dropped 2.5% YoY to ₹1,329 crore, while its earnings before interest, taxes, depreciation and amortisation (EBITDA) declined by 32% YoY to ₹519 crore. 

Hyderabad-based Natco Pharma develops, manufactures and markets generic pharmaceuticals, including finished dosage formulations (FDFs) and active pharmaceutical ingredients (APIs) for several therapeutic areas like oncology. It is also engaged in producing crop protection products.