Natco Pharma surges 5% after USFDA classifies Hyderabad facility as VAI

Natco Pharma stock was trading at ₹884.5, up 3.2 per cent compared to the previous session's close of ₹857.25 on the NSE

Natco Pharma share price today: Shares of pharmaceutical major Natco Pharm rose nearly 5 per cent to hit an intraday high of ₹896.95 on the NSE after the United States Food and Drug Administration (USFDA) issued an establishment inspection report (EIR) classifying its pharma division facility in Kothur, Hyderabad, as voluntary action indicated (VAI).

 

At 02:20 PM, the stock was trading at ₹884.5, up 3.2 per cent compared to the previous session's close of ₹857.25 on the NSE. The stock has recovered around 18 per cent from its 52-week low of ₹726.8 touched on April 7, 2025. However, on a year-to-date (YTD) basis, the stock has plunged over 38 per cent. The company's total market capitalisation stood at ₹15,831.5. 

 

 

In an exchange filing on Thursday, the company said, "USFDA 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)".

 

This indicates that the FDA found only minor issues during the inspection, which the company can address voluntarily. No regulatory action is required, and approvals for the facility are unlikely to be delayed, making this a positive outcome.

 

The company clarified that the inspection was procedural in nature and expressed confidence in its ability to address the observations comprehensively.

 

The inspection, carried out from June 9 to June 19, 2025, initially resulted in seven observations in a Form 483. 

 

Hyderabad-based Natco Pharma develops, manufactures and distributes generic and branded pharmaceuticals, speciality pharmaceuticals, active pharmaceutical ingredients and crop protection products.

Natco Pharma Q1FY26 results

In the April-June quarter of fiscal 2025-26 (Q1FY26), the generic drugmaker reported consolidated net profit of 480.3 crore, down 28 per cent from ₹668.5 crore in the year-ago period. Total revenue during the quarter slipped 1.42 per cent to ₹1,390.6 crore compared to ₹1,410.7 crore in the Q1FY25. The company's earnings from interest, tax, depreciation and amortisation fell 32 per cent to ₹519 crore from ₹764.9 crore a year earlier.  

According to the segmental revenue breakup, formulations export declined in the first quarter, to ₹1,126.5 crore from ₹1,210.1 crore. Revenue from active pharmaceutical ingredients (API) increased to ₹52.6 crore, while that from domestic formulations increased to ₹107 crore, and Crop Health Sciences revenue increased to ₹34.7 crore.