Natco Pharma shares drop as Chennai plant receives USFDA observations

Natco Pharma shares fell 2 per cent as it received seven observations in the Form-483 from the US Food and Drug Administration

Shares of Natco Pharma fell over 2 per cent after it received seven observations in the Form-483 from the US Food and Drug Administration (USFDA).

 

The pharma major's stock fell as much as 2.4 per cent during the day to ₹844.05 per share, the biggest intraday fall since November 6 this year. The Natco Pharma stock pared losses to trade 0.5 per cent lower at ₹860 apiece, compared to a 0.09 per cent advance in Nifty 50 as of 09:57 AM. 

 

Shares of the company fell for the second straight session and currently trade at less than 1 times the average 30-day trading volume, according to Bloomberg. The counter has fallen 38 per cent this year, compared to a 10.3 per cent advance in the benchmark Nifty 50. Natco Pharma has a total market capitalisation of ₹15,356.88 crore.   READ STOCK MARKET LATEST UPDATES LIVE

 

Natco Pharma receives USFDA observations 

Natco Pharma said that a US FDA Inspection was conducted at its Manali, Chennai, Active Pharmaceutical Ingredients (API) Unit. The inspection was conducted from 17 - 21 November 2025.

 

On conclusion of the inspection, the company received seven observations in the Form-483, it said in a statement. The company believes that the observations are procedural in nature and is confident to address these observations comprehensively.

Natco Pharma Q2 results 

Natco Pharma reported a 23.44 per cent decline in consolidated net profit at ₹517.9 crore in the second quarter ended September 30, 2025, impacted by higher R&D expenses and one-time employee bonus. Consolidated revenue from operations in the second quarter stood at ₹1,363 crore, as against ₹1,371.1 crore in the corresponding period last fiscal. 

 

During the quarter, the company incurred substantial R&D expenses on bioequivalence and one-time employee bonuses, in addition to other business-related provisions, Natco Pharma said. Formulations export revenue was lower at ₹1,147 crore in the second quarter, compared to ₹1,211.3 crore in the year-ago period. The active pharmaceutical ingredients (API) vertical recorded ₹53.9 crore, as against ₹49.6 crore.  ALSO READ | Here's what drove NBCC (India) share price higher by 5% 

Natco Pharma is a Hyderabad-based pharmaceutical company engaged in the development, manufacturing, and distribution of both generic and branded drugs. 

 

The company also operates in the specialty pharmaceutical and crop protection segments. Known for its strong focus on research and development, the company is a science-driven organisation with a leadership position in oncology, particularly in targeted therapies within the Indian market.