In an exchange filing dated 19 June 2025, Natco Pharma said the USFDA inspection was conducted from 9 June to 19 June 2025. Following the inspection, the company received seven observations in the Form-483.
The company expressed confidence in addressing the observations within the stipulated timeline and reaffirmed its commitment to cGMP compliance and supplying high-quality products to its global customers and patients.
NATCO Pharma, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products.
The company’s consolidated net profit fell 28.1% to Rs 480.70 crore in Q1 FY26, compared with Rs 668.50 crore in Q1 FY25. Revenue from operations declined 2.5% YoY to Rs 1,328.90 crore in Q1 FY26.