NATCO Pharma's Visakhapatnam unit gets Form 483 with 4 observations from US FDA

In a regulatory filing made post market hours yesterday, the pharmaceutical major said that the US FDA had conducted an inspection at the company?s FDF manufacturing plant located in Parawada, Visakhapatnam, Andhra Pradesh, India, which was conducted from 17th August 2026 to 21st August 2026.

Upon conclusion of the inspection, the c ompany has been issued a Form 483 with four observations.

The company believes that the observations are procedural in nature and is confident of addressing these observations comprehensively within stipulated timelines, NATCO Pharma said in a statement.

NATCO Pharma develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharma ingredients and crop protection products.

The company's consolidated net profit declined 57.04% to Rs 206.50 crore on a 44.68% fall in revenue to Rs 735.20 crore in Q1 FY27 as compared to Q1 FY26.

The scrip had risen 0.54% to end at Rs 882.50 on the BSE on Friday.

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