Natco Pharma receives seven observations from USFDA Following Inspection at Kothur Facility

Natco Pharma announced that its pharmaceutical manufacturing facility in Kothur, Hyderabad, has received seven observations from the United States Food and Drug Administration (USFDA) following a recent inspection.

In a regulatory filing, the company stated that the USFDA conducted the inspection from 9 June to 19 June 2025. At the conclusion of inspection, the USFDA has issued a Form 483 with seven observations.

Natco Pharma expressed confidence in addressing the observations within the stipulated timeline and reaffirmed its commitment to current Good Manufacturing Practices (cGMP) and the consistent supply of high-quality pharmaceutical products to global markets.

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 increased 5.3% to Rs 406.60 crore on a 14.3% jump in revenue from operations to Rs 1,221 crore in Q4 FY25 over Q4 FY24.

The counter shed 0.98% to Rs 872.75 on the BSE.

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