The U.S. Food and Drug Administration (FDA) conducted an inspection at Natco Pharma's API manufacturing plant in Mekaguda, Hyderabad from 9 June 2025 to 13 June 2025.
Natco Pharma received one observation in Form-483 upon conclusion of the inspection.
The company believes the observation is procedural in nature and is confident in addressing it comprehensively.
Natco Pharma remains committed to cGMP compliance and supplying high-quality products.