Natco Pharma Limited has informed the Exchange about the U.S. Food and Drug Administration (FDA) inspection at our Pharma Division located in Kothur, Hyderabad, India
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The US Food and Drug Administration (FDA) conducted a routine inspection at Natco Pharma's Pharma Division facility in Kothur, Hyderabad, from June 9 to June 19, 2025. At the end of the inspection, the company received a Form-483 with 7 observations, which are typically noted procedural or compliance issues the FDA wants the company to address. Natco has stated it is confident of responding to and resolving these observations within the timeline set by the FDA. The company has reaffirmed its commitment to current Good Manufacturing Practice (cGMP) standards and continuing to supply quality products to global markets.
Form-483 observations are common during US FDA inspections and are not equivalent to a warning letter or import alert, but a higher number of observations can sometimes raise short-term concerns among investors. For now, the impact on the stock is likely neutral to mildly negative until the company's response is reviewed and accepted by the FDA.