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Natco Pharma receives multiple compliance observations from US FDA
US FDA issues seven observations to Natco Pharma’s Chennai plant after inspection.
Natco Pharma’s Chennai facility has been issued seven observations by the US FDA following an inspection, indicating gaps that require corrective action. The company is reviewing the findings and preparing responses to address compliance requirements. Investors are monitoring the potential impact on ongoing product approvals and export plans as regulatory resolution timelines become clearer.