Dr Reddy’s says US FDA issued Form 483 with two observations for its FTO-11 facility in Andhra Pradesh
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Dr Reddy's reported a US FDA pre-approval inspection at its FTO-11 facility resulting in a Form 483 with two observations, which it plans to remediate on schedule. While not an approval denial, the observations introduce near-term regulatory overhang. The company also set an upcoming earnings release and call, with prior-quarter profitability pressured by semaglutide supply disruptions and US pricing competition, keeping focus on execution and compliance.
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India’s Dr Reddy’s Laboratories said the US Food and Drug Administration completed a pre-approval inspection at its FTO-11 manufacturing facility in Andhra Pradesh and issued a Form 483 with two observations. The company said it will respond and address the observations within the stipulated timeline. The stock closed down 1.86% in the prior session, and the company’s market capitalisation was about Rs 98,487 crore.
