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Dr Reddy's Receives US FDA Form 483 With Seven Observations At Biologics Plant


22 July 2026
Dr. Reddy's Laboratories Ltd.

Semaglutide Provision Clouds Q1 PAT at Rs 444 Cr in Q1 FY27, -69% YoY; includes Rs 240 Cr semaglutide provision. Revenue at Rs 8,071 Cr in Q1 FY27, -5.6% YoY. EBITDA at Rs 1,009 Cr, -55.7% YoY; includes Rs 240 Cr semaglutide inventory provision, ex-provision EBITDA Rs 1,249 Cr. EBITDA margin at 12.5% vs 26.7% (ex-provision 15.4%). Gross margin at 46.5% vs 56.9%; management cited lenalidomide decline, price erosion, and elevated solvent costs. Received a Form 483 with seven observations at the biologics facility. North America revenue declined 35% YoY due to lenalidomide erosion, while Emerging Markets grew 31% and India grew 17%. Received a Form 483 with seven observations at the biologics facility; Dr. Sridevi Khambhampaty appointed Global Head of Biologics; Deloitte Haskins & Sells appointed Independent Registered Public Accounting Firm.


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