FDA observations at Bachupally biologics facility
US FDA pre-approval inspection resulted in 9 observations. Management believes they are addressable but could delay biosimilar approvals if not resolved timely.
DRREDDY / Q2-FY24 / risks
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Dr. Reddy's Laboratories · Material risks, their source context, and severity in the latest available quarter.
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Material risks this quarter
high
India business growth trajectory uncertainty
Despite guidance for double-digit growth by year-end, India business has been range-bound for several quarters. Analyst questioned the timeline for material step-up.
Price erosion in US generics
Price erosion remains a headwind, though moderating. Management noted it fluctuates between high single-digit to low double-digit, impacting revenue growth.