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Dr. Reddy's Laboratories announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API manufacturing facility (CTO-5) located in Miryalaguda, Telangana.
The USFDA has classified the inspection outcome as Voluntary Action Indicated (VAI) and confirmed that the inspection is officially closed.
According to an exchange filing dated 24 May 2025, the inspection was conducted between 19 May and 24 May 2025. At the conclusion of the inspection, the USFDA had issued a Form 483 with two observations, which Dr. Reddy's stated it would address within the stipulated timeline.
Hyderabad-based Dr. Reddy's Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.
The company's consolidated net profit rose 1.8% to Rs 1,418.10 crore on 11.4% increase in revenue from operations to Rs 8,545.20 crore in Q1 FY26 over Q1 FY25.
The scrip rose 0.61% to Rs 1,219 on the BSE.
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