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Dr Reddy?s Labs UK facility flagged with 7 USFDA observations

08-Sep-2025 | 09:19
Dr Reddy?s Laboratories said that the US Food and Drug Administration (USFDA) has completed a good manufacturing practices (GMP) inspection at its active pharmaceutical ingredient (API) manufacturing facility in Mirfield, West Yorkshire, UK.
According to a regulatory filing, the inspection was conducted from 1 September to 5 September 2025. On conclusion, the USFDA issued a Form-483 with seven observations.

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 an 11.4% increase in revenue from operations to Rs 8,545.20 crore in Q1 FY26 over Q1 FY25.

Shares of Dr Reddys Laboratories shed 0.04% to Rs 1,268 on the BSE.

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