Dr Reddys Labs' manufacturing facility gets two form 483 observations from US FDA

Dr Reddys Laboratories said that the United States Food & Drug Administration (US FDA), post a GMP inspection, has issued a Form 483 with 2 observations to the company's Telangana-based manufacturing facility.

In a regulatory filing made on Saturday (24 May 2025), the company informed that the US FDA had conducted a GMP inspection at its API manufacturing facility in Miryalaguda, Telangana, India. The inspection was conducted from 19 May 2025 to 24 May 2025.

Post the inspection, the American regulatory agency has issued a Form 483 with 2 observations.

The pharmaceutical company stated that it would address the said observation from the US FDA within the stipulated timeline.

Hyderabad-based Dr. Reddys Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.

The company reported a consolidated net profit of Rs 1,594 crore for the quarter ended March 2025 (Q4FY25), marking a 22% year-on-year increase from Rs 1,307 crore in the same period last year. Revenue from operations rose 20% year-on-year to Rs 8,506 crore, compared to Rs 7,083 crore in Q4FY24.

The scrip rose 0.46% to currently trade at Rs 1235.40 on the BSE.

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