Dr Reddy's Lab receives EIR from USFDA for Middleburgh API facility

Dr. Reddy's Laboratories announced that its Active Pharmaceutical Ingredient (API) manufacturing facility in Middleburgh, New York, has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA).

In a regulatory filing, the company stated that the EIR was issued following a good manufacturing practice (GMP) inspection conducted by the USFDA. The inspection outcome has been classified as Voluntary Action Indicated (VAI), and the inspection is now officially closed under 21 CFR 20.64(d)(3).

This follows Dr. Reddys earlier disclosure dated 17 May 2025, in which it informed that the USFDA had completed a GMP inspection of the Middleburgh facility. The inspection took place from 12 May to 16 May 2025 (US EST) and concluded with the issuance of a Form 483 containing two observations. The company confirmed that it will address the observations 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.

Dr. Reddys Laboratories 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 shed 0.44% to Rs 1,254 on the BSE.

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