Shares of Dr Reddy’s Laboratories Ltd were trading in the red and 1% lower on 22 July despite the company announcing it had obtained the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) plant in Middleburgh, New York.

This follows the company’s previous notification, dated 17 May 2025, about the GMP inspection conducted at the site.  The USFDA has classed the inspection’s outcome as ‘Voluntary Action Indicated’ (VAI) and declared the inspection officially closed.

The FDA will issue an Establishment Inspection Report (EIR) within 30 days following the inspection based on the findings and the company’s response to the USFDA. The EIR is the FDA’s official assessment of a factory’s GMP compliance.

When infractions are discovered, but the issues do not warrant more regulatory action. Improving GMP compliance is entirely voluntary in this scenario. The facility can continue to sell approved pharmaceuticals while also receiving approvals for new filings.

Dr. Reddy’s Laboratories’ fourth-quarter net profit increased by 22% to Rs 1,594 crore, up from Rs 1,307 crore the previous year. Revenue for the quarter increased by 8.6% YoY to Rs 8,506 crore, above last year’s Rs 7,830 crore.

At 12:49 pm, the shares of Dr Reddy’s Lab were trading 1.54% lower at Rs 1,239.90 on NSE. 

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