The USFDA has classified the outcome of the inspection as ‘Voluntary Action Indicated’ (VAI) and has officially closed the inspection. Shares of Dr Reddy’s Laboratories Ltd ended at ₹1,259.50, up by ₹1.40, or 0.11%, on the BSE.
Dr Reddy’s Laboratories Limited on Monday (July 21) said it has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility located in Middleburgh, New York.
This follows the company’s earlier intimation dated May 17, 2025, regarding the GMP inspection conducted at the site. The USFDA has classified the outcome of the inspection as ‘Voluntary Action Indicated’ (VAI) and has officially closed the inspection.
What is an Establishment Inspection Report (EIR)?
Based on the inspection and the response given by the company to the USFDA, the FDA will release an Establishment Inspection Report (EIR) within 30 days of the inspection. The EIR reflects the FDA’s official determination of a factory’s GMP compliance.
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Voluntary Action Indicated (VAI):
Given when violations are found, but the problems do not justify further regulatory action. Improving GMP compliance is voluntary in this case. The facility can continue selling approved drugs and will also receive approvals for new filings.
Fourth Quarter Results
Dr Reddy’s Laboratories’ net profit for the fourth quarter rose 22% year-on-year to ₹1,594 crore, compared to ₹1,307 crore in the same quarter a year ago. The figure was also higher than CNBC-TV18 poll expectations of ₹1,491.6 crore.
Revenue for the quarter grew by 8.6% on a YoY basis to ₹8,506 crore, which is higher than last year’s ₹7,830 crore and CNBC-TV18’s estimate of ₹8,404.7 crore.
Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) for the quarter jumped 58.9% to ₹2,975 crore. The number was higher than the CNBC-TV18 poll of ₹2,323.7 crore. EBITDA margin for the quarter expanded by 510 basis points from last year to 29.1%, higher than the poll projection of 28%.
Also Read: Dr Reddy’s pins hopes on a diabetes treatment drug, but analysts remains cautious
Shares of Dr Reddy’s Laboratories Ltd ended at ₹1,259.50, up by ₹1.40, or 0.11%, on the BSE.