Dr Reddy’s Gets USFDA EIR for Srikakulam Plant, Shares Flat

Shares of Dr Reddy’s Laboratories Ltd are trading flat after touching a day’s high of Rs 1,316.40 on 6th March. This happened after the company said the United States Food and Drug Administration (USFDA) has classified the inspection of its formulations manufacturing facility in Srikakulam, Andhra Pradesh, as “Voluntary Action Indicated (VAI)”. Additionally, they issued the Establishment Inspection Report (EIR), thereby closing the inspection.

Dr Reddy’s Laboratories said it received the Establishment Inspection Report (EIR) for its Srikakulam facility on 4th March, 2026. The USFDA had conducted a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) at the formulation manufacturing unit. The company had earlier informed stock exchanges about the inspection on 12th December, 2025.

The USFDA issues an Establishment Inspection Report (EIR) after reviewing inspection findings and the company’s response. The report indicates whether a facility complies with Good Manufacturing Practice (GMP) standards.

The USFDA classifies inspections into three categories. No Action Indicated (NAI) means no violations were found. The facility can continue selling approved drugs and receive approvals for new filings. Voluntary Action Indicated (VAI) is issued when minor issues are found but do not require regulatory action. Therefore, the facility can continue operations. Official Action Indicated (OAI) indicates that serious violations were detected and that corrective regulatory actions are required.

Separately, last month, Dr Reddy’s said the US Securities and Exchange Commission (SEC) had concluded its investigation into alleged improper payments to healthcare professionals in Ukraine and other markets. The probe began in November 2020 under the US Foreign Corrupt Practices Act.

The company said the SEC does not intend to recommend enforcement action at this time. However, the regulator clarified that the communication does not constitute exoneration and does not rule out possible future action.

At 1:59 PM, shares of Dr Reddy’s were trading 0.14% lower at Rs 1,311.70 on the NSE.

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