On October 20, 2025, Dr Reddy's Laboratories received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its formulations facility located in Srikakulam, Andhra Pradesh. The inspection, which included current Good Manufacturing Practices (GMP) and a Pre-Approval Inspection (PAI), concluded with a Voluntary Action Indicated (VAI) status, marking the inspection as officially closed.
The USFDA has categorised the outcome of the inspection of Dr Reddy’s Srikakulam facility as “Voluntary Action Indicated (VAI)”, implying that the agency identified certain objectionable conditions. However, the findings were not severe enough to warrant regulatory or administrative action. The issuance of the EIR confirms that the USFDA has closed the inspection as of October 20, 2025.
A VAI status from the USFDA indicates that while some improvements may be required in operations or documentation, these are not significant enough to prevent the approval of pending drug applications or halt production. It is considered a satisfactory outcome compared to "Official Action Indicated (OAI)", which may involve warning letters or action.
The favourable VAI classification allows Dr Reddy’s to continue manufacturing and submitting applications for product approvals from the Srikakulam facility.
Read More: Alembic Pharma Secures USFDA Approval for 40 mg/mL Triamcinolone Acetonide Injection!
The Srikakulam plant plays a critical role in Dr Reddy's global supply chain, especially for the US market. Successful inspections and a compliant status support the company's regulatory track record and reinforce its credibility with international partners and clients.
On October 21, 2025, Dr Reddy's Laboratories share price opened at ₹1,288.00 on NSE, above the previous close of ₹1,282.00. During the day, it surged to ₹1,294.00 and dipped to ₹1,283.10. The stock is closed at ₹1,288.70 as of 12:00 AM. The stock registered a moderate gain of 0.52%.
Over the past week, it has moved up by 4.57%, over the past month, it has declined by 0.98%, and over the past 3 months, it has moved up by 2.33%.
Dr Reddy’s receiving a VAI status along with the USFDA’s issuance of the Establishment Inspection Report marks a positive development. It signals operational compliance and ensures continuity of production and product filings from the Srikakulam facility without regulatory hindrance.
Disclaimer: This blog has been written exclusively for educational purposes. The securities or companies mentioned are only examples and not recommendations. This does not constitute a personal recommendation or investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions.
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Published on: Oct 22, 2025, 10:17 AM IST
Team Angel One
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