Did Dr. Reddy's Srikakulam plant receive VAI status from USFDA?
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Synopsis
Dr. Reddy's Laboratories has announced that its Srikakulam facility has received a VAI status from the USFDA, marking a significant milestone. With the inspection officially closed, investors should take note of the potential impacts on stock performance and regulatory compliance.
Key Takeaways
- Dr. Reddy’s Srikakulam plant received VAI status from USFDA.
- The inspection is officially closed.
- VAI is a preferable classification compared to OAI.
- Stock reacted positively, closing 2.10% higher.
- Shares have fluctuated over the last month and year.
New Delhi, Oct 21 (NationPress) The Hyderabad-based pharmaceutical giant Dr. Reddy’s Laboratories announced on Tuesday that its manufacturing facility located in Srikakulam, Andhra Pradesh, has been granted a Voluntary Action Indicated (VAI) status by the US Food and Drug Administration (USFDA).
The company officially communicated this development to the stock exchanges, revealing that it received the Establishment Inspection Report (EIR) on October 20.
As per the company's statement, the USFDA inspection is now formally concluded. The VAI designation indicates that while the US health regulator identified some issues at the facility, it does not intend to pursue any regulatory or administrative measures at this juncture.
"We wish to inform you that the company has received the Establishment Inspection Report (EIR) on October 20, 2025. The USFDA has classified the inspection result as 'Voluntary Action Indicated (VAI)," it stated, adding that the inspection is officially closed.
This classification is deemed preferable to an Official Action Indicated (OAI), which may result in more severe consequences such as warning letters or import alerts.
Previously, Dr. Reddy’s reported that the Srikakulam facility underwent both a Good Manufacturing Practices (GMP) inspection and a Pre-Approval Inspection (PAI) by the USFDA.
In reaction to this news, shares of Dr. Reddy’s Laboratories closed 2.10 percent higher at Rs 1,282.40 on Monday.
In the past five days, the shares have generated a return of Rs 45.90 or 3.7 percent. However, over the last month, the shares declined by Rs 16.40 or 1.26 percent.
Over the last six months, the shares have provided a return of Rs 107.60 or 9.14 percent. Yet, the stock has fallen by nearly 6 percent year-to-date in 2025.
Over the course of the last year, the shares have decreased by Rs 54.48 or 4.07 percent, as per official data.
Point of View
The VAI status granted to Dr. Reddy's Srikakulam plant reflects a cautious approach by the USFDA toward regulatory compliance. This news is crucial for stakeholders, signaling that while there are areas for improvement, the company is not facing immediate penalties. Overall, this development may bolster investor confidence and stabilize stock performance moving forward.
NationPress
22/10/2025
Frequently Asked Questions
What does VAI status mean?
VAI status indicates that the USFDA found some issues at a facility but will not take regulatory action at this time.
When was the EIR received?
The Establishment Inspection Report was received on October 20, 2025.
How did the stock react to this news?
Following the announcement, shares of Dr. Reddy’s Laboratories closed 2.10 percent higher.
What is the significance of the inspection being closed?
The closure of the inspection indicates that the USFDA will not pursue further actions against the facility at this time.
How has the stock performed over the past year?
The stock has decreased by Rs 54.48 or 4.07 percent over the last year.
