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Dr Reddy’s Labs Gets US FDA EIR Classified as VAI for Srikakulam Facility

Synopsis:


Dr Reddy’s Laboratories Ltd has received an Establishment Inspection Report (EIR) from US Food & Drug Administration on 20 Oct 2025 for its Srikakulam, Andhra Pradesh facility, with classification as Voluntary Action Indicated (VAI). The Pre-Approval Inspection (PAI) and GMP review were conducted earlier.


Source:
Dr. Reddy’s Laboratories Press Release (NSE Exchange Fillings) | Published on Oct 21, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

Dr. Reddy Laboratories News Today

As quoted in the press release of Dr. Reddy’s Laboratories (NSE Exchange Filings), this leading pharmaceutical company announced it received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its formulation facility in Srikakulam, Andhra Pradesh. The inspection that occurred earlier in the year was categorized as Voluntary Action Indicated (VAI) and concluded the inspection process officially.

The US FDA had performed both a Good Manufacturing Practice (GMP) inspection and a Pre-Approval Inspection (PAI) on Dr. Reddy's Srikakulam plant (known as FTO 11) as part of its routine compliance inspections.  After the company's responses were received and reviewed, the FDA concluded the process on October 20, 2025.

Also read: Rubicon Research Subsidiary To Acquire GEnE Lifesciences Series Prime Stock

DR. REDDY S LABORATORIES

Trade

1277.2-11.50 (-0.89 %)

Updated - 23 October 2025
1303.60day high
DAY HIGH
1274.20day low
DAY LOW
436327
VOLUME (BSE)

Key Takeaways

  1. Dr Reddy’s Laboratories received the EIR from the US FDA for its Srikakulam facility.

  2. The inspection was classified as Voluntary Action Indicated (VAI).

  3. The US FDA inspection covered both GMP and Pre-Approval areas.

  4. The inspection has been officially closed with no further regulatory action planned.

  5. Dr Reddy’s Laboratories share price has remained stable in recent trading sessions.

Also read: Federal Bank Clarifies No Decision on 9.99% Preferential Issue

Inspection Details And Outcome

The company disclosed that the US FDA inspected its formulations manufacturing site FTO 11 in Srikakulam, Andhra Pradesh, in July 2025. The inspection included evaluation of Good Manufacturing Practice standards and Pre-Approval requirements associated with the manufacturing of pharmaceutical formulations. 

An Establishment Inspection Report (EIR) was issued on 20 October 2025 with a finding of voluntary action indicated (VAI). In this context, the regulator identified objectionable conditions, but did not recommend or initiate regulatory action. 

Therefore, the facility is deemed compliant for ongoing operations. The VAI finding indicates that minor issues may have been noted, but they were not significant enough to warrant enforcement action. The inspection outcome concludes that the company’s response and corrective actions are satisfactory.

Dr Reddy’s Laboratories Share Price Update

Dr Reddy’s Laboratories share price stands at ₹1,255.90 per share on the BSE as of 21 October 2025 at 15:30 PM IST, up by 1.2%. 

Table: Inspection Summary

Parameter

Details

Facility

FTO 11, Formulations Unit, Srikakulam, Andhra Pradesh

Regulator

US Food and Drug Administration (US FDA)

Inspection Type

GMP and Pre-Approval Inspection

EIR Received On

20 October 2025

Classification

Voluntary Action Indicated (VAI)

Status

Officially Closed

Operational Overview

This announcement signifies a key compliance action for Dr Reddy's Laboratories as it continues to engage with global manufacturing practices. Regulatory inspections are one component of the ongoing oversight of product quality that occurs around the world for a company like Dr Reddy's.

The Srikakulam site continues to be a core manufacturing facility globally. VAI indicates observances were noted but the outcome of the inspection indicates that manufacture and distribution can continue with ongoing compliance to the regulations.

Continuing operations provides clarity of the compliance for Dr Reddy's. This also demonstrates ongoing regulatory engagement and a commitment to the quality framework that the inspections represent.

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