Dr Reddys Laboratories , a leading Indian pharmaceutical company, has received positive news regarding its Active Pharmaceutical Ingredient (API) manufacturing facility in Miryalaguda, Telangana. The United States Food and Drug Administration (USFDA) has concluded its inspection of the plant with a 'Voluntary Action Indicated' (VAI) classification, marking a significant milestone for the company's manufacturing operations.

USFDA Inspection Outcome

According to a recent update from Dr. Reddy's, the company received an Establishment Inspection Report (EIR) from the USFDA. The regulatory body has officially closed the inspection of the Miryalaguda API manufacturing plant (CTO 5) under 21 CFR 20.64(d)(3), classifying it as 'Voluntary Action Indicated' (VAI).

Implications of VAI Classification

A VAI classification from the USFDA indicates that while inspectors may have found some minor violations, they are not significant enough to warrant official action. This outcome is generally considered favorable for pharmaceutical companies, as it allows them to address any issues voluntarily without facing severe regulatory consequences.

Timeline of Events

• Dr. Reddy's informed stakeholders about the USFDA's Good Manufacturing Practice (GMP) inspection at the Miryalaguda facility.
• The company received the Establishment Inspection Report (EIR) from the USFDA.
• Dr. Reddy's officially disclosed the inspection outcome to the stock exchanges.

Company's Response

K Randhir Singh, Company Secretary, Compliance Officer & Head-CSR of Dr. Reddy's Laboratories, communicated the development to the stock exchanges. The company's prompt disclosure aligns with its commitment to transparency and compliance with regulatory requirements.

Significance for Dr. Reddy's

The successful closure of the USFDA inspection with a VAI classification is a positive development for Dr. Reddy's Laboratories. It reflects well on the company's manufacturing practices and quality control measures at the Miryalaguda API facility. This outcome may potentially strengthen the company's position in the global pharmaceutical market, particularly in the United States.

As the pharmaceutical industry faces increasing scrutiny from regulatory bodies worldwide, such favorable inspection results can enhance a company's reputation and potentially lead to smoother approvals for future drug applications.

Dr. Reddy's Laboratories continues to maintain its focus on regulatory compliance and quality manufacturing, which are crucial factors in the highly regulated pharmaceutical industry. The company's ability to meet USFDA standards at its API manufacturing facility underscores its commitment to maintaining high-quality production processes and global compliance standards.

Dr Reddys Laboratories , a leading Indian pharmaceutical company, has announced the dissolution of its wholly owned subsidiary, Imperial Owners and Land Possessions Private Limited (formerly Imperial Credit Private Limited). This development marks the conclusion of a voluntary liquidation process that began in early 2023.

Key Details of the Dissolution

• Approval Date: The National Company Law Tribunal (NCLT), Hyderabad Bench, approved the voluntary liquidation through an order dated August 5, 2025.
• Effective Date: The dissolution became effective from August 5, 2025.
• Notification: Dr Reddys Laboratories received the certified copy of the order on August 7, 2025.

Background and Impact

The dissolution of Imperial Owners and Land Possessions Private Limited follows a series of intimations provided by Dr Reddys Laboratories regarding the ongoing voluntary liquidation process. These intimations were dated:

• March 23, 2023
• January 30, 2024
• October 10, 2024

It's important to note that Imperial was not considered a material subsidiary of Dr Reddys Laboratories. As such, the company has stated that the liquidation will have no material impact on its consolidated financial statements.

Regulatory Compliance

This announcement was made in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Dr Reddys Laboratories has duly informed the relevant stock exchanges, including:

• National Stock Exchange of India Ltd. (NSE)
• BSE Limited
• New York Stock Exchange Inc.
• NSE IFSC Ltd

Conclusion

The dissolution of Imperial Owners and Land Possessions Private Limited appears to be part of Dr Reddys Laboratories' ongoing efforts to streamline its corporate structure. While this development doesn't significantly impact the company's financials, it demonstrates the company's commitment to maintaining transparency with its stakeholders and adhering to regulatory requirements.