Dr. Reddy’s Laboratories Limited, one of India’s leading pharmaceutical companies, has announced the completion of a Pre-Approval Inspection (PAI) by the United States Food & Drug Administration (USFDA) at its biologics manufacturing facility in Bachupally, Hyderabad. The inspection, conducted from September 4, 2025, to September 12, 2025, aimed to ensure compliance with the stringent USFDA standards required for the approval of biologics products for the U.S. market.

Following the inspection, Dr. Reddy’s has been issued a Form 483 containing five observations. The company has committed to addressing these observations within the timeline stipulated by the USFDA, demonstrating its proactive approach to regulatory compliance and quality assurance.

This inspection is a continuation of regulatory scrutiny and follows a previous inspection disclosed to the stock exchanges on October 12, 2023. The PAI process is a critical step in securing USFDA approval, which is essential for Dr. Reddy’s to manufacture and supply biologics products to the U.S. market.

Dr. Reddy’s Hyderabad facility is part of the company’s global manufacturing network, which focuses on high-quality biologics production. The company remains committed to maintaining global regulatory standards, ensuring the safety, efficacy, and quality of its products.

Investors and stakeholders have been informed of the inspection outcome through disclosures to NSE, BSE, NSE IFSC, and NYSE, reinforcing Dr. Reddy’s dedication to transparency and corporate governance. The company’s compliance team will work closely with the USFDA to resolve the observations promptly and efficiently.

Dr. Reddy’s continues to strengthen its position in the global pharmaceutical industry by maintaining high standards in manufacturing, regulatory compliance, and ethical business practices. The company’s leadership has assured that all required corrective actions will be implemented, underscoring its commitment to excellence and patient safety.

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