FDA Flags 6 Observations in Lupin’s New Jersey Facility Inspection

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Synopsis:

Lupin's Somerset, NJ facility, inspected by the FDA from May 7 to May 17, 2024, received Form-483 with six observations. The company's Q4 FY24 saw a 41.38% net profit drop to ₹359.43 crore on a 3.64% revenue decline to ₹4895.11 crore.

Lupin News Today

Lupin Limited, a pharmaceutical company known for its innovation, underwent a pre-approval inspection by the US Food and Drug Administration (FDA) at its manufacturing facility in Somerset, New Jersey.

Explore: Lupin Limited Share Price

Form-483 Issued with Six Observations

The inspection was carried out from May 7 to May 17, 2024, and resulted in the issuance of a Form-483 by the FDA. This form highlighted six observations made by the inspectors regarding potential regulatory violations.

Response to FDA Observations

Lupin promptly responded to the FDA's observations, pledging to address them comprehensively. As per regulatory requirements, the company will provide a detailed corrective action plan within the specified timeframe to ensure compliance with FDA regulations.

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Lupin’s Q4 Results

In the fourth quarter of FY24, Lupin witnessed a significant decline in its consolidated net profit, plummeting by 41.38% to ₹359.43 crore. Additionally, the company's revenue from operations saw a decrease of 3.64% to ₹4895.11 crore compared to Q4 FY23.

Regulatory Disclosure

Lupin disclosed the outcome of the FDA inspection in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. This communication was made to the Bombay Stock Exchange (BSE), ensuring transparency and adherence to regulatory norms.

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