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Laurus Labs’ US Arm Gets FDA Form 483 After Inspection

Written by: Team Angel OneUpdated on: Jan 28, 2025, 2:32 PM IST
Laurus Labs' US arm, Laurus Generics Inc., received a Form 483 with one observation from the US FDA after a PADE inspection, which is being addressed.
Laurus Labs’ US Arm Gets FDA Form 483 After Inspection
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Laurus Generics Inc. (LGI), the wholly-owned US subsidiary of Laurus Labs Ltd., recently underwent a Post-Marketing Adverse Drug Experience (PADE) inspection by the United States Food and Drug Administration (US FDA). The inspection, conducted over 4days between January 13 and January 21, 2025, focused on the company’s processes for reporting adverse events related to its marketed pharmaceutical products worldwide.

Issuance of Form 483

Following the inspection, the US FDA issued a Form 483 to Laurus Generics Inc., citing one observation. The Form 483 is a document that talks about specific issues identified during inspections but does not represent a final determination of the company’s compliance with regulations. Laurus Labs stated that it would address the observation within the prescribed timelines.

Details from Regulatory Filing

In a regulatory filing with the Bombay Stock Exchange (BSE) and the National Stock Exchange of India (NSE), Laurus Labs disclosed the inspection outcome. The filing clarified that the company is taking the necessary steps to address the observation and ensure compliance with US FDA guidelines.

What is a Form 483?

A Form 483 is issued by FDA inspectors when they observe practices or conditions that may violate regulatory requirements during an inspection. It serves as a preliminary finding, and companies are expected to respond within 15 days with details on corrective actions they will take to address the concerns raised.

Additional Observations 

Such inspections are part of routine regulatory processes as a part of compliance with Good Manufacturing Practices (GMP). The outcome of this process will determine whether additional regulatory actions are required.

Stock Performance

On January 22, 2025, the day of the announcement, the stock closed at ₹571.45, showing a drop of ₹5.45 or 0.94%. However, Laurus Labs Ltd is currently trading at ₹577.50, up ₹6.65 (1.16%) as of 11:38 AM today, on January 23, 2025, indicating a 34.16% increase over the past six months and a 44.75% rise over the past year.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions. 

Investments in the securities market are subject to market risks, read all the related documents carefully before investing

Published on: Jan 23, 2025, 2:47 PM IST

Team Angel One

Team Angel One is a group of experienced financial writers that deliver insightful articles on the stock market, IPO, economy, personal finance, commodities and related categories.

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