Lupin Shares in Focus; Gets Zero 483 Observations in USFDA Pre-Approval Inspection

Lupin announced that its Somerset, New Jersey facility successfully completed a USFDA Pre-Approval Inspection for Edaravone Oral Suspension with zero 483 observations, demonstrating the company’s commitment to high-quality standards, the company said in a press release on the stock exchanges.

Overview of Successful U.S. FDA Pre-Approval Inspection

The inspection, which took place from January 28 to February 1, 2025, at Lupin’s manufacturing facility in Somerset, New Jersey, concluded with zero 483 observations, affirming the company’s high standards of quality and compliance.

Lupin Limited, a global leader in the pharmaceutical industry, has announced the successful completion of a Pre-Approval Inspection (PAI) by the U.S. Food and Drug Administration (FDA) for its Edaravone Oral Suspension, 105 mg/5 mL.

Lupin’s Commitment to Quality

In a statement, Nilesh Gupta, Managing Director of Lupin, expressed his satisfaction with the inspection’s outcome, stating, “The successful outcome of the US FDA inspection at our Somerset facility is a testament to our commitment to uphold and maintain the highest standards of quality, compliance, and safety across our facilities. We remain steadfast in our mission to improve the lives of our patients globally.”

This achievement highlights Lupin’s dedication to ensuring its manufacturing processes meet stringent regulatory standards, reflecting the company’s ongoing efforts to maintain and enhance the quality of its products across various therapeutic areas.

About Lupin

Lupin is a prominent global pharmaceutical company headquartered in Mumbai, India, and is known for its wide range of products, including branded and generic formulations, biotechnology products, and active pharmaceutical ingredients. With a strong presence in over 100 markets, Lupin has 15 state-of-the-art manufacturing sites and 7 research centres worldwide.

Share Price Performance

As of February 3, 2025, Lupin Limited’s share price traded at ₹2,016.80 at 10:00 AM on the NSE, reflecting a decline of ₹39.45 or -1.92% from the previous closing price of ₹2,056.25. The stock opened at ₹2,056.25 and reached a high of ₹2,074.90 and a low of ₹2,006.25 during the trading session.

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