Lupin Share Price in Focus As It Gets USFDA Approval for Constipation Drug Prucalopride Tablets

Pharmaceutical company Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride Tablets in strengths of 1 mg and 2 mg. These tablets are used for treating Chronic Idiopathic Constipation (CIC) in adult patients.

About the Drug and Manufacturing

According to Lupin’s statement, the Prucalopride Tablets are bioequivalent to the brand-name drug Motegrity®, which is marketed by Takeda Pharmaceuticals USA Inc. Lupin will manufacture the approved product at its Goa facility in India.

This marks another important step in Lupin’s strategy of expanding its presence in the US generics market by providing affordable alternatives to branded drugs.

Market Opportunity in the US

Based on IQVIA sales data from April 2025, the 1 mg and 2 mg versions of Prucalopride Tablets (Motegrity®) recorded annual sales of approximately $184 million in the United States. Lupin's entry into this segment is expected to capture a share of this sizable market.

Lupin Share Price Performance

As of 9:55 AM IST on June 26, Lupin share price was trading at ₹1,934.60, down ₹0.70 or 0.036% for the day. The stock opened at ₹1,940.00 and touched an intraday high of ₹1,941.10 and a low of ₹1,926.10. The company’s market capitalisation stands at ₹88,280 crore, with a price-to-earnings (P/E) ratio of 26.98. It does not offer a dividend yield. Over the past year, the stock has reached a 52-week high of ₹2,402.90 and a 52-week low of ₹1,545.00.

Lupin Q4 FY25 Earnings Performance

In May, Lupin had reported a strong Q4 FY25 performance:

• Net profit rose to ₹794.86 crore, a 121.1% increase from ₹359.43 crore in the same quarter last year.
• Revenue climbed 12.2% year-on-year to ₹5,567.1 crore.
• EBITDA grew by 22.5% to ₹996.85 crore.
• The company’s EBITDA margin expanded to 21.9%, up from 20.1% in the previous year.

Read More: How to Buy NSE Unlisted Shares in India?

About Lupin

Lupin Limited ranks among the world’s largest generic drug manufacturers by revenue. The company operates in a wide range of therapeutic areas, including:

• Paediatrics
• Cardiovascular diseases
• Anti-infectives
• Diabetology
• Asthma
• Anti-tuberculosis

Conclusion

Lupin’s USFDA approval for Prucalopride Tablets strengthens its product portfolio in the US market and supports its commitment to providing high-quality, cost-effective generic medicines. With strong financial performance and a growing pipeline of approvals, Lupin continues to cement its position as a leading global pharma player.

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