Lupin's Share Price Gains Focus Following USFDA Approval for Generic Sutab Tablets
Lupin Share Price in Focus as US FDA Approves Sodium Sulfate Tablets
The United States Food and Drug Administration (US FDA) has granted approval to Lupin for its abbreviated new drug application for sodium sulfate, magnesium sulfate, and potassium chloride tablets, 1.479 g/0.225 g/0.188 g. This approval will remain in focus on June 1.
The approved tablets are bioequivalent to Sutab Tablets, the reference listed drug (RLD) of Azurity Pharmaceuticals. The medication is indicated for colon cleansing as a preparation for colonoscopy procedures in adults. Lupin is the exclusive first-to-file applicant for this product, making it eligible for 180 days of generic drug exclusivity in the US market.
The product will be manufactured at Lupin's Nagpur facility in India. This approval is a significant milestone for the company, which has been expanding its presence in the US market.
Lupin has also received regulatory approvals from other key markets. Last week, the company received the Establishment Inspection Report (EIR) from the US FDA for its Ankleshwar manufacturing facility in Gujarat. Additionally, results from its Phase 1a clinical trial evaluating LNP8701, a novel SOS1 inhibitor, have been accepted for publication at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting.
In May, the company received China's National Medical Products Administration approval for its Abbreviated New Drug Application for Oseltamivir Phosphate, in partnership with Yabao Pharmaceuticals. These regulatory approvals demonstrate Lupin's commitment to expanding its global presence.
Market Performance
In the previous trading session, the share closed at Rs 2,272.45, down Rs 4.30, or 0.19 percent. The share touched a 52-week high of Rs 2,492.00 and a 52-week low of Rs 1,838.65 on 07 May, 2026 and 06 August, 2025, respectively. Currently, the stock is trading 8.81 percent below its 52-week high and 23.59 percent above its 52-week low. The market capitalisation of the company stands at Rs 103,900.02 crore.
Read also: Treasury Yields Experience Largest Increase in Two Weeks Following Release of Labor Market Data
Investor Takeaway
Investors should monitor Lupin's share price for potential gains following the USFDA approval for its generic Sutab Tablets.
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