Lupin share price rises 3% as USFDA okays schizophrenia drug; details

Drugmaker Lupin said it has received the USFDA's approval for Risperidone for extended-release injectable suspension

Lupin share price today: Shares of pharmaceutical major Lupin rose over 3 per cent on Wednesday, September 3, to hit an intraday high of ₹1,950.7 after the company said it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Injectable.

 

At 02:30 PM, the company's share price was trading 3.2 per cent higher at ₹1,950.2 per share against the previous close of ₹1,889.7 on the NSE. In comparison, NSE Nifty50 was up 0.38 per cent at 24,672.1 levels. The market capitalisation of the company stood at ₹46,855.5 crore. The 52-week high of the stock was at ₹2,402.9 per share, and the 52-week low was at ₹1,795.20.

 

Make smarter market moves with The Smart Investor. Daily insights on buzzing stocks and actionable information to guide your investment decisions delivered to your inbox.

Subscribe

What's driving Lupin stock today?

In an exchange filing on Wednesday, Lupin said it has received the USFDA's approval for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial in Single-Dose Vials.

 

The drugmaker said this is its first product using proprietary Nanomi BV’s (Nanomi) technology and has a 180-day CGT exclusivity. Nanomi, a Lupin subsidiary, is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients. 

 

Risperidone injectable is bioequivalent to the reference listed drug (RLD), Risperdal Consta Long-Acting Injection. It is used for the treatment of schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.

 

Vinita Gupta, chief executive officer of Lupin, said as the company executes its strategy to evolve speciality/novel products, it plans to leverage the Nanomi platform for novel long-acting injectables that meet unmet patient needs. 

Lupin Q1 results

In the April-June quarter of fiscal 2025-26 (Q1FY26), the drug maker reported a profit after tax (PAT) of ₹1,221 crore, up 72 per cent year-on-year (Y-o-Y). Revenue increased to ₹6,164 crore in the June quarter as against ₹5,514 crore in the year-ago period. 

 

The company said its sales in the United States stood at ₹2,404 crore in the first quarter, a growth of 24 per cent as compared to ₹1,934 crore in the year-ago period. India sales for Q1FY26 stood at ₹2,089 crore, up 8 per cent from ₹1,938 crore.

Motilal Oswal Financial Services on Lupin

In its post-results review, Motilal Oswal Financial Services (MOFSL) raised its earnings estimates for Lupin by 5.5 per cent for FY26 and 2 per cent for FY27, citing superior execution in limited-competition products in the US market, loss of exclusivity in one of its in-licensed products in the domestic formulations (DF) market, and lower operating expenses.

 

The brokerage noted that Lupin has delivered a 3x growth in Ebitda and an 8x jump in PAT over FY23–25. Looking ahead, it estimates a 14 per cent Ebitda and 16 per cent PAT CAGR for FY25–27, driven by a strong US product pipeline and a chronic-focused strategy in the Indian market. However, the brokerage believes current valuations leave limited upside potential and has a Neutral rating on the stock. MOFSL values Lupin at 22 times its 12-month forward earnings, arriving at a target price of ₹2,000.