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.

 

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.