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Lupin today announced the launch of Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials, with 180-day CGT exclusivity in the U.S. This follows the recent approval received from the United States Food and Drug Administration (U.S. FDA). This is Lupin's first product using proprietary technology from PrecisionSphere™, the long-acting injectable (LAI) platform developed by Lupin's subsidiary Nanomi B.V.'s (Nanomi).
Nanomi's LAI platform has demonstrated efficacy and safety in drug delivery. Its proprietary PrecisionSphere™ technology creates uniform microspheres that deliver extended-release profiles from weeks to months, superior injectability through smaller needles, and consistent drug concentrations. Lupin is expanding the reach of its PrecisionSphere™ technology by fostering collaborations with companies looking to extend their product lifecycles.
Lupin Manufacturing Solutions (LMS), a wholly owned subsidiary of global pharma major Lupin, today announced the commissioning of its dedicated Oncology Block at its Vizag facility in India. The new high-containment unit significantly enhances LMS's end-to-end Contract Development and Manufacturing capabilities for High Potent Active Pharmaceutical Ingredients. It will support clients across the oncology development lifecycle from preclinical research to commercial manufacturing, addressing growing global demand for oncology drug development and manufacturing.
Spanning 4,270 square meters, the new facility, is equipped with 20 reactors, ranging from 250L to 2000L, with over 20 isolators and advanced containment systems, ensuring exposure levels of ≤0.05 µg/m³. Designed with flexible scale-up capabilities (1–35 kg batch range) and comprehensive environmental controls (≤25°C, ≤45% RH), the facility allows for safe, efficient, and compliant production of oncology APIs that meet global quality standards.
Profit before tax stood at Rs 2,006.97 crore during the quarter, up 90.25% from Rs 1,054.86 crore recorded in Q2 FY25.
EBITDA stood at Rs 2,431.3 crore in Q2 FY26, registering 75.8% growth compared with Rs 1,382.7 crore in Q2 FY25. The EBITDA margin improved 1,040 basis points to 35.6% in Q2 FY26 from 25.2% in Q2 FY25.
U.S. sales for Q2 FY26 were Rs 2,762.4 crore, up 47.3% compared to Rs 1,875.3 crore in Q2 FY25, accounting for 40% of Lupin’s global sales. The company received six ANDA approvals from the U.S. FDA and launched six products in the U.S. market during the quarter. Lupin now has 147 generic products in the U.S. market.
Lupin continues to be the third-largest pharmaceutical player in both the U.S. generic market and the overall U.S. prescription market (IQVIA Qtr. TRx Sep 2025). The company leads in 49 of its marketed generics in the U.S. and ranks among the top three in 113 products (IQVIA Qtr. Sep 2025 by extended units).
India sales for Q2 FY26 stood at Rs 2,077.7 crore, up 3.4% compared to Rs 2,009.6 crore in Q2 FY25, accounting for 30% of global sales. India Region Formulation sales rose 8.8% YoY, with six brand launches across therapies during the quarter. Lupin ranks as the eighth-largest company in the Indian pharmaceutical market (IQVIA MAT Sep 2025).
Other developed markets sales for Q2 FY26 were Rs 811.7 crore, up 18.9% YoY, accounting for 12% of Lupin’s global sales.
Emerging markets sales stood at Rs 922.8 crore, up 45.3% YoY, accounting for 14% of global sales.
Global API sales were Rs 256.8 crore, down 12.8% YoY compared to Rs 294.4 crore in Q2 FY25, representing 4% of global sales.
Investment in R&D stood at Rs 509.1 crore (7.5% of sales) for the quarter, compared to Rs 448.1 crore (8.2% of sales) in Q2 FY25. Lupin received approvals for six ANDAs from the U.S. FDA during the quarter. Cumulative ANDA filings with the U.S. FDA stood at 433 as of 30 September 2025, with the company having received 341 approvals to date. The company now has 50 First-to-File (FTF) filings, including 20 exclusive FTF opportunities. Cumulative U.S. DMF filings stood at 91 as of 30 September 2025.
Nilesh Gupta, managing director, Lupin, said “We are delighted to present one of our strongest performances ever in this second quarter of FY26. We continue to see robust growth in revenues and EBITDA led by strong performance across the board, in the U.S., emerging markets, other developed markets and in India, supported by higher operational efficiencies and sustained investments. We intend to leverage the performance of H1 to deliver a strong FY26”
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The counter rose 0.77% to Rs 1,971.15 on the BSE.
Lupin Digital Health announced the launch of VITALYFE™, an AI-powered cardiometabolic wellness platform designed to help India's working professionals reclaim their heart health. Built on the foundation of LYFE — India's first CDSCO-approved Class C software medical device (SaMD) for critical cardiac conditions — VITALYFE™ extends hospital-grade cardiac expertise to preventive wellness for its users.
“Cardiometabolic risks silently erode both health and productivity,” said Rajeev Sibal, President – India Region Formulations, Lupin. “With VITALYFE, we are enabling insurers and employers to combine clinical expertise with AI-driven technology to deliver scalable, measurable wellness outcomes for millions of working Indians.”
Lupin Ltd fell for a fifth straight session today. The stock is quoting at Rs 1906.1, down 0.87% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is down around 0.15% on the day, quoting at 25926.8. The Sensex is at 84589.71, down 0.22%.Lupin Ltd has eased around 1.4% in last one month.Meanwhile, Nifty Pharma index of which Lupin Ltd is a constituent, has increased around 3.3% in last one month and is currently quoting at 22310.4, down 0.56% on the day. The volume in the stock stood at 3.07 lakh shares today, compared to the daily average of 8.64 lakh shares in last one month.
The benchmark October futures contract for the stock is quoting at Rs 1912.4, down 0.64% on the day. Lupin Ltd tumbled 13.6% in last one year as compared to a 5.97% rally in NIFTY and a 1.84% fall in the Nifty Pharma index.
The PE of the stock is 16.65 based on TTM earnings ending June 25.
The approximately 18,000 square foot office will accommodate various corporate functions, including commercial, HR, finance, legal, marketing, business development, and R&D. Lupin first entered the state in 2016, acquiring a manufacturing facility in Somerset.
The medication, indicated for the chronic management of patients with urea cycle disorders (UCDs), is designed for those who cannot be effectively managed through dietary protein restriction or amino acid supplementation alone.
The company's consolidated net profit jumped 52.13% to Rs 1,219.03 crore on an 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.
Shares of Lupin rose 0.04% to currently trade at Rs 1,940.85 on the BSE.