Lupin Ltd

Lupin has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its facility in Goa, India, with a satisfactory Voluntary Action Indicated (VAI) classification. The EIR was issued following an inspection of the facility from November 10 to November 21, 2025. Nilesh Gupta, Managing Director, Lupin, stated, 'We are pleased to have received the EIR with a VAI classification from the US FDA for our Goa facility. This outcome reflects our continued focus on quality excellence and regulatory compliance, reinforcing our commitment to delivering safe and effective medicines to patients worldwide.'Powered by Capital Market - Live

The EIR follows an inspection conducted at the site from 10 November to 21 November, 2025, confirming compliance with regulatory standards. Nilesh Gupta, managing director (MD), Lupin, stated, 'We are pleased to have received the EIR with a VAI classification from the US FDA for our Goa facility. This outcome reflects our continued focus on quality excellence and regulatory compliance, reinforcing our commitment to delivering safe and effective medicines to patients worldwide.' 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 pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025. Shares of Lupin shed 0.03% to currently trade at Rs 2,322.40 on the BSE. Powered by Capital Market - Live

Lupin has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10 mg/mL. Brivaracetam is the bioequivalent to Briviact' Oral Solution, 10 mg/mL, of UCB, Inc. and is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Following the approval, the company initiated the launch of Brivaracetam Oral Solution in the United States. Brivaracetam Oral Solution (RLD Briviact) had an estimated annual sale of USD 135 million in the U.S. (IQVIA MAT December 2025). Powered by Capital Market - Live

Lupin Ltd is up for a third straight session in a row. The stock is quoting at Rs 2286.5, up 1.61% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.17% on the day, quoting at 25467.85. The Sensex is at 82264.76, up 0.05%. Lupin Ltd has risen around 6.32% in last one month. Meanwhile, Nifty Pharma index of which Lupin Ltd is a constituent, has risen around 5.38% in last one month and is currently quoting at 22632.05, up 1.45% on the day. The volume in the stock stood at 5.95 lakh shares today, compared to the daily average of 8.04 lakh shares in last one month. The benchmark March futures contract for the stock is quoting at Rs 2302.7, up 1.91% on the day. Lupin Ltd is up 20.91% in last one year as compared to a 12.96% spurt in NIFTY and a 13.66% spurt in the Nifty Pharma index.The PE of the stock is 18.61 based on TTM earnings ending December 25.Powered by Capital Market - Live

Brivaracetam Oral Solution is bioequivalent to Briviact Oral Solution, 10 mg/mL, of UCB, Inc. and is indicated for the treatment of partial-onset seizures in patients aged one month and older. Following the regulatory approval, the company has initiated the launch of Brivaracetam Oral Solution in the United States market. According to IQVIA MAT data for December 2025, Brivaracetam Oral Solution (RLD Briviact) recorded estimated annual sales of $135 million in the US. The approval strengthens Lupin's portfolio in the central nervous system (CNS) segment and reinforces its presence in the US generics market. 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 pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025. The counter rose 0.48% to Rs 2,263.85 on the BSE. Powered by Capital Market - Live

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A. Its indications encompass the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization. The company's biosimilar ranibizumab will be commercialized by Sandoz across the European Union (excluding Germany). In France, the product will be commercialized by two companies, Sandoz and Biogaran. Thierry Volle, President EMEA and Emerging Markets, Lupin, said, 'We are very pleased to receive the European Commission approval for ranibizumab. This achievement underscores the strength and quality of our scientific capabilities and manufacturing excellence. We remain firmly committed to expanding access to innovative, high-quality, and affordable biologic therapies for underserved patients worldwide.' Dr. Cyrus Karkaria, president Biotechnology, Lupin, said, 'The approval from the European Commission for our biosimilar ranibizumab is a milestone that validates our unwavering commitment and scientific standards to making advanced biologic therapies more accessible.' 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 pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025. The counter fell 0.33% to end at Rs 2237.80 on the BSE.Powered by Capital Market - Live

Lupin has received the approval from European Commission for its biosimilar ranibizumab, RanluspecTM (for vials and pre-filled syringes), following the recent positive opinion from the Committee for Medicinal Products for Human Use. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A. Its indications encompass the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization. Lupin's biosimilar ranibizumab will be commercialized by Sandoz across the European Union (excluding Germany). In France, the product will be commercialized by two companies, Sandoz and Biogaran. Powered by Capital Market - Live

DeslaFlex is an innovative antidepressant formulation developed by Spektus using its proprietary Flexitab oral drug-delivery platform. This strategic partnership combines Lupin's strong commercial footprint in Canada and Spektus's capabilities in developing differentiated, novel formulations to successfully introduce DeslaFlex and establish a robust platform for future launches. The collaboration further strengthens Lupin's CNS portfolio with physician-endorsed, value-added therapies, well aligned with a supportive regulatory environment. Claus Jepsen, President, Global Speciality, Lupin, 'This milestone reinforces our long-term commitment to advancing Lupin's CNS footprint and deepens our commitment to Canadian healthcare. The addition of DeslaFlex' to our portfolio provides patients and clinicians with much-needed flexibility in the management of Major Depressive Disorder, enabling clinicians to deliver more personalized, patient-focused care.' Zarvaan Merchant, Chief Executive Officer of Spektus Pharma, said, 'This partnership with Lupin represents a key milestone as Spektus transitions from development to commercial execution. Lupin's global brand and established commercial strength in Canada make it an ideal partner to realize the full value of DeslaFlex' for patients across this important market.' 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. Lupin reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025. Powered by Capital Market - Live

Securities in F&O Ban: Sammaan Capital and Steel Authority of India shares are banned from F&O trading on 17 February 2026. Stocks to Watch: Lupin announced that it has entered into a licensing and supply agreement with Spektus to commercialize its antidepressant formulation DeslaFlex in Canada. NTPC announced that its joint venture NTPC-SAIL Power Company has commenced operations of an additional 5 MW at its Bhilai Solar Project, taking the group's total commercial capacity to 86,729 MW. Cochin Shipyard has emerged as the L1 (lowest) bidder for a Rs 5,000 crore order from the Ministry of Defence to manufacture five survey vessels for the Indian Navy. Texmaco Rail & Engineering has secured a Rs 219 crore contract from Mumbai Railway Vikas Corporation for construction work in the Mumbai suburban railway network. BLS E-Services announced that it has signed binding term sheet, to acquire a 100% stake in Atyati Technologies for Rs 154 crore. TVS Supply Chain Solutions has signed a memorandum of understanding (MoU) with Italy-based ALA Group to provide services to the Indian aerospace and defence market. Powered by Capital Market - Live

Lupin has allotted 75,273 equity shares under ESOP on 13 February 2026. In view of the above, the issued and paid-up share capital of the Company has increased to Rs 91,40,86,438 consisting of 45,70,43,219 equity shares of Rs 2/- each.Powered by Capital Market - Live