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Lupin Gets Tentative U.S. FDA Approval For Pitolisant Tablets 4.45mg And 17.8mg

Lupin Limited has secured tentative approval from the U.S. FDA for its Pitolisant Tablets in two strengths (4.45mg and 17.8mg), which are bioequivalent to the reference drug Wakix®. The tablets will be manufactured at the company's Nagpur facility, strengthening Lupin's presence in the central nervous system therapy segment and expanding its generic pharmaceutical portfolio.

24Mar 26

Lupin Allots 135,892 Equity Shares Under Employee Stock Option Plan

Lupin Limited allotted 135,892 equity shares under its ESOP on March 24, 2026, to employees of the company and its subsidiaries. The shares, with a face value of ₹2/- each, were issued following the exercise of vested stock options. This allotment increased Lupin's paid-up share capital to ₹91,43,58,222, comprising 45,71,79,111 equity shares. The decision was approved by the Operations and Finance Committee and disclosed to stock exchanges in compliance with SEBI regulations.

19Mar 26

Lupin Announces Strategic Expansion of Dabhasa Manufacturing Facility in India

Lupin Manufacturing Solutions has announced a strategic expansion of its Dabhasa manufacturing facility in India, introducing two specialized peptide manufacturing units and enhanced infrastructure to boost development and manufacturing capabilities. The expansion aims to support growing global demand for complex pharmaceutical solutions, particularly peptides and biologic ADCs, reinforcing LMS's position in the global peptide ecosystem.

18Mar 26

Lupin Records ₹32.74 Crore Block Trade on NSE at ₹2,300.20 Per Share

Lupin Ltd. executed a significant block trade on NSE worth ₹32.74 crores, involving approximately 142,339 shares at ₹2,300.20 per share. The transaction highlights substantial institutional trading activity in the pharmaceutical company's stock and represents a notable block deal in the current market environment.

09Mar 26

Lupin Reports Cargo Movement Disruptions Due to Container Delays at European and Middle Eastern Ports

Lupin reports cargo movement disruptions due to container delays at European and Middle Eastern ports, affecting its supply chain operations. The pharmaceutical company also faces potential cost pressures from higher oil prices that may increase solvent costs. These challenges highlight the operational difficulties pharmaceutical manufacturers are experiencing due to global supply chain issues and commodity price volatility.

09Mar 26

Lupin's Ankleshwar Manufacturing Facility Receives FDA Form-483 with Two Observations

Lupin Limited disclosed that its Ankleshwar manufacturing facility in India received a Form-483 from the U.S. FDA containing two observations after a five-day inspection concluded on March 07, 2026. The company has committed to addressing the FDA's findings within the required timeframe while maintaining its focus on Current Good Manufacturing Practice standards across all facilities.

04Mar 26

Lupin GST Inspection Concludes With No Adverse Findings, Zero Financial Impact

Lupin Limited has successfully concluded a GST Department inspection at its Mumbai registered office with no adverse findings reported. The inspection by the Assistant Commissioner of State Tax, Maharashtra, was conducted under Section 67 of Maharashtra GST Act, 2017, focusing on GST payment documentation and input tax credit claims, with the company confirming zero financial impact from the proceedings.

27Feb 26

Lupin: Nanomi B.V. Delays Purchase of Visufarma B.V.; Deal Now Anticipated to Finalize in April 2026, Awaiting Required Approvals

Lupin Limited has announced a timeline extension for its subsidiary Nanomi B.V.'s acquisition of Netherlands-based VISUfarma B.V., pushing the completion date from February 28, 2026 to April 2026. The delay is attributed to pending satisfaction of specific closing conditions required for the cross-border transaction, with the deal still subject to regulatory approvals and other conditions precedent.

27Feb 26

Lupin Receives Satisfactory US FDA Inspection Report for Goa Manufacturing Facility

Lupin Limited announced receipt of a satisfactory Establishment Inspection Report from the US FDA for its Goa manufacturing facility, with Voluntary Action Indicated classification. The inspection was conducted from November 10-21, 2025, and the positive outcome ensures continued manufacturing operations and US market access while demonstrating the company's commitment to quality excellence and regulatory compliance.

26Feb 26

Lupin Announces CEO Vinita Gupta's Recognition on 2026 CNBC Changemakers List

Lupin Limited announced through a Regulation 30 disclosure that CEO Vinita Gupta has been recognized on the prestigious 2026 CNBC Changemakers list of Women Transforming Business. Under her leadership, Lupin has grown to become the third-largest generic medicine supplier to the U.S. and the world's seventh-largest pharmaceutical company by volume, with recent achievements including FDA approval for its first biosimilar and plans for a new inhalation facility in Florida.

26Feb 26

Lupin Achieves Global Leadership in ESG with Top Rankings in S&P Corporate Sustainability Assessment 2025

Lupin Limited has achieved the No. 1 position globally in pharmaceuticals and leads all sectors in India in the S&P Global Corporate Sustainability Assessment 2025, scoring 91 out of 100 and ranking in the top 1% worldwide. This marks the company's third consecutive inclusion in the Sustainability Yearbook 2026, with only 848 companies out of more than 9,200 assessed earning this recognition. The achievement reflects Lupin's sustained commitment to ESG principles, responsible business practices, and positive stakeholder impact across its global operations.

25Feb 26

Lupin Gets FDA Approval For Brivaracetam Oral Solution, Estimated U.S. Sales Of $135 Million

Lupin Limited has secured FDA approval for its Brivaracetam Oral Solution 10 mg/mL and commenced commercial launch in the U.S. market. The generic formulation serves as a bioequivalent to UCB's Briviact, targeting the treatment of partial-onset seizures across all age groups from 1 month onwards, with the reference drug generating estimated annual sales of USD 135 million in the American market.

23Feb 26

Lupin Receives European Commission Approval for Biosimilar Ranibizumab

Lupin Limited announced European Commission approval for its biosimilar ranibizumab, branded as Ranluspec™, available in vials and pre-filled syringes formats. The biosimilar treats various eye conditions including age-related macular degeneration and diabetic complications. Sandoz will handle commercialization across the European Union excluding Germany, while France will see dual commercialization through both Sandoz and Biogaran.

14Feb 26

Lupin Limited Announces Anand Kripalu as Independent Director with Strong Mandate

Lupin Limited has officially appointed Anand Kripalu as Independent Director following overwhelming shareholder approval through postal ballot process. The appointment received 96.53% votes in favor with strong 90.17% participation rate across all shareholder categories. Kripalu brings extensive leadership experience from FMCG sector including roles at EPL Limited, Diageo India, Mondelez International, and Unilever, strengthening Lupin's board composition for strategic growth initiatives.

13Feb 26

Lupin Allots 75,273 Equity Shares Under Employee Stock Option Plan

Lupin Limited allotted 75,273 equity shares under its ESOP on February 13, 2026, following approval by the Operations and Finance Committee. The shares, with a face value of ₹2 each, were granted to employees upon exercising vested options. Post-allotment, the company's paid-up capital stands at ₹91,40,86,438 comprising 45,70,43,219 equity shares, demonstrating the company's commitment to employee equity participation.

13Feb 26

Lupin Board Approves Q3 FY26 Results with Strong 26.4% Sales Growth

Lupin Limited's Board of Directors approved strong Q3 FY26 financial results with consolidated sales growing 26.4% to ₹71,005 million. The company demonstrated robust operational efficiency with EBITDA margins expanding to 33.5% and net profit increasing 37.4% to ₹11,805 million, driven primarily by exceptional 54% growth in the US market.

10Feb 26

Lupin Settles Patent Dispute with Astellas Pharma for USD 90 Million

Lupin Limited has resolved its patent infringement dispute with Astellas Pharma entities through a USD 90 million settlement agreement regarding its Mirabegron product. The settlement includes a USD 75 million prepaid option payment and additional per-unit license fees for sales through September 2027. This agreement allows Lupin to continue selling its Mirabegron product while resolving all pending litigation, providing operational certainty and eliminating legal risks for the pharmaceutical company.

04Feb 26

Lupin Launches Topiramate Extended-Release Capsules in U.S. Market with USD 164 Million Sales Potential

Lupin has launched Topiramate Extended-Release Capsules in the U.S. market, targeting an estimated annual sales opportunity of USD 164 million. This product launch strengthens the company's generic pharmaceutical portfolio in the United States and demonstrates its continued expansion strategy in key international markets.

02Feb 26

Lupin Launches Dasatinib Tablets in US Market Following FDA Approval

Lupin has successfully launched Dasatinib tablets in the US market following FDA approval for its ANDA, developed in partnership with Pharmascience Inc. The bioequivalent tablets are available in six dosage strengths and indicated for various Philadelphia chromosome-positive cancer treatments in both adult and pediatric patients, with expected annual sales of USD 930 million.

02Feb 26

Lupin Announces Strategic TB Alliance Partnership for Telacebec Development

Lupin Limited has formally announced a strategic partnership with TB Alliance under SEBI Regulation 30 to advance Telacebec development for multiple mycobacterial diseases. The collaboration combines TB Alliance's drug development expertise with Lupin's global manufacturing, regulatory affairs, and supply chain capabilities to ensure equitable access to this investigational treatment for tuberculosis, leprosy, and Buruli ulcer.

01Feb 26

DGTR Finds Dumping of Ethambutol Hydrochloride Imports from China and Thailand, Flags Injury to Domestic Players

India's DGTR has issued preliminary findings concluding that Ethambutol Hydrochloride imports from China and Thailand constitute dumping practices. The trade regulator has identified this as causing material injury to domestic pharmaceutical manufacturers. This development could lead to protective measures benefiting Indian companies like Lupin that produce this anti-tuberculosis drug domestically.

29Jan 26

Lupin Ltd. Records Rs. 19.17 Crore Block Trade on NSE

Lupin Ltd. recorded a significant block trade on NSE worth Rs. 19.17 crores involving approximately 90,749 shares at Rs. 2,112.70 per share. The transaction reflects substantial institutional trading activity and demonstrates market participation through organized block trading mechanisms. Such large-scale transactions typically indicate strategic portfolio movements by institutional investors in the pharmaceutical company's shares.

28Jan 26

Lupin Limited Schedules Board Meeting on February 12, 2026 for Q3FY26 Financial Results Review

Lupin Limited has announced a Board of Directors meeting on February 12, 2026, to review and approve Q3FY26 unaudited financial results for the quarter and nine months ended December 31, 2025. The company has implemented a trading window closure from January 1, 2026, until February 15, 2026, affecting promoters, directors, and other designated persons in compliance with SEBI insider trading regulations.

27Jan 26

Lupin Limited Allots 169,140 Equity Shares Under Employee Stock Option Plan

Lupin Limited allotted 169,140 equity shares of ₹ 2 each under its ESOP on January 27, 2026, to employees of the company and subsidiaries. The allotment increased the company's paid-up share capital to ₹ 91,39,35,892, comprising 45,69,67,946 equity shares. The decision was approved by the Operations and Finance Committee and disclosed to stock exchanges in compliance with SEBI regulations.

23Jan 26

Lupin Limited Achieves Highest CDP ESG Rating for Climate Change and Water Security

Lupin Limited has received the highest 'A' leadership rating from Climate Disclosure Project (CDP) for both Climate Change and Water Security, marking significant improvement from previous years' ratings. The company also achieved an S&P Global ESG score of 91.00 in 2025, positioning it among elite global companies. This recognition reflects Lupin's commitment to sustainability through initiatives focused on climate risk mitigation, carbon emission reduction, and responsible water management across its global operations.

21Jan 26

Lupin Limited Partners with Galenicum for Semaglutide Distribution Across 23 Countries

Lupin Limited has announced a licensing and supply agreement with Galenicum Health for injectable Semaglutide across 23 countries including Canada, Europe, Southeast Asia and Latin America. Under the partnership, Galenicum will handle development and manufacturing while Lupin manages regulatory affairs and commercialization. The collaboration strengthens Lupin's diabetes care portfolio and positions the company to capitalize on growth opportunities in the expanding GLP-1 market for diabetes and obesity treatment.

19Jan 26

Lupin Limited Receives ESG Rating of 67 in Strong Category from Independent Assessment

Lupin Limited has been independently assigned an ESG rating of 67 by ESG Risk Assessments & Insights Limited, placing it in the Strong category. The assessment was conducted without company engagement, using only publicly available data, and was disclosed to stock exchanges on January 19, 2026, in compliance with SEBI regulations.

14Jan 26

Lupin Issues Postal Ballot Notice for Anand Kripalu's Independent Director Appointment

Lupin Limited has issued a postal ballot notice dated January 14, 2026, seeking shareholder approval for Mr. Anand Kripalu's appointment as Independent Director for a five-year term from February 01, 2026 to January 31, 2031. The remote e-voting process will be conducted through NSDL from January 15 to February 13, 2026, with results to be declared by February 17, 2026.

30Dec 25

Lupin VISUfarma Acquisition Delayed; GLP-1 Drug Deal Reinforces Growth Strategy

Lupin announces revised timeline for VISUfarma BV acquisition completion to February 28, 2026, extending from original end-2025 target. The company simultaneously reaffirms its strategic GLP-1 drug licensing deal with Gan & Lee Pharmaceuticals for Bofanglutide commercialization in India's substantial diabetes and obesity treatment market.

30Dec 25

Lupin Delays €190 Million VISUfarma Acquisition Timeline to February 2026

Lupin Limited has updated the timeline for its €190 million acquisition of Netherlands-based VISUfarma B.V., pushing the completion date from end-2025 to February 28, 2026. The transaction, being executed through wholly-owned subsidiary Nanomi B.V., will strengthen Lupin's European ophthalmology presence with VISUfarma's 60+ branded products and established market presence across major European countries.

30Dec 25

Lupin Secures Exclusive Rights for Innovative GLP-1 Drug in India Through Chinese Partnership

Lupin Ltd. has entered into an exclusive licensing agreement with China's Gan & Lee Pharmaceuticals for Bofanglutide, a fortnightly injectable GLP-1 drug for diabetes and obesity management in India. The drug offers potential advantages over existing treatments with its reduced dosing frequency. This strategic partnership aims to strengthen Lupin's position in the diabetes and obesity treatment markets in India.

19Dec 25

Lupin Signs Exclusive Licensing Agreement With Neopharmed For Gastroenterology Brand

Lupin has entered into an exclusive licensing agreement with Neopharmed for the gastroenterology brand Plasil, covering the Philippines and Brazil markets. This strategic partnership leverages Neopharmed's regional expertise and distribution networks to expand Lupin's international presence in the gastroenterology therapeutic segment.

18Dec 25

Lupin Signs Licensing Deal with Neopharmed for Plasil in Philippines and Brazil

Lupin's subsidiaries in the Philippines and Brazil have entered an exclusive licensing agreement with Neopharmed Gentili for the gastroenterology brand Plasil (metoclopramide). The deal grants Lupin exclusive marketing and promotional rights for Plasil in these markets. In the Philippines, Neopharmed will oversee product supply, while in Brazil, production will be transferred to Lupin's Medquimica facility. This partnership aims to strengthen Lupin's position in the gastroenterology segment across key emerging markets.

17Dec 25

Lupin Receives Positive CHMP Opinion for Biosimilar Ranibizumab Ranluspec

Lupin Limited has received a positive CHMP opinion from the European Medicines Agency for its biosimilar ranibizumab product Ranluspec, available in both vial and pre-filled syringe formulations. The recommendation is based on comprehensive clinical evidence including a 600-patient global Phase III trial conducted across multiple countries, with Sandoz Group AG set to commercialize the product across most EU markets.

17Dec 25

Lupin Receives US FDA EIR Approval for Nagpur Injectable Manufacturing Plant

Lupin has secured Establishment Inspection Report (EIR) approval from the US FDA for its injectable manufacturing facility in Nagpur. This regulatory milestone validates the facility's compliance with current Good Manufacturing Practices and strengthens Lupin's position in the US pharmaceutical market.

12Dec 25

Lupin Manufacturing Solutions Forms Strategic Alliance with PolyPeptide Group

Lupin Manufacturing Solutions, a subsidiary of Lupin Limited, has formed a long-term strategic alliance with PolyPeptide Group AG to strengthen global peptide supply chain capabilities and meet rising demand for peptide-based therapeutics. The partnership focuses on expanding sourcing options, integrating procurement planning, and ensuring quality delivery for both innovator and generic markets, with particular emphasis on metabolic disease therapies including GLP-1 treatments.

10Dec 25

Lupin Expands U.S. Presence with New Jersey Office and Updates ESOP Allotment

Lupin has expanded its U.S. presence with new corporate offices in Bridgewater, New Jersey, accommodating over 300 employees across various functions. The company's Operations and Finance Committee allotted 36,626 equity shares under ESOP, updating the share capital to ₹91,35,97,612 with total equity shares reaching 45,67,98,806, reflecting continued commitment to employee ownership and strategic growth.

01Dec 25

Lupin Secures U.S. FDA Approval for First Biosimilar Drug Armlupeg, Marking Entry into Biologics Market

Lupin Limited has received U.S. FDA approval for Armlupeg (pegfilgrastim-unne), its first biosimilar drug. Armlupeg is a biosimilar to Neulasta, with estimated annual sales of $1,295 million in the U.S. The 6mg/0.6mL injection is manufactured at Lupin's Biotech facility in Pune, India. It's indicated for reducing infection risk in cancer patients receiving chemotherapy and increasing survival in patients exposed to myelosuppressive radiation doses. This approval marks Lupin's entry into the biologics market, showcasing its advanced manufacturing capabilities and commitment to providing affordable medicines.

15Nov 25

Lupin's Nagpur Unit-1 Facility Aces U.S. FDA Inspection with Zero Observations

Lupin Limited's Nagpur Unit-1 oral solid dosage manufacturing facility successfully completed a product-specific Pre-Approval Inspection by the U.S. FDA with zero 483 observations. The inspection, conducted from November 10 to 14, focused on FDA regulation compliance. Nilesh Gupta, Managing Director of Lupin, emphasized the company's commitment to maintaining high quality, compliance, and safety standards across its facilities.

14Nov 25

Lupin Launches Risperidone Long-Acting Injectable in U.S., Marking Milestone for PrecisionSphere Platform

Lupin Limited has launched Risperidone Long-Acting Injectable in the U.S. market with 180-day Competitive Generic Therapy exclusivity. The antipsychotic medication is available in 25 mg, 37.5 mg, and 50 mg dosages. This marks the first commercial product using Lupin's proprietary PrecisionSphere™ long-acting injectable platform. The launch taps into a market with estimated sales of USD 187.00 million for the combined dosages. Lupin aims to expand its portfolio of complex products and explore partnerships to extend the use of its PrecisionSphere™ technology.

13Nov 25

Lupin Achieves Remarkable 91 S&P Global ESG Score, Setting New Industry Benchmark

Lupin Limited has attained an S&P Global ESG Score of 91, significantly above the pharmaceutical industry average of 28. This marks a substantial improvement from 17 in 2021 and a 15-point increase from the previous year. The company has made notable progress across environmental, social, and governance pillars, including increased use of renewable energy, promotion of diversity initiatives, and enhanced transparency in business practices. Ramesh Swaminathan, Executive Director at Lupin, emphasized the rarity of achieving a score above 90 globally and its implications for setting new industry standards.

13Nov 25

Lupin Reports Record Q2 Revenue of INR 7,048 Crores, Raises EBITDA Margin Guidance

Lupin Limited announced strong Q2 financial results with total revenue reaching INR 7,048 crores, a 24% year-over-year increase. EBITDA grew to INR 2,138 crores with margins expanding to 31.3%. U.S. business grew by 47%, while India business outperformed the market. The company raised its full-year EBITDA margin guidance to 25-26%. Lupin plans to acquire VISUfarma, expanding its European presence in ophthalmology. The company secured U.S. FDA approvals for complex injectables and is investing in respiratory product manufacturing and biosimilars development.

12Nov 25

Lupin Manufacturing Solutions Unveils Advanced Oncology Block in Vizag

Lupin Manufacturing Solutions (LMS), a subsidiary of Lupin Limited, has commissioned a new Oncology Block at its Vizag facility in India. The state-of-the-art facility enhances LMS's capabilities in developing and manufacturing High Potent Active Pharmaceutical Ingredients (HPAPIs) for oncology drugs. The block features a 4,270 sq. ft. area, 20 KL reactor capacity, and advanced containment systems. It supports the entire lifecycle of oncology drug development, from preclinical research to commercial manufacturing, with integrated Process Development and Quality Control laboratories. The facility adheres to global regulatory standards and implements stringent safety measures, including isolator-based operations and robust effluent detoxification systems.

10Nov 25

Lupin Shares Rise 3% on Strong Q2 Results and Ambitious Growth Plans

Lupin's shares rose 3% to Rs 2,027 after Jefferies maintained a Buy rating following impressive Q2 FY24 results. Net profit increased 73.34% YoY to Rs 1,478 crore, with revenue up 24.2% to Rs 7,047.50 crore. The company raised its EBITDA margin guidance to 25-26% for FY26, expects US revenue to exceed $1 billion, and plans over 15 product filings in FY26. Lupin aims to launch 20 complex products by 2028 and have 5 biosimilars in the market by FY30. Jefferies increased FY26 and FY27 EPS estimates by 7% and 5% respectively.

08Nov 25

Lupin's Bioresearch Center Aces U.S. FDA Inspection with Zero Observations

Lupin Limited's Bioresearch Center in Pune successfully completed a U.S. FDA inspection, receiving zero observations. The inspection included an onsite clinical inspection and a bio-analytical Remote Regulatory Assessment. This outcome reinforces Lupin's commitment to quality and compliance in pharmaceutical research and development. Nilesh Gupta, Managing Director of Lupin, emphasized the importance of this achievement for the company's global patient care efforts.

07Nov 25

Lupin Reports Strong Q2 FY26 Performance with 24% Sales Growth and Margin Expansion

Lupin Limited announced robust Q2 FY26 financial results. Sales increased 24.3% YoY to ₹68,314.00 million. EBITDA grew 63.4% to ₹21,376.00 million, with margin expanding to 31.3%. Net income rose 73.3% to ₹14,779.00 million. North America segment grew 46% YoY. The company launched new products in the U.S., expanded globally through VISUfarma acquisition, and partnered with Sandoz for Ranibizumab Biosimilar. Lupin received regulatory approvals in Taiwan, Brazil, and Mexico, and invested ₹5,091.00 million in R&D.

06Nov 25

Lupin Reports Strong Q2 FY2026 Performance with 24% Revenue Growth and 73% Net Income Surge

Lupin Limited announced robust Q2 FY2026 financial results, with sales reaching ₹68,314.00 mn, up 24.3% YoY. EBITDA grew 63.4% to ₹21,376.00 mn, with margin expanding to 31.3%. Net income increased 73.3% to ₹14,779.00 mn. North America sales rose 46%, while India saw 3% growth. The company maintained its position as the 3rd largest U.S. generic player by prescriptions, received 6 ANDA approvals, and launched 6 products in the U.S. R&D investment was ₹5,091.00 mn, 7.5% of sales. Lupin also strengthened its global specialty ophthalmology presence and entered strategic partnerships for biosimilars and long-acting injectables.

06Nov 25

Lupin Reports 73% Jump in Net Profit, Beats Analyst Estimates

Lupin Limited announced robust Q2 FY2026 results, with consolidated sales increasing 24.20% to ₹7,047.50 crore. EBITDA grew 74.70% to ₹2,341.70 crore, while net income rose 73.34% to ₹1,478.00 crore. The EBITDA margin expanded by 960 basis points to 33.20%. The company outperformed analyst estimates in both revenue and net profit. Despite strong results, Lupin shares closed down 2.11% at ₹1,956.05 on the BSE.

05Nov 25

Lupin Receives U.S. FDA Approval for Pithampur Unit-3 Facility

Lupin Limited has received an Establishment Inspection Report (EIR) from the U.S. FDA for its Pithampur Unit-3 facility following an inspection from July 7 to July 17. The facility manufactures metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions. This EIR signifies FDA's acceptance of the facility's compliance with cGMP regulations. Nilesh Gupta, Managing Director, expressed satisfaction with the outcome, emphasizing Lupin's commitment to maintaining high quality and compliance standards.

30Oct 25

Lupin Launches Vitalyfe™: AI-Driven Wellness Platform Targeting India's Workforce Heart Health

Lupin Digital Health, a subsidiary of Lupin Limited, has introduced Vitalyfe™, an AI-powered cardiometabolic wellness platform targeting heart health concerns among India's working professionals. The platform offers features like Heart Age Journey, AI-enabled nutrition tracking, camera-guided exercises, and gamified challenges. Vitalyfe™ aims to address the high prevalence of hypertension and dyslipidemia among corporate employees in India. It is designed to integrate with corporate health benefits programs and complies with data protection regulations.

24Oct 25

Lupin Expands U.S. Portfolio with Authorized Generic of Ravicti Oral Liquid

Lupin Limited has introduced an authorized generic version of Ravicti Oral Liquid in the United States. This medication is used to manage chronic urea cycle disorders (UCDs), rare genetic conditions affecting nitrogen processing in the body. The launch aims to strengthen Lupin's presence in the specialized pharmaceutical segment, potentially improving patient access to this important treatment and expanding the company's product portfolio in the U.S. market.

13Oct 25

Lupin to Present Phase 1 Data for LNP3693 at ESMO Congress 2025

Lupin will present Phase 1 data for its drug candidate LNP3693 at the ESMO Congress on October 19, 2025. The presentation will focus on the safety profile and anti-tumor effects of the drug. This marks a significant milestone in Lupin's drug development pipeline, providing insights into early-stage clinical trials of LNP3693. The Phase 1 data is crucial as it typically involves the first human testing, assessing safety, tolerability, and preliminary effectiveness against tumors.

11Oct 25

Lupin's New Jersey Facility Passes FDA Inspection; Plans $250M Investment in Florida

Lupin's Somerset, New Jersey facility received one observation in a recent FDA inspection. The company plans to invest $250 million over five years to establish a new pharmaceutical manufacturing facility in Coral Springs, Florida, focusing on respiratory medicines. Lupin's shares closed with minimal gains of 0.09% at ₹1,959.00, but have increased 3.41% over the past three months.

09Oct 25

Lupin Expands PrecisionSphere Platform and Plans New Florida Facility

Lupin Limited announced two major developments: the launch of a partnership program for its PrecisionSphere™ Long-Acting Injectable Platform, with the first product receiving FDA approval, and plans for a new $250 million pharmaceutical manufacturing plant in Coral Springs, Florida. The Florida facility will produce over 25 critical respiratory medicines, create over 200 jobs by 2030, and span 70,000 square feet. This expansion aims to enhance U.S.-based pharmaceutical capacity and strengthen Lupin's position in the global respiratory market.

08Oct 25

Lupin Unveils $250M Investment Plan for New Pharmaceutical Plant in Florida

Lupin announced plans to establish a $250 million state-of-the-art manufacturing facility in Coral Springs, Florida, focusing on respiratory medicines. The project will create 200 new jobs by 2030 and includes a 70,000 square foot facility on over 5 acres. The plant will have the capacity to manufacture over 25 critical respiratory drugs, including albuterol inhalers. This expansion is supported by Florida government incentives and aligns with the state's economic development goals in life sciences and advanced manufacturing.

06Oct 25

Lupin Launches Liraglutide Injection in US Market, Faces FDA Inspection Outcome

Lupin has launched Liraglutide injection in the US market, estimated at $350 million in annual sales. However, the FDA has classified its Pithampur Unit-2 inspection as 'Official Action Indicated' with four observations, presenting regulatory challenges alongside market opportunities.

04Oct 25

Lupin Faces FDA Scrutiny and Launches Diabetes Drug in US Market

Lupin received an 'Official Action Indicated' classification from the FDA for its Pithampur Unit 2 facility after an inspection resulted in Form 483 with four observations. The company is working to address compliance issues. Simultaneously, Lupin launched Liraglutide injection in the US market, a bioequivalent to Novo Nordisk's Victoza® for type 2 diabetes management. The reference drug has estimated annual US sales of $350 million. Lupin's stock closed 0.3% lower at ₹1,975.00, with a year-to-date decline of 16.5%.

03Oct 25

Lupin Launches Diabetes Injection in US, Receives FDA Approvals for Additional Generic Drugs

Lupin Ltd has launched Liraglutide injection for blood sugar control in the US, expanding its complex injectables portfolio. The product, bioequivalent to Novo Nordisk's Victoza®, has estimated annual US sales of $350 million. Lupin also received FDA approvals for Rivaroxaban oral suspension and tentative approval for a generic version of Biktarvy tablets for HIV treatment. These developments strengthen Lupin's position in the US pharmaceutical market across diabetes, cardiovascular, and HIV treatments.

30Sept 25

Lupin Secures U.S. FDA Approval for Rivaroxaban Oral Suspension, Expanding Anticoagulant Portfolio

Lupin Limited has received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for Oral Suspension, 1 mg/mL. The product is bioequivalent to Janssen Pharmaceuticals' Xarelto® and will be manufactured at Lupin's Chhatrapati Sambhajinagar facility in India. Estimated annual sales for this product in the U.S. market are $11.00 million. It's indicated for treating venous thromboembolism in pediatric patients and thromboprophylaxis in children with congenital heart disease after the Fontan procedure.

24Sept 25

Lupin Receives FDA Approval for HIV Drug Amid Anti-Dumping Probe on TB Treatment Ingredient

Lupin Limited has received tentative FDA approval for a generic HIV treatment, potentially tapping into a $16.2 billion U.S. market. Simultaneously, India's DGTR has initiated an anti-dumping investigation on Ethambutol Hydrochloride imports from China and Thailand, which could impact tuberculosis treatment supply chains and costs for pharmaceutical companies.

20Sept 25

Lupin's Pune Biotech Facility Receives Four FDA Observations in Pre-Approval Inspection

Lupin Limited's Pune Biotech facility underwent a U.S. FDA Pre-Approval Inspection from September 8 to 19, resulting in four observations. The company plans to respond within the stipulated timeframe and reaffirms its commitment to CGMP quality standards. Separately, Lupin received FDA approval for generic Lenalidomide Capsules. The company's shares closed 0.51% lower at Rs 2,057.00 following the news.

17Sept 25

Lupin Secures U.S. FDA Approval for Generic Lenalidomide Capsules, Expanding Cancer Treatment Options

Lupin Limited has obtained U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules in six strengths. The capsules, bioequivalent to Bristol-Myers Squibb's Revlimid®, will be manufactured at Lupin's Pithampur facility in India. Lenalidomide is used to treat multiple myeloma and certain myelodysplastic syndromes. The reference drug Revlimid® had estimated annual U.S. sales of USD 7,511.00 million as of July 2025.

16Sept 25

Lupin's Nagpur Injectable Facility Faces FDA Scrutiny with Six Observations

Lupin Limited's Nagpur Injectable facility underwent an FDA inspection from September 8 to 16, 2025, resulting in six observations. The company has committed to addressing these observations promptly and submitting a response within the stipulated timeframe. Lupin's Managing Director, Nilesh Gupta, reaffirmed the company's commitment to CGMP quality standards across all facilities.

10Sept 25

Lupin Secures FDA Nod for Risperidone Long-Acting Injectable with 180-Day Exclusivity

Lupin has received FDA approval for Risperidone Long-Acting Injectable, marking the first launch from its Nanomi's Long-Acting Injectable Platform. The approval comes with a 180-day Competitive Generic Therapy (CGT) exclusivity, giving Lupin a significant advantage in the U.S. market. This milestone expands Lupin's psychiatric medicine portfolio and positions the company for potential increased sales and market share in the competitive generic drug market.

08Sept 25

Lupin Receives Two Observations in USFDA Inspection at Chhatrapati Sambhajinagar Facility

Lupin Limited's Chhatrapati Sambhajinagar facility received two observations from a USFDA inspection conducted from September 1-5, 2025. Zydus Lifesciences' injectable plant in Jarod, Gujarat received four observations, while Aurobindo Pharma's Unit-XII in Bachupally, Telangana received eight procedural observations. All three companies have committed to addressing the observations within the stipulated timeframes. These inspections are part of the USFDA's ongoing scrutiny of pharmaceutical manufacturing facilities supplying to the U.S. market.

03Sept 25

Lupin Secures FDA Approval for Risperidone Injectable with 180-Day Exclusivity

Lupin Limited has received U.S. FDA approval for Risperidone Long-Acting Injectable Suspension, the first product from Nanomi's Long-Acting Injectable platform. The approval includes a 180-day Competitive Generic Therapy exclusivity. The product has estimated annual U.S. sales of $190 million, marking a significant milestone in Lupin's product portfolio expansion and showcasing its capabilities in developing complex pharmaceuticals.

26Aug 25

Lupin Seeks Shareholder Approval for Director Re-appointment and Managing Director Pay Revision

Lupin Limited has issued a postal ballot notice for two key resolutions. The first proposes re-appointing Mark D. McDade as an Independent Director for a second five-year term. The second seeks approval for a significant increase in Managing Director Nilesh D. Gupta's remuneration, including a rise in basic salary to ₹72.00 million per annum and total fixed cost to approximately ₹109.70 million. The company cites strong growth under Gupta's leadership, with standalone revenue increasing by 53.90% and net profits by 446.10% from FY2020 to FY2025. Shareholders can vote through remote e-voting from August 27 to September 25, 2025.

21Aug 25

Lupin Ltd. Executes Rs. 39.99 Crore Block Trade on NSE

Lupin completed a significant block trade on the NSE, involving 203,861 shares valued at Rs. 39.99 crores, with each share priced at Rs. 1,961.70. The company's Board of Directors has also approved the re-appointment of Mr. Mark D. McDade as an Independent Director for a second term, extending from January 28, 2026, to January 27, 2031, subject to shareholder approval. Mr. McDade brings over four decades of experience in the biopharmaceutical industry.

20Aug 25

Lupin Launches Bosentan Tablets in US Market, Secures 180-Day Exclusivity

Lupin Limited has introduced Bosentan Tablets for Oral Suspension, 32 mg, in the United States market. The launch follows FDA approval of NATCO Pharma Limited's Abbreviated New Drug Application. NATCO holds exclusive first-to-file status with 180-day generic drug exclusivity. The product, bioequivalent to Tracleer®, treats pulmonary arterial hypertension in children aged 3 and older. Bosentan Tablets (RLD Tracleer®) had estimated annual US sales of $10 million according to IQVIA data.

12Aug 25

Lupin Expands Biosimilar Portfolio with Ranibizumab Licensing Deal

Lupin Limited has announced a licensing agreement for a ranibizumab biosimilar, marking its strategic expansion into the biosimilar market. The company is focusing on developing a diverse biosimilar portfolio, including ophthalmology treatments, pegfilgrastim, etanercept, and respiratory products. Lupin's management expressed optimism about improved market access and easing regulatory requirements in the U.S. biosimilar market. The company is leveraging strategic partnerships, such as an agreement with Zentiva for European distribution, to enhance its global presence. While specific financial details were not disclosed, Lupin expects biosimilars to be significant growth drivers in the coming years, particularly from FY27 onwards.

11Aug 25

Lupin Launches Glucagon for Injection in U.S., Reports Strong Q1 FY2026 Results

Lupin Limited has launched Glucagon for Injection USP in the United States, a product with estimated annual sales of $122 million. The company also reported robust Q1 FY2026 results, with revenue up 11.8% to INR 6,164 crores and EBITDA increasing 27.6% to INR 1,641 crores. U.S. business grew 22.3%, driven by Tolvaptan launch. India business expanded 7.8%, outperforming in key therapeutic areas. The company expects strong double-digit growth for FY2026 with 24-25% EBITDA margin guidance, despite potential competitive pressures.

11Aug 25

Lupin Launches Glucagon Injection in U.S., Targeting $122 Million Annual Sales

Lupin Limited has introduced Glucagon for Injection USP, 1mg/vial in an emergency kit to the United States market. The product, bioequivalent to Eli Lilly's version, is used for treating severe hypoglycemia in diabetes patients and as a diagnostic aid. The estimated annual sales for this product in the U.S. market are $122.00 million, presenting a significant opportunity for Lupin.

07Aug 25

Lupin Eyes Strong Growth, Sets Ambitious Targets for FY26-28

Lupin Limited anticipates double-digit growth for overall and U.S. operations in FY26. The company targets 24-25% EBITDA margin and expects a 19% effective tax rate. Q1 FY26 showed impressive results with 12% YoY sales growth to ₹61,638.00 million. Lupin plans to launch 15+ products in FY26, focusing on complex generics. The company aims to introduce over 80 products in India in the next five years and expects high single-digit growth for FY27.

18Jul 25

Lupin's Dabhasa API Facility Secures TGA Australia GMP Certification

Lupin Limited's API facility in Dabhasa, Gujarat, operated by its subsidiary Lupin Manufacturing Solutions Limited, has received Good Manufacturing Practice (GMP) certification from Australia's Therapeutic Goods Administration (TGA). This certification validates Lupin's high-quality manufacturing standards and is expected to strengthen its position in the global pharmaceutical market, particularly in Australia and regions recognizing TGA certifications. The achievement aligns with Lupin's strategy to expand its global presence and reinforces its commitment to quality and compliance in pharmaceutical manufacturing.

17Jul 25

Lupin's Pithampur Unit-2 Faces FDA Scrutiny: 4 Observations Issued

Lupin Limited's Pithampur Unit-2 manufacturing facility underwent a U.S. FDA inspection from July 8 to July 17, resulting in four observations. The company has committed to addressing these concerns promptly and ensuring full compliance with FDA requirements. Lupin will respond to the U.S. FDA within the stipulated timeframe, emphasizing their commitment to CGMP quality standards across all facilities. The company's Pithampur Unit-3 also received three observations in a separate FDA inspection.

17Jul 25

Lupin's Dabhasa API Facility Secures TGA Australia GMP Certification

Lupin Limited's API facility in Dabhasa, Gujarat, operated by its subsidiary Lupin Manufacturing Solutions Limited, has received Good Manufacturing Practice (GMP) certification from Australia's Therapeutic Goods Administration (TGA). This certification is expected to enhance Lupin's market access in Australia and reinforces its commitment to global quality standards. Dr. Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions, emphasized the company's focus on quality, compliance, and operational integrity. Lupin, headquartered in Mumbai, has a global presence with products in over 100 markets, 15 manufacturing sites, and 7 research centers worldwide.

16Jul 25

Lupin Expands U.S. Portfolio with Launch of Loteprednol Etabonate Ophthalmic Suspension

Lupin Limited has introduced Loteprednol Etabonate Ophthalmic Suspension, 0.5% in the United States. This eye medication expands Lupin's pharmaceutical portfolio in the U.S. market. The launch aligns with Lupin's strategy to diversify its product offerings and strengthen its presence in one of the world's largest pharmaceutical markets.

11Jul 25

Lupin Ltd. Sees Significant Block Trade on NSE Amidst ESG Rating Update

Lupin Ltd. experienced a significant block trade on the NSE, with 302,321 shares changing hands at Rs. 1,886.80 per share, totaling Rs. 57.04 crores. The company also received an ESG rating of '62' for FY24 from NSE Sustainability Ratings & Analytics Limited, based on publicly available data. Lupin disclosed this rating in compliance with SEBI regulations.

10Jul 25

Lupin Ltd. Shares See Significant Block Trade of Rs. 30.84 Crores on NSE

A significant block trade of 163,326 Lupin Ltd. shares occurred on the National Stock Exchange (NSE), valued at Rs. 30.84 crores. The transaction was executed at Rs. 1,888.50 per share. While the parties involved remain undisclosed, such large trades can indicate strategic moves by major investors or institutions.

09Jul 25

Lupin Inks $60 Million Deal with Zentiva for Certolizumab Licensing

Lupin Limited has partnered with Zentiva for the licensing and supply of Certolizumab. The deal includes a $10 million upfront payment and potential earnings of up to $50 million in development and regulatory milestones. This strategic move aims to expand Lupin's product portfolio and strengthen its market position in the pharmaceutical industry, particularly in the autoimmune disease treatment sector.

04Jul 25

Lupin Expands U.S. Portfolio with Launch of Ipratropium Bromide Nasal Spray

Lupin Limited has introduced Ipratropium Bromide Nasal Spray in the United States market in 0.03% and 0.06% strengths. This anticholinergic medication is used to treat allergic and non-allergic rhinitis symptoms. The launch is expected to strengthen Lupin's position in the U.S. pharmaceutical market, diversify its product portfolio, and potentially increase its market share in the respiratory medication segment.

02Jul 25

Lupin Secures FDA Approval for Loteprednol Etabonate Ophthalmic Gel with 180-Day Exclusivity

Lupin Limited has received FDA approval for its Loteprednol Etabonate Ophthalmic Gel, granting the company a 180-day exclusivity period in the U.S. market. This corticosteroid gel, used for treating eye inflammation, presents a significant opportunity for Lupin to establish a strong market presence, potentially set favorable pricing, and gain valuable insights before competitors enter the market. The approval marks a milestone in Lupin's U.S. market strategy, particularly in the ophthalmic medication segment.

01Jul 25

Lupin Secures FDA Approval for Loteprednol Etabonate Eye Gel with 180-Day Exclusivity

Lupin has received FDA approval for Loteprednol Etabonate Eye Gel, granting them 180-day exclusive marketing rights in the United States. This approval expands Lupin's ophthalmic portfolio and provides a significant market opportunity. Loteprednol Etabonate is a corticosteroid used for post-operative inflammation and pain following ocular surgery.

01Jul 25

Lupin Spins Off Consumer Healthcare Business as LupinLife Consumer Healthcare Ltd

Lupin Limited has spun off its consumer healthcare business into a wholly owned subsidiary named LupinLife Consumer Healthcare Ltd, effective July 1. Anil Kaushal has been appointed as the CEO of the new entity. This strategic move aims to expand Lupin's presence in the over-the-counter (OTC) market, enhance focus on consumer healthcare, accelerate growth, and expand market presence. The spin-off is expected to diversify Lupin's revenue streams, provide access to a broader consumer base, and strengthen its brand presence among consumers.

30Jun 25

Lupin Restructures Operations: Transfers API R&D Division to Wholly Owned Subsidiary

Lupin Limited has executed an agreement to transfer its Active Pharmaceutical Ingredient (API) Research and Development division to a wholly owned subsidiary. This strategic restructuring aims to streamline research activities, potentially enhancing operational efficiency and focused management of research initiatives. The move could lead to more focused R&D efforts, increased operational flexibility, improved financial transparency for the API R&D segment, and a stronger strategic position in the pharmaceutical market, particularly in the API sector.

30Jun 25

Lupin to Shift OTC Business to LupinLife Consumer by 2025

Lupin Limited announced the transfer of its Over-The-Counter (OTC) business to its subsidiary, LupinLife Consumer, effective July 1, 2025. This strategic move aims to streamline operations, potentially allowing Lupin to focus on core pharmaceutical activities while enabling specialized management of the consumer health segment. The transfer may impact operational focus, brand management, and financial reporting for the company.

16Jun 25

Lupin Expands into Chinese Market with Tiotropium DPI Partnership

Lupin Limited has entered into a license and supply agreement with Sino Universal Pharmaceuticals for its Tiotropium Dry Powder Inhaler (DPI) product in China. This strategic move aims to introduce Lupin's respiratory medication for chronic obstructive pulmonary disease (COPD) to the Chinese market. The partnership leverages local expertise to navigate regulatory and distribution challenges, potentially opening new revenue streams for Lupin in one of the world's largest pharmaceutical markets.

05Jun 25

Lupin Secures Legal Victory in Mirabegron Case

Lupin has obtained legal relief concerning Mirabegron, a medication used to treat overactive bladder (OAB). While specific details are undisclosed, this victory could positively impact Lupin's operations and market presence. Mirabegron works by relaxing bladder muscles to increase capacity and treat symptoms like urinary urgency and frequent urination. The case's outcome may affect Lupin's ability to manufacture, market, or distribute Mirabegron-related products.

27May 25

Lupin to Showcase Oncology Research at ASCO 2025 with Phase 1 Data on LNP7457

Lupin Limited will present Phase 1 data on LNP7457, a new PRMT5 inhibitor, at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2025. This presentation marks a significant step in Lupin's oncology research, focusing on the safety, tolerability, and preliminary efficacy of the drug candidate. The development of LNP7457 reflects Lupin's strategic expansion into the oncology sector and could potentially open new avenues for cancer treatment.

26May 25

Lupin to Showcase Phase 1 Data on Novel Cancer Drug at ASCO 2025

Lupin Limited plans to present Phase 1 data on its cancer drug candidate LNP7457, a PRMT5 inhibitor, at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2025. This milestone marks Lupin's progress in oncology research and its entry into targeted cancer therapies. The presentation at ASCO, a prestigious oncology conference, indicates the advancement of Lupin's research to human trials and showcases the company's commitment to expanding its presence in the oncology market.

26May 25

Lupin Expands Footprint in Latin America with Biosimilar Ranibizumab Deal

Lupin Ltd has entered a strategic agreement with SteinCares for the supply and commercialization of biosimilar Ranibizumab in Latin America, excluding Mexico and Argentina. Lupin will manufacture the biosimilar, while SteinCares will handle regulatory filings and commercialization. Ranibizumab is used to treat various retinal conditions including age-related macular degeneration and diabetic macular edema. This partnership aims to expand Lupin's biosimilar portfolio and geographical reach in the Latin American market.

23May 25

Lupin Restructures $44.3M Debt to Equity in Oncology Subsidiary

Lupin Inc. USA, a subsidiary of Lupin Limited, has converted a $41 million loan and $3.3 million in outstanding interest into equity in Lupin Oncology Inc., USA. This $44.3 million debt-to-equity conversion is expected to strengthen Lupin Oncology's balance sheet, increase Lupin Inc. USA's stake in the oncology unit, and provide greater financial flexibility for the cancer-focused subsidiary.

20May 25

Lupin Partners with Honeywell for Eco-Friendly Inhaler Technology

Lupin Ltd. has announced a partnership with Honeywell to introduce an environmentally friendly propellant, Solstice Air, for its next-generation inhalers. This technology is expected to reduce carbon emissions by up to 99.90% compared to traditional HFC-based propellants. Lupin aims to be the first Indian pharmaceutical company to use this propellant at scale in its pressurized metered-dose inhalers for asthma and COPD patients.

16May 25

Lupin Targets Sustainable Double-Digit Growth, Aims to Outpace Market

Lupin Limited announces strong growth projections and margin enhancements. EBITDA margins now align with industry peers and are expected to improve further. The company targets quarterly revenues exceeding $250 million and aims to outpace market growth by 20-30%. Lupin is positioning itself for sustainable double-digit growth, reflecting confidence in its product portfolio and market strategy.

15May 25

Lupin Secures FDA Approval for Rivaroxaban Tablets and Reports Strong Q4 Results

Lupin Limited has received FDA approval for Rivaroxaban Tablets in 10 mg, 15 mg, and 20 mg strengths, entering a U.S. market worth $8 billion annually. The company also reported impressive Q4 financial results with a 12.20% increase in revenue to ₹5,567.10 crore and a 121.10% surge in profit to ₹794.86 crore. U.S. sales reached $245 million, up from $209 million in the previous year.