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Latest news about Lupin

Lupin's Bioresearch Center Aces U.S. FDA Inspection with Zero Observations 19 hours ago Yesterday

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.

Lupin Reports Strong Q2 FY26 Performance with 24% Sales Growth and Margin Expansion 2 days ago

Lupin Reports Strong Q2 FY2026 Performance with 24% Revenue Growth and 73% Net Income Surge 2 days ago

Lupin Reports 73% Jump in Net Profit, Beats Analyst Estimates 2 days ago

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

More news about Lupin

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.

28Oct 25

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

Lupin Limited has opened new corporate offices in Bridgewater, New Jersey, spanning 18,000 square feet and accommodating various functions including Commercial, HR, Finance, and R&D. The company currently employs over 300 people in New Jersey with plans for continued growth. Separately, Lupin's Operations and Finance Committee has allotted 4,312 new equity shares under its Employee Stock Ownership Plan, increasing the total share capital to ₹91,35,24,360 with 45,67,62,180 equity shares.

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.

29Sept 25

Lupin Expands European Footprint with €190 Million Acquisition of VISUfarma

Lupin's subsidiary Nanomi B.V. is acquiring VISUfarma B.V., a Netherlands-based specialty pharmaceutical company, for €190 million. VISUfarma offers over 60 branded ophthalmology products across major European countries. The acquisition aligns with Lupin's strategy to expand its European business and global specialty franchise in ophthalmology. VISUfarma's revenue was €48.10 million in 2024. The deal, financed through existing cash, is expected to be accretive to Lupin's growth and margin profile. Completion is anticipated by the end of 2025, subject to regulatory approvals.

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.

15May 25

Lupin's Q4 Profit Soars, Revenue Climbs Amid Strong Financial Performance

Lupin reported impressive Q4 FY2025 results with consolidated net profit surging 121.10% YoY to ₹794.86 crore. Revenue increased by 12.20% to ₹5,567.10 crore, while EBITDA grew 22.50% to ₹996.85 crore. North American market performance was strong, with US sales reaching $245.00 million, up from $209.00 million the previous year. The results indicate Lupin's strengthening market position and effective business strategies in the pharmaceutical sector.

13May 25

Lupin Launches Tolvaptan Tablets in U.S. Market with 180-Day Exclusivity

Lupin Limited has introduced Tolvaptan tablets in the United States market with a 180-day exclusivity period. Tolvaptan, used to treat hyponatremia and slow kidney function decline in ADPKD, has reported U.S. sales of $1.50 billion. This launch positions Lupin as the sole generic provider for six months, potentially leading to significant revenue and market share gains in a billion-dollar market.

08May 25

Lupin Secures FDA Approval for Raltegravir Tablets, Gains 180-Day Exclusivity

Lupin Limited has received FDA approval for Raltegravir Tablets USP, 600 mg, an antiretroviral medication for HIV treatment. As the exclusive first-to-file applicant, Lupin gains 180-day generic drug exclusivity in the U.S. market. This approval is expected to boost Lupin's revenue, strengthen its market position in the U.S. generic drug sector, and provide a competitive edge in the HIV treatment segment.

08May 25

Lupin Launches Generic Eslicarbazepine Acetate Tablets in U.S., Tapping into $395 Million Market

Lupin Limited has introduced generic Eslicarbazepine Acetate Tablets in the United States, targeting a market with $395 million annual sales potential. The company has secured 180 days of shared generic exclusivity, positioning itself to capture significant market share in the competitive U.S. generics market.

07May 25

Lupin Launches Generic Eslicarbazepine Acetate Tablets in U.S., Eyeing $395 Million Market

Lupin Limited has introduced generic Eslicarbazepine Acetate Tablets in the United States, entering a market with an estimated annual value of $395.00 million. The company has been granted 180 days of shared generic exclusivity for this antiepileptic drug, which is used to treat partial-onset seizures. This launch represents a significant opportunity for Lupin to expand its U.S. portfolio and potentially capture a considerable market share in the competitive pharmaceutical landscape.

24Apr 25

Lupin Secures FDA Approval for Tolvaptan, Eyeing $1.5B Market with Exclusivity

Lupin Limited has received FDA approval for its generic version of Tolvaptan tablets in multiple strengths. As the exclusive first-to-file applicant, Lupin has secured a 180-day generic drug exclusivity. The tablets, bioequivalent to Otsuka's Jynarque®, are used to treat autosomal dominant polycystic kidney disease. Analysts project potential revenue of $150-200 million in FY26, contributing over 25% to the company's earnings. The product will be manufactured at Lupin's Nagpur facility and launched soon.

23Apr 25

Lupin Diagnostics Achieves Full NABL Accreditation, Solidifying Position in Indian Diagnostic Sector

Lupin Diagnostics, a subsidiary of Lupin Limited, has obtained National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation for all 27 of its greenfield laboratories. This achievement positions the company among India's top fully accredited diagnostic chains. The accreditation ensures high-quality standards and reliable test results. Lupin Diagnostics has also received several industry awards, including 'Patient-Centric Diagnostic Laboratories Company of the Year' and 'Emerging Diagnostics Chain of the Year'. The company offers over 3,000 tests and operates a 45,000 sq. ft. National Reference Laboratory in Navi Mumbai.

17Apr 25

Lupin Receives FDA Approval for Nagpur Facility Amid Patent Litigation

Lupin Limited received FDA approval for its Nagpur facility for drug-device combination products. Simultaneously, the company faces a setback in patent litigation with Astellas Pharma Inc. over generic Mirabegron products, with a Delaware court ruling in favor of Astellas. Lupin maintains there are no material financial implications and is considering further legal action. A consolidated jury trial is scheduled for 2026.

16Apr 25

Lupin Faces Setback in Patent Litigation for Myrbetriq Drug

Lupin Limited and Zydus lost a patent litigation case in the Federal Circuit court regarding the overactive bladder drug Myrbetriq. The court ordered both companies to withdraw their versions of the medication from the market. This ruling is expected to result in financial penalties for Lupin, including legal expenses and potential damages. The market withdrawal will impact Lupin's product portfolio and revenue projections in the overactive bladder treatment segment. This case highlights the challenges faced by generic drug manufacturers in navigating pharmaceutical patents and emphasizes the need for robust patent strategies and thorough legal due diligence.

02Apr 25

Lupin Expands UK Presence: Acquires Renascience Pharma for £12.3 Million

Lupin Healthcare (UK) Limited has acquired Renascience Pharma Limited for £12.30 million, expanding its specialty pharmaceutical portfolio in the UK market. The acquisition brings four specialty products targeting unmet medical needs, including treatments for non-viral infectious diseases, pain management, and cardiology/nephrology indications. Two lead products, XAQUA and OTIGO, currently face no generic competition in the UK. This strategic move aligns with Lupin's transition towards becoming a more specialized pharmaceutical organization.

02Apr 25

Lupin Ltd. Shares See Major Block Trade Worth Rs. 40.48 Crores on NSE

A significant block trade of 201,611 Lupin Ltd. shares was executed on the National Stock Exchange (NSE) at ₹2,007.75 per share, totaling ₹40.48 crore. This large transaction indicates potential institutional activity and demonstrates strong liquidity in Lupin's stock.

31Mar 25

Lupin Restructures: API R&D Division Transfer and OTC Business Modification

Lupin Limited is transferring its API R&D division to subsidiary LMSL for ₹175-225 million, and modifying its OTC Consumer Healthcare Business transfer to LCHL for ₹8,000-9,000 million. The API R&D division transfer, valued at ₹191.70 million net worth, is expected to complete by April 2025. The expanded OTC business transfer, now including an additional brand, represents ₹2,003 million in revenue and ₹1,680 million in net worth. Both moves aim to streamline operations and enhance market position, with completion expected by June 2025.

24Mar 25

Lupin's Digital Health Division Launches Innovative Post-Cardiac Procedure Care Guide

Lupin Limited's Digital Health division has introduced a comprehensive home-based care guide for patients recovering from cardiac procedures. Developed in collaboration with the American College of Cardiology, this guide aims to enhance post-operative care and improve patient recovery. The initiative is designed to empower patients, reduce complications, improve outcomes, and ease the transition from hospital to home care.

17Mar 25

Lupin Secures Tentative FDA Approval for Amifampridine Tablets, Eyeing $306 Million Market

Lupin Limited has received tentative approval from the U.S. FDA for its Amifampridine tablets, used to treat Lambert-Eaton myasthenic syndrome. The global market for this product is estimated at $306 million. This approval marks a significant step for Lupin in expanding its presence in the U.S. pharmaceutical market, particularly in specialty and complex generics. The company now awaits final FDA approval before commercialization.

10Mar 25

Lupin to Launch Affordable Generic Empagliflozin, Boosting Diabetes Care Accessibility in India

Lupin Limited is set to launch a generic version of empagliflozin, a crucial diabetes medication, at a significantly reduced price. The generic drug is expected to cost between Rs 9 to Rs 14 per tablet, compared to the current branded version's price of Rs 60 per tablet. This move, part of a broader initiative by Indian pharmaceutical companies, aims to improve accessibility and affordability of diabetes treatment for millions of patients in India. The dramatic price reduction could lead to improved treatment adherence and lower overall diabetes management costs.

07Mar 25

Lupin Expands U.S. Portfolio with Launch of Rivaroxaban Tablets

Lupin Limited has launched Rivaroxaban Tablets USP, 2.5mg, in the United States following FDA approval. The generic equivalent of Xarelto® has estimated annual sales of USD 446 million in the U.S. The medication is used to reduce cardiovascular risks in patients with coronary artery disease and peripheral artery disease.

21Feb 25

Lupin's Somerset Facility Receives Clean Bill of Health from U.S. FDA

Lupin Limited has received the Establishment Inspection Report (EIR) from the U.S. FDA for its Somerset, New Jersey manufacturing facility following an inspection from January 27-31, 2025. This signifies successful closure of the FDA inspection and validates Lupin's commitment to quality standards. Managing Director Nilesh Gupta expressed satisfaction with the outcome, highlighting its importance for the company's position in the pharmaceutical industry.